European Parliament resolution of 11 December 2018 on education in the digital era: challenges, opportunities and lessons for EU policy design (2018/2090(INI))

P8_TA(2018)0485 A8-0400/2018

The European Parliament,

–  having regard to Articles 165 and 166 of the Treaty on the Functioning of the European Union,

–  having regard to the Charter of Fundamental Rights of the European Union, and in particular Article 14 thereof,

–  having regard to Article 2 of the Protocol to the Council of Europe Convention for the Protection of Human Rights and Fundamental Freedoms, concerning the right to education,

–  having regard to Decision (EU) 2018/646 of the European Parliament and of the Council of 18 April 2018 on a common framework for the provision of better services for skills and qualifications (Europass) and repealing Decision No 2241/2004/EC(1),

–  having regard to its resolution of 12 June 2018 on modernisation of education in the EU(2),

–  having regard to its resolution of 14 September 2017 on a new skills agenda for Europe(3),

–  having regard to its resolution of 19 January 2016 on skills policies for fighting youth unemployment(4),

–  having regard to its resolution of 9 September 2015 on empowering girls through education in the EU(5),

–  having regard to its resolution of 8 September 2015 on promoting youth entrepreneurship through education and training(6),

–  having regard to its resolution of 15 April 2014 on new technologies and open educational resources(7),

–  having regard to the Council recommendation of 22 May 2018 on key competences for lifelong learning(8),

–  having regard to the Council conclusions of 22 May 2018 on moving towards a vision of a European education area,

–  having regard to the Council recommendation of 22 May 2017 on the European Qualifications Framework for lifelong learning and repealing the recommendation of the European Parliament and of the Council of 23 April 2008 on the establishment of the European Qualifications Framework for lifelong learning(9),

–  having regard to the Council conclusions of 30 May 2016 on developing media literacy and critical thinking through education and training,

–  having regard to the Council recommendation of 19 December 2016 entitled ‘Upskilling pathways: new opportunities for adults’(10),

–  having regard to the Council conclusions of 27 May 2015 on the role of early childhood education and primary education in fostering creativity, innovation and digital competence,

–  having regard to the Council conclusions of 20 May 2014 on effective teacher education,

–  having regard to the Council recommendation of 20 December 2012 on the validation of non-formal and informal learning(11),

–  having regard to the Council resolution of 28 November 2011 on a renewed European agenda for adult learning(12),

–  having regard to the Commission communication of 17 January 2018 on the Digital Education Action Plan (COM(2018)0022),

–  having regard to the Commission communication of 30 May 2017 on school development and excellent teaching for a great start in life (COM(2017)0248),

–  having regard to the Commission communication of 2 May 2012 on a European strategy for a better internet for children (COM(2012)0196),

–  having regard to the Commission communication of 10 June 2016 on a new Skills Agenda for Europe (COM(2016)0381),

–  having regard to the Commission communication of 7 December 2016 on improving and modernising education (COM(2016)0941),

–  having regard to the opinion of the Committee of the Regions of 30 November 2017 on modernising school and higher education(13),

–  having regard to the report of the European Centre for the Development of Vocational Training of 9 March 2018 entitled ‘Skill needs anticipation: systems and approaches. Analysis of stakeholder survey on skill needs assessment and anticipation’,

–  having regard to the Commission’s 2017 policy report entitled ‘DigComp 2.1: The digital competence framework for citizens: With eight proficiency levels and examples of use’,

–  having regard to Rule 52 of its Rules of Procedure,

–  having regard to the report of the Committee on Culture and Education and the opinion of the Committee on Industry, Research and Energy (A8-0400/2018),

A.  whereas, with technology developing at an accelerating rate, the digital society and economy are now a fact of life, meaning that digital skills are essential for the successful professional realisation and personal development of all citizens;

B.  whereas digital competence is a key competence for lifelong learning, as defined in the Reference Framework annexed to the Council recommendation of 22 May 2018;

C.  whereas the innovative capacity of technology is conditioned, inter alia, by critical thinking, the level of people’s digital and creative skills, and the quality and reach of internet connectivity;

D.  whereas a basic knowledge of digital technologies is vital for completing essential administrative and everyday tasks;

E.  whereas it is estimated that approximately half of the current jobs worldwide – and 30 % in the European Union – will disappear over the next 25 years(14), with the emergence of new professions requiring advanced digital skills;

F.  whereas digital skills, which go well beyond the requirements of the labour market, offer people better opportunities to participate in the life of society, both today and in the future, facilitate information and cultural exchange, and give people a greater say in political decision-making;

G.  whereas it is essential to reclaim the internet as a common good and promote active e-citizenship;

H.  whereas the technological transformation across industries means that digital tools are frequently used even in traditionally non-technical professions, with 9 out of 10 jobs in the near or immediate future estimated to require digital skills;

I.  whereas currently 44 % of the EU population aged between 16 and 74 lack basic digital skills and 19 % have no digital skills at all, with substantial disparities across the Member States, a situation that risks creating a new social divide;

J.  whereas the importance of digital skills, the skills gap, which is particularly significant between men and women, generations and different social groups, and disparities in digital skills across the Member States demand a joined-up policy response;

K.  whereas it is essential that educational institutions prepare pupils and students to confront the social and economic challenges brought about by rapid technological and social developments, by equipping them with the appropriate skills to adapt to the challenges of the digital world;

L.  whereas access to and the use of the internet and of technological and digital equipment have transformed social behaviour and relationships, particularly among the younger sections of society;

M.  whereas the goal of ensuring that by 2025 all schools in the EU have access to internet connections with download/upload speeds of 1 gigabit of data per second has yet to be reached;

N.  whereas excessive use of technological and digital equipment, such as computers and tablets, can cause problems related to health and well-being, including sleep deprivation, a sedentary lifestyle and addiction;

O.  whereas digital learning strategies also need to take into account research on the detrimental effects that early use of digital technology may have on the development of young children’s brains;

P.  whereas digital technologies should be an integral part of a learner-focused, age-appropriate approach to education and can offer new and innovative approaches to teaching and learning; whereas it is vital to maintain personal contact between students and teachers and to prioritise the well-being and healthy development of children and adult learners;

Q.  whereas technologies should be better used to support new pedagogies that focus on learners as active participants with tools for inquiry-based learning and collaborative workspaces;

R.  whereas basic education in cyber hygiene, cyber safety, data protection and media literacy must be age- and development-oriented in order to help children become critical learners, active citizens, internet users and shapers of a democratic digital society, make informed decisions, and be aware of and able to counter the risks associated with the internet, such as online disinformation, harassment and personal data breaches; whereas cybersecurity-related teaching programmes should be introduced in academic and vocational training curricula;

S.  whereas quality, innovative digital learning can be captivating and interactive, thus complementing lecture-style teaching methods and providing platforms for collaboration and knowledge creation;

T.  whereas we are seeing the growing commercial use of education by large digital companies, which are trying to influence teaching practices by introducing equipment, software and educational resources or providing training for teachers;

U.  whereas, to better deliver on the promise of technology, Member States need effective strategies to build teachers’ capacity and policymakers need to do more to build support for this agenda;

V.  whereas public libraries participate in the common effort to familiarise citizens with digital skills, by providing open services for digital support in a social and helpful environment;

W.  whereas adults who are out of work or in jobs that do not require digital skills tend to fall quickly behind their more digitally proficient peers, thus hampering their job prospects and exacerbating social and economic disparities;

X.  whereas the progressive digitalisation of work will result in the disappearance of many professions and an increase in unemployment; whereas the new professions that will emerge with digitalisation may compensate for some of the jobs lost;

Y.  whereas digital technologies can facilitate access to knowledge and learning and their use enables all training facilities at various levels to be easily accessible and inclusive;

Z.  whereas without appropriate and targeted policies, older people and people with disabilities are likely to suffer the most from the digital transformation;

AA.  whereas women make up only 20 % of professionals in the field of science, only 27 % of engineering graduates(15) and only 20 % of computer science graduates(16); whereas the share of men working in the digital sector is 3.1 times greater than the share of women; whereas only 19 % of workers in ICT have a female boss, compared with 45 % of workers in other sectors;

AB.  whereas lifelong learning opportunities tend to be far more available to already highly-skilled workers(17);

AC.  whereas ongoing monitoring and assessment of digital skills proficiency both in organisations and among individuals is a prerequisite for effective policy delivery;

AD.  whereas mastering basic transversal skills, such as numeracy, critical thinking and social communication skills, is a fundamental prerequisite for the acquisition of digital skills and competences;

1.  Underlines that digital skills acquisition requires a coherent, lifelong-learning approach anchored in formal, non-formal and informal education settings, with a policy response and targeted interventions appropriate to the needs of different age groups and learners;

2.  Underlines the potential of digital technologies to support a shift towards more learner-centred pedagogical approaches if incorporated into the learning process in a planned and purposeful way; believes that learners need to be guided towards innovative, bottom-up practices of knowledge creation for genuine educational transformation to occur;

3.  Stresses that a transformation of the educational and training systems at all levels is necessary to make full use of the opportunities offered by information and communication technologies and the media and to develop the skills and competences required to meet the demands of the society and labour market of the future; reiterates that such a transformation must continue to guarantee the right to personal fulfilment, strike the right balance between the relevant digital skills and life skills, and support individual resilience, critical thinking and innovation potential;

4.  Believes that educational institutions cannot afford to neglect the all-round education of their students, involving the cultivation and development of a critical and holistic outlook that enables them to assert themselves as active citizens; understands that critical thinking cannot be strengthened only by teaching digital skills and that all-round education is also required;

5.  Stresses that while it is essential to increase learners’ basic and advanced digital skills, traditional and humanistic skills should nevertheless continue to be nurtured;

6.  Recalls that, as the Commission acknowledges in its Digital Education Action Plan of January 2018, the necessary adaptation of educational institutions to new technologies and innovative pedagogical approaches should never be seen as an end in itself, but rather as a tool for improving the quality and inclusivity of education;

7.  Stresses, while recognising the need for more digital skills, that the impact of digital technologies on education is not at present easy to assess, meaning that it is vital to take into account neurological research into the effects of digital technology on brain development; calls, therefore, for investment in unbiased and interdisciplinary research into the various impacts of digital technologies on education, linking education sciences, pedagogy, psychology, sociology, neuroscience and computer science so as to achieve as deep an understanding as possible of how the minds of children and adults are responding to the digital environment, with a view to maximising the benefits of the use of digital technology in education and minimising its risks; stresses the need to promote responsible use of digital tools that protects the physiological, neurosensory and behavioural development of learners, particularly during childhood, and strikes the right balance in the daily use of technological and digital equipment, both in educational institutions and in private life;

8.  Regrets that while the use of online and mobile applications and new technologies, such as the internet of things, has become more widespread than ever, citizens, in particular minors, are often unaware of the risks associated with the use of the internet and ICT tools, such as personal data breaches, pervasive end-user tracking and cybercrime; calls, therefore, on Member States to assign an appropriate role to data protection and basic cyber hygiene in school curricula;

9.  Calls on the Member States, the Commission and educational institutions to improve children’s safety online and address the issues of cyberbullying, exposure to harmful and disturbing content, and other cybersecurity threats by developing and implementing prevention programmes and awareness-raising campaigns; encourages the Member States to further promote the #SafeInternet4EU campaign;

10.  Stresses that in order to achieve better learning experiences and outcomes, digital tools must be adapted to the needs of students, and that this is a way for students to become active citizens and not merely passive consumers of technology;

11.  Regrets that despite the potential of digitalisation for enhancing and fostering different and personalised learning methods, the impact of digital technologies on education itself has been limited; expresses its concern, in particular, that investments in ICT in schools and training centres have not yet resulted in the transformation of educational practices hoped for; recalls that schools and other learning environments need to support all students and learners and respond to their specific needs by developing appropriate and effective measures to foster digital skills, particularly among students with disabilities, minority groups, migrant communities, early school leavers, the long-term unemployed and the elderly; believes that such support can be facilitated through the use of new technologies;

12.  Notes the growing gap between men and women’s participation in the digital sector with respect to education, career pathways and entrepreneurship; stresses that ensuring a gender-balanced approach to the promotion of ICT and digital careers is key, and that more female students and women should be supported in pursuing a career in the digital field; underlines the importance of ensuring digital literacy and the participation of women and girls in ICT education and training; encourages the Member States to introduce age-appropriate ICT education in the early stages of school, with a particular focus on measures to overcome the digital gender gap and provide girls with alternative avenues for access to STEAM subjects, since gender stereotypes surrounding these subjects and the lack of female role models tend to be a barrier to access for girls; considers that a fine-tuned Women in Digital Strategy, coupled with the Commission’s forthcoming action plan to reduce the gender divide in tech, could help to boost efforts in this field;

13.  Stresses that the lack of digital equipment and connectivity in schools across Member States has a detrimental effect on the digital skills education of students and the availability of digital teaching tools; calls on the Member States to make substantial public investments to provide all schools with high-capacity broadband and to make use of existing EU programmes for this purpose, notably the Connecting Europe Facility, which can support the physical infrastructure of high-capacity broadband networks, and the WiFi4EU voucher scheme; emphasises that connectivity efforts and funding should be focused in particular on rural and disadvantaged areas, and the outermost and mountainous regions;

14.  Points out that education and training institutions require assistance from the Union and Member States, as well as close cooperation between all stakeholders, industry, local and regional authorities, communities and civil society, to develop their ICT and media education in accordance with their specific pedagogical approach and to make the difficult transition to a more digitalised learning environment; underlines, in this regard, the need for a whole-school and interdisciplinary approach towards digital change in education;

15.  Stresses that teachers and trainers should be at the core of the digital transformation and therefore require adequate initial preparation and continuous training, which must include modules on age- and development-oriented teaching practices; insists that this training requires time and should not come as an extra task on top of their daily activities; highlights that, even more than the teaching of other basic skills, such as numeracy and literacy, digital skills teaching requires teachers to update their knowledge and skills on a continuous basis; argues, therefore, that teachers need suitable, flexible and high-quality continuous professional development that corresponds to their needs; takes a positive view, in this regard, of the use of European online platforms to increase professional development opportunities and encourage the exchange of best practices;

16.  Notes that those entrusted with education now have increased responsibilities owing to the increased use of digital applications in school work; considers that they too must be involved in the learning process and the use of technology, since if they do not have the necessary digital skills, it will be more difficult to involve their students in the learning process, which may result in more social exclusion;

17.  Supports and encourages the implementation of measures concerning the digitalisation of administrative processes in schools in order to further reduce the administrative burden at all levels;

18.  Encourages the Member States to promote and finance regional and local initiatives that support quality teaching practices aimed at enhancing innovation;

19.  Stresses the value of school autonomy in achieving innovation in education;

20.  Calls on the Commission and the Member States to offer appropriate guidance on the legal application of exceptions to copyright law in the educational sphere and straightforward access to licences for public, non-profit-making establishments in formal and informal education; takes the view that teachers and pupils need security when using digitally accessible resources and imparting and learning skills; recommends, in this regard, that the Commission provide guidance for educational institutions, educators and students to that end;

21.  Points out that the lack of digital tools for mobile students can undermine the quality of educational experiences in Europe; encourages the Commission to continue its European Student Card and Erasmus without Paper pilot initiatives, with a view to launching them during the next multiannual programming period; calls on the Member States to make responsible and effective use of Union financial support and to promote funding opportunities among the wider public and educational institutions, with a view to making access to digital learning content, tools and solutions a reality for all;

22.  Points out that, in line with the lifelong learning approach required for digital skills, governments, in cooperation with stakeholders such as companies and civil society organisations, and through both formal and non-formal settings, should ensure a sustainable digital transformation with nobody left behind;

23.  Highlights that inclusiveness and innovation should be the leading principles for education and training in the digital age; believes that digital technologies should not reinforce existing inequalities, but instead be used to close the digital divide between students from different socio-economic backgrounds and regions of the EU; stresses that an inclusion-driven approach must take advantage of the full potential of the resources provided by new digital technologies, including personalised education and partnerships between educational institutions, and, in so doing, can enable access to quality education and training for people from disadvantaged groups and those with fewer opportunities and support the integration of migrants and refugees;

24.  Stresses that the promotion of digital access in education does not necessarily imply equal access to learning opportunities and that, while technologies are becoming increasingly accessible, the acquisition of basic digital skills remains a barrier and the digital divide persists; points out that Eurostat data show that the digital divide is not closing and that 44 % of people in the European Union do not have basic digital skills(18);

25.  Points out that the complex digital skills required for the efficient use of ICT depend on the acquisition of basic skills, that not everyone is on an equal footing, with major gaps remaining at basic levels and particularly affecting disadvantaged groups and a large number of adults, that more educated people are three times more likely to use the internet to acquire new skills and create new opportunities than those with lower levels of education(19), and that we run the risk of technology becoming a training tool for the privileged rather than an opportunity for all;

26.  Stresses the need for a change in the institutional and pedagogical practices of schools and other learning environments, including non-formal learning settings, in order to make them more equitable by providing substantially diversified and in-depth support structures for all, in particular those belonging to groups at risk of exclusion, such as the unemployed, migrants, the low-skilled, those with disabilities and the elderly;

27.  Recommends that Member States develop digital literacy programmes in Europe’s minority and regional languages and introduce language technology training and tools in their school, university and vocational college curricula; stresses once more that literacy remains a significant factor and an absolute prerequisite for progress in the digital inclusion of communities;

28.  Stresses that the Member States should provide the support that educational institutions need in order to improve the digitalisation of languages in the EU; recommends that schools across the EU make use of digital technologies to increase the use of cross-border educational exchanges, through video conferences and virtual classrooms; stresses that schools across the EU could benefit from cross-border access to digital content;

29.  Underlines the key role played by libraries in providing citizens with digital services and making online learning and services available in a safe environment open to all; recommends, therefore, that these efforts be duly funded under European, national, regional and local schemes, complementary to one another, and that libraries are given greater recognition for their essential role in developing media literacy;

30.  Calls for a shift towards more non-formal learning and workplace training opportunities and insists on the need for high-quality, inclusive and well-resourced education and training systems; believes that opportunities for re-skilling and upskilling are essential, with relevant digital skills components mainstreamed in workplace training programmes and special training solutions for people working in small and medium-sized enterprises; stresses the importance of strengthening connections between education and employment and the role of lifelong career guidance and counselling in supporting access to suitable, flexible and high-quality training and career paths;

31.  Stresses that traineeships in the digital sector can help students and young adults acquire practical digital skills on the job; welcomes, in this context, the new pilot project introducing Digital Opportunity Traineeships under Erasmus+ and Horizon 2020; calls for a renewed impetus in this direction under the new multiannual financial framework (MFF) programmes;

32.  Recommends that Member States, in close cooperation with local communities and education and training providers, give adults with limited digital skills access to upskilling pathways, which provide them with the opportunity to acquire a minimum level of digital competence;

33.  Calls on Member States, in collaboration with businesses, local and regional communities, education and training centres and civil society stakeholders, to identify existing skills gaps, expand digital and internet literacy, enhance media literacy, in particular among minors, and establish a high level of digital connectivity and inclusion;

34.  Welcomes the participation of businesses in founding and funding schools;

35.  Welcomes the establishment of strategic partnerships between academic and research institutions and public and private partners as part of Key Action 2 of the Erasmus+ programme, with a view to setting up ICT centres of excellence and fostering the development of technological start-ups;

36.  Recalls that proper assessment and monitoring of digital skills is essential to achieve progress; welcomes the development of EU-level tools for organisations (e.g. the Digital Competences Framework and the Reference Framework on Key Competences for Lifelong Learning) and for individuals (e.g. SELFIE); insists, however, that effective digital skills assessment methods must be dynamic, flexible, constantly updated and tailored to learners’ needs, and must also achieve much broader uptake across the Union at national, regional and local levels;

37.  Calls on the Member States to work with the Commission to ensure that the SELFIE self-reflection tool is available in Member States’ regional and minority languages;

38.  Welcomes the Union’s increased policy focus on digital skills and education, as evidenced notably by the Digital Education Action Plan, which builds on a number of successful small-scale policy initiatives, such as EU Code Week, the Digital Skills and Jobs Coalition, and the Sofia Call for Action on Digital Skills and Education; takes the view that the teaching of programming should be part of a broader educational approach to information technology and critical and computational thinking;

39.  Notes, however, that Union initiatives often emanate from different Directorates-General within the Commission, frustrating a coordinated approach to digital skills policy;

40.  Supports the increased funding available for digital skills across the next generation of MFF programmes; insists on the need for the Commission to promote synergies across and ensure coordination between these programmes, including Erasmus+, Horizon Europe, InvestEU and Digital Europe, so as to maximise the effectiveness of funding for high-quality digital skills development and deliver lasting results for learners of all ages and backgrounds; stresses the need, furthermore, to set aside funding under these programmes and the European Structural and Investment Funds for the digitalisation of libraries, archives and museums to increase and improve their use in education and culture;

41.  Emphasises the need for the Union to develop capabilities in areas such as artificial intelligence, big data, software engineering, quantum computing and web design; welcomes, in this context, the digital skills component of the Digital Europe programme;

42.  Encourages greater synergies between Member States and the wider world in the field of internet education and active e-citizenship through various EU external action mechanisms and programmes, including Erasmus Mundus;

43.  Highlights that open data and collaborative digital technology tools and methods can enable innovation in education and further develop Open Science, thereby contributing to the prosperity and entrepreneurial spirit of the European economy; points out, moreover, that the collection of data on digitalisation in education and training institutions and on the use of digital technologies in learning are vital policy-making inputs; recommends, therefore, that the Commission and the Member States collect data on the degree of connectivity of education and training institutions and the arrangements for issuing digitally certified qualifications and validating digitally acquired skills, which is an objective of the Digital Education Action Plan;

44.  Regrets that no overarching digital skills strategy has been developed at EU level, while the implications of the digital transformation for the EU’s internal market are clear; believes that disparities among Member States illustrate the need for such a strategy;

45.  Emphasises that recommendations for a minimum level of digital competence to be acquired by students during their studies should be drawn up; calls, therefore, for the introduction across the Member States of a specific ICT module, for example based on the PISA ICT module, and for teachers to be involved in its design and implementation; stresses that the ICT module should be designed to ensure that educational establishments in Member States aim for the same level of digital competence, through ongoing assessment rather than a test-driven approach, and that any problems are pinpointed quickly; encourages Member States to share lessons and best practices, in particular in the area of educational innovation;

46.  Believes that the Digital Education Action Plan should be viewed as the first step towards a fully-fledged EU strategy on digital education and skills based on a lifelong-learning approach, which can provide both a more coordinated policy framework and simultaneously be adaptable to changing realities; calls, therefore, on the Commission to critically evaluate the 11 actions under the Plan, including their social inclusiveness, to prepare for the 2020 mid-term review; recalls that a proper review should imply a willingness to focus only on the best-performing actions, to jettison those that are not delivering and to develop new actions as required; stresses that enhancing digital skills through collaborations with non-formal education providers and in the harder-to-reach adult population is currently a glaring gap in the Plan;

47.  Instructs its President to forward this resolution to the Council and the Commission.

(1) OJ L 112, 2.5.2018, p. 42. (2) Texts adopted, P8_TA(2018)0247. (3) OJ C 337, 20.9.2018, p. 135. (4) OJ C 11, 12.1.2018, p. 44. (5) OJ C 316, 22.9.2017, p. 182. (6) OJ C 316, 22.9.2017, p. 76. (7) OJ C 443, 22.12.2017, p. 31. (8) OJ C 189, 4.6.2018, p. 1. (9) OJ C 189, 15.6.2017, p. 15. (10) OJ C 484, 24.12.2016, p. 1. (11) OJ C 398, 22.12.2012, p. 1. (12) OJ C 372, 20.12.2011, p. 1. (13) OJ C 164, 8.5.2018, p. 24. (14) http://eskills-scale.eu/fileadmin/eskills_scale/all_final_deliverables/scale_digitalisation_report.pdf (15) European Commission, Education and Training Monitor 2017. (16) European Commission, Women in the Digital Age, Luxembourg, 2018. (17) European Commission, Joint Employment Report 2018. (18) Eurostat, 2016. (19) Commission Staff Working Document of 9 October 2008 entitled ‘The use of ICT to support innovation and lifelong learning for all – A report on progress’ (SEC(2008)2629).

European Parliament legislative resolution of 11 December 2018 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 516/2014 of the European Parliament and the Council, as regards the re-commitment of the remaining amounts committed to support the implementation of the Council Decisions (EU) 2015/1523 and (EU) 2015/1601 or the allocation thereof to other actions under the national programmes (COM(2018)0719 – C8-0448/2018 – 2018/0371(COD))

P8_TA(2018)0486 A8-0370/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0719),

–  having regard to Article 294(2) and Articles 78(2) and 79(2) and (4) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0448/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 30 November 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs (A8-0370/2018),

A.  Whereas for reasons of urgency it is justified to proceed to the vote before the expiry of the deadline of eight weeks laid down in Article 6 of Protocol No 2 on the application of the principles of subsidiarity and proportionality;

1.  Adopts its position at first reading hereinafter set out(1);

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 11 December 2018 with a view to the adoption of Regulation (EU) 2018/… of the European Parliament and of the Council amending Regulation (EU) No 516/2014 of the European Parliament and of the Council, as regards the recommitment of the remaining amounts committed to support the implementation of Council Decisions (EU) 2015/1523 and (EU) 2015/1601 or the allocation of those amounts to other actions under the national programmes

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2018/2000.)

(1) This position replaces the amendments adopted on 29 November 2018 (Texts adopted P8_TA(2018)0468).

Amendments adopted by the European Parliament on 11 December 2018 on the proposal for a regulation of the European Parliament and of the Council establishing a Programme for the Environment and Climate Action (LIFE) and repealing Regulation (EU) No 1293/2013 (COM(2018)0385 - C8-0249/2018 – 2018/0209(COD))(1)

P8_TA(2018)0487 A8-0397/2018

(Ordinary legislative procedure: first reading)

Text proposed by the Commission   Amendment Amendment 1 Proposal for a regulation Recital 2 (2)  The Programme for the Environment and Climate Action (LIFE), established by Regulation (EU) No 1293/2013 of the European Parliament and of the Council6 for the period 2014 to 2020 is the latest in a series of Union programmes over 25 years which support the implementation of environmental and climate legislation and policy priorities. It was positively assessed in a recent mid-term evaluation7 as being on track to be effective, efficient and relevant. The 2014-2020 LIFE Programme should therefore be continued with certain modifications identified in the mid-term evaluation and subsequent assessments. Accordingly, a Programme for the Environment and Climate Action (LIFE) (the ‘Programme’) should be established for the period starting 2021. (2)  The Programme for the Environment and Climate Action (LIFE), established by Regulation (EU) No 1293/2013 of the European Parliament and of the Council6 for the period 2014 to 2020 is the latest in a series of Union programmes over 25 years which support the implementation of environmental and climate legislation and policy priorities. It was positively assessed in a recent mid-term evaluation7 as being already highly cost-effective and on track to be effective in general terms, efficient and relevant. The 2014-2020 LIFE Programme should therefore be continued with certain modifications identified in the mid-term evaluation and subsequent assessments. Accordingly, a Programme for the Environment and Climate Action (LIFE) (the ‘Programme’) should be established for the period starting 2021. _________________ _________________ 6 Regulation (EU) No 1293/2013 of the European Parliament and of the Council of 11 December 2013 on the establishment of a Programme for the Environment and Climate Action (LIFE) and repealing Regulation (EC) No 614/2007 (OJ L 347, 20.12.2013, p. 185). 6 Regulation (EU) No 1293/2013 of the European Parliament and of the Council of 11 December 2013 on the establishment of a Programme for the Environment and Climate Action (LIFE) and repealing Regulation (EC) No 614/2007 (OJ L 347, 20.12.2013, p. 185). 7 Report on the Mid-term Evaluation of the Programme for Environment and Climate Action (LIFE)(SWD(2017)0355). 7 Report on the Mid-term Evaluation of the Programme for Environment and Climate Action (LIFE)(SWD(2017)0355). Amendment 102 Proposal for a regulation Recital 3 (3)  Pursuing the achievement of the Union's objectives and targets set by environmental, climate and related clean energy legislation, policy, plans and international commitments, the Programme should contribute to the shift towards a clean, circular, energy-efficient, low-carbon and climate-resilient economy, to the protection and improvement of the quality of the environment and to halting and reversing biodiversity loss, either through direct interventions or by supporting the integration of those objectives in other policies. (3)  Pursuing the achievement of the Union's objectives and targets set by environmental, climate and related clean energy legislation, policy, plans and international commitments, the Programme should contribute within the framework of just transition to the shift towards a clean, circular, energy-efficient, net-zero emission and climate-resilient economy, to the protection and improvement of the environment and health, to halting and reversing biodiversity loss, including through the support of the Natura 2000 network, effective management and tackling the degradation of ecosystems, either through direct interventions or by supporting the integration of those objectives in other policies. The just transition should be achieved in consultation and dialogue with social partners and the regions and communities affected. These should also be included to the extent possible in the development and implementation of projects. Amendment 3 Proposal for a regulation Recital 4 (4)  The Union is committed to developing a comprehensive response to the sustainable development goals of the United Nations 2030 Agenda for the Sustainable Development, which highlight the intrinsic connection between the management of natural resources to ensure their long-term availability, ecosystem services, their link to human health and sustainable and socially inclusive economic growth. In this spirit, the Programme should make a material contribution to both economic development and social cohesion. (4)  The Union is committed to developing a comprehensive response to the sustainable development goals of the United Nations 2030 Agenda for the Sustainable Development, which highlight the intrinsic connection between the management of natural resources to ensure their long-term availability, ecosystem services, their link to human health and sustainable and socially inclusive economic growth. In this spirit, the Programme should reflect the principles of solidarity and responsibility-sharing, while making a material contribution to both economic development and social cohesion. Amendment 4 Proposal for a regulation Recital 4 a (new) (4a)  With a view to promoting sustainable development, environmental and climate protection requirements should be integrated into the definition and implementation of all Union policies and activities. Synergies and complementarity with other Union funding programmes should, therefore, be promoted, including by facilitating the funding of activities that complement strategic integrated projects and strategic nature projects and support the uptake and replication of solutions developed under the Programme. Coordination is required to prevent double funding. The Commission and Member States should take steps to prevent administrative overlap and burden on project beneficiaries, arising from reporting obligations from different financial instruments. Amendment 5 Proposal for a regulation Recital 5 (5)  The Programme should contribute to sustainable development and to the achievement of the objectives and targets of the Union environment, climate and relevant clean energy legislation, strategies, plans and international commitments, in particular the United Nations 2030 Agenda for the Sustainable Development8 , the Convention on Biological Diversity9 and the Paris Agreement adopted under the United Nations Framework Convention on Climate Change10 ("Paris Agreement on Climate Change"). (5)  The Programme should contribute to sustainable development and to the achievement of the objectives and targets of the Union environment, climate and relevant clean energy legislation, strategies, plans and international commitments, in particular the United Nations 2030 Agenda for the Sustainable Development8, the Convention on Biological Diversity9, the Paris Agreement adopted under the United Nations Framework Convention on Climate Change10 ("Paris Agreement on Climate Change"), the UNECE Convention on Access to Information, Public Participation and Access to Justice in Environmental Matters (the “Aarhus Convention”), the UNECE Convention on Long-Range Transboundary Air Pollution, the UN Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal, the UN Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade and the UN Stockholm Convention on Persistent Organic Pollutants. _________________ _________________ 8 Agenda 2030, Resolution adopted by UN GA on 25/09/2015. 8 Agenda 2030, Resolution adopted by UN GA on 25/09/2015. 9 93/626/EEC: Council Decision of 25 October 1993 concerning the conclusion of the Convention on Biological Diversity, (OJ L 309, 13.12.1993, p. 1). 9 93/626/EEC: Council Decision of 25 October 1993 concerning the conclusion of the Convention on Biological Diversity, (OJ L 309, 13.12.1993, p. 1). 10 OJ L 282, 19.10.2016, p. 4. 10 OJ L 282, 19.10.2016, p. 4. Amendments 6 and 101 Proposal for a regulation Recital 6 (6)  For achieving the overarching objectives, the implementation of the Circular economy package11 , the 2030 Climate and Energy Policy Framework12 ,13 ,14 , Union nature legislation15 , as well as of related policies16 ,17 ,18 ,19 ,20 , is of particular importance. (6)  For achieving the overarching objectives, the implementation of the Circular economy package11 , the 2030 Climate and Energy Policy Framework12 ,13 ,14 , Union nature acquis14a, 14b, 15 , as well as of related policies16 ,17 ,18 ,19 ,20, 20a, is of particular importance, as is the implementation20b of the general action programmes on environment and climate policy adopted in accordance with Article 192(3) TFEU, such as the 7th Environment Action Programme20c. _________________ _________________ 11 COM(2015)0614, 02.12.2015. 11 COM(2015)0614, 02.12.2015. 12 2030 Climate and Energy Policy Framework, COM(2014)0015, 22.01.2014. 12 2030 Climate and Energy Policy Framework, COM(2014)0015, 22.01.2014. 13 EU Strategy on adaptation to climate change, COM(2013)0216, 16.04.2013. 13 EU Strategy on adaptation to climate change, COM(2013)0216, 16.04.2013. 14 Clean Energy for all Europeans package, COM(2016)0860, 30.11.2016. 14 Clean Energy for all Europeans package, COM(2016)0860, 30.11.2016. 14a Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). 14b Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). 15 Action Plan for nature, people and the economy, COM(2017)0198, 27.04.2017. 15 Action Plan for nature, people and the economy, COM(2017)0198, 27.04.2017. 16 Clean Air Programme for Europe, COM(2013)0918. 16 Clean Air Programme for Europe, COM(2013)0918. 17 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 17 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 18 Thematic Strategy for Soil Protection, COM(2006)0231. 18 Thematic Strategy for Soil Protection, COM(2006)0231. 19 Low Emission Mobility Strategy, COM(2016)0501. 19 Low Emission Mobility Strategy, COM(2016)0501. 20 Action Plan on Alternative Fuels Infrastructure under Article 10(6) of Directive 2014/94/EU, 8.11.2017. 20 Action Plan on Alternative Fuels Infrastructure under Article 10(6) of Directive 2014/94/EU, 8.11.2017. 20a Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 20b Proposal for a Regulation of the European Parliament and of the Council on minimum requirements for water reuse. 20c Decision No 1386/2013/EU of the European Parliament and of the Council of 20 November 2013 on a General Union Environment Action Programme to 2020 ‘Living well, within the limits of our planet’ (OJ L 354, 28.12.2013, p. 171). Amendment 7 Proposal for a regulation Recital 6 a (new) (6a)  The Union attaches great importance to the long-term sustainability of the results of LIFE projects, and to the capacity to secure and maintain those results after project implementation, inter alia by project continuation, replication and/or transfer. This implies having special requirements for the applicants as well as the need for Union-level guarantees to ensure that other Union funded projects do not undermine the results of any implemented LIFE projects. Amendment 8 Proposal for a regulation Recital 7 (7)  Complying with the Union's commitments under the Paris Agreement on Climate Change requires the transformation of the Union into an energy efficient, low carbon and climate resilient society. This in turn requires actions, with a special focus on sectors that contribute most to the current levels of CO2 output and pollution, contributing to the implementation of the 2030 energy and climate policy framework and the Member States' Integrated National Energy and Climate Plans and preparations for the Union's mid-century and long-term climate and energy strategy. The Programme should also include measures contributing to the implementation of the Union's climate adaptation policy to decrease vulnerability to the adverse effects of climate change. (7)  Complying with the Union's commitments under the Paris Agreement on Climate Change requires the transformation of the Union into a sustainable, circular, renewable, energy efficient, net zero-emission and climate resilient society. This in turn requires actions, with a special focus on sectors that contribute most to the current levels of greenhouse gas output and pollution, contributing to the implementation of the 2030 energy and climate policy framework and the Member States' Integrated National Energy and Climate Plans and to the implementation of the Union's mid-century and long-term climate and energy strategy, in line with the decarbonisation objective of the Paris Agreement. The Programme should also include measures contributing to the implementation of the Union's climate adaptation policy to decrease vulnerability to the adverse effects of climate change. Amendment 9 Proposal for a regulation Recital 8 (8)  The transition to clean energy is an essential contribution to the mitigation of climate change with co-benefits for the environment. Actions for capacity building supporting the clean energy transition, funded until 2020 under Horizon 2020, should be integrated in the Programme since their objective is not to fund excellence and generate innovation, but to facilitate the uptake of already available technology that will contribute to climate mitigation. The inclusion of these capacity building activities into the Programme offers potential for synergies between the sub-programmes and increases the overall coherence of Union funding. Therefore, data should be collected and disseminated on the uptake of existing research and innovation solutions in the LIFE projects, including from the Horizon Europe programme and its predecessors. (8)  The transition to renewable, energy efficient and net-zero emission energy is an essential contribution to the mitigation of climate change with co-benefits for the environment. Actions for capacity building supporting the clean energy transition, funded until 2020 under Horizon 2020, should be integrated in the Programme since their objective is not to fund excellence and generate innovation, but to facilitate the uptake of already available technology for renewable energy and energy efficiency, that will contribute to climate mitigation. The Programme should involve all stakeholders and sectors involved in a clean energy transition, such as the building sector, industry, transport and agriculture. The inclusion of these capacity building activities into the Programme offers potential for synergies between the sub-programmes and increases the overall coherence of Union funding. Therefore, data should be collected and disseminated on the uptake of existing research and innovation solutions in the LIFE projects, including from the Horizon Europe programme and its predecessors. Amendment 10 Proposal for a regulation Recital 9 (9)  The impact assessments of the Clean Energy legislation estimate that the delivery of the Union's 2030 energy targets will require additional investments of EUR 177 billion annually in the period 2021-2030. The biggest gaps relate to the investments in buildings decarbonisation (energy efficiency and small-scale renewable energy sources), where capital needs to be channelled towards projects of highly distributed nature. One of the objectives of the Clean Energy Transition sub-programme is to build capacity for projects development and aggregation, thereby also helping to absorb funds from the European Structural and Investment Funds and catalyse investments in clean energy also using the financial instruments provided under InvestEU. (9)  The impact assessments of the Clean Energy legislation estimate that the delivery of the Union's 2030 energy targets will require additional investments of EUR 177 billion annually in the period 2021-2030. The biggest gaps relate to the investments in buildings decarbonisation (energy efficiency and small-scale renewable energy sources), where capital needs to be channelled towards projects of highly distributed nature. One of the objectives of the Clean Energy Transition sub-programme is to build capacity for project development and aggregation, thereby also helping to absorb funds from the European Structural and Investment Funds and catalyse investments in renewable energy and energy efficiency, also using the financial instruments provided under InvestEU. Amendment 11 Proposal for a regulation Recital 9 a (new) (9a)   The LIFE programme is the only programme dedicated specifically to environment and climate action, and therefore plays a crucial role in supporting the implementation of Union legislation in those areas. Amendment 12 Proposal for a regulation Recital 11 (11)  An action that has received a contribution from the Programme can also receive a contribution from any other Union programme, provided that the contributions do not cover the same costs. Actions that receive cumulative funding from different Union programmes shall be audited only once, covering all involved programmes and their respective applicable rules. (11)  An action that has received a contribution from the Programme can also receive a contribution from any other Union programme, provided that the contributions do not cover the same costs. Actions that receive cumulative funding from different Union programmes should be audited only once, covering all involved programmes and their respective applicable rules. Amendment 13 Proposal for a regulation Recital 12 (12)  The Union's most recent Environmental Implementation Review package21 indicates that significant progress is required to accelerate implementation of the Union environment acquis and enhance the integration of environmental and climate objectives into other policies. The Programme should therefore act as a catalyst to achieve the required progress through developing, testing and replicating new approaches; supporting policy development, monitoring and review; enhancing stakeholder involvement; mobilising investments across Union investment programmes or other financial sources and supporting actions to overcome the various obstacles to the effective implementation of key plans required by environment legislation. (12)  The Union's most recent Environmental Implementation Review (EIR) package21 indicates that significant progress is required to accelerate implementation of the Union environment acquis and enhance the integration and mainstreaming of environmental and climate objectives into other policies. The Programme should therefore act as a catalyst to tackle horizontal, systemic challenges as well as the root causes for implementation deficiencies as identified in the EIR and to achieve the required progress through developing, testing and replicating new approaches; supporting policy development, monitoring and review; improving governance on environmental, climate change and related clean energy transition matters, including through enhancing multi-level public and stakeholder involvement, capacity building, communication and awareness; mobilising investments across Union investment programmes or other financial sources and supporting actions to overcome the various obstacles to the effective implementation of key plans required by environment legislation. _________________ _________________ 21 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - The EU Environmental Implementation Review: Common challenges and how to combine efforts to deliver better results (COM(2017)0063). 21 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - The EU Environmental Implementation Review: Common challenges and how to combine efforts to deliver better results (COM(2017)0063). Amendment 14 Proposal for a regulation Recital 13 (13)  Halting and reversing biodiversity loss, including in marine ecosystems, requires support for the development, implementation, enforcement and assessment of relevant Union legislation and policy, including the EU Biodiversity Strategy to 202022 , Council Directive 92/43/EEC23 and Directive 2009/147/EC of the European Parliament and of the Council24 and Regulation (EU) 1143/2014 of the European Parliament and of the Council25 , in particular by developing the knowledge base for policy development and implementation and by developing, testing, demonstrating and applying best practices and solutions on small scale or tailored to specific local, regional or national contexts, including integrated approaches for the implementation of the prioritised action frameworks prepared on the basis of Directive 92/43/EEC. The Union should track its biodiversity-related expenditure to fulfil its reporting obligations under the Convention on Biological Diversity. Requirements for tracking in other relevant Union legislation should also be met. (13)  Halting and reversing biodiversity loss and the degradation of ecosystems, including in marine and other aquatic ecosystems, requires support for the development, implementation, enforcement and assessment of relevant Union legislation and policy, including the EU Biodiversity Strategy to 202022 , Council Directive 92/43/EEC23 and Directive 2009/147/EC of the European Parliament and of the Council24 and Regulation (EU) No 1143/2014 of the European Parliament and of the Council25 , in particular by developing the knowledge base for policy development and implementation and by developing, testing, demonstrating and applying best practice and solutions, such as effective management, on small scale or tailored to specific local, regional or national contexts, including integrated approaches for the implementation of the prioritised action frameworks prepared on the basis of Directive 92/43/EEC. The Union and the Member States should track their biodiversity-related expenditure to fulfil their reporting obligations under the Convention on Biological Diversity. Requirements for tracking in other relevant Union legislation should also be met. _________________ _________________ 22 COM(2011)0244. 22 COM(2011)0244. 23 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). 23 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). 24 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). 24 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). 25 Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35). 25 Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35). Amendment 15 Proposal for a regulation Recital 14 (14)  Recent evaluations and assessments, including the mid-term review of the EU Biodiversity Strategy to 2020 and the Fitness Check of Nature legislation, indicate that one of the main underlying causes for insufficient implementation of Union nature legislation and of the biodiversity strategy is the lack of adequate financing. The main Union funding instruments, including the [European Regional Development Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund], can make a significant contribution towards meeting those needs. The Programme can further improve the efficiency of such mainstreaming through strategic nature projects dedicated to catalysing the implementation of Union nature and biodiversity legislation and policy, including the actions set out in the Priority Action Frameworks developed in accordance with Directive 92/43/EEC. The strategic nature projects should support programmes of actions in Member States for the mainstreaming of relevant nature and biodiversity objectives into other policies and financing programmes, thus ensuring that appropriate funds are mobilised for implementing these policies. Member States could decide within their Strategic Plan for the Common Agricultural Policy to use a certain share of the European Agricultural Fund for Rural Development allocation to leverage support for actions that complement the Strategic Nature Projects as defined under this Regulation. (14)  Recent evaluations and assessments, including the mid-term review of the EU Biodiversity Strategy to 2020 and the Fitness Check of Nature legislation, indicate that one of the main underlying causes for insufficient implementation of Union nature legislation and of the biodiversity strategy is the lack of adequate financing. The main Union funding instruments, including the [European Regional Development Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund], can make a significant contribution towards meeting those needs, with the precondition that the funding has to be complementary. The Programme can further improve the efficiency of such mainstreaming through strategic nature projects dedicated to catalysing the implementation of Union nature and biodiversity legislation and policy, including the actions set out in the Priority Action Frameworks developed in accordance with Directive 92/43/EEC. The strategic nature projects should support programmes of actions to assist in the mainstreaming of relevant nature and biodiversity objectives into other policies and financing programmes, thus ensuring that appropriate funds are mobilised for implementing these policies. Member States could decide within their Strategic Plan for the Common Agricultural Policy to use a certain share of the European Agricultural Fund for Rural Development allocation to leverage support for actions that complement the Strategic Nature Projects as defined under this Regulation. Amendment 16 Proposal for a regulation Recital 15 (15)  The voluntary scheme for Biodiversity and Ecosystem Services in Territories of European Overseas (BEST) promotes the conservation of biodiversity, including marine biodiversity, and sustainable use of ecosystem services, including ecosystem-based approaches to climate change adaptation and mitigation, in the Union's Outermost Regions and Overseas Countries and Territories. BEST has helped to raise awareness for the ecological importance of the Outermost Regions and Overseas Countries and Territories for conserving global biodiversity. In their Ministerial Declarations in 2017 and 2018, Overseas Countries and Territories have expressed their appreciation for this small grant scheme for biodiversity. It is appropriate to allow the Programme to continue financing small grants for biodiversity in both the Outermost Regions and the Overseas Countries and Territories. (15)  The voluntary scheme for Biodiversity and Ecosystem Services in Territories of European Overseas (BEST) promotes the conservation of biodiversity, including marine biodiversity, and sustainable use of ecosystem services, including ecosystem-based approaches to climate change adaptation and mitigation, in the Union's Outermost Regions and Overseas Countries and Territories. Through the BEST preparatory action adopted in 2011 and the subsequent BEST 2.0 Programme and BEST RUP project, BEST has helped to raise awareness for the ecological importance of the Outermost Regions and Overseas Countries and Territories and their key role in conserving global biodiversity. The Commission estimates that the need for financial support for projects on the ground in those territories is EUR 8 million per year. In their Ministerial Declarations in 2017 and 2018, Overseas Countries and Territories have expressed their appreciation for this small grant scheme for biodiversity. It is therefore appropriate for the Programme to continue to finance small grants for biodiversity, including capacity building and the capitalisation of actions funded, in both the Outermost Regions and the Overseas Countries and Territories. Amendment 17 Proposal for a regulation Recital 16 (16)  Promoting the circular economy requires a mentality shift in the way of designing, producing, consuming and disposing of materials and products, including plastics. The Programme should contribute to the transition to a circular economy model through financial support targeting a variety of actors (businesses, public authorities and consumers), in particular by applying, developing, and replicating best technology, practices and solutions tailored to specific local, regional or national contexts, including through integrated approaches for the implementation of waste management and prevention plans. Through supporting the implementation of the plastics strategy, action can be taken to address the problem of marine litter in particular. (16)  Promoting the circular economy and resource efficiency requires a mentality shift in the way of designing, producing, consuming and disposing of materials and products, including plastics. The Programme should contribute to the transition to a circular economy model through financial support targeting a variety of actors (businesses, public authorities, civil society and consumers), in particular by applying, developing, and replicating best technology, practices and solutions tailored to specific local, regional or national contexts, including through integrated approaches for the application of the waste hierarchy and the implementation of waste management and prevention plans. Through supporting the implementation of the plastics strategy, action can be taken to address the problem of marine litter in particular. Amendment 18 Proposal for a regulation Recital 16 a (new) (16a)  A high level of environmental protection is of fundamental importance for the health and well-being of Union citizens. The Programme should support the Union’s objective to produce and use chemicals in ways that lead to the minimisation of significant adverse effects on human health and the environment, and to develop a Union strategy for a non-toxic environment. The Programme should also support activities to facilitate the implementation of Directive 2002/49/EC of the Parliament and of the Council1a in order to achieve noise levels that do not give rise to significant negative impacts on and risks to human health. ___________________ 1a Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise - Declaration by the Commission in the Conciliation Committee on the Directive relating to the assessment and management of environmental noise (OJ L 189, 18.7.2002, p. 12). Amendment 19 Proposal for a regulation Recital 17 (17)  The Union's long-term objective for air policy is to achieve levels of air quality that do not cause significant negative impacts on and risks to human health. Public awareness about air pollution is high and citizens expect authorities to act. Directive (EU) 2016/2284 of the European Parliament and of the Council26 stresses the role Union funding can play in achieving clean air objectives. Therefore, the Programme should support projects, including strategic integrated projects, which have the potential to leverage public and private funds, to be showcases of good practice and catalysts for the implementation of air quality plans and legislation at local, regional, multi-regional, national and trans-national level. (17)  The Union's long-term objective for air policy is to achieve levels of air quality that do not cause significant negative impacts on and risks to human health and the environment, while reinforcing the synergies between air quality improvements and greenhouse gas emission reduction. Public awareness about air pollution is high and citizens expect authorities to act, in particular in areas where the population and ecosystems are exposed to high levels of air pollutants. Directive (EU) 2016/2284 of the European Parliament and of the Council26 stresses the role Union funding can play in achieving clean air objectives. Therefore, the Programme should support projects, including strategic integrated projects, which have the potential to leverage public and private funds, to be showcases of good practice and catalysts for the implementation of air quality plans and legislation at local, regional, multi-regional, national and trans-national level. _________________ _________________ 26 Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1). 26 Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1). Amendment 20 Proposal for a regulation Recital 19 (19)  The protection and restoration of the marine environment is one of the overall aims of the Union's environment policy. The Programme should support the following: the management, conservation, restoration and monitoring of biodiversity and marine ecosystems in particular in Natura 2000 marine sites and the protection of species in accordance with the prioritised action frameworks developed pursuant to Directive 92/43/EEC; the achievement of Good Environmental Status in line with the Directive 2008/56/EC of the European Parliament and of the Council28 ; the promotion of clean and healthy seas; the implementation of the European strategy for plastic in a circular economy, to address the problem of lost fishing gear and marine litter in particular; and the promotion of the Union's involvement in international ocean governance which is essential for achieving the goals of the United Nations 2030 Agenda for Sustainable Development and to guarantee healthy oceans for future generations. The Programme's strategic integrated projects and strategic nature projects should include relevant actions aiming at the protection of the marine environment. (19)  The protection and restoration of the aquatic environment is one of the overall aims of the Union's environment policy. The Programme should support the following: the management, conservation, restoration and monitoring of biodiversity and aquatic ecosystems in particular in Natura 2000 marine sites and the protection of species in accordance with the prioritised action frameworks developed pursuant to Directive 92/43/EEC; the achievement of Good Environmental Status in line with the Directive 2008/56/EC of the European Parliament and of the Council28 ; the promotion of clean and healthy seas; the implementation of the European strategy for plastic in a circular economy, to address the problem of lost fishing gear and marine litter in particular; and the promotion of the Union's involvement in international ocean governance which is essential for achieving the goals of the United Nations 2030 Agenda for Sustainable Development and to guarantee healthy oceans for future generations. The Programme's strategic integrated projects and strategic nature projects should include relevant actions aiming at the protection of the aquatic environment. _________________ _________________ 28 Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). 28 Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). Amendment 21 Proposal for a regulation Recital 19 a (new) (19a)  The current conservation status of Natura 2000 areas on agricultural land is very poor, which indicates that such areas are still in need of protection. Current CAP payments for Natura 2000 areas are the most effective means of preserving biodiversity in agricultural land1a. However, such payments are insufficient and they do not represent a high value for natural capital. To incentivise environmental protection of such areas, CAP payments for Natura 2000 areas should therefore be increased. _________________ 1a G. Pe’er, S. Lakner, R. Müller, G. Passoni, V. Bontzorlos, D. Clough, F. Moreira,C. Azam, J. Berger, P. Bezak, A. Bonn, B. Hansjürgens, L. Hartmann, J.Kleemann, A. Lomba, A. Sahrbacher, S. Schindler, C. Schleyer, J. Schmidt, S.Schüler, C. Sirami, M. von Meyer-Höfer, and Y. Zinngrebe (2017). Is the CAP Fit for purpose? An evidence based fitness-check assessment. Leipzig, German Centre for Integrative Biodiversity Research (iDiv) Halle-Jena-Leipzig. Amendment 22 Proposal for a regulation Recital 20 (20)  The improvement of governance on environmental, climate change and related clean energy transition matters requires involvement of civil society by raising public awareness, consumer engagement, and broadening of stakeholder involvement, including non-governmental organisations, in consultation on and implementation of related policies. (20)  The improvement of governance on environmental, climate change and related clean energy transition matters requires involvement of civil society by raising public awareness, including through a communication strategy that takes into account new media and social networks, consumer engagement, and broadening of multi-level public and stakeholder involvement, including non-governmental organisations, in consultation on and implementation of related policies. It is, therefore, appropriate that the Programme support a broad range of NGOs as well as networks of non-profit-making entities that pursue an aim which is of general Union interest, and that are primarily active in the field of environment or climate action, by awarding, in a competitive and transparent manner, operating grants, in order to help such NGOs, networks and entities to make effective contributions to Union policy, and to build up and strengthen their capacity to become more efficient partners. Amendment 23 Proposal for a regulation Recital 21 (21)  Whilst improving governance at all levels should be a cross-cutting objective for all sub-programmes of the Programme, the Programme should support the development and implementation of the horizontal legislation on the environmental governance, including the legislation implementing the United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters29 . (21)  Whilst improving governance at all levels should be a cross-cutting objective for all sub-programmes of the Programme, the Programme should support the development, implementation and enforcement of, and effective compliance with, the environment and climate acquis, in particular the horizontal legislation on the environmental governance, including the legislation implementing the United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters29 29a, and the Aarhus Convention Compliance Committee. _________________ _________________ 29 OJ L 124, 17.5.2005, p. 4. 29 OJ L 124, 17.5.2005, p. 4. 29a Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13). Amendment 24 Proposal for a regulation Recital 22 (22)  The Programme should prepare and support market players for the shift towards a clean, circular, energy-efficient, low-carbon and climate-resilient economy by testing new business opportunities, upgrading professional skills, facilitating consumers' access to sustainable products and services, engaging and empowering influencers and testing novel methods to adapt the existing processes and business landscape. To support a broader market uptake of sustainable solutions, general public acceptance and consumer engagement should be promoted. (22)  The Programme should prepare and support market players for the shift towards a clean, circular, energy-efficient, net-zero emission and climate-resilient economy by testing new business opportunities, upgrading professional skills, facilitating consumers' access to sustainable products and services, engaging and empowering influencers and testing novel methods to adapt the existing processes and business landscape. To support a broader market uptake of sustainable solutions, general public acceptance and consumer engagement should be promoted. Amendment 25 Proposal for a regulation Recital 22 a (new) (22a)  The Programme is designed to support the demonstration of techniques, approaches and best practice that can be replicated and upscaled. Innovative solutions would contribute to the improvement of environmental performance and sustainability, in particular for the development of sustainable farming practices in the areas active in the fields of climate, water, soil, biodiversity and waste. Synergies with other programmes and policies, such as the European Innovation Partnership for Agricultural Productivity and Sustainability and the EU Eco-Management and Audit Scheme, should be emphasised in this regard. Amendment 26 Proposal for a regulation Recital 23 (23)  At Union level, large investments in environmental and climate actions are primarily funded by major Union funding programmes (mainstreaming). In the context of their catalytic role, strategic integrated projects and strategic nature projects to be developed under the Programme should leverage financing opportunities under those funding programmes and other sources of funding such as national funds, and create synergies. (23)  At Union level, large investments in environmental and climate actions are primarily funded by major Union funding programmes. It is therefore imperative to step up the mainstreaming efforts, to ensure sustainability, biodiversity and climate proofing of other Union funding programmes and the integration of sustainability safeguards in all Union instruments. The Commission should have the power to adopt a common methodology and take effective measures to ensure that LIFE projects are not negatively affected by other Union programmes and policies. In the context of their catalytic role, strategic integrated projects and strategic nature projects to be developed under the Programme should leverage financing opportunities under those funding programmes and other sources of funding such as national funds, and create synergies. Amendment 27 Proposal for a regulation Recital 23 a (new) (23a)  The success of strategic nature projects and strategic integrated projects depends on close cooperation between national, regional and local authorities and the non-state actors affected by the Programme's objectives. The principles of transparency and disclosure regarding decisions concerning the development, implementation, assessment and monitoring of projects should, therefore, be applied, in particular in the case of mainstreaming or when multiple funding sources are involved. Amendment 28 Proposal for a regulation Recital 24 (24)  Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Programme will contribute to mainstream climate actions and to the achievement of an overall target of 25 % of the EU budget expenditures supporting climate objectives. Actions under this Programme are expected to contribute 61% of the overall financial envelope of the Programme to climate objectives. Relevant actions will be identified during the Programme's preparation and implementation, and reassessed in the context of the relevant evaluations and review processes. (24)  Reflecting the importance of tackling climate change in a coordinated and ambitious manner, in line with the Union's commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Programme will contribute to mainstream climate actions and to the achievement of an overall target of at least 25%of the EU budget expenditures supporting climate objectives over the MFF 2021-2027 period, and an annual target of 30 % as soon as possible and at the latest by 2027. Actions under this Programme are expected to contribute [61%] of the overall financial envelope of the Programme to climate objectives. Relevant actions will be identified during the Programme's preparation and implementation, and reassessed in the context of the relevant evaluations and review processes. Amendment 29 Proposal for a regulation Recital 25 (25)  In the implementation of the Programme due consideration should be given to the strategy for outermost regions in view of Article 349 TFEU and the specific needs and vulnerabilities of these regions. Union policies other than environmental, climate and relevant clean energy transition policies should also be taken into account. (25)  In the implementation of the Programme due consideration should be given to the strategy for outermost regions in view of Article 349 TFEU and the specific needs and vulnerabilities of these regions. Union and Member State funding should be appropriately strengthened in that regard. Union policies other than environmental, climate and relevant clean energy transition policies should also be taken into account. Amendment 30 Proposal for a regulation Recital 26 (26)  In support of the implementation of the Programme, the Commission should collaborate with the Programme’s national contact points, organise seminars and workshops, publish lists of projects funded under the Programme or undertake other activities to disseminate project results and to facilitate exchanges of experience, knowledge and best practices and the replication of project results across the Union. Such activities should in particular target Member States with a low uptake of funds and should facilitate the communication and cooperation between project beneficiaries, applicants or stakeholders of completed and ongoing projects in the same field. (26)  In support of the implementation of the Programme, the Commission should collaborate with the Programme’s national regional and local contact points, including in the set-up of an advisory network at local level to facilitate the development of projects with high added-value and policy impact and to ensure the provision of information on complementary financing, transferability of projects as well as long-term sustainability, organise seminars and workshops, publish lists of projects funded under the Programme or undertake other activities, such as media campaigns, in order to better disseminate project results and to facilitate exchanges of experience, knowledge and best practices and the replication of project results across the Union, thus promoting cooperation and communication. Such activities should in particular target Member States with a low uptake of funds and should facilitate the communication and cooperation between project beneficiaries, applicants or stakeholders of completed and ongoing projects in the same field. It is essential that such communication and cooperation also involve regional and local authorities and stakeholders. Amendment 31 Proposal for a regulation Recital 28 a (new) (28a)  The minimum and maximum co-financing rates should be set at levels such as are necessary to maintain the effective level of support provided by the Programme, while taking into account the necessary flexibility and adaptability that is needed to respond to the existing range of actions and entities. Amendment 32 Proposal for a regulation Recital 31 (31)  The types of financing and the methods of implementation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. As regards grants, this should include consideration of the use of lump sums, flat rates and scales of unit costs. (31)  The types of financing and the methods of implementation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. As regards grants, this should include consideration of the use of lump sums, flat rates and scales of unit costs. The Commission should ensure that implementation is easy to understand, and should promote genuine simplification for project developers. Amendment 33 Proposal for a regulation Recital 36 a (new) (36a)  In order to ensure that support from and implementation of the Programme is consistent with the policies and priorities of the Union and complementary to other financial instruments of the Union, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in order to supplement this Regulation by adopting multiannual work programmes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. Amendment 34 Proposal for a regulation Recital 38 (38)  Since the objectives of this Regulation, namely contributing to sustainable development and to the achievement of the objectives and targets of the Union environment, climate and relevant clean energy legislation, strategies, plans or international commitments cannot be sufficiently achieved by the Member States but can rather, by reason of scale and effects of this Regulation, 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. (38)  Since the objectives of this Regulation, namely contributing to a high level of environmental protection and ambitious climate action with good governance and a multi-stakeholder approach and to the achievement of the objectives and targets of the Union environment, biodiversity, climate, circular economy and relevant renewable energy and energy efficiency legislation, strategies, plans or international commitments, cannot be sufficiently achieved by the Member States but can rather, by reason of scale and effects of this Regulation, 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. Amendment 35 Proposal for a regulation Article 1 – paragraph 1 This Regulation establishes the Programme for the Environment and Climate Action (LIFE) (the ‘Programme’). This Regulation establishes a Programme for the Environment and Climate Action (LIFE) (the ‘Programme’), covering the period from 1 January 2021 to 31 December 2027. Amendment 36 Proposal for a regulation Article 1 – paragraph 2 It lays down the objectives of the Programme, the budget for the period 2021-2027, the forms of Union funding and the rules for providing such funding. It lays down the objectives of the Programme, the budget for that period, the forms of Union funding and the rules for providing such funding. Amendment 37 Proposal for a regulation Article 2 – paragraph 1 – point 1 (1)  'strategic nature projects' means projects that support the achievement of Union nature and biodiversity objectives by implementing coherent programmes of action in the Member States to mainstream these objectives and priorities into other policies and financing instruments, including through coordinated implementation of the priority action frameworks established pursuant to Directive 92/43/EEC; (1)  'strategic nature projects' means projects that support the achievement of Union nature and biodiversity objectives, by implementing coherent programmes of action, in particular by mainstreaming these objectives and priorities into other policies and financing instruments, including through coordinated implementation of the priority action frameworks established pursuant to Directive 92/43/EEC; Amendment 103 Proposal for a regulation Article 3 – paragraph 1 1.  The general objective of the Programme is to contribute to the shift towards a clean, circular, energy-efficient, low-carbon and climate-resilient economy, including through the transition to clean energy, to the protection and improvement of the quality of the environment and to halting and reversing biodiversity loss, thereby contributing to sustainable development. 1.  The general objective of the Programme is to contribute within the framework of just transition to the shift towards a clean, circular, energy-efficient, net-zero emission and climate-resilient economy, to protect and improve the quality of the environment and to halt and reverse biodiversity loss and the degradation of ecosystems, thereby contributing to sustainable development. Amendment 39 Proposal for a regulation Article 3 – paragraph 2 – point a (a)  to develop, demonstrate and promote innovative techniques and approaches for reaching the objectives of the Union legislation and policy on environment and climate action, including the transition to clean energy, and to contribute to the application of best practice in relation to nature and biodiversity; (a)  to develop, demonstrate and promote innovative techniques and approaches for reaching the objectives of the Union legislation and policy on environment and climate action, including the transition to clean, renewable energy and increased energy efficiency, and to contribute to the knowledge base, effective management and application of best practice, in relation to nature and biodiversity, including through the support of the Natura 2000 network; Amendment 40 Proposal for a regulation Article 3 – paragraph 2 – point b (b)  to support the development, implementation, monitoring and enforcement of the relevant Union legislation and policy, including by improving governance through enhancing capacities of public and private actors and the involvement of civil society; (b)  to support the development, implementation, monitoring, effective compliance and enforcement of the relevant Union legislation and policy, in particular by supporting the implementation of General Union Environment Action Programmes that have been adopted pursuant to Article 192(3) TFEU and by improving environmental and climate governance at all levels, including by enhancing capacities of public and private actors and the involvement of civil society; Amendment 41 Proposal for a regulation Article 5 – paragraph 1 1.  The financial envelope for the implementation of the Programme for the period 2021-2027 shall be EUR 5 450 000 000 in current prices. 1.  The financial envelope for the implementation of the Programme for the period 2021-2027 shall be EUR 6 442 000 000 in 2018 prices (EUR 7 272 000 000 in current prices). Amendment 42 Proposal for a regulation Article 5 – paragraph 2 2.  The indicative distribution of the amount referred to in paragraph 1 shall be: 2.  The indicative distribution of the amount referred to in paragraph 1 shall be: (a)  EUR 3 500 000 000 for the field Environment, of which (a)  EUR 4 715 000 000 in 2018 prices (EUR 5 322 000 000 in current prices, which constitutes 73,2% of the total financial envelope of the Programme) for the field Environment, of which (1)  EUR 2 150 000 000 for the sub-programme Nature and Biodiversity and (1)  EUR 2 829 000 000 in 2018 prices (EUR 3 261 420 000 in current prices which constitutes 44,9% of the total financial envelope of the Programme) for the sub-programme Nature and Biodiversity and (2)  EUR 1 350 000 000 for the sub-programme Circular Economy and Quality of Life; (2)  EUR 1 886 000 000 in 2018 prices (EUR 2 060 580 000 in current prices which constitutes 28,3% of the total financial envelope of the Programme) for the sub-programme Circular Economy and Quality of Life; (b)  EUR 1 950 000 000 for the field Climate Action, of which (b)  EUR 1 950 000 000 for the field Climate Action, of which (1)  EUR 950 000 000 for the sub-programme Climate Change Mitigation and Adaptation and (1)  EUR 950 000 000 for the sub-programme Climate Change Mitigation and Adaptation and (2)  EUR 1 000 000 000 for the sub-programme Clean Energy Transition. (2)  EUR 1 000 000 000 for the sub-programme Clean Energy Transition. Amendment 43 Proposal for a regulation Article 6 – paragraph 1 – introductory part 1.  The Programme shall be open to the following third countries: 1.  Subject to fully complying with all its rules and regulations, the Programme shall be open to the following third countries: Amendment 44 Proposal for a regulation Article 6 a (new) Article 6a International cooperation In the course of implementing the Programme, cooperation with relevant international organisations, and with their institutions and bodies, shall be possible where needed for the purpose of achieving the general objectives set out in Article 3. Amendment 45 Proposal for a regulation Article 7 The Programme shall be implemented in a way which ensures its consistency with the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development, and the European Maritime and Fisheries Fund, Horizon Europe, the Connecting Europe Facility and InvestEU, in order to create synergies, particularly as regards strategic nature projects and strategic integrated projects, and to support the uptake and replication of solutions developed under the Programme. The Commission shall ensure the consistent implementation of the Programme and the Commission and the Member States shall ensure coherence and coordination with the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development, the European Maritime and Fisheries Fund, Horizon Europe, the Connecting Europe Facility, the Emissions Trading System Innovation Fund and InvestEU, in order to create synergies, particularly as regards strategic nature projects and strategic integrated projects, and to support the uptake and replication of solutions developed under the Programme The Commission and Member States shall ensure complementarity at all levels. The Commission shall identify specific actions and shall mobilise relevant finance under other Union programmes, and facilitate the coordinated and coherent implementation of the complementary actions financed from other sources. Amendment 104 Proposal for a regulation Article 8 – paragraph 1 a (new) 1a.  The Programme shall be implemented within the framework of just transition, whereby the communities and territories affected are included in the development and implementation of projects, in particular through consultations and dialogue. Amendment 46 Proposal for a regulation Article 10 – paragraph 3 3.  Projects under the sub-programme Nature and Biodiversity concerning the management, restoration and monitoring of Natura 2000 sites in accordance with Directives 92/43/EEC and 2009/147/EC shall be supported in accordance with prioritised action frameworks established pursuant to Directive 92/43/EEC. 3.  Projects under the sub-programme Nature and Biodiversity concerning the management, restoration and monitoring of Natura 2000 sites in accordance with Directives 92/43/EEC and 2009/147/EC shall take account of priorities set out in national and regional plans, strategies and policies, inter alia in prioritised action frameworks established pursuant to Directive 92/43/EEC. Amendment 47 Proposal for a regulation Article 10 – paragraph 4 4.  Grants may finance activities outside the Union, provided that the project pursues Union environmental and climate objectives and the activities outside the Union are necessary to ensure the effectiveness of interventions carried out in Member State territories. 4.  Grants may finance activities outside a Member State or an overseas country or territory linked to it, provided that the project pursues Union environmental and climate objectives and the activities outside the Union are necessary to ensure the effectiveness of interventions carried out in Member State territories or an overseas country or territory, or to support international agreements to which the Union is party. Amendment 48 Proposal for a regulation Article 11 – paragraph 2 – point a – point 3 (3)  other third countries listed in the work programme under the conditions specified in paragraphs 4 to 6; (3)  other third countries listed in the multiannual work programmes, under the conditions specified in paragraphs 4 to 6; Amendment 49 Proposal for a regulation Article 11 – paragraph 6 a (new) 6a.   In order to ensure effective use of the Programme’s funds and efficient participation by the legal entities referred to in paragraph 4, the Commission is empowered to adopt delegated acts in accordance with Article 21 to supplement this Article by laying down the extent to which participation by those legal entities in the environmental and climate policy conducted by the Union is sufficient for them to be considered eligible for the Programme. Amendment 50 Proposal for a regulation Article 12 a (new) Article 12a Project submission and selection procedures 1.  The Programme shall introduce the following procedures for the submission and selection of projects: (a)  a simplified two-stage approach based on the submission and evaluation of a summary, followed by a full proposal for those candidates whose proposals have been pre-selected; (b)  a standard one-stage approach based solely on the submission and evaluation of a full proposal. If the standard approach is chosen in preference to the simplified approach, reasons shall be given for that choice in the work programme, in view of the organisational and operational constraints linked to each sub-programme and, if applicable, to each call for proposals. 2.  For the purposes of paragraph 1, a ‘summary’ means a note of no more than 10 pages including a description of the project’s content, the potential partner(s), constraints that are likely to arise and the emergency plan to address them, as well as the strategy selected to ensure the sustainability of the project’s results after it has ended, administrative forms relating to the beneficiaries participating in the project and a detailed project budget. Amendment 51 Proposal for a regulation Article 13 Article 13 Article 13 Award criteria Award criteria Award criteria shall be set out in the calls for proposals taking into account the following: Award criteria shall be defined in the multiannual work programmes, as set out in Article 17, and in the calls for proposals taking into account the following: (a)  projects financed by the Programme shall avoid undermining environmental, climate or relevant clean energy objectives of the Programme and, where possible, shall promote the use of green public procurement; (a)  projects financed by the Programme shall not undermine environmental, climate or relevant clean energy objectives of the Programme and, whenever possible, shall promote the use of green public procurement; (aa)  projects shall ensure a cost-effective approach and be technically and financially coherent; (ab)  projects with the highest potential contribution for the achievement of the objectives set out in Article 3 shall be given priority; (b)  projects that provide co-benefits and promote synergies between the sub-programmes referred to in Article 4 shall be given priority; (b)  projects that provide co-benefits and promote synergies between the sub-programmes referred to in Article 4 shall be given priority; (c)  projects with the highest potential of being replicated and taken-up by the public or private sector or of mobilising the largest investments or financial resources (catalytic potential) shall be given priority; (c)  projects with the highest potential of being replicated and taken-up by the public or private sector or of mobilising the largest investments or financial resources (catalytic potential) shall benefit from a bonus in their evaluation; (d)  the replicability of standard action project results shall be ensured; (d)  the replicability of standard action project results shall be ensured; (e)  projects that build on or upscale the results of other projects funded by the Programme, its predecessor programmes or with other Union funds shall benefit from a bonus in their evaluation; (e)  projects that build on or upscale the results of other projects funded by the Programme, its predecessor programmes or with other Union funds shall benefit from a bonus in their evaluation; (f)  where appropriate, special regard shall be given to projects in geographical areas with specific needs or vulnerabilities, such as areas with specific environmental challenges or natural constraints, trans-border areas or outermost regions. (f)  where appropriate, special regard shall be given to the biogeographic balance of projects and projects in geographical areas with specific needs or vulnerabilities, such as areas with specific environmental challenges or natural constraints, trans-border areas, areas of high natural value or outermost regions. Amendment 52 Proposal for a regulation Article 15 – paragraph 1 1.  An action that has received a contribution from another Union programme may also receive a contribution under the Programme, provided that the contributions do not cover the same costs. The rules of each contributing Union programme shall apply to its respective contribution to the action. The cumulative funding shall not exceed the total eligible costs of the action and the support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 1.  An action that has received a contribution from another Union programme may also receive a contribution under the Programme, provided that the contributions do not cover the same costs. In order to be eligible for contributions under the Programme, actions that have been financed by other Union programmes shall have avoided undermining the environmental or climate objectives set out in Article 3. The rules of each contributing Union programme shall apply to its respective contribution to the action. The cumulative funding shall not exceed the total eligible costs of the action and the support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. Amendment 53 Proposal for a regulation Article 15 – paragraph 2 2.  Actions awarded a Seal of Excellence certification, or which comply with the following cumulative, comparative conditions: 2.  Actions awarded a Seal of Excellence certification, or which comply with the following cumulative, comparative conditions: (a)  they have been assessed in a call for proposals under the Programme; (a)  they have been assessed in a call for proposals under the Programme; (b)  they comply with the minimum quality requirements of that call for proposals; (b)  they comply with the minimum quality requirements of that call for proposals; (c)  they may not be financed under that call for proposals due to budgetary constraints. (c)  they may not be financed under that call for proposals due to budgetary constraints. may receive support from the European Regional Development Fund, the Cohesion Fund, the European Social Fund+ or the European Agricultural Fund for Rural Development, in accordance with paragraph 5 of Article [67] of Regulation (EU) XX [Common Provisions Regulation] and Article [8] or Regulation (EU) XX [Financing, management and monitoring of the Common Agricultural Policy], provided that such actions are consistent with the objectives of the programme concerned. The rules of the Fund providing support shall apply. may receive support from the European Regional Development Fund, the Cohesion Fund, the European Social Fund+ or the European Agricultural Fund for Rural Development, in accordance with paragraph 5 of Article [67] of Regulation (EU) XX [Common Provisions Regulation] and Article [8] or Regulation (EU) XX [Financing, management and monitoring of the Common Agricultural Policy], provided that such actions are consistent with the objectives and eligibility criteria of the programme concerned. The rules of the Fund providing support shall apply. Amendment 54 Proposal for a regulation Article 16 – paragraph 1 Blending operations under this Programme shall be implemented in accordance with the [InvestEU Regulation] and Title X of the Financial Regulation. Blending operations under this Programme shall be implemented in accordance with the [InvestEU Regulation] and Title X of the Financial Regulation, with due regard to sustainability and transparency requirements. Amendment 55 Proposal for a regulation Article 17 – title Work programme Multiannual work programme Amendment 56 Proposal for a regulation Article 17 – paragraph 1 1.  The Programme shall be implemented by at least two multiannual work programmes referred to in Article 110 of the Financial Regulation. Work programmes shall set out, where applicable, the overall amount reserved for blending operations. 1.  The Programme shall be implemented by at least two multiannual work programmes referred to in Article 110 of the Financial Regulation. The Commission is empowered to adopt delegated acts in accordance with Article 21 in order to supplement this Regulation by adopting those multiannual work programmes. Amendment 57 Proposal for a regulation Article 17 – paragraph 1 a (new) 1a.   The Commission shall ensure that the co-legislators and relevant stakeholders, including civil society organisations, are adequately consulted when the multiannual work programmes are developed. Amendment 58 Proposal for a regulation Article 17 – paragraph 2 – point a a (new) (aa)  the minimum and the maximum levels for co-financing rates, differentiated amongst the sub-programmes set out in Article 4 and eligible actions set out in Article 10, for which the total maximum co-financing rates in the first multiannual work programme for the actions referred to in points (a), (b) and (d) of Article 10(2) shall be up to [60%] of eligible costs and [75%] in the case of projects, funded under the sub-programme Nature and Biodiversity, that concern priority habitats or species for the implementation of Directive 92/43/EEC or the species of birds considered as a priority for funding by the Committee for Adaptation to Technical and Scientific Progress, set up pursuant to Article 16 of Directive 2009/147/EC, when necessary to achieve the conservation objective; Amendment 59 Proposal for a regulation Article 17 – paragraph 2 – point a b (new) (ab)  the maximum overall amount reserved for blending operations; Amendment 60 Proposal for a regulation Article 17 – paragraph 2 – point d a (new) (da)  indicative timetables for the calls for proposals for the period covered by the multiannual work programme; Amendment 61 Proposal for a regulation Article 17 – paragraph 2 – point d b (new) (db)  the technical methodology for the project submission and selection procedure and selection and award criteria, set out in Article 13, for grants. Amendment 62 Proposal for a regulation Article 17 – paragraph 2 a (new) 2a.  The duration of the first multiannual work programme shall be four years and the duration of the second multiannual work programme shall be three years. Amendment 63 Proposal for a regulation Article 17 – paragraph 2 b (new) 2b.  The Commission shall ensure that unused funds in a given call for proposals are reallocated between the different types of actions referred to in Article 10(2). Amendment 64 Proposal for a regulation Article 17 – paragraph 2 c (new) 2c.  The Commission shall ensure stakeholder consultation in the development of the multiannual work programmes. Amendment 65 Proposal for a regulation Article 19 – paragraph 1 1.  Evaluations shall be carried out in a timely manner to feed into the decision-making process. 1.  Evaluations shall be carried out in a timely manner to feed into the decision-making process with due regard to coherence, synergies, Union added value and long-term sustainability, using priorities of the relevant Environment Action Programme. Amendment 66 Proposal for a regulation Article 19 – paragraph 2 2.  The interim evaluation of the Programme shall be performed once there is sufficient information available about the implementation of the Programme, but no later than four years after the start of the Programme implementation. 2.  The mid-term evaluation of the Programme shall be performed once there is sufficient information available about the implementation of the Programme, but no later than three years after the start of the Programme implementation, making use of the output and result indicators as set in accordance with Annex II. The evaluation shall, if necessary, be accompanied by a proposal for an amendment of this Regulation. The evaluation shall cover at least the following: (a)  qualitative and quantitative aspects of the implementation of the Programme; (b)  efficiency of the use of resources; (c)  the degree to which the objectives of all the measures have been achieved, specifying where possible, results and impacts; (d)  the actual or expected success of projects in leveraging other Union funds, taking into account, in particular, the benefits of increased coherence with other Union financial instruments; (e)  the extent to which synergies between the objectives have been reached and its complementarity with other relevant Union programmes; (f)  the Union added value and long-term impact of the Programme, with a view to taking a decision on the renewal, modification or suspension of the measures; (g)  the extent to which stakeholders have been involved; (h)  a quantitative and qualitative analysis of the contribution of the Programme to the conservation status of habitats and species listed under Directives 92/43/EEC and 2009/147/EC. Amendment 67 Proposal for a regulation Article 19 – paragraph 3 3.  At the end of the implementation of the Programme, but no later than four years after the end of the period specified in the second paragraph of Article 1, a final evaluation of the Programme shall be carried out by the Commission. 3.  At the end of the implementation of the Programme, but no later than four years after the end of the period specified in the second paragraph of Article 1, a final evaluation of the Programme shall be carried out by the Commission and be complemented by an external and independent ex-post evaluation report covering the implementation and results of the Programme. Amendment 68 Proposal for a regulation Article 19 – paragraph 4 4.  The Commission shall communicate the conclusions of the evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. 4.  The Commission shall submit the conclusions of the evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions and the Commission shall make the results of the evaluations publicly available. Amendment 69 Proposal for a regulation Article 20 – paragraph 1 1.  The recipients of Union funding shall acknowledge the origin and ensure the visibility of the Union funding (in particular when promoting the projects and their results), by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 1.  The recipients of Union funding shall acknowledge the origin and ensure the visibility of the Union funding (in particular when promoting the projects and their results), by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. For that purpose, the recipients shall use the Programme logo, as depicted in Annex IIa, for all communication activities and that logo shall appear on notice boards visible to the public at strategic places. All durable goods acquired in the framework of the Programme shall bear the Programme logo except in cases specified by the Commission. Amendment 70 Proposal for a regulation Article 23 – paragraph 4 4.  Reflows from financial instruments established under Regulation (EU) No 1293/2013 may be invested in the financial instruments established under [InvestEU Fund]. 4.  Reflows from financial instruments established under Regulation (EU) No 1293/2013 shall be reallocated between the actions under this Programme. Amendment 71 Proposal for a regulation Annex II – point 2 – point 2.1 – indent 3 a (new) —  Chemicals Amendment 72 Proposal for a regulation Annex II – point 2 – point 2.1 – indent 5 a (new) —  Noise Amendment 73 Proposal for a regulation Annex II – point 2 – point 2.1 – indent 5 b (new) —  Resource use and efficiency Amendment 74 Proposal for a regulation Annex II – point 2 – point 2.2 a (new) 2.2a.  Public Awareness Amendment 75 Proposal for a regulation Annex II a (new) ANNEX IIa Programme logo

(1) The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A8-0397/2018).

European Parliament legislative resolution of 11 December 2018 on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (COM(2017)0011 – C8-0010/2017 – 2017/0004(COD))

P8_TA(2018)0488 A8-0142/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2017)0011),

–  having regard to Article 294(2) and Article 153(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0010/2017),

–  having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 31 May 2017(1),

–  after consulting the Committee of the Regions,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 24 October 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 and 39 of its Rules of Procedure,

–  having regard to the report of the Committee on Employment and Social Affairs (A8-0142/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 11 December 2018 with a view to the adoption of Directive (EU) 2019/… of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2019/130.)

(1) OJ C 288, 31.8.2017, p. 56.

Amendments adopted by the European Parliament on 11 December 2018 on the proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods] (COM(2018)0179 – C8-0144/2018 – 2018/0088(COD))(1)

P8_TA(2018)0489 A8-0417/2018

(Ordinary legislative procedure: first reading)

Draft legislative resolution   Amendment Amendment 1 Proposal for a regulation Citation 1 Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, and 168(4)(b) thereof, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, 168(4)(b) and 192(1) thereof, Amendment 2 Proposal for a regulation Recital 2 a (new) (2a)  Risk management, assessment and communication activities should be based on a thorough application of, inter alia, the precautionary principle. Amendment 3 Proposal for a regulation Recital 4 (4)  It is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process. (4)  It is therefore necessary to ensure a transparent, independent, continuous and inclusive risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should regain citizens' trust that the whole process is underpinned by the objective of this Regulation, which is to ensure high level of human life and health and the protection of consumers' interests. That process should also be capable of contributing to a participatory and open dialogue between all interested parties, particularly the public, to ensure prevalence of public interest only, accuracy, comprehensiveness, transparency, consistency, and accountability within the risk analysis process. Amendment 4 Proposal for a regulation Recital 4 a (new) (4a)  On signing trade agreements, the Union needs to ensure that the food legislation of third-country partners is at least as protective of food safety as Union law, so as to guarantee consumer safety and prevent unfair competition with European products. Amendment 5 Proposal for a regulation Recital 5 (5)  Particular emphasis should be placed on explaining in a coherent, appropriate and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant. (5)  Particular emphasis should be placed on explaining in an accurate, clear, objective and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant. Amendment 7 Proposal for a regulation Recital 6 (6)  To this effect, it is necessary to establish general objectives and principles of risk communication, taking into account the respective roles of risk assessors and managers. (6)  To this effect, it is necessary to establish general objectives and principles of risk communication. In this connection, the respective roles of risk assessors and managers should be taken into account, while guaranteeing their independence. Amendment 8 Proposal for a regulation Recital 8 (8)  The general plan should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential public health impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication. (8)  The general plan should lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency in the risk management process. It should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential impact on public health, animal health and the environment, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to minimise or control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication. Amendment 9 Proposal for a regulation Recital 9 (9)  Transparency of the risk assessment process contributes to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission, increases their confidence in its work and ensures that the Authority is more accountable to the Union citizens in a democratic system. It is therefore essential to maintain the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency. (9)  Improving transparency of the risk assessment process would contribute to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission, increase their confidence in its work and ensure that the Authority is more accountable to the Union citizens in a democratic system. It is therefore essential to rebuild the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation, functioning and independence of the Authority and transparency. Amendment 10 Proposal for a regulation Recital 10 (10)  It is appropriate to align the composition of the Management Board of the Authority to the Common Approach on decentralised agencies, in accordance with the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 201222. deleted __________________ 22 https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf. Amendment 11 Proposal for a regulation Recital 11 (11)  Experience shows that the role of the Management Board of the Authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority. It is thus appropriate to include representatives of all Member States in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment. (11)  Experience shows that the role of the Management Board of the Authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority. It is thus appropriate to include representatives of all Member States, the Commission, the European Parliament, as well as civil society and industry associations in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment and that any conflict of interest is avoided. Amendment 12 Proposal for a regulation Recital 12 (12)  The Management Board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission. (12)  The Management Board should be selected in such a way as to secure the highest standards of competence and commitment to the protection of health and the environment and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission. Amendment 13 Proposal for a regulation Recital 13 (13)  The Fitness Check of the General Food Law identified certain shortcomings in the long-term capability of the Authority to maintain its high-level expertise. In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels. The system has thus to be strengthened and Member States should take a more active role to ensure that a sufficient pool of experts is available to meet the needs of the Union risk assessment system in terms of high level of scientific expertise, independence and multidisciplinary expertise. (13)  The Fitness Check of the General Food Law identified certain shortcomings in the long-term capacity of the Authority to maintain its high-level expertise through expert personnel. Moreover, there has been a decrease in the number of candidates applying to be members of the Scientific Panels, and the reason for this decline should be examined. Six Member States provide two thirds of the experts on the scientific panels. As the United Kingdom currently provides approximately 20% of the national experts, the problem will be further exacerbated with the withdrawal of the United Kingdom from the Union. In order to tackle this phenomenon more effectively, the system has thus to be strengthened and promoted, must encourage candidates to apply and Member States should support the dissemination of the Authority’s calls for expressions of interest for membership of the Scientific Panels and Scientific Committee, to ensure that a sufficient pool of independent experts is available, by undertaking support actions and using incentives and rewards to increase the level of participation and the degree of interest in seeking to engage in it. Amendment 14 Proposal for a regulation Recital 14 (14)  To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director whose function is to defend EFSA’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures should also be put in place to ensure that scientific experts have the means to act independently. (14)  To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director, who is the legal representative of the Authority and whose function is to defend EFSA’s interests and to monitor its performance and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures, including proper financial compensation, should also be put in place to ensure that scientific experts have the means to act independently and to dedicate sufficient time to their risk assessment work for the Authority. Amendment 15 Proposal for a regulation Recital 15 (15)  It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise. It is therefore necessary to strengthen the support provided by the Authority and the Member States to the work of the Authority’s Scientific Panels. In particular, the Authority should organise the preparatory work supporting the Panels’ tasks, including by requesting the Authority’s staff or national scientific organisations networking with the Authority to draft preparatory scientific opinions to be peer-reviewed and adopted by the Panels. (15)  It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise. It is therefore necessary to strengthen the support provided by the Authority and the Member States to the work of the Authority’s Scientific Panels. In particular, the Authority should organise the preparatory work supporting the Panels’ tasks, including by requesting the Authority’s staff or national scientific organisations networking with the Authority to draft preparatory scientific opinions to be peer-reviewed and adopted by the Panels. This should be without prejudice to the independence of the Authority’s scientific assessments. Amendment 16 Proposal for a regulation Recital 16 (16)  Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter. (16)  Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health and the environment are better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter. Amendment 17 Proposal for a regulation Recital 16 a (new) (16a)  A comparison of Union agencies shows that the Authority needs up to 55 months for an authorisation procedure or five times longer than the European Medicines Agency (EMA). This discourages firms from investing in innovative products and reduces Union’s competitiveness in the long run. In addition, long authorisation procedures weaken confidence in the Authority. It is therefore urgently advisable to ensure the efficiency of the risk assessment by means of better human and financial resources. Amendment 18 Proposal for a regulation Recital 17 (17)  Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process, the advice of the Authority should be made public. (17)  Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted. By ... 36 months after the entry into force of this amending Regulation, the Commission should evaluate the impact of the general advice provided on the functioning of the Authority. In particular, the Commission should evaluate its impact on the allocation of the Authority's resources and on its independence. Amendment 19 Proposal for a regulation Recital 18 (18)  The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency. (18)  The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation or renewal under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned in the Union or beyond. Information about the notified studies should be made public only once a corresponding application for authorisation or renewal has been made public in accordance with the applicable rules on transparency. Amendment 20 Proposal for a regulation Recital 20 (20)  There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. The Authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment. In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available. To increase the effectiveness of the consultation, the consultation should take place when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation. (20)  There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. In the case of a new application for an authorisation or a renewal procedure, the Authority should always conduct searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment and, where necessary, demand additional studies. The Authority should provide public access to all relevant scientific literature on the matter, which it holds. In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available. To increase the effectiveness of the consultation, the consultation should take place immediately after the studies submitted by industry included in an application for authorisation have been made public, under the transparency rules of this Regulation. Amendment 158 Proposal for a regulation Recital 21 (21)  Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law usually comply with internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results. However, issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the Commission. (21)  Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law should be based on independent peer-reviewed literature or comply with internationally recognised standards and Good Laboratory Practice (GLP) principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results. However, issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State or third-country controls, in collaboration with the Commission’s Directorate for Health and Food Audits and Analysis on the implementation of those principles by the laboratories carrying out such studies and tests in the Union and in third countries would be verified by the Commission. Amendment 22 Proposal for a regulation Recital 21 a (new) (21a)  Sufficient flexibility ought to be built into the process so that new insights into serious health adverse effects can be promptly taken into consideration, even when they are not specifically covered by regulatory data requirements. Amendment 23 Proposal for a regulation Recital 22 (22)  Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available). (22)  Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should, in case of divergent scientific findings, be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake in the risk assessment process (for example new scientific developments becoming available). Amendment 24 Proposal for a regulation Recital 23 a (new) (23a)   The Aarhus Convention establishes a number of rights of the public with regard to the environment. The Aarhus Convention provides for the right of everyone to receive environmental information that is held by public authorities, the right to participate in environmental decision-making, and the right to review procedures to challenge public decisions that have been made without respecting the two aforementioned rights or environmental law in general. Amendment 25 Proposal for a regulation Recital 24 (24)  The European Citizens’ Initiative “Ban glyphosate and protect people and the environment from toxic pesticides” further confirmed concerns regarding transparency with respect to studies commissioned by the industry and submitted in authorisation application23. (24)  As a Party to the Aarhus Convention, the Union has recognised that, in the field of the environment, improved access to information and public participation in decision-making enhance the quality and the implementation of decisions, contribute to public awareness of environmental issues, give the public the opportunity to express its concerns and enable public authorities to take due account of such concerns. The European Citizens’ Initiative “Ban glyphosate and protect people and the environment from toxic pesticides” further confirmed concerns regarding transparency with respect to studies commissioned by the industry and submitted in authorisation application23. __________________ __________________ 23 Communication from the Commission on the ECI “Ban glyphosate and protect people and the environment from toxic pesticides”, C(2017)8414. 23 Communication from the Commission on the ECI “Ban glyphosate and protect people and the environment from toxic pesticides”, C(2017)8414. Amendment 26 Proposal for a regulation Recital 25 a (new) (25a)  Using the Board of Appeal of the European Chemicals Agency as its model, as set out in Articles 89 to 93 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council1a, an EFSA Board of Appeal should be established by means of delegated acts. _______________ 1a Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). Amendment 27 Proposal for a regulation Recital 27 (27)  To determine what level of disclosure strikes the appropriate balance, the relevant rights of the public to transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002. (27)  To determine what level of proactive disclosure strikes the appropriate balance, the need to ensure transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002, of a high level of protection of human life and health, the protection of consumers' interests, as well as the protection of animal health and welfare, plant health and the environment. Amendment 28 Proposal for a regulation Recital 27 a (new) (27a)   The provisions on active dissemination laid down in this Regulation are not meant to limit, in any manner, the scope of the rights provided for by Regulations (EC) No 1049/2001 and (EC) No 1367/2006. Amendment 29 Proposal for a regulation Recital 30 (30)  It is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account Regulation (EC) No 45/2001 of the European Parliament and of the Council24 and Regulation (EU) 2016/679 of the European Parliament and of the Council25. Accordingly, no personal data should be made publicly available under this Regulation, unless it is necessary and proportionate for the purposes of ensuring the transparency, independence and the reliability of the risk assessment process, while preventing conflicts of interests. (30)  It is also necessary to refer, for the protection and confidentiality of personal data for the purposes of the transparency of the risk assessment process, to Regulation (EC) No 45/2001 of the European Parliament and of the Council24 and Regulation (EU) 2016/679 of the European Parliament and of the Council25. Accordingly, no personal data should be made publicly available under this Regulation, unless it is necessary and proportionate for the purposes of ensuring the transparency, independence and the reliability of the risk assessment process, while preventing conflicts of interests. For the purpose of ensuring the transparency, independence, sustainability and reliability of the risk assessment process, in particular to avoid conflicts of interest, it is considered necessary and proportionate to publish the names of any individual designated by the Authority to contribute to the Authority’s decision making process, including in the context of the adoption of guidance documents. __________________ __________________ 24 Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). 24 Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). 25 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). 25 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). Amendment 30 Proposal for a regulation Recital 31 (31)  For the purposes of increased transparency and in order to ensure that requests for scientific outputs received by the Authority are processed in an effective manner, standard data formats and software packages should be developed. In order to ensure uniform conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council26. (31)  For the purposes of increased transparency and in order to ensure that requests for scientific outputs received by the Authority are processed in an effective manner, standard data formats and software packages should be developed. In order to ensure uniform and harmonised conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council26. _________________ _________________ 26 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). 26 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). Amendment 31 Proposal for a regulation Recital 33 (33)  Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority, in accordance with the Common Approach on Decentralised Agencies. The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests. (33)  Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to conduct an independent evaluation of the Authority. The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests. Amendment 32 Proposal for a regulation Recital 33 a (new) (33a)  The Seventh European Environment Action Programme has prioritised the development and realisation of pathways to address the combined effects of chemicals on human health and the environment. Assessment of ‘cocktail effects’ requires a cross-sectoral approach, closer cooperation between monitoring agencies at European level and the formulation of suitable procedures. Amendment 33 Proposal for a regulation Recital 35 (35)  For the purposes of ensuring transparency of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products. (35)  For the purposes of ensuring the transparency and independence of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products. Amendment 34 Proposal for a regulation Recital 36 (36)  To ensure that sectoral specificities with respect to confidential information are taken into account, it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process, including those flowing from the Aarhus Convention35, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002. (36)  To ensure that sectoral specificities with respect to confidential information are taken into account, it is necessary to weigh up the relevant rights of the public to transparency, including the right to benefit from proactive information related to the risk assessment process, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002. The provisions on active dissemination laid down in this Regulation and the assessment of a confidentiality request by the Authority should not in any manner limit the scope of the rights provided by Regulations (EC) No 1049/2001 and (EC) No 1367/2006. _____________________________ 35 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p.13). Amendment 35 Proposal for a regulation Recital 36 a (new) (36a)  The Fitness Check of the General Food Law also highlighted a lack of transparency of the risk management process. There is a need to better inform the public on the risk management options under consideration, the level of protection to consumer and animal health and the environment that each of these options would achieve, as well as on the factors, other than the results of the risk assessment, which are taken into account by the risk managers, and how they are weighed up against each other in the decision-making process. Amendment 36 Proposal for a regulation Recital 37 (37)  In order to further strengthen the link between risk assessors and risk managers at Union and national levels as well as the coherence and consistency of risk communication, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (37)  In order to improve the interactive exchange of information, throughout the risk analysis process, amongst the risk assessors and risk managers at Union and national levels, as well as with other stakeholders of the food chain such as economic operators, consumer and other civil society organisations, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. The general plan on risk communication should lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency of the risk management process. Therefore, it is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. Amendment 37 Proposal for a regulation Recital 37 a (new) (37a)  Provisions regarding what information should be made public should be without prejudice to Regulation (EC) No 1049/2001, as well as national or Union law regarding public access to official documents. Amendment 38 Proposal for a regulation Recital 38 (38)  In order to enable the Authority and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation. (38)  In order to enable the Authority, Member States, the Commission and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation. Amendment 39 Proposal for a regulation Recital 39 a (new) (39a)  Since the amendments contained in this proposal serve to transfer far-reaching competencies for risk assessment and confidentiality checks to the Authority, a significant increase in the budget for the Authority pursuant to Annex 3 of the Commission’s proposal is necessary. The financing proposal is compatible with the current multiannual financial framework but may entail the use of special instruments as defined in Council Regulation (EU, Euratom) No 1311/2013. Should discussions between the European Parliament and the Member States on the Union budget not leave sufficient room for the necessary budgetary resources, then the Commission would have to propose an alternative financing proposal under a delegated act. Amendment 40 Proposal for a regulation Recital 40 a (new) (40a)  Recent food safety incidents have demonstrated the need to establish appropriate measures in emergency situations ensuring that all foods, whatever their type and origin, and all feed should be subject to common measures in the event of a serious risk to human health, animal health or the environment. This comprehensive approach to emergency food safety measures should enable effective action to be taken, avoiding artificial disparities in the treatment of any serious risk to food or feed through a harmonised joint food alerts management procedure. Amendment 41 Proposal for a regulation Article 1 – paragraph – point -1 (new) Regulation (EC) No 178/2002 Article 6 – paragraph 2 (-1)  In Article 6, paragraph 2 is replaced as follows: 2.  Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner. “2. "Risk assessment shall be based on all available scientific evidence and undertaken in an independent, objective and transparent manner." (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Amendment 42 Proposal for a regulation Article 1 – paragraph 1 – point -1 a (new) Regulation (EC) No 178/2002 Article 7 – paragraph 1 (-1a)  In Article 7, paragraph 1 is replaced as follows: 1.  In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment. "1. In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, risk management measures necessary to ensure the high level of health protection chosen in the Community shall be adopted, pending further scientific information for a more comprehensive risk assessment." Amendment 43 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8a Article 8a Article 8a Objectives of risk communication Objectives of risk communication Risk communication shall pursue the following objectives, while taking into account the respective roles of risk assessors and risk managers: Risk communication shall pursue the following objectives, while taking into account the respective roles of risk assessors and risk managers: (a)  promote awareness and understanding of the specific issues under consideration during the entire risk analysis process; (a)  promoting awareness and understanding of the specific issues under consideration during the entire risk analysis and management process; (b)  promote consistency and transparency in formulating risk management recommendations; (b)  promoting consistency, transparency and clarity in formulating risk management options, recommendations and decisions; (c)  provide a sound basis for understanding risk management decisions; (c)  providing a sound scientific basis for understanding risk management decisions, including information on: (i)  how the risk management option chosen reflects the degree of uncertainty of the risk assessment, and the level of consumer and animal health and environmental protection it would achieve; (ii)  as referred to in Article 6(3), the factors, other than the results of the risk assessment, which were considered by the risk managers, and how these factors were weighed up against each other; (d)  foster public understanding of the risk analysis process so as to enhance confidence in its outcome; (d)  fostering public understanding of the risk analysis process so as to enhance confidence in its outcome, including the provision of clear and consistent information regarding the respective tasks, powers and responsibilities of risk assessors and risk managers; (e)  promote appropriate involvement of all interested parties; and, (e)  promoting the balanced involvement of all interested parties, including economic operators of the food chain, consumers and other civil society organisations; (f)  ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain. (f)  ensuring a transparent and equitable exchange of information with the interested parties referred to in point (e) in relation to risks associated with the agri-food chain; (fa)  informing consumers about risk prevention strategies; and (fb)  combating the dissemination of false information and the sources thereof. Amendment 44 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8b Article 8b Article 8b General principles of risk communication General principles of risk communication Taking into account the respective roles of risk assessors and risk managers, risk communication shall: Taking into account the respective roles of risk assessors and risk managers, risk communication shall: (a)  ensure that accurate, appropriate and timely information is interactively exchanged, based on the principles of transparency, openness, and responsiveness; (a)  ensure that accurate, complete and timely information is interactively exchanged with all interested parties, based on the principles of transparency, openness, and responsiveness; (b)  provide transparent information at each stage of the risk analysis process from the framing of requests for scientific advice to the provision of risk assessment and the adoption of risk management decisions; (b)  provide transparent information at each stage of the risk analysis process from the framing of requests for scientific advice to the provision of risk assessment and the adoption of risk management decisions; (c)  take into account risk perceptions; (c)  address risk perceptions; (d)  facilitate understanding and dialogue amongst all interested parties; and, (d)  facilitate understanding and dialogue amongst all interested parties; (e)  be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data. (e)  be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data; and (ea)  formulate approaches to better communicate the difference between hazard and risk. Amendment 45 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8c Article 8c Article 8c General plan for risk communication General plan for risk communication 1.  The Commission, in close cooperation with the Authority, the Member States and following appropriate public consultations shall be empowered to adopt delegated acts in accordance with Article 57a establishing a general plan for risk communication on matters relating to the agri-food chain, taking into account the relevant objectives and general principles set out in Articles 8a and 8b. 1.  The Commission is empowered to adopt, in close cooperation with the Authority, the Member States and following appropriate public consultations, delegated acts in accordance with Article 57a which supplement this Regulation by establishing a general plan for risk communication on matters relating to the agri-food chain, taking into account the relevant objectives and general principles set out in Articles 8a and 8b. 2.  The general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at Union and national level. It shall: 2.  The general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at Union and national level. It shall: (a)  identify the key factors that need to be taken into account when considering the type and level of risk communications’ activities needed; (a)  identify the key factors that need to be taken into account when considering the type and level of risk communications’ activities needed; (b)  identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups; and, (b)  identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the need to ensure the balanced involvement of all interested parties, including economic operators of the food chain, and consumer and other civil society organisations; (c)  establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue amongst all interested parties. (c)  establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers, including by systematically acknowledging and explaining divergences in scientific assessment or in the perception of the acceptable level of risk; (ca)  lay down the practical arrangements and a timeline for making the information referred to in Article 55a(1) available to the public. 3.  The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and experience gained. 3.  The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and experience gained. Amendment 46 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 178/2002 Article 8 d (new) Article 8d Transparency of risk communication 1.  The Commission, the Authority and the Member States shall carry out their tasks as regards risk communication in relation to food law with a high level of transparency. 2.  The Commission may issue appropriate guidelines. Amendment 47 Proposal for a regulation Article 1 – paragraph 1 – point 1 a (new) Regulation (EC) No 178/2002 Article 9 (1a)  Article 9 is replaced by the following: Article 9 "Article 9 Public consultation Public consultation There shall be open and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it. There shall be open and transparent public consultation, directly or through representative bodies, during the risk analysis, as well as during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it." Amendment 48 Proposal for a regulation Article 1 – paragraph 1 – point 1 b (new) Regulation (EC) No 178/2002 Article 10 (1b)  Article 10 is replaced by the following: Article 10 “Article 10 Public information Public information Without prejudice to the applicable provisions of Community and national law on access to documents, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, then, depending on the nature, seriousness and extent of that risk, public authorities shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or feed, or type of food or feed, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk. 1.   Without prejudice to the applicable provisions of Community and national law on access to documents, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, then public authorities shall take appropriate and timely steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the concerned products, the risk that they may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk. This paragraph shall also apply in case of suspected non-compliances resulting from possible intentional violations of applicable Union legislation perpetrated through fraudulent or deceptive practices. 2.  For the purpose of ensuring the uniform implementation of paragraph 1, the Commission shall adopt implementing acts on the modalities of its application by ... 12 months after the entry into force of this amending Regulation.” Amendment 49 Proposal for a regulation Article 1 – paragraph 1 – point 1 c (new) Regulation (EC) No 178/2002 Article 22 – paragraph 7 (1c)  In Article 22(7), the second subparagraph is replaced by the following: It shall act in close cooperation with the competent bodies in the Member States carrying out similar tasks to these of the Authority. “It shall act in cooperation with the other European Union evaluation agencies.” Amendment 50 Proposal for a regulation Article 1 – paragraph 1 – point 1 d (new) Regulation (EC) No 178/2002 Article 23 – paragraph 1 – point b (1d)  In the first paragraph of Article 23, point (b) is replaced by the following: (b)  to promote and coordinate the development of uniform risk assessment methodologies in the fields falling within its mission; “(b) to promote and coordinate in a cross-cutting approach the development of uniform methods for risk assessment in the areas within its mission, in particular taking into account the “cocktail effects” of chemical substances which may have an impact on human health and the environment;” Amendment 51 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point b Regulation (EC) No 178/2002 Article 25 – paragraph 1a 1a.  In addition to members and alternate members referred to in paragraph 1, the Management Board shall include: 1a.  In addition to members and alternate members referred to in paragraph 1, the Management Board shall include: (a)  two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote. (a)  two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote. (b)  one member appointed by the European Parliament, with the right to vote. (b)  two representatives appointed by the European Parliament, with the right to vote. (c)  four members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members. (c)  six members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from public health non-governmental organisations, one from farmers organisations, one from the agro-chemical organisations and one from food industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members. Amendment 52 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point c Regulation (EC) No 178/2002 Article 25 – paragraph 2 2.  The term of office of members and alternate members shall be four years. However, the term of office of the members referred to in paragraph 1a (a) and (b) shall not be limited in duration. The term of office of the members referred to in paragraph 1a(c) may be renewable only once. 2.  The term of office of members referred to in point (b) of paragraph 1a shall be maximum 2,5 years. The term of office of the members referred to in points (a) and (c) of paragraph 1a shall be five years. The term of office of the members referred to in point (c) of paragraph 1a may be renewable only once. Amendment 159 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point -a (new) Regulation (EC) No 178/2002 Article 28– paragraph 4 – subparagraph 1 - introductory part (-a)   In Article 28(4), the introductory part is replaced by the following: "4. The Scientific Panels shall be composed of independent scientists who are actively conducting research, and publishing their research findings in peer-reviewed scientific journals." Amendment 53 Proposal for a regulation Article 1 – paragraph 1 – point 3 – points a and b Regulation (EC) No 178/2002 Article 28 – paragraphs 5 to 5g 5.  The members of the Scientific Committee who are not members of Scientific Panels and the additional members referred to in paragraph 5b shall be appointed by the Management Board, acting upon a proposal from the Executive Director, for a five year term of office, which may be renewable, following publication in the Official Journal of the European Union, in relevant leading scientific publications and on the Authority’s website of a call for expressions of interest.”, 5.  The members of the Scientific Committee who are not members of Scientific Panels and the members of the Scientific Panels shall be appointed by the Management Board for a renewable five year term of office in accordance with the following procedure: 5a.  The members of the Scientific Panels shall be appointed by the Management Board for a renewable five year term of office in accordance with the following procedure: (a)  The Executive Director, after consulting the Management Board, shall send to the Member States the request for the specific multidisciplinary expertise needed in each Scientific Panel and shall indicate the number of experts to be nominated by the Member States. The Executive Director shall notify the Member States of the Authority’s independence policy and implementing rules applicable to Scientific Panels’ members. Member States shall launch a call for interest as a basis for their nominations. The Executive Director shall inform the Management Board of the requests sent to the Member States. (a)  The Executive Director, after consulting the Management Board, shall publish a call for expression of interest in the Official Journal of the European Union, in relevant leading scientific publications and on the Authority`s website, and shall inform the Member States. The call shall lay down the specific multidisciplinary expertise needed in each Scientific Panel and shall indicate the number of experts required. (b)  Member States shall nominate experts with a view to collectively reach the number indicated by the Executive Director. Each Member State shall nominate at least 12 scientific experts. Member States may nominate nationals of other Member States. (b)  Member States shall ensure the broad dissemination of the call for expression of interest across the scientific community. They may also nominate experts for the fields indicated, provided that such nominations are made on the basis of a national call for expression of interest. (c)  On the basis of the nominations made by Member States, the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed. The Executive Director may not draw up such a list where he/she can justify that the nominations received do not allow him, given the criteria for selection set up in point d) of this paragraph, to draw up a larger list. The Executive Director shall submit the list to the Management Board for appointment. (c)  On the basis of the applications and nominations received and in accordance with the Authority’s independence policy and implementing rules applicable to Scientific Panels’ members, the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed. The Executive Director may not draw up such a list where he or she can justify that the applications and nominations received do not allow him or her, given the criteria for selection set up in point (d) of this paragraph, to draw up a larger list. The Executive Director shall submit the list to the Management Board for appointment. (d)  The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria: (d)  The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria: (i)  A high level of scientific expertise; (i)  A high level of scientific expertise; (ii)  Independence and absence of conflict of interests in accordance with Article 37(2) and the Authority’s independence policy and implementing rules on the independence of the Scientific Panels’ members; (ii)  Independence and absence of conflict of interests in accordance with Article 37(2) and the Authority’s independence policy and implementing rules on the independence of the Scientific Panels’ members; (iii)  Meeting the needs for the specific multi-disciplinary expertise of the Panel to which they will be appointed and the applicable language regime. (iii)  Meeting the needs for the specific multi-disciplinary expertise of the Panel to which they will be appointed and the applicable language regime. (e)  The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments. (e)  The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments. 5b.  When the Authority identifies that specific expertise is missing in a Panel or several Panels, the Executive Director shall propose additional members of the Panel(s) for appointment to the Management Board in accordance with the procedure laid down in paragraph 5. 5a.  When the Authority identifies that specific expertise is missing in a Panel or several Panels, the Executive Director shall propose additional members of the Panel(s) for appointment to the Management Board in accordance with the procedure laid down in paragraph 5. 5c.  The Management Board shall adopt, on the basis of a proposal of the Executive Director, rules on the detailed organisation and timing of the procedures set up in paragraphs 5a and 5b of the present Article. 5b.  The Management Board shall adopt, on the basis of a proposal of the Executive Director, rules on the detailed organisation and timing of the procedures set up in paragraphs 5 and 5a of the present Article. 5d.  The Member States shall put in place measures ensuring that the members of the Scientific Panels act independently and remain free from conflict of interests as provided for in Article 37(2) and the Authority’s internal measures. Member States shall ensure that the members of the Scientific Panels have the means to dedicate the necessary time and effort to contribute to the work of the Authority. Member States shall ensure that the members of the Scientific Panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at Union level is recognised as a priority task for the protection of the safety of the food chain. 5c.  Members of the Scientific Panels shall act independently and remain free from conflict of interests as provided for in Article 37(2) and the Authority’s internal measures. They shall have the means to dedicate the necessary time and effort to contribute to the work of the Authority, shall not receive any instruction at any national level, and their independent scientific contribution to the risk assessment system at Union level shall be recognised as a priority task for the protection of the safety of the food chain. 5e.  Member States shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures provided for in paragraph 5d. 5d.  As appropriate, Member States shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures which are necessary to ensure that the conditions referred to in paragraph 5c are met. 5f.  The Authority shall support the tasks of the Panels by organising their work, in particular the preparatory work to be undertaken by the Authority’s staff or by designated national scientific organisations referred to in the Article 36 including by organising the possibility for preparing scientific opinions to be peer-reviewed by the Panels before they adopt them. 5e.  The Authority shall support the tasks of the Panels by organising their work, in particular the preparatory work to be undertaken by the Authority’s staff or by designated national scientific organisations referred to in the Article 36 including by organising the possibility for preparing scientific opinions to be peer-reviewed by the Panels before they adopt them. 5g.  Each Panel shall include a maximum of 21 members. 5f.  Each Panel shall include a maximum of 21 members. 5fa.  The Authority shall offer members of Panels comprehensive training on the risk assessment process. Amendment 54 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point c Regulation (EC) No 178/2002 Article 28 – paragraph 9 – point b The number of members in each Scientific Panel within the maximum provided for in paragraph 5g. (b)  The number of members in each Scientific Panel within the maximum provided for in paragraph 5f. Amendment 55 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point c a (new) Regulation (EC) No 178/2002 Article 28 – paragraph 9 – point g a (new) (ca)  In Article 28(9), the following point is added: “(ga) the possibility for applicants to address, in a maximum period of six months unless otherwise agreed with the Authority, and previous to the publication of the draft opinion of the Authority, critical areas of concern by new data.” Amendment 56 Proposal for a regulation Article 1 – paragraph 1 – point 3 a (new) Regulation (EC) No 178/2002 Article 29 – paragraph 6 (3a)  The following sentence is added at the end of Article 29(6): "They shall not allow a priori exclusion of certain scientific evidences, especially when these have been published after a peer-review process."; Amendment 57 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32a At the request of a potential applicant for a food law authorisation, the staff of the Authority shall advise on the relevant provisions and the required content of the application for authorisation. The advice provided by the staff of the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. The Authority shall publish a guidance document that includes a list of questions and answers regarding the administrative and scientific requirements of an application for authorisation. At the request of a potential applicant for a food law authorisation, the Authority shall also offer consultation sessions to explain what information is required and how the various tests and studies necessary to prove the quality, safety and efficacy of the planned product are to be carried out. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. The staff of the Authority providing the advice shall not be involved in any preparatory scientific work that is directly or indirectly relevant to the application that is the subject of the advice. Within ... [36 months after the entry into force of the amending Regulation], the Commission shall assess the impact of this Article on the functioning of the Authority. Particular attention shall be paid to the additional workload and mobilisation of staff, and whether it has led to any shift in the allocation of the Authority’s resources, at the expense of activities of public interest. Amendment 58 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 1 1.  A Union register of studies commissioned by business operators to obtain an authorisation under Union food law is hereby established. Business operators shall notify, without delay, to the Authority the subject matter of any study commissioned to support a future application for an authorisation under Union food law. The register shall be managed by the Authority. 1.  A Union register of studies commissioned by business operators seeking to obtain an authorisation or renewal under Union food law is hereby established. Business operators shall notify, without delay, to the Authority the subject matter of any study commissioned in the Union and beyond to support a future application for an authorisation or renewal under Union food law. The register shall be managed by the Authority. Amendment 59 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 1 a (new) 1a.  Any studies commissioned shall take account of Directive 2010/63/EU of the European Parliament and of the Council1a . ________________ 1a Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33). Amendment 60 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 2 2.  The notification obligation under paragraph 1, also applies to Union laboratories carrying out those studies. 2.  The notification obligation under paragraph 1 also applies to any institution carrying out the studies, including laboratories, institutes or universities. Amendment 61 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 2 a (new) 2a.  Data from a test commissioned but not registered shall not be used in a risk assessment. Amendment 62 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 2 b (new) 2b.  The subject matter shall not be authorised unless all data from all registered studies are submitted. Amendment 63 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 3 a (new) 3a.  Where the Authority requests and receives additional data by an applicant, this data is, marked as such, also added to the Union register and made available to the public. Amendment 64 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 4 a (new) 4a.  The Commission shall adopt delegated acts in accordance with Article 57a supplementing this Regulation by establishing penalties for breaches of the notification obligation. Amendment 65 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32b – paragraph 4 b (new) 4b.  This Article shall not be applicable to studies commissioned before ... [the date of entry into force of this amending Regulation]. Amendment 66 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32c – paragraph 1 1.  Where Union food law provides that an authorisation may be renewed, the potential applicant for the renewal shall notify the Authority of the studies it intends to perform for that purpose. Following this notification, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal and shall provide advice on the content of the intended renewal application taking into account the received comments. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications for renewal of authorisation by the Scientific Panels. 1.  Where Union food law provides that an authorisation may be renewed, the potential applicant for the renewal shall notify the Authority of the studies it intends to perform for that purpose. Following this notification, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal and shall provide advice on the content of the intended renewal application taking into account the received comments which are relevant for the risk assessment of the intended renewal. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications for renewal of authorisation by the Scientific Panels. Amendment 67 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32c – paragraph 2 2.  The Authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation. This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process. 2.  The Authority shall, within two months, consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies that are based on independent peer-reviewed literature or have been carried out in accordance with international guidelines and Good Laboratory Practices (GLP) are available on the subject matter concerned by the application for authorisation, and are without prejudice to the Authority’s own obligations under Article 33. This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process. Amendment 68 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32d The Commission experts shall perform controls, including audits, to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States. The Commission’s Directorate for Health and Food Audits and Analysis experts shall perform controls, including audits, to obtain assurance that testing facilities in the Union and in third countries comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States or of the third countries concerned. Amendment 161 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32e Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances, may request the Authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification. Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, in the event of divergent scientific findings, the Commission may request the Authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification in the risk assessment process. Verification studies shall be funded via the contributions of applicants to a common fund. The Commission shall adopt a delegated act in accordance with Article 57a to determine the modalities of that fund. Amendment 70 Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32e – paragraph 1 a (new) Any studies commissioned shall take into account Directive 2010/63/EU. Amendment 71 Proposal for a regulation Article 1 – paragraph 1 – point 4 a (new) Regulation (EC) No 178/2002 Article 33 – paragraph 1 – point d a (new) (4a)  In Article 33(1), the following point is added: “(da) combinatorial and accumulated effects.” Amendment 72 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – introductory part 1.  The Authority shall carry out its activities with a high level of transparency. It shall in particular make public without delay: 1.  The Authority shall carry out its activities with a high level of transparency in line with Regulation (EC) No 1367/2006 and without prejudice to Regulation (EC) No 1049/2001. It shall in particular make public without delay: Amendment 73 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point a (a)  agendas and minutes of the Scientific Committee and the Scientific Panels and their Working Groups; (a)  agendas, participants lists, and minutes of the Management Board, the Advisory Committee, the Scientific Committee and the Scientific Panels and their Working Groups; Amendment 74 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point c (c)  scientific data, studies and other information supporting applications for authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, taking into account protection of confidential information and protection of personal data in accordance with Articles 39 to 39f. (c)  scientific data, studies and other information supporting applications for authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, taking into account the overriding public interest in disclosure and the protection of confidential information and protection of personal data in accordance with Articles 39 to 39f. Amendment 75 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point d (d)  the information on which its scientific outputs, including scientific opinions are based, taking into account protection of confidential data and protection of personal data in accordance with Articles 39 to 39f; (d)  the information on which its scientific outputs, including scientific opinions are based, taking into account the overriding public interest in disclosure and the protection of confidential data and protection of personal data in accordance with Articles 39 to 39f; Amendment 76 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point h a (new) (ha)  information on the name of the applicant and the title of the application; Amendment 77 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point i (i)  advice provided by the Authority to potential applicants at pre-submission phase pursuant to Article 32a and 32c. (i)  the general advice provided by the Authority to potential applicants at pre-submission phase pursuant to Articles 32a and 32c. Amendment 78 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 2 Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority’s website. That section shall be publicly available and easily accessible. The relevant items shall be available to download, print and search through in an electronic format. Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority’s website. That section shall be publicly available and easily accessible subject to clear undertakings recorded electronically by those accessing it and subject to measures and penalties which are effective, proportionate and dissuasive against any commercial use. The relevant items shall be available to download, print with a watermark for traceability and search through in an electronic format, which is machine-readable. Those measures shall focus on the commercial use of documents and their submission. Such measures shall be designed to protect effectively against commercial use of items referred to in the first subparagraph both within the Union and in third countries. Amendment 79 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1a – subparagraph 1 – introductory part 1a.  The disclosure of the information mentioned in paragraph (1)(c) to the public shall be without prejudice: 1a.  The disclosure of the information mentioned in points (c), (d) and (i) of paragraph 1 to the public shall be without prejudice: Amendment 80 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1a – subparagraph 1 – point a (a)  to any intellectual property right which may exist over documents or their content; and, deleted Amendment 163 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1a – subparagraph 2 The disclosure to the public of the information mentioned in paragraph (1)(c) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used, reproduced, or otherwise exploited and its use by third parties shall not engage the responsibility of the European Union. The disclosure to the public of the information mentioned in paragraph (1)(c) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be commercially used, reproduced, or otherwise exploited for commercial purposes. For the avoidance of doubt, the information published may be used for the purpose of public and academic scrutiny of the results, including a better understanding of the potential adverse effects on health and the environment, and its use by third parties shall not engage the responsibility of the Union. Amendment 82 Proposal for a regulation Article 1 – paragraph 1 – point 5 – point c a (new) Regulation (EC) No 178/2002 Article 38 – paragraph 3 a (new) (ca)   the following paragraph is added: “3a. This Article is without prejudice to Directive 2003/4/EC and to Regulations (EC) No 1049/2001 and (EC) No 1367/2006.” Amendment 83 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 1 1.  By way of derogation from Article 38, the Authority shall not make public information for which confidential treatment has been requested under the conditions laid down in this Article. 1.  By way of derogation from Article 38 and without prejudice to Regulation (EC) No 1049/2001 and Directive 2003/4/EC and the general principle that the interests of public health always prevail over private interests, the Authority shall not make public information for which confidential treatment has been requested and granted in fulfilment of the conditions laid down in this Article. Amendment 84 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 1 (1)  the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion; (1)  the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion, except when relevant to understanding the potential effects on health and the environment, and provided that the applicant demonstrates with verifiable justification that such method does not entail information about emissions in the environment and about impacts on health and environment; Amendment 85 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 3 (3)  commercial information revealing sourcing, market shares or business strategy of the applicant; and (3)  commercial information revealing sourcing, innovative ideas for the product/substance, market shares or business strategy of the applicant; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Amendment 86 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 4 (4)  quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion. (4)  quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion, except when relevant to understanding the potential effects on health and the environment. Amendment 87 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point a (a)  Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and, (a)  Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; or, Amendment 88 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b (b)  information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable health effects. (b)  information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable effects on public health, animal health and the environment. Amendment 89 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b a (new) (ba)  where an overriding public interest in disclosure exists. Amendment 90 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b b (new) (bb)  any information for which there is an overriding public interest in disclosure under Article 4(2) of Regulation (EC) No 1049/2001 and Article 6 of Regulation (EC) No 1367/2006, in particular where the information relates to emissions into the environment. Amendment 91 Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 a (new) 4a.  This Article is without prejudice to Directive 2003/4/EC and Regulations (EC) No 1049/2001 and (EC) No 1367/2006. Amendment 92 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39a – paragraph 2 2.  Where an applicant submits a request for confidentiality, it shall provide a non-confidential version and a confidential version of the information submitted in accordance with standard data formats, where they exist, pursuant to Article 39f. The non-confidential version shall be without the information the applicant deems confidential in accordance with paragraphs 2 and 3 of Article 39. The confidential version shall contain all information submitted, including information the applicant deems confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information. 2.  Where an applicant submits a request for confidentiality, it shall provide a non-confidential version and a confidential version of the information submitted in accordance with standard data formats, where they exist, pursuant to Article 39f. The non-confidential version shall edit, with black bars, the information, for which confidential treatment has been requested by the applicant in accordance with paragraphs 2 and 3 of Article 39. The confidential version shall contain all information submitted, including information the applicant considers as confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate verifiable justifications and evidence on the basis of which confidentiality is requested for the different pieces of information. Amendment 167 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 - subparagraph 1 - point a (a)  make public, without delay, the non-confidential version, as submitted by the applicant; (a)  make public, without delay, the non-confidential version of the application, as submitted by the applicant, once that application has been considered admissible; Amendment 93 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – subparagraph 1 – point c (c)  inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant disagrees with the assessment of the Authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the Authority’s position. (c)  inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant objects to the assessment of the Authority it may (1) state its views, (2) withdraw its application, or (3) request a review to the Authority’s Board of Appeal within four weeks from the date on which it was notified of the Authority’s position. The applicant may provide written notice to the Authority that it wishes to request a re-examination of the opinion to the Authority’s Board of Appeal. In that case, the applicant shall forward to the Authority the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days after receipt of the grounds for the request, the Authority’s Board of Appeal shall re-examine its opinion; Amendment 94 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – subparagraph 1 – point d (d)  adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within ten weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, as appropriate, of its decision; and, (d)  adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within eight weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, in every case, of its decision; and, Amendment 140 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – subparagraph 1 - point e (e)  make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place, pursuant to point (d). (e)  publish non-confidential data and information relating to the application only once a final decision has been taken in respect of the confidentiality request pursuant to this Article and the Authority has published its draft scientific opinion in line with Article 38. Where an applicant withdraws the application pursuant to Article 39(c) because the applicant deems the publication of the information planned by the Authority to be too comprehensive, the Authority, the Commission and the Member States shall refrain from publishing any information on the application for authorisation. Amendment 96 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39b – paragraph 1 – subparagraph 2 Decisions taken by the Authority pursuant to this Article may be subject to an action before the Court of Justice of the European Union, under the conditions laid down in Articles 263 and 278 of the Treaty respectively. Decisions taken by the Authority pursuant to this Article may be subject to an action before the Authority’s Board of Appeal, which shall be established by the Commission by means of delegated acts. Those delegated acts shall be adopted in accordance with Article 57a of this Regulation. A submission of an appeal pursuant to this paragraph shall have suspensive effect. The applicant may provide written notice to the Authority that he or she wishes to request a re-examination of the opinion to the Authority’s Board of Appeal. In that case the applicant shall forward to the Authority the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days after receipt of the grounds for the request, the Authority’s Board of Appeal shall re-examine its opinion. In case of a contesting decision taken by the Authority’s Board of appeal, a case may be brought before the Court of Justice of the European Union under the conditions laid down in Article 263 of the Treaty. Amendment 97 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39d – paragraph 2 2.  The Commission and the Member States shall take the necessary measures so that information received by them under Union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and has become definitive. The Commission and the Member States shall also take the necessary measures so that information for which confidential treatment has been accepted by the Authority is not made public. 2.  The Commission and the Member States shall take the necessary measures so that information received by them under Union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and has become definitive, except for when access to information is requested in accordance with Directive 2003/4/EC or national law on access to documents. The Commission and the Member States shall also take the necessary measures so that information for which confidential treatment has been accepted by the Authority is not made public, except for when access to information is requested in accordance with Directive 2003/4/EC or national law on access to documents. Amendment 98 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39d – paragraph 3 3.  If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public the information for which confidentiality has been requested. 3.  If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. The Authority shall not publish any information, confidential or non-confidential, should an applicant decide to withdraw its application. Amendment 99 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39e – paragraph 1 – point c (c)  the names of all participants in meetings of the Scientific Committee and the Scientific Panels and their Working Groups. (c)  the names of all participants and observers in meetings of the Scientific Committee and the Scientific Panels, their Working Groups and any other ad hoc Group meeting on the subject. Amendment 101 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39f – paragraph 1 1.  For the purposes of Article 38(1)(c) and in order to ensure the efficient processing of requests to the Authority for a scientific output, standard data formats and software packages shall be adopted to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union food law. These draft standard data formats and software packages shall not be based on proprietary standards and shall ensure interoperability with existing data submission approaches to the extent possible. 1.  For the purposes of Article 38(1)(c) and in order to ensure the efficient processing of requests to the Authority for a scientific output, standard data formats and software packages shall be adopted to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union food law and feasibility for small and medium-sized enterprises. These draft standard data formats and software packages shall not be based on proprietary standards and shall ensure interoperability with existing data submission approaches to the extent possible. Amendment 102 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39f – paragraph 2 a (new) 2a.  The standard data formats and software packages shall only apply to data generated after adoption of the implementing acts in accordance with point (b) of paragraph 2. Amendment 103 Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39g – paragraph 1 The information systems operated by the Authority to store its data, including confidential and personal data shall be designed to a high level of security appropriate to the security risks at stake, taking into account Articles 39 to 39f of this Regulation. Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security. The system shall ensure that any access to it is fully auditable. The information systems operated by the Authority to store its data, including confidential and personal data shall be designed in a way that guarantees that the highest standards of security appropriate to the security risks at stake will be attained, taking into account Articles 39 to 39f of this Regulation. Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security. The system shall ensure that any access to it is fully auditable. Amendment 104 Proposal for a regulation Article 1 – paragraph 1 – point 9 Regulation (EC) No 178/2002 Article 41 – paragraph 1 Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council39 shall also apply. The Authority shall ensure wide access to the documents held by it. Where environmental information is concerned, Regulation (EC) No 1367/2006 of the European Parliament and of the Council39 shall also apply. Articles 38 to 39 of this Regulation shall apply without prejudice to the application of Regulations (EC) No 1049/2001 and (EC) No 1367/2006. __________________ __________________ 39 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13). 39 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13). Amendment 106 Proposal for a regulation Article 1 – paragraph 1 – point 9 b (new) Regulation (EC) No 178/2002 Article 51 – paragraph 1 a (new) (9b)  In Article 51, the following paragraph is inserted: “1a. The Commission shall adopt a delegated act in accordance with Article 57a to develop a harmonised food alert network management system between the Commission and the Member States.” Amendment 107 Proposal for a regulation Article 1 – paragraph 1 – point 10 Regulation (EC) No 178/2002 Article 57a – paragraph 2 2.  The powers to adopt delegated acts referred to in Article 8(c) shall be conferred upon the Commission for an indeterminate period of time from [date of entry into force of this Regulation]. 2.  The powers to adopt delegated acts referred to in Article 8(c), 32b(4a), subparagraph 2 of Article 39b(1) and Article 51(1a) shall be conferred upon the Commission for a period of five years from [date of entry into force of this Regulation]. Amendment 108 Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 Article 61 Article 61 Review clause Review clause 1.  The Commission shall ensure the regular review of the application of this Regulation. 1.  The Commission shall ensure the regular review of the application of this Regulation. 2.  Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority’s performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines. The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification. 2.  Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Authority jointly with the Commission shall commission an independent external evaluation of their performance and achievements in relation to their objectives, mandates, tasks, procedures and locations. The evaluation shall be based on the Management Board’s work programme in agreement with the Commission. It shall assess the working practices and the impact of the Authority and address the possible need to modify the mandate of the Authority, including the financial implications of any such modification. It shall, furthermore, address the possible need to coordinate and dovetail the Authority’s activities more closely with those of the competent bodies in the Member States and other Union agencies. The evaluation shall take into account the views of the stakeholders, at both Union and national level. 2a.  The Management Board shall examine the conclusions of the evaluation and issue recommendations to the Commission, which may concern changes in the Authority. 3.  Where the Commission considers that the continuation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed. 4.  The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings. The findings of the evaluation shall be made public. 4.  The evaluations and recommendations referred to in paragraphs 2 and 2a shall be forwarded to the Commission, the Council, the European Parliament and the Management Board. The findings of the evaluation and the recommendations shall be made public. Amendment 109 Proposal for a regulation Article 2 – paragraph 1 – point 2 a (new) Directive 2001/18/EC Article 24 – paragraph 2 a (new) (2a)   In Article 24, the following paragraph is added: “2a. The obligation to proactively disseminate the information set out in paragraph 1 of this Article, in line with Article 25 of this Directive, and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.” Amendment 110 Proposal for a regulation Article 3 – paragraph 1 – point 9 Regulation (EC) No 1829/2003 Article 29 – paragraph 1 1.  The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions and opinions from the competent authorities referred to in Article 4 of Directive 2001/18/EC, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation. 1.  The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, monitoring reports as well as its scientific opinions and opinions from the competent authorities referred to in Article 4 of Directive 2001/18/EC, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation. Amendment 111 Proposal for a regulation Article 3 – paragraph 1 – point 9 Regulation (EC) No 1829/2003 Article 29 – paragraph 1 a (new) 1a.   The obligation to proactively disseminate the information set out in paragraph 1 of this Article, in line with Article 30 of this Regulation, and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006. Amendment 112 Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) Regulation (EC) No 1831/2003 Article 17 – paragraph 2 a (new) (1a)   In Article 17, the following paragraph is added: “2a. The obligation to proactively disseminate information set out in this Article and in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.” Amendment 113 Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3 3.  In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) of that Regulation, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: deleted (a)  the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) and Annex I to this Regulation; and, (b)  specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment. Amendment 114 Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3 a (new) 3a.   The Authority shall apply the principles of Regulation (EC) No 1049/2001 when handling applications for access to documents held by the Authority. Amendment 115 Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3 b (new) 3b.   The Member States, the Commission and the Authority shall keep confidential all the information identified as confidential under paragraph 2 of this Article except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001. Amendment 116 Proposal for a regulation Article 5 – paragraph 1 – point 2 Regulation (EC) No 2065/2003 Article 14 – paragraph 1 a (new) 1a.  The obligation to proactively disseminate information set out in paragraph 1 of this Article, in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006. Amendment 117 Proposal for a regulation Article 6 – paragraph 1 – point 2 a (new) Regulation (EC) No 1935/2004 Article 19 – paragraph 2 a (new) (2a)  In Article 19, the following paragraph is added: “2a. The obligation to proactively disseminate information set out in paragraph 1 of this Article, including Article 20 of this Regulation, and Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulations (EC) No 1049/2001 and (EC) No 1367/2006.” Amendment 119 Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 2 – point b (b)  the trademark under which the substance, shall be marketed as well as the tradename of the preparations, material or articles in which it shall be used, where applicable; and, deleted Amendments 120 and 121 Proposal for a regulation Article 7 – paragraph 1 – point 2 Regulation (EC) No 1331/2008 Article 11 – paragraph 1 a (new) 1a.  The obligation to proactively disseminate information set out in paragraph 1 of this Article, in line with Article 12 of this Regulation and Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006. Amendment 122 Proposal for a regulation Article 7 – paragraph 1 – point 3 Regulation (EC) No 1331/2008 Article 12 – paragraph 3 a (new) 3a.  The provisions on active dissemination laid down in Articles 11 and 12 of this Regulation, and Articles 38 and 39 of Regulation (EC) No 178/2002, are without prejudice to the right of access to documents upon request set in Regulation (EC) No 1049/2001. Amendment 170 Proposal for a regulation Article 8 – paragraph 1 – point 4 Regulation (EC) No 1107/2009 Article 16 The Authority shall assess, without delay, any request for confidentiality and make available to the public the information provided by the applicant under Article 15 as well as any other supplementary information submitted by the applicant, except for information in respect of which confidential treatment has been requested and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and pursuant to Article 63 of this Regulation. The Authority shall assess, without delay, any request for confidentiality and make available to the public the information provided by the applicant under Article 15 as well as any other supplementary information submitted by the applicant, except for information in respect of which confidential treatment has been requested and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and pursuant to Article 63 of this Regulation, unless there is an overriding public interest in its disclosure. Amendment 123 Proposal for a regulation Article 8 – paragraph 1 – point 4 a (new) Regulation (EC) No 1107/2009 Article 23 – paragraph 1 – last sentence (4a)  In Article 23(1), the last sentence is replaced by the following: For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance. “For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as an approved basic substance.” Amendment 124 Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 1 1.  In accordance with the conditions and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this article, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification. 1.  In accordance with the conditions and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this Article, except for information that is considered toxicologically, ecotoxicologically or environmentally relevant, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by adequate and verifiable justification. The justification shall include verifiable evidence to show that the disclosure of the information might undermine his commercial interests, or the protection of privacy and the integrity of the individual. Amendment 126 Proposal for a regulation Article 8 – paragraph 1 – point 5 a (new) Regulation (EC) No 1107/2009 Article 63 – paragraph 3 (5a)   in Article 63, paragraph 3 is replaced by the following: 3.  This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information “3. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and to Regulations (EC) No 1049/2001 and (EC) No 1367/2006.” Amendment 127 Proposal for a regulation Article 9 – paragraph 1 – point 1 – point a Regulation (EC) No 2015/2283 Article 10 – paragraph 1 1.  The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission’s initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002. The Commission shall make the application available to the Member States without delay. 1.  The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission’s initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002. The Commission shall make the application available to the Member States and the summary of the application publicly available without delay. Amendment 128 Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 4 a (new) 4a.  The provisions on active dissemination laid down in Article 23 of this Regulation, and Articles 38 and 39 of Regulation (EC) No 178/2002, are without prejudice to the right of access to documents upon request set in Regulation (EC) No 1049/2001. Amendment 129 Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 4 b (new) 4b.  The Commission may, by means of implementing acts, adopt detailed rules on the implementation of paragraphs 1 to 4 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3). Amendment 130 Proposal for a regulation Article 9 – paragraph 1 – point 4 a (new) Regulation (EU) No 2015/2283 Article 25 – paragraph 1 a (new) (4a)   In Article 25, the following paragraph is added: “1a. The obligation to proactively disseminate the information set out in this Regulation, in line with Articles 38 and 39 of Regulation (EC) No 178/2002, is without prejudice to the right of any natural or legal person to access documents upon request as set out in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.” Amendment 131 Proposal for a regulation Article 9 a (new) Article 9a Transparency of risk management 1.  The Commission and the Member States shall carry out their risk management activities in the context of the legislative acts referred to in Articles 1 to 9 with a high level of transparency. They shall in particular make public without undue delay: (a)  at an early stage of the risk management process, any envisaged the draft risk management measures; (b)  the agendas and proceedings, detailed summary reports of meetings, and the draft measures, to be adopted, as appropriate, in the form of delegated or implementing acts, including the results and explanations of votes by individual Member States in committees within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council 1a, including the appeal committees, which assist the Commission in the implementation of [Regulation (EC) No 178/2002, Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 2065/2003, Regulation (EC) No 1935/2004, Regulation (EC) No 1331/2008, Regulation (EC) No 1107/2009 and Regulation No 2015/2283], where and in which the risk management measures are discussed and put to a vote; and (c)  the agendas and the detailed minutes of meetings of the Member States working groups in which the risk management measures are discussed. 2.  For the purposes of paragraph 1 of this Article, the Commission shall attach to each draft measure to be adopted on in accordance with Article 58 [of the GFL Regulation], Article 30 of Directive 2001/18/EC, Article 35 of Regulation (EC) No 1829/2003, Article 22 of Regulation (EC) No 1831/2003, Article 19 of Regulation (EC) No 2065/2003, Article 23 of Regulation (EC) No 1935/2004, Article 14 of Regulation (EC) No 1331/2008, Article 79 of Regulation (EC) No 1107/2009, and Articles 30 and 32 of Regulation EU (No) 2015/2283 an explanatory statement comprising: (a)  the reasons for and objectives of the measure; (b)  the justification of the measure taking into consideration both need and proportionality; (c)  the impact of the measure on public and animal health, the environment, on the society and on food manufacturers as indicated by the impact assessment; and (d)  the results of any public consultation, including pursuant to Article 9 of [the GFL Regulation]. _______________ 1a Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(1) The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A8-0417/2018).

European Parliament legislative resolution of 11 December 2018 on the proposal for a regulation of the European Parliament and of the Council establishing a European Centre for the Development of Vocational Training (Cedefop) and repealing Regulation (EEC) No 337/75 (COM(2016)0532 – C8-0343/2016 – 2016/0257(COD))

P8_TA(2018)0490 A8-0273/2017

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2016)0532),

–  having regard to Article 294(2) and to Article 166(4), Article 165(4) and Article 149 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0343/2016),

–  having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 30 March 2017(1),

–  after consulting the Committee of the Regions,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 9 November 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rules 59 and 39 of its Rules of Procedure,

–  having regard to the report of the Committee on Employment and Social Affairs and the opinion of the Committee on Budgets (A8-0273/2017),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 11 December 2018 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council establishing a European Centre for the Development of Vocational Training (Cedefop) and repealing Council Regulation (EEC) No 337/75

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/128.)

(1) OJ C 209, 30.6.2017, p. 49.

European Parliament legislative resolution of 11 December 2018 on the proposal for a regulation of the European Parliament and of the Council establishing the European Agency for Safety and Health at Work (EU-OSHA), and repealing Council Regulation (EC) 2062/94 (COM(2016)0528 – C8-0344/2016 – 2016/0254(COD))

P8_TA(2018)0491 A8-0274/2017

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2016)0528),

–  having regard to Article 294(2) and Article 153(2)(a) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0344/2016),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 30 March 2017(1),

–  after consulting the Committee of the Regions,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 9 November 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Employment and Social Affairs and the opinion of the Committee on Budgets (A8-0274/2017),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 11 December 2018 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council establishing the European Agency for Safety and Health at Work (EU-OSHA), and repealing Council Regulation (EC) No 2062/94

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/126.)

(1) OJ C 209, 30.6.2017, p. 49.

European Parliament legislative resolution of 11 December 2018 on the proposal for a regulation of the European Parliament and of the Council establishing the European Foundation for the improvement of living and working conditions (Eurofound), and repealing Council Regulation (EEC) No 1365/75 (COM(2016)0531 – C8-0342/2016 – 2016/0256(COD))

P8_TA(2018)0492 A8-0275/2017

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2016)0531),

–  having regard to Article 294(2) and point (a) of Article 153(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0342/2016),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 30 March 2017(1),

–  after consulting the Committee of the Regions,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 9 November 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Employment and Social Affairs and the opinion of the Committee on Budgets (A8-0275/2017),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 11 December 2018 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council establishing the European Foundation for the improvement of living and working conditions (Eurofound), and repealing Council Regulation (EEC) No 1365/75

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/127.)

(1) OJ C 209, 30.6.2017, p. 49.

European Parliament legislative resolution of 11 December 2018 on the proposal for a regulation of the European Parliament and of the Council complementing EU type-approval legislation with regard to the withdrawal of the United Kingdom from the Union (COM(2018)0397 – C8-0250/2018 – 2018/0220(COD))

P8_TA(2018)0493 A8-0359/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0397),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0250/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 September 2018(1),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 28 November 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0359/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 11 December 2018 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council complementing Union type-approval legislation with regard to the withdrawal of the United Kingdom from the Union

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/26.)

(1) OJ C 440, 6.12.2018, p. 95.

European Parliament resolution of 11 December 2018 with recommendations to the Commission on Humanitarian Visas (2018/2271(INL))

P8_TA(2018)0494 A8-0423/2018

The European Parliament,

–  having regard to Article 225 of the Treaty on the Functioning of the European Union,

–  having regard to the Charter of Fundamental Rights of the European Union, and in particular Articles 4, 18 and 19 thereof,

–  having regard to the Convention Relating to the Status of Refugees, signed in Geneva on 28 July 1951 and the 1967 Protocol thereto,

–  having regard to Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code)(1),

–  having regard to the United Nations Global Compact for Safe, Orderly and Regular Migration and to the United Nations Global Compact on Refugees, which followed the New York Declaration for Refugees and Migrants adopted unanimously by the United Nations General Assembly on 19 September 2016,

–  having regard to the European Added Value Assessment on Humanitarian Visas prepared by the European Parliamentary Research Service,

–  having regard to Rules 46 and 52 of its Rules of Procedure,

–  having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs (A8-0423/2018),

A.  whereas, despite numerous announcements and requests for safe and legal pathways offering access to European territory for persons seeking international protection, there is currently no harmonisation at Union level of protected entry procedures (PEPs) and no legal framework at Union level for humanitarian visas, i.e. visas issued for the purpose of reaching the territory of the Member States in order to seek international protection;

B.  whereas, according to the judgment of the Court of Justice of 7 March 2017 in Case C-638/16(2), X and X v État belge, Member States are not required, under Union law, to grant humanitarian visas to persons who wish to enter their territory with a view to applying for asylum, but they remain free to do so on the basis of their national law; whereas this ruling interprets existing Union law, which may be modified;

C.  whereas several Member States currently have or have previously had national schemes for issuing humanitarian visas or residence permits to guarantee national PEPs for people in need;

D.  whereas the number of persons admitted on the basis of national entry procedures for humanitarian protection or through resettlement remains low in comparison to global needs, with significant disparities between Member States; whereas the scope of national entry procedures for humanitarian protection and resettlement is narrowly defined and, in the case of resettlement, is strictly connected to the criteria of vulnerability and registration as a refugee of the Office of the United Nations High Commissioner for Refugees;

E.  whereas, as a result, an estimated 90 % of those granted international protection have reached the Union through irregular means, which leads to them being stigmatised before they even arrive at the external borders of the Member States;

F.  whereas single women travelling alone or with children, women heads of household, pregnant and lactating women, people with disabilities, adolescent girls and elderly women are among those who are particularly vulnerable along migration routes to Europe and are facing particular greater risks of gender-based violence, such as rape, violence and being the target of smugglers and traffickers to be sexually and economically exploited; whereas women and girls furthermore tend to be more vulnerable to all forms of exploitation, including labour exploitation and sexual exploitation, along the migration routes to the Union and are often forced into survival sex in exchange for continuing their journey;

G.  whereas the human cost of those policies has been put at at least 30 000 deaths at the Union's borders since 2000; whereas a Union legal framework is urgently needed as one means to address the intolerable death toll in the Mediterranean and on the migration routes to the Union, to truly combat human smuggling, exposure to trafficking in human beings, to labour exploitation and violence, to manage the orderly arrival, dignified reception and fair processing of asylum claims and to optimise Member States’ and the Union’s budget for asylum, procedures, border control and search and rescue activities as well as to achieve coherent practices in the Union asylum acquis;

H.  whereas Parliament has tried to include provisions in that vein in its amendments to Regulation (EC) No 810/2009;

I.  whereas both the Council and the Commission have rejected those amendments on the ground, among others, that such provisions should not be included in Regulation (EC) No 810/2009 given that its scope covers short-stay visas only;

J.  whereas Parliament, faced with the Commission’s inaction, has therefore decided to proceed with drawing up this resolution on humanitarian visas;

K.  whereas intensive work was undertaken, including with the help of experts, to draw up the recommendations which are annexed to this resolution;

1.  Requests the Commission to submit, by 31 March 2019, on the basis of point (a) of Article 77(2) of the Treaty on the Functioning of the European Union (TFEU), a proposal for a regulation establishing a European Humanitarian Visa following the recommendations set out in the Annex hereto;

2.  Considers that Member States should have the possibility to issue European Humanitarian Visas to persons seeking international protection to allow those persons to enter the territory of the Member State issuing the visa for the sole purpose of making an application for international protection in that Member State;

3.  Considers that European Humanitarian Visas should be complementary to, and not substitute, the existing national entry procedures for humanitarian protection, resettlement procedures and spontaneous applications under international refugee law, and that the decision to issue European Humanitarian Visas should remain the sole competence of the Member States;

4.  Considers that any initiative on European Humanitarian Visas should be without prejudice to other migration policy initiatives, including those aiming to address the root causes of migration;

5.  Emphasises the pressing need for safe and legal pathways to the Union, of which the European Humanitarian Visa should be one, which is also especially important from a gender perspective since women are particularly vulnerable and therefore more exposed to sexual and gender-based violence along routes and in reception centres; emphasises that vulnerable economic and other types of dependencies often put women and girls in third countries in a situation where it is even more difficult for them than for men to safely seek asylum;

6.  Considers that part of the financial implications of the requested proposal should be covered by the general budget of the Union as a practical expression of the principle of solidarity and fair sharing of responsibility, including its financial implications, between the Member States, in accordance with Article 80 TFEU;

7.  Instructs its President to forward this resolution and the accompanying recommendations to the Commission and the Council, and to the national parliaments, the Court of Justice of the European Union, the European External Action Service, the European Asylum Support Office, the European Border and Coast Guard Agency, the European Union Agency for Law Enforcement Cooperation and the European Union Agency for Fundamental Rights.

ANNEX TO THE RESOLUTION

RECOMMENDATIONS AS TO THE CONTENT OF THE PROPOSAL REQUESTED

The European Parliament considers that the legislative act to be adopted should:

1.  FORM AND TITLE OF THE INSTRUMENT TO BE ADOPTED

–  be a separate legal act to be adopted in the form of a regulation entitled “Regulation of the European Parliament and of the Council establishing a European Humanitarian Visa”,

2.  LEGAL BASIS

–  have point (a) of Article 77(2) of the Treaty on the Functioning of the European Union (TFEU) as its legal basis,

3.  JUSTIFICATION

–  be justified by:

–  the current legal gap in Union law which, in addition to resettlement procedures applicable to vulnerable refugees, does not provide for procedures, either in the visa acquis or in the borders or asylum acquis, for the admission to the territory of the Member States of persons seeking protection, with an estimated 90 % of the persons subsequently being recognised as refugees and beneficiaries of subsidiary protection reaching the territory of the Member States irregularly,(3) often through life-threatening routes,

–  the risk of fragmentation as Member States increasingly set up their own programmes of humanitarian admission and procedures, going against the general aim under Article 78(1) TFEU to develop a common policy on asylum, subsidiary protection and temporary protection, and leading also to the risk that these different schemes undermine the uniform application of the common provisions on entry to the territory of the Member States of third-country nationals as laid down in the Regulations (EC) No 810/2009(4) and (EU) 2016/399(5) of the European Parliament and of the Council,

–  the high costs, in human but also in social, economic and budgetary terms, associated with the status quo for the third-country nationals concerned (smuggler fees, risk of trafficking and exploitation, risk of persecution, risk of death and ill treatment, etc.) and for Member States and the Union (elevated budget for search and rescue, including for private shipping, border protection, cooperation with third countries, asylum procedures and possibly return in case of rejected applications for international protection as well as the fight against organised crime, trafficking and smuggling etc.),

–  the added value of Union action, in terms of ensuring compliance with Union values, including fundamental rights, mutual trust between Member States and confidence in the system by asylum seekers, legal certainty, foreseeability, and the uniform application and implementation of the rules, the achievement of economies of scale, and the reduction of the above-cited costs of the status quo,

–  recall that Directive 2013/32/EU of the European Parliament and of the Council(6) and Regulation (EU) No 604/2013 of the European Parliament and of the Council(7) only apply on the territory of the Member States, while there are, at present, insufficient legal ways for asylum applicants to reach that territory,

–  recall that, after the submission of an asylum application in a Member State, the provisions of the Union’s Common European Asylum System apply,

–  stress that a refusal of an application for a European Humanitarian Visa does not affect in any way the right to apply for asylum within the Union nor does it prevent the applicant from entering other available protection schemes,

4.  GENERAL PROVISIONS

–  have as an objective the laying down of provisions on the procedures and conditions under which a Member State may issue a European Humanitarian Visa to persons seeking international protection to allow those persons to enter the territory of the Member State issuing the visa for the sole purpose of making an application for international protection in that Member State,

–  cover in its scope third-country nationals who must be in possession of a visa when crossing the external borders of the Member States, pursuant to Council Regulation (EC) No 539/2001(8), and where the claims of exposure to or risk of persecution as defined in Directive 2011/95/EU of the European Parliament and of the Council(9) are manifestly well founded, but who are not already in a resettlement process as defined in national resettlement schemes or in the proposed Regulation establishing a Union Resettlement Framework and amending Regulation (EU) No 516/2014 of the European Parliament and of the Council(10) or Council Directive 2001/55/EC(11),

–  exclude from its scope family members who would otherwise have a right to join their family in a Member State in a timely manner in accordance with other legal acts of the Union or national law,

5.  PROCEDURES FOR ISSUING HUMANITARIAN VISAS

–  provide for such visa applications to be lodged directly, by electronic means or in writing, at any consulate or embassy of the Member States,

–  provide for practical modalities for such visa applications, including the filling out of an application form, the provision of information on the applicant’s identity, including biometric identifiers, and the provision of reasons, as far as possible documented, of the fear of persecution or serious harm,

–  provide that the applicant for such a visa be invited to an interview (with the assistance of an interpreter if necessary), which may also be conducted by remote means of audio and video communication, which ensure an appropriate level of safety, security and confidentiality,

–  provide that the documents submitted be assessed, including as regards their authenticity, by a competent, independent, and impartial authority, with adequate knowledge and expertise in matters of international protection,

–  provide that applications for such a visa be assessed on the basis of the applicant’s declaration and interview and, where available, supporting documentation, without conducting a full status determination process,

–  provide that, before the issuing of such a visa, each applicant be subject to a security screening, through the relevant national and Union databases in full respect of applicable data protection provisions, in order to ensure that he or she does not pose a security risk,

–  provide that such visa applications be decided on within 15 calendar days of the date of lodging the application,

–  provide that the decision on the application be communicated to the applicant and that it be individualised, written and motivated,

–  provide that a third-country national refused such a visa has the possibility for an appeal as is currently foreseen in the case of a refusal of a short-stay visa or a refusal of entry at the border,

6.  ISSUING A HUMANITARIAN VISA

–  provide for such visas to be issued by means of a common sticker and inserted into the Visa Information System,

–  provide that once a humanitarian visa is issued it allows its holder to enter the territory of the Member State issuing the visa for the sole purpose of making an application for international protection in that Member State,

7.  ADMINISTRATIVE MANAGEMENT AND ORGANISATION

–  provide that applications for such a visa be assessed by properly trained staff,

–  provide that such staff may either be posted in embassies or consulates or in Member States, in the event of which applications be electronically transmitted and interviews conducted remotely,

–  provide that certain aspects of the process, which do not entail any pre-selection of cases, assessment or decision making of any kind, may be managed by external service providers, including the provision of information, the management of appointments for interviews, and the collection of biometric identifiers,

–  provide that appropriate measures be put in place to ensure data protection, data security and confidentiality of communications,

–  provide that Member States cooperate with each other, Union agencies, international organisations, governmental and non-governmental organisations and other relevant stakeholders to ensure its harmonised application,

–  provide that information on the procedures and conditions of such a visa as well as about the conditions and procedures to obtain international protection in the territory of the Member States be made widely available, including on the websites of the Member States’ embassies and consulates and via the European External Action Service,

8.  FINAL PROVISIONS

–  provide for significant financial support from the Integrated Border Management Fund to be made available to Member States for its implementation,

–  provide that a Member State that issues such a humanitarian visa has access to the same compensation from the Asylum, Migration and Integration Fund as when a Member State receives a refugee through the European Resettlement Framework,

9.  AMENDMENT OF OTHER LEGAL ACTS

–  provide for amendments to:

–  Regulation (EC) No 810/2009 to clarify that for persons seeking international protection the provisions of the Regulation establishing a European Humanitarian Visa apply,

–  Regulation (EC) No 767/2008 of the European Parliament and of the Council(12) to provide for applications for a European Humanitarian Visa to be entered into the Visa Information System,

–  Regulation (EU) 2016/399 to adjust the entry conditions for persons who have obtained a European Humanitarian Visa,

–  the Integrated Border Management Fund to provide funding for Member States for the implementation of the Regulation establishing a European Humanitarian Visa,

–  Article 26 of the Convention implementing the Schengen Agreement of 14 June 1985 between the Governments of the States of the Benelux Economic Union, the Federal Republic of Germany and the French Republic on the gradual abolition of checks at their common borders(13) and to Council Directive 2001/51/EC(14) in order to exempt carriers transporting third-country nationals from liability, obligations and penalties where the third-country nationals involved declare their intention to apply for international or humanitarian protection in the territory of the Member States.

(1) OJ L 243, 15.9.2009, p. 1. (2) Judgment of the Court of Justice of 7 March 2017, X and X v État belge, C-638/16, ECLI:EU:C:2017:173. (3) HEIN / DONATO (CIR) 2012: exploring avenues for protected entry in Europe, p. 17. (4) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1). (5) Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1). (6) Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60). (7) Regulation (EU) No 604/2013 of the European Parliament and of the Council of 26 June 2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person (OJ L 180, 29.6.2013, p. 31). (8) Council Regulation (EC) No 539/2001 of 15 March 2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (OJ L 81, 21.3.2001, p. 1). (9) Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted (OJ L 337, 20.12.2011, p. 9). (10) 2016/0225(COD). (11) Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof (OJ L 212, 7.8.2001, p. 12). (12) Regulation (EC) No 767/2008 of the European Parliament and of the Council of 9 July 2008 concerning the Visa Information System (VIS) and the exchange of data between Member States on short-stay visas (VIS Regulation) (OJ L 218, 13.8.2008, p. 60). (13) OJ L 239, 22.9.2000, p. 19. (14) Council Directive 2001/51/EC of 28 June 2001 supplementing the provisions of Article 26 of the Convention implementing the Schengen Agreement of 14 June 1985 (OJ L 187, 10.7.2001, p. 45).

Amendments adopted by the European Parliament on 11 December 2018 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 810/2009 establishing a Community Code on Visas (Visa Code) (COM(2018)0252 – C8-0114/2018 – 2018/0061(COD))(1)

P8_TA(2018)0495 A8-0434/2018

(Ordinary legislative procedure: first reading)

Text proposed by the Commission   Amendment Amendment 1 Proposal for a regulation Recital 1 (1)  The European Union’s common short-stay visa policy has been an integral part to the establishment of an area without internal borders. Visa policy should remain an essential tool for facilitating tourism and business, while helping counter security risks and the risk of irregular migration to the Union. (1)  The European Union’s common short-stay visa policy has been an integral part to the establishment of an area without internal borders. A visa policy which respects human rights and fundamental freedoms should facilitate travel by third-country nationals to the EU while guaranteeing free movement of persons and maintaining the security of people within EU territory. The common visa policy should be consistent with other Union policies, including those on freedom of movement, residence and mobility. Amendment 3 Proposal for a regulation Recital 2 a (new) (2a)   When applying this Regulation, Member States should respect their respective obligations under international law, in particular the United Nations Convention relating to the Status of Refugees, the European Convention for the Protection of Human Rights and Fundamental Freedoms, the International Covenant on Civil and Political Rights, the United Nations Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, the United Nations Convention on the Rights of the Child and other relevant international instruments. Amendment 4 Proposal for a regulation Recital 4 (4)  The visa application procedure should be as easy as possible for applicants. It should be clear which Member State is competent for examining an application for a visa in particular where the intended visit covers several Member States. Where possible, Member States should allow for application forms to be completed and submitted electronically. Deadlines should be established for the various steps of the procedure in particular to allow travellers to plan ahead and avoid peak seasons in consulates. (4)  The visa application procedure should be as easy and at reasonable costs as possible for applicants. It should be clear which Member State is competent for examining an application for a visa in particular where the intended visit covers several Member States. Member States should allow for application forms to be completed and submitted electronically. Deadlines should be established for the various steps of the procedure in particular to allow travellers to plan a reasonable time in advance and avoid peak seasons in consulates. As part of the further development of the acquis towards a truly common visa policy, procedures and conditions for issuing visas should be further harmonised and their uniform application be reinforced. Amendment 6 Proposal for a regulation Recital 4 a (new) (4a)   Visa applications and decisions on applications are examined and taken by consulates. Member States should ensure that they are present or represented by another Member State in third countries whose nationals are subject to the visa requirement and ensure that consulates have sufficient knowledge of the local situation to ensure the integrity of the visa application procedure. Amendment 7 Proposal for a regulation Recital 5 (5)   Member States should not be obliged to maintain the possibility of direct access for the lodging of applications at the consulate in places where an external service provider has been mandated to collect visa applications on its behalf, without prejudice to the obligations imposed on Member States by Directive 2004/38/EC18, in particular its Article 5(2). deleted _________________ 18 Council Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States, OJ L 229, 29.6.2004, p. 35. Amendment 8 Proposal for a regulation Recital 5 a (new) (5a)  Applicants should not be required to present travel medical insurance when lodging an application for a short-stay visa. It is a disproportionate burden for visa applicants and there is no evidence that holders of short-stay visas present a bigger risk in terms of public medical expenditure in Member States than visa-exempted third country nationals. Amendment 9 Proposal for a regulation Recital 6 (6)  The visa fee should ensure that sufficient financial resources are available to cover the expenses of visa processing, including appropriate structures and sufficient staff to ensure the quality and integrity of the examination of visa applications. The amount of the visa fee should be revised on a two-yearly basis on the basis of objective criteria. (6)  The visa fee should ensure that sufficient financial resources are available to cover the expenses of visa processing, including appropriate structures and sufficient staff to ensure the quality, speed and integrity of the examination of visa applications. The amount of the visa fee should be revised every two years on the basis of objective assessment criteria. Amendment 10 Proposal for a regulation Recital 6 a (new) (6a)   The arrangements for the reception of applicants should duly respect human dignity and fundamental rights, as referred to in the Charter of Fundamental Rights of the European Union and the Convention for the Protection of Human Rights and Fundamental Freedoms. Visa applications should be processed on a non-discriminatory basis and in a professional manner which respects applicants. Amendment 11 Proposal for a regulation Recital 7 (7)  To ensure that nationals of third countries subject to the visa requirement can lodge their visa application in their place of residence even if no Member State is present for the purpose of collecting applications, external service providers should be enabled to provide the necessary service for a fee exceeding the general maximum level. (7)  To ensure that nationals of third countries subject to the visa requirement can lodge their visa application as close as possible to their place of residence, external service providers should be enabled to collect applications for a fee exceeding the general maximum level. Amendment 12 Proposal for a regulation Recital 8 (8)  Representation arrangements should be streamlined and obstacles to the conclusion of such arrangements among Member States should be avoided. The representing Member State should be responsible for the entire processing of visa applications without the involvement of the represented Member State. (8)  Representation arrangements should be streamlined and eased and obstacles to the conclusion of such arrangements among Member States should be avoided. The representing Member State should be responsible for the entire processing of visa applications without the involvement of the represented Member State. Amendment 14 Proposal for a regulation Recital 11 (11)  In case of lack of cooperation of certain third countries to readmit their nationals apprehended in an irregular situation and failure of those third countries to cooperate effectively in the return process, a restrictive and temporary application of certain provisions of Regulation (EC) No 810/2009 should on the basis of a transparent mechanism based on objective criteria, be applied to enhance a given third country's cooperation on readmission of irregular migrants. (11)  In case of satisfactory cooperation or a lack of cooperation by certain third countries to readmit their nationals apprehended in an irregular situation and either satisfactory willingness or failure of those third countries to cooperate effectively in the return process, a restrictive and temporary application of certain provisions of Regulation (EC) No 810/2009 should on the basis of a transparent mechanism based on objective criteria, be applied to enhance a given third country's cooperation on readmission of irregular migrants, or to encourage its continuation. Amendment 15 Proposal for a regulation Recital 12 (12)  Applicants who have been refused a visa should have the right to appeal which should, at a certain stage of the proceedings, guarantee an effective judicial appeal. More detailed information on the refusal grounds and procedures for appeal of negative decisions should be provided in the notification of the refusal. (12)  Applicants who have been refused a visa should have the right to appeal which should guarantee an effective and prompt judicial appeal. Detailed information on the refusal grounds and procedures for appeal of negative decisions should be provided in the notification of the refusal. Amendment 17 Proposal for a regulation Recital 13 a (new) (13a)   This Regulation respects fundamental rights and observes the rights and principles recognised in particular by international treaties and the Charter of Fundamental Rights of the European Union. In particular, it seeks to ensure full respect for the right to protection of personal data as set out in Article 16 TFEU, the right to private and family life as set out in Article 7, the right to asylum as set out in Article 18 and the rights of the child as set out in Article 24 of that Charter, and protection of vulnerable publics. Amendment 18 Proposal for a regulation Recital 16 (16)  Flexible rules should be established to allow Member States to optimise the sharing of resources and to increase consular coverage. Cooperation among Member States (Schengen Visa Centres) could take any form suited to local circumstances in order to increase geographical consular coverage, reduce Member States' costs, increase the visibility of the Union and improve the service offered to visa applicants. (16)  Flexible rules should be established to allow Member States to optimise the sharing of resources and to increase consular coverage. Cooperation among Member States (Schengen Visa Centres) could take any form suited to local circumstances in order to increase geographical consular coverage, reduce Member States' costs, increase the visibility of the Union and improve the service offered to visa applicants. The common visa policy should contribute to generating growth and be coherent with other Union policies, such as those concerning external relations, trade, education, culture and tourism. Amendment 19 Proposal for a regulation Recital 17 (17)  Electronic visa application systems developed by Member States help to facilitate application procedures for applicants and consulates. A common solution allowing full digitisation should be developed, making full use of the recent legal and technological developments. (17)  Electronic visa application systems developed by Member States are essential in order to facilitate application procedures for applicants and consulates. A common solution ensuring full digitisation should be developed by 2025 in the form of an online platform and an EU E-visa, thereby making full use of the recent legal and technological developments, to allow visa application online to accommodate the needs of applicants and attract more visitors to the Schengen area. The electronic visa application system should be fully accessible for the people with disabilities. Straightforward and streamlined procedural guarantees should be strengthened and uniformly applied. Amendment 20 Proposal for a regulation Recital 17 a (new) (17a)  When applying Regulation (EC) No 810/2009, Member States should respect their respective obligations under international law, in particular the United Nations Convention Relating to the Status of Refugees, the European Convention for the Protection of Human Rights and Fundamental Freedoms, the International Covenant on Civil and Political Rights, the United Nations Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, the United Nations Convention on the Rights of the Child and other relevant international instruments. Amendment 21 Proposal for a regulation Recital 27 a (new) (27a)   The necessary measures shall be taken to implement this Regulation. The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission for the purposes of making technical amendments to the Annexes to this Regulation. Amendment 22 Proposal for a regulation Recital 27 b (new) (27b)   Appropriate measures should be adopted for the monitoring and evaluation of this Regulation in relation to harmonisation of the processing of visa applications. Monitoring and evaluation should also seek to monitor full respect for fundamental rights by Member States when processing applications, as well as the application of the principle of non-discrimination and the protection of personal data. Amendment 23 Proposal for a regulation Article 1 – paragraph 1 – point 1 Regulation (EC) No 810/2009 Article 1 – paragraph 1 1.  This Regulation establishes the conditions and procedures for issuing visas for intended stays on the territory of the Member States not exceeding 90 days in any 180-days period.; 1.  This Regulation establishes the conditions and procedures for issuing visas for intended stays on the territory of the Member States not exceeding 90 days in any 180-days period, and intended stays by Sport and Culture Professionals for up to one year without staying more than 90 days in any 180-day period in any single Member State. Amendment 24 Proposal for a regulation Article 1 – paragraph 1 – point 1 a (new) Regulation (EC) No 810/2009 Article 1 – paragraph 3 a (new) (1a)  In Article 1, the following paragraph is added: ‘3a. When applying this Regulation, Member States shall act in full compliance with relevant Union law, including the Charter of Fundamental Rights of the European Union (‘the Charter’), relevant international law, including the United Nations Convention Relating to the Status of Refugees (‘the Geneva Convention’), obligations related to access to international protection, in particular the principle of non-refoulement, and fundamental rights. In accordance with the general principles of Union law, decisions under this Regulation shall be taken on an individual basis.’; Amendment 25 Proposal for a regulation Article 1 – paragraph 1 – point 1 b (new) Regulation (EC) No 810/2009 Article 1 – paragraph 3 b (new) (1b)  In Article 1, the following paragraph is added: (3b)   The European Commission shall present an electronic visa application, E-visa, by 2025. Amendment 26 Proposal for a regulation Article 1 – paragraph 1 – point 2 – point d Regulation (EC) No 810/2009 Article 2 – point 12 a (new) 12a.   Sport and Culture Professionals: Third-country nationals who are not citizens of the Union within the meaning of Article 20(1) of the Treaty, and belong to the following categories: performing artists and their support staff, elite sports persons and their support staff and, where applicable, family members of those categories, who have been able to demonstrate clearly the administrative and logistical obstacles to organising a tour or a competition in several Member States in the Schengen area lasting more than three months. Amendment 27 Proposal for a regulation Article 1 – paragraph 1 – point 3 – point a (new) Regulation (EC) No 810/2009 Article 3 – paragraph 5 (3)  in Article 3(5) points (b) and (c) are replaced by the following: (3)  in Article 3(5) points (b) and (c) are replaced by the following: "(b) third-country nationals holding a valid residence permit issued by a Member State which does not take part in the adoption of this Regulation or by a Member State which does not yet apply the provisions of the Schengen acquis in full, or third-country nationals holding one of the valid residence permits listed in Annex V issued by Andorra, Canada, Japan, San Marino or the United States of America guaranteeing the holder’s unconditional readmission, or holding a residence permit for the Caribbean parts of the Kingdom of the Netherlands (Aruba, Curaçao, Sint Maarten, Bonaire, Sint Eustatius and Saba); (c)  third-country nationals holding a valid visa for a Member State which does not take part in the adoption of this Regulation, or for a Member State which does not yet apply the provisions of the Schengen acquis in full, or for a country party to the Agreement on the European Economic Area, or for Canada, Japan or the United States of America, or holders of a valid visa for the Caribbean parts of the Kingdom of the Netherlands (Aruba, Curaçao, Sint Maarten, Bonaire, Sint Eustatius and Saba), when travelling to the issuing country or to any other third country, or when, having used the visa, returning from the issuing country;"; Amendment 28 Proposal for a regulation Article 1 – paragraph 1 – point 5 Regulation (EC) No 810/2009 Article 5 – paragraph 1 b (b)  if the visit includes more than one destination, or if several separate visits are to be carried out within a period of two months, the Member State whose territory constitutes the main destination of the visit(s) in terms of the length of stay, counted in days; or; (b)  if the visit includes more than one destination, or if several separate visits are to be carried out within a period of two months, the Member State where the host organisation or undertaking is located, if applicable, or the Member State whose territory constitutes the main destination of the visit(s) in terms of the length of stay, counted in days or, if the main destination cannot be ascertained, the Member States through whose external border the applicant intends to enter the territory of the Member States; Amendment 29 Proposal for a regulation Article 1 – paragraph 1 – point 5 a (new) Regulation (EC) No 810/2009 Article 5 – paragraph 2 a (new) (5a)  In Article 5, the following paragraph is inserted: ‘2a. If the Member State that is competent in accordance with points (a) or (b) of paragraph 1,, is neither present nor represented in the third country where the applicant lodges the application in accordance with Article 10, the applicant shall be entitled to lodge the application: (a)  at the consulate of one of the Member States of destination of the intended visit, (b)  at the consulate of the Member State of first entry, if point (a) is not applicable, (c)  in all other cases at the consulates of any of the Member States that are present in the country where the applicant lodges the application. If the consulate of the Member State that is competent in accordance with paragraph 1 or the consulate of the Member State referred to in the first subparagraph of this paragraph are located at a distance of more than 500 km from the applicant’s place of residence, or if a return journey by public transport from the applicant's place of residence would require an overnight stay, and if the consulate of another Member State is located closer to the applicant’s place of residence, the applicant shall be entitled to lodge the application at the consulate of the latter Member State.’; Amendment 30 Proposal for a regulation Article 1 – paragraph 1 – point 5 b (new) Regulation (EC) No 810/2009 Article 5 – paragraph 2 b (new) (5b)  In Article 5, the following paragraph is inserted: ‘2b. If the Member State that is competent in accordance with paragraphs 1 or 2 has, in accordance with Article 8, established a representation arrangement with another Member State for the purpose of considering applications and issuing visas on its behalf, the applicant shall submit his or her application to the consulate of the representing Member State.’; Amendment 31 Proposal for a regulation Article 1 – paragraph 1 – point 6 – point -a (new) Regulation (EC) No 810/2009 Article 8 – paragraph 1 1.  A Member State may agree to represent another Member State that is competent in accordance with Article 5 for the purpose of examining applications and issuing visas on behalf of that Member State. A Member State may also represent another Member State in a limited manner solely for the collection of applications and the enrolment of biometric identifiers. ‘1. Without prejudice to Article 6, a Member State may agree to represent another Member State that is competent in accordance with Article 5 for the purpose of examining applications and issuing visas on behalf of that Member State. A Member State may also represent another Member State in a limited manner solely for the collection of applications and the enrolment of biometric identifiers.’; Amendment 32 Proposal for a regulation Article 1 – paragraph 1 – point 6 – point b a (new) Regulation (EC) No 810/2009 Article 8 – paragraph 6 (ba)   in Article 8, paragraph 6 is amended 6.  With a view to ensuring that a poor transport infrastructure or long distances in a specific region or geographical area does not require a disproportionate effort on the part of applicants to have access to a consulate, Member States lacking their own consulate in that region or area shall endeavour to conclude representation arrangements with Member States that have consulates in that region or area. ‘6. With a view to ensuring that a poor transport infrastructure or long distances in a specific region or geographical area does not require a disproportionate effort on the part of applicants to have access to a consulate, Member States lacking their own consulate in that region or area shall endeavour to conclude representation arrangements with Member States that have consulates in that region or area in order to combat discrimination between third-country nationals due to inequality of access to consular services. Such agreements may also be concluded with the representation of an EU Member State in a neighbouring country of the third country concerned if it is closer to the home of the applicant.’ Amendment 33 Proposal for a regulation Article 1 – paragraph 1 – point 7 – point a Regulation (EC) No 810/2009 Article 9 – paragraph 1 Applications may be lodged no more than six months, and for seafarers in the performance of their duties, no more than nine months before the start of the intended visit and, as a rule, no later than 15 calendar days before that start.; Applications may be lodged no more thannine months before the start of the intended visit and, as a rule, no later than 15 calendar days before that start. In justified individual cases of urgency, including when it is necessary on professional grounds, on humanitarian grounds, for reasons of national interest or because of international obligations, the consulate may waive the latter time limit.; Amendment 34 Proposal for a regulation Article 1 – paragraph 1 – point 7 – point a a (new) Regulation (EC) No 810/2009 Article 9 – paragraph 3 (aa)   In Article 9, paragraph 3 is amended In justified cases of urgency, the consulate may allow applicants to lodge their applications either without appointment, or an appointment shall be given immediately. ‘In justified cases of urgency, the consulate may allow applicants to lodge their applications either without appointment, or an appointment shall be given immediately. In an electronic procedure, in the event of failure to reply within one month of the submission of the application, provision shall be made for a remedy to enable the application to be examined in any event.’ Amendment 35 Proposal for a regulation Article 1 – paragraph 1 – point 7 – point b Regulation (EC) No 810/2009 Article 9 – paragraph 4 – point a a (new) (a a)  by the legal representatives of the applicant Amendment 36 Proposal for a regulation Article 1 – paragraph 1 – point 8 – point a Regulation (EC) No 810/2009 Article 10 – paragraph 1 Applicants shall appear in person when lodging an application for the collection of fingerprints, in accordance with Article 13 (2), (3) and (7)(b).; Without prejudice to the provisions of Articles 13, 42, 43 and 45, applicants may lodge their applications in person or electronically. Amendment 37 Proposal for a regulation Article 1 – paragraph 1 – point 9 a (new) Regulation (EC) No 810/2009 Article 13 – paragraph 2 – subparagraph 1 a (new) (9a)  in Article 13, paragraph 2 the following subparagraph is added: ‘Without prejudice to paragraph 3, the applicant may not be requested by an external service provider to appear in person for each application in order to collect the biometric identifiers each time. To enable external service providers to verify that biometric identifiers have been collected, the applicant shall be issued with a receipt after the collection of the biometric identifiers.’; Amendment 38 Proposal for a regulation Article 1 – paragraph 1 – point 10 – point a Regulation (EC) No 810/2009 Article 14 – paragraph 4 – subparagraph 1 4.  Member States may require applicants to present a proof of sponsorship and private accommodation or both by completing a form drawn up by each Member State. That form shall indicate in particular: 4.  Member States may require applicants to present a proof of sponsorship and private accommodation or both by completing a form drawn up by the Commission. That form shall indicate in particular: Amendment 39 Proposal for a regulation Article 1 – paragraph 1 – point 10 – point a Regulation (EC) No 810/2009 Article 14 – paragraph 4 – subparagraph 2 In addition to the Member State’s official language(s), the form shall be drawn up in at least one other official language of the institutions of the Union. A specimen of the form shall be sent to the Commission. The Commission shall adopt the form by means of implementing acts in accordance with the examination procedure referred to in Article 52(2). The form shall be used to inform the sponsor/inviting person about the processing of their personal data and the applicable rules. In addition to the Member State’s official language(s), the form shall be drawn up in at least one other official language of the institutions of the Union. Amendment 40 Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 810/2009 Article 15 (11)  Article 15 is amended as follows: Article 15 is deleted (a)  paragraph 1 is replaced by the following: Deletion of Travel Medical Insurance “1. Applicants for a uniform visa for one entry shall prove that they are in possession of adequate and valid travel medical insurance to cover any expenses that might arise in connection with repatriation for medical reasons, urgent medical attention and emergency hospital treatment or death, during their intended stay on the territory of the Member States.;” (b)  in paragraph 2, the first subparagraph is replaced by the following: “2. Applicants for a uniform visa for multiple entries shall prove that they are in possession of adequate and valid travel medical insurance covering the period of their first intended visit.;” Amendment 41 Proposal for a regulation Article 1 – paragraph 1 – point 12 Regulation (EC) No 810/2009 Article 16 Article 16 will be replaced as follows: Article 16 “Article 16 Visa fee Visa fee 1.  Applicants shall pay a visa fee of EUR 80. 1.  Applicants shall pay a visa fee of EUR 80. 1a.   Applicants whose data are already entered registered in the Visa Information System and whose biometric identifiers have been collected in accordance with Article 13 shall pay a visa fee of EUR 60. 2.  Children from the age of six years and below the age of 12 years shall pay a visa fee of EUR 40; 2.  Children from the age of 12 years and below 18 years shall pay a visa fee of EUR 40. 2a.   Applicants which form part of a group travelling for sports, cultural or educational purposes shall pay a visa fee of EUR 60. 4.  The visa fee shall be waived for applicants belonging to one of the following categories: 4.  The visa fee shall be waived for applicants belonging to one of the following categories: (a)  children under six years; (a)  children under twelve years; (b)  school pupils, students, postgraduate students and accompanying teachers who undertake stays for the purpose of study or educational training; (b)  school pupils, students, postgraduate students and accompanying teachers who undertake stays for the purpose of study or educational training; (c)  researchers from third countries travelling for the purpose of carrying out scientific research as defined in Recommendation No 2005/761/EC27 of the European Parliament and of the Council of 28 September 2005 to facilitate the issue by the Member States of uniform short-stay visas for researchers from third countries travelling within the Community for the purpose of carrying out scientific research (21); (c)  researchers from third countries, as defined in Council Directive 2005/71/EC27, travelling for the purpose of carrying out scientific research or participating in a scientific seminar or conference; (d)  representatives of non-profit organisations aged 25 years or less participating in seminars, conferences, sports, cultural or educational events organised by non-profit organisations. (d)  representatives of non-profit organisations aged 25 years or less participating in seminars, conferences, sports, cultural or educational events organised by non-profit organisations. (e)  family members of the citizens of the Union as referred in to Article 5(2) of Directive 2004/38/EC 5.  The visa fee may be waived for: 5.  The visa fee may be waived for: (a)  children from the age of six years and below the age of 12 years; (a)  children from the age of twelve years and below the age of 18 years; (b)  holders of diplomatic and service passports; (b)  holders of diplomatic and service passports; (c)  participants aged 25 years or less in seminars, conferences, sports, cultural or educational events, organised by non-profit organisations. (c)  participants aged 25 years or less in seminars, conferences, sports, cultural or educational events, organised by non-profit organisations. (d)  applicants for a visa with limited territorial validity issued on humanitarian grounds, for reasons of national interest or because of international obligations as well as beneficiaries of a Union resettlement or relocation programme. (e)  applicants for a visa with limited territorial validity 6.  In individual cases, the amount of the visa fee to be charged may be waived or reduced when to do so serves to promote cultural or sporting interests as well as interests in the field of foreign policy, development policy and other areas of vital public interest or for humanitarian reasons. 6.  In individual cases, the amount of the visa fee to be charged may be waived or reduced when to do so serves to promote cultural or sporting interests, interests in the field of foreign policy, development policy and other areas of vital public interest, or for humanitarian reasons or because of international obligations.”; ________________ ________________ 27 Council Directive 2005/71/EC of 12 October 2005 on a specific procedure for admitting third-country nationals for the purpose of scientific research (OJ L 289, 3.11.2005, p. 15). 27 Council Directive 2005/71/EC of 12 October 2005 on a specific procedure for admitting third-country nationals for the purpose of scientific research (OJ L 289, 3.11.2005, p. 15). Amendment 42 Proposal for a regulation Article 1 – paragraph 1 – point 13 Regulation (EC) No 810/2009 Article 17 (13)  Article 17 will be amended as follows: Article 17 Service fee 1.  A service fee may be charged by an external service provider referred to in Article 43. The service fee shall be proportionate to the costs incurred by the external service provider while performing one or more of the tasks referred to in Article 43(6). 1.  A service fee may be charged by an external service provider referred to in Article 43. The service fee shall be proportionate to the costs incurred by the external service provider while performing one or more of the tasks referred to in Article 43(6). 2.  The service fee shall be specified in the legal instrument referred to in Article 43(2). 2.  The service fee shall be specified in the legal instrument referred to in Article 43(2). 3.  Within the framework of local Schengen cooperation, Member States shall ensure that the service fee charged to an applicant duly reflects the services offered by the external service provider and is adapted to local circumstances. Furthermore, they shall aim to harmonise the service fee applied. 4.  The service fee shall not exceed half of the amount of the visa fee set out in Article 16(1), irrespective of the possible reductions in or exemptions from the visa fee as provided for in Article 16(2), (4), (5) and (6). 4.  The service fee shall not exceed half of the amount of the visa fee set out in Article 16(1), irrespective of the possible reductions in or exemptions from the visa fee as provided for in Article 16(2), (4), (5) and (6). It shall include all costs related to the submission of the visa application, including the transmission of the application and the travel document from the external service provider to the consulate and the return of the travel document to the external service provider’. 5.  The Member State(s) concerned shall maintain the possibility for all applicants to lodge their applications directly at its/their consulates. 5.  The Member State(s) concerned shall maintain the possibility for all applicants to lodge their applications directly at its/their consulates or at the consulate of a Member State with which it/they have a representation arrangement, in accordance with Article 40. 5a.  The applicant shall be given a receipt upon payment of the service fee. Amendment 43 Proposal for a regulation Article 1 – paragraph 1 – point 13 a (new) Regulation (EC) No 810/2009 Article 19 – paragraph 3 (13 a)  Article 19 - paragraph 3 Where the competent consulate finds that the conditions referred to in paragraph 1 have not been fulfilled, the application shall be inadmissible and the consulate shall without delay: “Where the competent consulate finds that the conditions referred to in paragraph 1 have not been fulfilled, it shall, where appropriate, notify the applicant, indicate the deficiencies and allow the applicant to correct them. If the deficiencies are not corrected, the application shall be inadmissible and the consulate shall without delay: —  return the application form and any documents submitted by the applicant, —  return the application form and any documents submitted by the applicant, —  destroy the collected biometric data, —  destroy the collected biometric data, —  reimburse the visa fee, and —  reimburse the visa fee, and —  not examine the application. —  not examine the application.” Amendment 44 Proposal for a regulation Article 1 – paragraph 1 – point 13 a (new) Regulation (EC) No 810/2009 Article 19 – paragraph 4 (13a)  in Article 19, paragraph 4 is replaced by the following: 4.  By way of derogation, an application that does not meet the requirements set out in paragraph 1 may be considered admissible on humanitarian grounds or for reasons of national interest. ‘4. By way of derogation, an application that does not meet the requirements set out in paragraph 1 may be considered admissible on humanitarian grounds, for reasons of national interest or because of international obligations.’; Amendment 45 Proposal for a regulation Article 1 – paragraph 1 – point 14 – point a Regulation (EC) No 810/2009 Article 21 – paragraph 3 – point e (a)  in paragraph 3, point (e) is replaced by the following : (a)  in paragraph 3, point (e) is deleted. Amendment 46 Proposal for a regulation Article 1 – paragraph 1 – point 14 – point c Regulation (EC) No 810/2009 Article 21 – paragraph 8 8.  During the examination of an application, consulates may in justified cases carry out an interview with the applicant and request additional documents. 8.  During the examination of an application, consulates may in justified cases carry out an interview with the applicant and request additional documents. These interviews may be conducted using modern digital tools and remote means of communication, such as voice or video calls via internet. Fundamental rights of applicants shall be guaranteed during the process. Amendment 47 Proposal for a regulation Article 1 – paragraph 1 – point 15 – point a a (new) Regulation (EC) No 810/2009 Article 22 – paragraph 4 (aa)  paragraph 4 is replaced by the following: 4.  The Commission shall inform Member States of such notifications. ‘4. The Commission shall publish such notifications.’; Amendment 48 Proposal for a regulation Article 1 – paragraph 1 – point 16 – point a Regulation (EC) No 810/2009 Article 23 – paragraph 1 Applications shall be decided within 10 calendar days of the date of the lodging of an application which is admissible in accordance with Article 19. Applications shall be decided within 10 calendar days of the date of the lodging of an application which is admissible in accordance with Article 19, or within five calendar days for visa applicants whose data are already recorded in the Visa Information System and whose biometric identifiers have been collected in accordance with Article 13. Amendment 49 Proposal for a regulation Article 1 – paragraph 1 – point 16 – point a Regulation (EC) No 810/2009 Article 23 – paragraph 1 – subparagraph 2 That period may be extended up to a maximum of 45 calendar days in individual cases, notably when further scrutiny of the application is needed. That period may be extended up to a maximum of 30 calendar days in individual cases, notably when further scrutiny of the application is needed. Amendment 50 Proposal for a regulation Article 1 – paragraph 1 – point 16 – point a a (new) Regulation (EC) No 810/2009 Article 23 – paragraph 2 a (new) (aa)  the following paragraph is inserted: ‘2a. Applications shall be decided on without delay in justified individual cases of urgency, including when it is necessary on professional grounds, on humanitarian grounds, for reasons of national interest or because of international obligations.’; Amendment 51 Proposal for a regulation Article 1 – paragraph 1 – point 17 – point a a (new) Regulation (EC) No 810/2009 Article 24 – paragraph 1a (new) 1a.  Applicants whom the consulates consider to meet the entry conditions and in respect of whom no grounds for refusal referred to Article 32 exist shall be issued a visa in accordance with this Article. Amendment 52 Proposal for a regulation Article 1 – paragraph 1 – point 17 – point b Regulation (EC) No 810/2009 Article 24 – paragraph 2 – point a (a)  for a validity period of one year, provided that the applicant has obtained and lawfully used three visas within the previous two years; (a)  for a validity period of one year, provided that the applicant has obtained and lawfully used three visas within the previous two years, and for the case of seafarers in the performance of their duties, for a validity period of one year, provided that the applicant has obtained and lawfully used two visas within the previous two years; Amendment 53 Proposal for a regulation Article 1 – paragraph 1 – point 17 – point b Regulation (EC) No 810/2009 Article 24 – paragraph 2 – point b (b)  for a validity period of two years shall be issued, provided that the applicant has obtained and lawfully used a previous multiple-entry visa valid for one year; (b)  for a validity period of 2 years if the applicant has obtained, within the preceding two years, a multiple-entry visa valid for one year; Amendment 54 Proposal for a regulation Article 1 – paragraph 1 – point 17 – point b Regulation (EC) No 810/2009 Article 24 – paragraph 2 – point c (c)  for a validity period of five years, provided that the applicant has obtained and lawfully used a previous multiple-entry visa valid for two years.; (c)  for a validity period of five years if the applicant has obtained, within the preceding three years, a previous multiple-entry visa valid for two years.; Amendment 55 Proposal for a regulation Article 1 – paragraph 1 – point 17 – point c Regulation (EC) No 810/2009 Article 24 – paragraph 2 c 2c.  Without prejudice to paragraph 2, a multiple entry visa valid for up to five years may be issued to applicants who prove the need or justify their intention to travel frequently and/or regularly provided that they prove their integrity and reliability, in particular the lawful use of previous visas, their economic situation in the country of origin and their genuine intention to leave the territory of the Member States before the expiry of the visa for which they have applied. 2c.  Without prejudice to paragraph 2, a multiple entry visa valid for up to five years shall be issued to applicants who prove the need or justify their intention to travel frequently and/or regularly, in particular due to their occupational or family status, such as business persons, civil servants engaged in regular official contacts with Member States and EU institutions, representatives of civil society organisations travelling for the purpose of educational training, seminars and conferences, family members of citizens of the Union, family members of third-country nationals legally residing in Member States and seafarers, provided that they prove their integrity and reliability, in particular the lawful use of previous visas, their economic situation in the country of origin and their genuine intention to leave the territory of the Member States before the expiry of the visa for which they have applied. Amendment 57 Proposal for a regulation Article 1 – paragraph 1 – point 18 Regulation (EC) No 810/2009 Article 25 a “Article 25a “Article 25a Cooperation on readmission Cooperation on readmission 1.  Article 14 (6), Article 16(1) and (5), point (b), Article 23(1), and Article 24(2) shall not apply to applicants or categories of applicants, who are nationals of a third country that is considered not to be cooperating sufficiently with Member States on the readmission of irregular migrants, on the basis of relevant and objective data, in accordance with this Article. This Article is without prejudice to the powers conferred on the Commission by Article 24(2d). 1.  Depending on third countries’ levels of cooperation with Member States on the readmission of irregular migrants, assessed on the basis of relevant and objective data, the application of Article 16(1a) and (5), point (b) and Article 24(2) hereafter may be adjusted for categories of applicants or all applicants with the nationality of that third country as specified in paragraph 4. This article is without prejudice to the powers conferred on the Commission by Article 24(2d) 2.  The Commission shall regularly assess third countries' cooperation with regard to readmission, taking account, in particular, of the following indicators: 2.  The Commission shall regularly, at least once a year, assess relevant third countries’ cooperation with regard to readmission, taking account, in particular, of the following indicators: (a)  the number of return decisions issued to persons illegally staying on the territory of the Member States from the third country in question; (a)  the number of third-country nationals who are subject to an administrative or judicial decision in accordance with Directive 2008/115/EC of the European Parliament and of the Council; (b)   the number of actual returns of persons issued with return decisions as a percentage of the number of return decisions issued to citizens of the third country in question including, where appropriate, on the basis of Union or bilateral readmission agreements, the number of third country nationals who have transited through its territory; (c)   the number of readmission requests accepted by the third country as a percentage of the number of such applications submitted to it. (b)  the number of readmission requests by a Member State accepted by the third country as a percentage of the number of such applications submitted to it; (c)  the levels of practical cooperation in the area of return at the different stages of the return procedure, such as: (i)  timely assistance of identification procedures; (ii)  delivery and acceptance of necessary travel documents; The Commission shall report the results of its assessment to the European Parliament and the Council, which shall discuss the matter, in particular with regard to the level of cooperation with the relevant third country in the readmission of irregular migrants. In particular, the following elements shall be considered to assess a country’s cooperation on readmission: (a)  participation in pilot projects on labour migration, thus contributing to the desincentivizing irregular migration; (b)  demonstrated efforts to reintegrate returnees and ensure the sustainability of returns; (c)  demonstrated efforts to fight against trafficking and smuggling and ensuing violations of rights of involved individuals (participation in capacity building and training activities including on preventing abuse and exploitation). The Parliament shall be informed by the Commission of the conclusions of the assessment. 3.  A Member State may also notify the Commission if it is confronted with substantial and persisting practical problems in the cooperation with a third country in the readmission of irregular migrants on the basis of the same indicators as those listed in paragraph 2. 3.  A Member State may also notify the Commission if it observes substantial and persisting problems as well as substantial cooperation improvement encountered with a third country in the readmission of irregular migrants on the basis of the same indicators as those listed in paragraph 2. 4.   The Commission shall examine any notification made pursuant to paragraph 3 within a period of one month. The Commission shall examine any notification within a period of 15 days. The Commission shall immediately inform the Council and the Parliament of the results of its examination. 5.   Where, on the basis of the analysis referred to in paragraphs 2 and 4, the Commission decides that a country is not cooperating sufficiently, and that action is therefore needed, it may, taking also account of the Union’s overall relations with the third country concerned, adopt an implementing act, in accordance with the examination procedure referred to in Article 52(2): 4.   Where, on the basis of the analysis referred to in paragraphs 2 and 3, taking account of the Union’s overall relations with the third country concerned, especially in cooperation in the field of readmission, and taking into account the assessment and discussions referred to in paragraph 2, the Commission decides that a country is: (a)  temporarily suspending the application of either Article 14(6), Article 16(5) point (b), Article 23(1), or Article 24(2), or of some or all of those provisions, to all nationals on the third country concerned or to certain categories thereof, or (a)  cooperating sufficiently, it shall adopt an implementing act, in accordance with the examination procedure referred to in Article 52(2a), for certain categories of nationals or for all nationals of the third country concerned applying for visa on the territory of that third country: (i)  lowering the visa fee according to Article 16(2a); (ii)  reducing the time within which decisions on an application shall be made, according to Article 23(1a); (iii)  increasing the period of validity of multiple entry visas according to the last subparagraph of Article 24(2); and/or (iv)  facilitating participation in labour migration projects; (b)  applying the visa fee set out in Article 16(2a) to all nationals of the third country concerned or to certain categories thereof. (b)   not cooperating sufficiently, it may, taking also account of the Union’s overall relations with the third country concerned, adopt an implementing act, in accordance with the examination procedure referred to in Article 52(2a): (i)  temporarily modifying the application of either Article 14(6) or of Article 23(1), or temporarily suspending Article 16(5b), Article 23(1), or some of their provisions, or Article 24(2).” 6.  The Commission shall continuously assess on the basis of the indicators set out in paragraph 2 whether significant improvement in the given third country's cooperation on readmission of irregular migrants can be established and, taking also account of the Union’s overall relations with the third country concerned, may decide to repeal or amend the implementing act referred to in paragraph 5. 7.  At the latest six months after the entry into force of the implementing act referred to in paragraph 5, the Commission shall report to the European Parliament and to the Council on progress achieved in that third country's cooperation on readmission.” Amendment 58 Proposal for a regulation Article 1 – paragraph 1 – point 22 – point a a (new) Regulation (EC) No 810/2009 Article 32 – paragraph 1 – paragraph a – point vii (aa)   in Article 32, paragraph 1, point (vii) is deleted (vii)  does not provide proof of holding adequate and valid travel medical insurance, where applicable; Amendment 59 Proposal for a regulation Article 1 – paragraph 1 – point 22 – point a b (new) Regulation (EC) No 810/2009 Article 32 – paragraph 2 (ab)  paragraph 2 is replaced by the following: 2.  A decision on refusal and the reasons on which it is based shall be notified to the applicant by means of the standard form set out in Annex VI. ‘2. A decision on refusal and the reasons on which it is based shall be notified to the applicant by means of the standard form set out in Annex VI in a language which the applicant understands or can be reasonably supposed to understand.’; Amendment 60 Proposal for a regulation Article 1 – paragraph 1 – point 22 – point b Regulation (EC) No 810/2009 Article 32 – paragraph 3 3.  Applicants who have been refused a visa shall have the right to appeal which shall, at a certain stage of the proceedings, guarantee an effective judicial appeal. Appeals shall be instituted against the Member State that has taken the final decision on the application and in accordance with the national law of that Member State. Member States shall provide applicants with detailed information regarding the procedure to be followed in the event of an appeal, as specified in Annex VI.; 3.  Applicants who have been refused a visa shall have the right to appeal which shall, at a certain stage of the proceedings, guarantee an effective judicial appeal. Appeals shall be instituted against the Member State that has taken the final decision on the application and in accordance with the national law of that Member State. The deadline for appeal shall be at least 30 calendar days. Member States shall provide applicants with detailed information regarding the procedure to be followed in the event of an appeal, as specified in Annex VI, in a language the applicants understand or are reasonably supposed to understand.; Amendment 61 Proposal for a regulation Article 1 – paragraph 1 – point 22 – point b Regulation (EC) No 810/2009 Article 32 – paragraph 3 a 3a.   The standard form for notifying and motivating refusal, annulment or revocation of a visa set out in Annex VI shall be available, as a minimum, in the following languages: (a)  the official language(s) of the Member State for which a visa is requested; and (b)  the official language(s) of the host country. In addition to the language(s) referred to in point (a), the form may be made available in any other official language(s) of the institutions of the European Union.; A translation of this form into the official language(s) of the host country shall be produced under local Schengen cooperation provided for in Article 48. Amendment 62 Proposal for a regulation Article 1 – paragraph 1 – point 22 c (new) Regulation (EC) No 810/2009 Article 34 – point 7 (22c)   in Article 34, paragraph 7 is amended 7.  A visa holder whose visa has been annulled or revoked shall have the right to appeal, unless the visa was revoked at his request in accordance with paragraph 3. Appeals shall be conducted against the Member State that has taken the decision on the annulment or revocation and in accordance with the national law of that Member State. Member States shall provide applicants with information regarding the procedure to be followed in the event of an appeal, as specified in Annex VI. ‘7. A visa holder whose visa has been annulled or revoked shall have the right to appeal, unless the visa was revoked at his request in accordance with paragraph 3.Appeals shall be conducted against the Member State that has taken the decision on the annulment or revocation and in accordance with the national law of that Member State. Member States shall provide applicants with information regarding the procedure to be followed in the event of an appeal, as specified in Annex VI. If the recipient of an annulled visa is already present on the territory of a Member State, no return decision may be taken until the appeal period is exhausted or the final decision on the appeal has been duly notified to the recipient.’ Amendment 63 Proposal for a regulation Article 1 – paragraph 1 – point 22 b (new) Regulation (EC) No 810/2009 Article 35 – paragraph 2 (22b)  in Article 35, paragraph 2 is deleted; Amendment 64 Proposal for a regulation Article 1 – paragraph 1 – point 24 Regulation (EC) No 810/2009 Article 36a – paragraph 3 3.  The Member State concerned shall establish appropriate structures and deploy specially trained staff for the processing of visa applications and the carrying out of all verifications and risk assessment, as set out in Article 21. 3.  The Member State concerned shall establish appropriate structures and deploy specially trained staff for the processing of visa applications and the carrying out of all verifications and risk assessment, as set out in Article 21. Staff shall receive training on digital file management. Amendment 65 Proposal for a regulation Article 1 – paragraph 1 – point 24 b (new) Regulation (EC) No 810/2009 Article 37 – point 2 (24b)   in Article 37, paragraph 2 is amended 2.  The storage and handling of visa stickers shall be subject to adequate security measures to avoid fraud or loss. Each consulate shall keep an account of its stock of visa stickers and register how each visa sticker has been used. ‘2. The storage and handling of visa stickers shall be subject to adequate security measures to avoid fraud or loss. Each consulate shall keep an account of its stock of visa stickers and register how each visa sticker has been used. Any fraud or major loss must be reported to the Commission.’ Amendment 66 Proposal for a regulation Article 1 – paragraph 1 – point 25 Regulation (EC) No 810/2009 Article 37 – paragraph 3 – subparagraph 2 Individual application files shall be kept for a minimum of one year from the date of the decision on the application as referred to in Article 23(1) or, in the case of appeal, until the end of the appeal procedure. Individual application files shall be kept for a minimum of two years from the date of the decision on the application as referred to in Article 23(1) or, in the case of appeal, until the end of the appeal procedure. Amendment 67 Proposal for a regulation Article 1 – paragraph 1 – point 26 a (new) Regulation (EC) No 810/2009 Article 38 – paragraph 4 a (new) (26a)  in Article 38, the following paragraph is inserted: ‘4a. Member States shall ensure that consulates have a complaints procedure in place for visa applicants. Information on this procedure shall be made available by the consulate on their website and, where applicable, by the external service provider. Member States shall ensure that a record of complaints is kept.’; Amendment 68 Proposal for a regulation Article 1 – paragraph 1 – point 26 b (new) Regulation (EC) No 810/2009 Article 39 – paragraph 1 (26b)   in Article 39, paragraph 1 is amended 1.  Member States’ consulates shall ensure that applicants are received courteously. ‘1. Member States’ consulates shall ensure that applicants are received courteously. The arrangements for the reception of applicants and for processing their applications should duly respect fundamental rights, as referred to in the Charter of Fundamental Rights of the European Union and the Convention for the Protection of Human Rights and Fundamental Freedoms. Visa applications should be processed on a non-discriminatory basis and in a professional manner which respects applicants.’ Amendment 88 Proposal for a regulation Article 1 – paragraph 1 – point 26 c (new) Regulation (EC) No 810/2009 Article 39 – paragraph 3 (26c)  in Article 39, paragraph 3 is amended as follows: 3.  While performing their tasks, consular staff shall not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation. "3. While performing their tasks, consular staff shall not discriminate against persons on grounds of nationality, sex, gender, family status, origin, actual or assumed religion, belief, disability, age or sexual orientation." Amendment 70 Proposal for a regulation Article 1 – paragraph 1 – point 29 – point d Regulation (EC) No 810/2009 Article 43 – paragraph 9 9.  Member States shall be responsible for compliance with the rules on the protection of personal data and ensure that the external service provider is subject to the monitoring by the data protection supervisory authorities pursuant to Article 51(1) of Regulation (EU) 2016/679. 9.  The Member State(s) concerned shall still be responsible for compliance with the rules, including with regard to respect for fundamental rights, and in particular the principle of non-discrimination and the protection of personal data, and shall ensure that the external service provider is subject to the monitoring by the data protection supervisory authorities pursuant to Article 51(1) of Regulation (EU) 2016/679. Amendment 71 Proposal for a regulation Article 1 – paragraph 1 – point 33 – point b Regulation (EC) No 810/2009 Article 48 – paragraph 1 a – point (c) (c)  ensure a common translation of the application form, where relevant; (c)  ensure a common translation of the application form, and of the standard form for notifying and giving reasons for refusal, annulment or revocation of a visa, where relevant; Amendment 72 Proposal for a regulation Article 1 – paragraph 1 – point 33 – point d Regulation (EC) No 810/2009 Article 48 – paragraph 3 – point (b) – (vi) (vi)  trends in refusals; (vi)  trends in refusals and the reasons therefor; Amendment 73 Proposal for a regulation Article 1 – paragraph 1 – point 33 – point d Regulation (EC) No 810/2009 Article 48 – paragraph 3 – point d (d)  information on insurance companies providing adequate travel medical insurance, including verification of the type of coverage and possible excess amount. deleted Amendment 74 Proposal for a regulation Article 1 – paragraph 1 – point 34 a (new) Regulation (EC) No 810/2009 Article 49 (34a)   Article 49 is amended Article 49 ‘Article 49 Arrangements in relation to the Olympic Games and Paralympic Games Arrangements in relation to the Olympic and Paralympic Games and other high-level international sporting competitions Member States hosting the Olympic Games and Paralympic Games shall apply the specific procedures and conditions facilitating the issuing of visas set out in Annex XI. Member States hosting the Olympic and Paralympic Games and other high-level international sporting competitions shall apply the specific procedures and conditions facilitating the issuing of visas set out in Annex XI.’ Amendment 75 Proposal for a regulation Article 1 – paragraph 1 – point 35 Regulation (EC) No 810/2009 Article 50 b – paragraph 1 1.  Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 1.  Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall be forwarded simultaneously and without delay and shall state the reasons for the use of the urgency procedure. Amendment 76 Proposal for a regulation Article 2 – paragraph 1 1.  Three years after [the date of entry into force of this Regulation], the Commission shall produce an evaluation of the application of this Regulation. This overall evaluation shall include an examination of the results achieved against objectives and of the implementation of the provisions of this Regulation. 1.  Two years after [the date of entry into force of this Regulation], the Commission shall produce an evaluation of the application of this Regulation. This overall evaluation shall include an examination of the results achieved against objectives and of the implementation of the provisions of this Regulation. Amendment 77 Proposal for a regulation Article 2 – paragraph 2 a (new) 2a.   No later than one year after [the date of entry into force of this Regulation], the Commission shall submit an evaluation report to the European Parliament and to the Council on the abolition of visa stickers and the introduction of the digital visa making it possible for a Schengen visa to be issued simply by registering it in the VIS and sending an electronic notification to the applicant. Amendment 78 Proposal for a regulation Annex IV a (new) Regulation (EC) No 810/2009 Annex XI ANNEX XI SPECIFIC PROCEDURES AND CONDITIONS FACILITATING THE ISSUING OF VISAS TO MEMBERS OF THE OLYMPIC FAMILY PARTICIPATING IN THE OLYMPIC GAMES AND PARALYMPIC GAMES ‘ANNEX XI SPECIFIC PROCEDURES AND CONDITIONS FACILITATING THE ISSUING OF VISAS TO MEMBERS OF THE OLYMPIC AND SPORTING FAMILY PARTICIPATING IN THE OLYMPIC GAMES, PARALYMPIC GAMES AND HIGH-LEVEL SPORTING COMPETITIONS’