Official Journal C 195 of the European Union

Volume 61 English edition Information and Notices 7 June 2018

Contents

I Resolutions, recommendations and opinions

RECOMMENDATIONS

Council

2018/C 195/01 Council Recommendation of 22 May 2018 on promoting common values, inclusive education, and the European dimension of teaching ...... 1

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 195/02 Non-opposition to a notified concentration (Case M.8887 — Platinum Equity/LifeScan) (1) ...... 6

2018/C 195/03 Non-opposition to a notified concentration (Case M.8771 — Total/Engie (Part of Liquefied Natural Gas Business)) (1) ...... 6

EN (1) Text with EEA relevance. IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

2018/C 195/04 Council conclusions on moving towards a vision of a European Education Area ...... 7

2018/C 195/05 Council conclusions on the role of young people in building a secure, cohesive and harmonious society in Europe ...... 13

European Commission

2018/C 195/06 Euro exchange rates ...... 19

2018/C 195/07 Commission Implementing Decision of 6 June 2018 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2022, 2023 and 2024 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (1) ...... 20

Court of Auditors

2018/C 195/08 Special Report No 12/2018 — ‘Broadband in the EU Member States: despite progress, not all the Europe 2020 targets will be met’ ...... 23

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

2018/C 195/09 Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC ) No 1907/2006 (REACH) in the first half of 2016 ...... 24

2018/C 195/10 Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the second half of 2016 ...... 25

2018/C 195/11 Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016 ...... 26

(1) Text with EEA relevance. V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2018/C 195/12 Prior notification of a concentration (Case M.8954 — BPEA/PAI/WFC) — Candidate case for simplified procedure (1) ...... 44

2018/C 195/13 Prior notification of a concentration (Case M.8928 — Francisco Partners/VeriFone) — Candidate case for simplified procedure (1) ...... 46

OTHER ACTS

European Commission

2018/C 195/14 Publication of an amendment in accordance with Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs ...... 47

(1) Text with EEA relevance.

7.6.2018 EN Official Journal of the European Union C 195/1

I (Resolutions, recommendations and opinions)

RECOMMENDATIONS

COUNCIL

COUNCIL RECOMMENDATION of 22 May 2018 on promoting common values, inclusive education, and the European dimension of teaching (2018/C 195/01)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 165 and 166 thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) The Union is based on the common values and general principles of respect for human dignity, freedom, democ­ racy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minori­ ties, stipulated in Article 2 of the Treaty on European Union. Pursuant to Article 3 of the Treaty on European Union, it is the aim of the Union to uphold and promote its values.

(2) Inspired by these values, the Union has succeeded in bringing countries, communities and people together in a unique political project, enabling Europe’s longest period of peace, which in turn has fostered social stability and economic prosperity. Member States’ adoption of the values set out in the Treaty creates common ground that makes up the distinct feature of the European way of life and identity and gives the Union its place on the global stage.

(3) The Union and its Member States are faced with a variety of challenges, including populism, xenophobia, divisive nationalism, discrimination, the spreading of fake news and misinformation, as well as the challenge of radicali­ sation leading to violent extremism. These phenomena could pose a serious threat to the foundations of our democracies, undermine trust in the rule of law and democratic institutions, and hinder a common sense of belonging within and amongst our European societies.

(4) A lack of awareness of the origins of the Union, the reasons for its creation and its basic functioning favours misinformation and prevents the formation of informed opinions on its actions. Knowledge of the diversity of the Union and its Member States supports mutual respect, understanding and cooperation within and amongst Member States.

(5) Education in all of its types and at all levels and from an early age plays a pivotal role in promoting common values. It helps to ensure social inclusion by providing every child with a fair chance and equal opportunities to succeed. It provides opportunities to become active and critically aware citizens, and increases understanding of the European identity.

(6) At the Leaders’ Agenda meeting in November 2017 in Gothenburg, European leaders discussed the importance of education and culture for the future of Europe. Informing this debate, the Commission set out its vision for a European Education Area and proposed a number of initiatives in its Communication on ‘Strengthening Euro­ pean Identity through Education and Culture’ (1), which states that ‘strengthening our European identity remains essential and education and culture are the best vectors to ensure this’.

(1) COM(2017) 673 final. C 195/2 EN Official Journal of the European Union 7.6.2018

(7) Following the Leaders’ meeting in Gothenburg, the European Council in its conclusions of 14 December 2017 highlighted that education and culture are key to building inclusive and cohesive societies, and to sustaining our competitiveness (1).

(8) One of the objectives of the ET2020 framework for European cooperation in education and training (2), namely to promote equity, social cohesion and active citizenship, has been established on the basis that education should promote intercultural competences, democratic values and respect for fundamental rights, prevent and combat all forms of discrimination and racism, and equip children, young people and adults to interact positively with their peers from diverse backgrounds.

(9) The Paris Declaration adopted on 17 March 2015 by European education ministers indicated the commitment by the Member States to promote common values, enhance critical thinking and media literacy, inclusive educa­ tion and intercultural dialogue. Responses to an EU-wide public consultation (3) clearly show that inclusive educa­ tion should be promoted. Only 16 % of the respondents feel that education is currently achieving this goal; 95 % feel that education should help young people understand the importance of common values and that the Union should help Member States in achieving this task (98 %).

(10) A 2017 Eurydice survey on Citizenship Education at School in Europe shows that citizenship education is cur­ rently in the spotlight in a number of European countries. However, nearly half of the countries still have no policies on including citizenship education in initial teacher training. Therefore, teachers should be supported and empowered through measures to create an open learning culture and environment and deal with diverse learning groups in order to teach civic competences, transmit Europe’s shared heritage, promote common values and act as role models for learners.

(11) Radicalisation leading to violent extremism remains an acute problem in several Member States. Promoting com­ mon values as a vector of social cohesion and integration, including through education policies, is an integral part of the solution. In order to support Member States in their endeavours, in July 2017, the European Com­ mission established a High Level Group on Radicalisation (4) to identify support measures, including in education.

(12) The most recent results of the PISA survey and the 2017 Education and Training Monitor emphasise the link between educational inequalities and students’ socioeconomic background. PISA data illustrate that students from poorer households are three times more likely to perform worse than their wealthier counterparts and that stu­ dents of migrant background are more than twice as likely to be low achievers as other students. To prevent the marginalisation of young people, it is vital to have inclusive and equitable education systems that foster cohesive societies and lay the foundations for active citizenship and enhance employability.

(13) The International Association for the Evaluation of Educational Achievement’s International Civic and Citizenship Education Study 2016 suggests that national and European identities can positively coexist and do not contradict each other. The study also shows that students with higher levels of civic knowledge also tended to be the stu­ dents expressing more tolerant attitudes.

(14) Eurobarometer surveys highlight a remarkably low level of knowledge of the Union. According to a 2014 opin­ ion poll, 44 % of people feel that they have limited understanding of how the Union works while a 2011 survey shows that a relative majority feel they are not well informed about the European Union. The same study also revealed that a third of people do not know exactly how many Member States there are in the Union. The 2017 Eurobarometer survey shows that 89 % of young Europeans agree that national governments should strengthen school education about their rights and responsibilities as citizens of the Union. Finally, the most recent Euro­ barometer survey highlights that 35 % of respondents consider comparable education standards to be the most helpful for the future of Europe.

(1) EUCO 19/1/17 REV 1 (2) 2015 Joint Report of the Council and the Commission on the implementation of the strategic framework for European cooperation in education and training (ET 2020) — New priorities for European cooperation in education and training (OJ C 417, 15.12.2015, p. 25). (3) SWD(2018) 13 final. (4) Commission Decision of 27 July 2017 setting up the High-Level Commission Expert Group on radicalisation (OJ C 252, 3.8.2017, p. 3). 7.6.2018 EN Official Journal of the European Union C 195/3

(15) Against this background, it is of the essence that Member States step up their efforts to further implement all the objectives of the 2015 Paris Declaration. It is particularly important to continue promote common values as vectors of cohesion and inclusion, favour the implementation of participatory learning environments at all levels of education, improve training for teachers on citizenship and diversity and enhance the media literacy and criti­ cal thinking skills of all learners.

(16) Ensuring effective equal access to quality inclusive education for all learners, including those of migrant origins, those from disadvantaged socioeconomic backgrounds, those with special needs and those with disabilities — in line with the Convention on the Rights of Persons with Disabilities — is indispensable for achieving more cohesive soci­ eties. In this endeavour, Member States could benefit from existing Union instruments, notably Erasmus+, the Euro­ pean Structural and Investment Funds, Creative Europe, Europe for Citizens, the Rights, Equality and Citizenship Programme, the European Solidarity Corps and Horizon 2020, as well as the guidance and expertise of the European Agency for Special Needs and Inclusive Education.

(17) The Erasmus+ programme shows that mobility and cross-border contacts are an efficient way to experience European identity. It is essential that all categories of learners across Europe benefit equally from the opportuni­ ties offered by this programme; notably through school exchanges between Member States. Virtual mobility, especially through the e-Twinning network, is an excellent tool to enable direct contact between pupils, and shall be used on a larger scale in the following years, and in combination with physical mobility.

(18) Introducing a European dimension of teaching should aim to help learners experience European identity in all its diversity and strengthen a European positive and inclusive sense of belonging complementing their local, regional and national identities and traditions. It is also important for promoting a better understanding of the Union as well as an understanding of its Member States.

(19) This Recommendation fully respects the principles of subsidiarity and proportionality. The content of this Recommendation is without prejudice to existing national initiatives in these fields, notably in national civic education,

HAS ADOPTED THIS RECOMMENDATION:

The Member States should: Promotion of common values 1. increase the sharing of the common values set out in Article 2 of the Treaty on European Union from an early age and at all levels and types of education and training in a l ifelong perspective to strengthen social cohesion and a positive and inclusive common sense of belonging at local, regional, national and Union level;

2. continue to implement the commitments of the Paris Declaration, notably through:

(a) promoting active citizenship and ethics education as well as an open classroom climate to foster tolerant and democratic attitudes and social, citizenship and intercultural competences;

(b) enhancing critical thinking and media literacy, particularly in the use of the internet and social media, so as to raise awareness of risks related to the reliability of information sources and to help exercise sound judgment;

(c) using existing or, where necessary, developing new structures that promote the active participation of teachers, parents, students and the wider community in schools; and

(d) supporting opportunities for young people’s democratic participation and an active, critically aware and respon­ sible community engagement;

3. make effective use of existing tools to promote citizenship education, such as the Council of Europe’s Competences for Democratic Culture framework;

Provision of inclusive education 4. promote inclusive education for all learners, notably by:

(a) including all learners in quality education from early childhood and throughout life; C 195/4 EN Official Journal of the European Union 7.6.2018

(b) providing the necessary support to all learners according to their particular needs, including those from disad­ vantaged socioeconomic backgrounds, those from a migrant background, those with special needs and the most talented learners;

(c) facilitating the transition between various educational pathways and levels and enabling the provision of adequate educational and career guidance;

5. make effective use of the European Agency for Special Needs and Inclusive Education, on a voluntary basis, to imple­ ment and monitor successful inclusive approaches in their education systems;

Promotion of a European dimension of teaching 6. promote a European dimension of teaching by encouraging:

(a) an understanding of the European context and common heritage and values and an awareness of the unity and diversity, social, cultural and historical, of the Union and the Member States of the Union;

(b) an understanding of the origins, values and functioning of the Union;

(c) the participation of pupils and teachers in the e-Twinning network, in cross-border mobility, and transnational projects, especially for schools;

(d) grass-roots projects to raise awareness of and improve understanding of the European Union in learning settings, notably through direct interaction with young people, such as an annual celebration, on a voluntary basis, of a ‘Day of the European Union’ in learning settings;

Support educational staff and teaching 7. enable educational staff to promote common values and deliver inclusive education, through:

(a) measures to empower educational staff helping them convey common values, and promote active citizenship while transmitting a sense of belonging and responding to the diverse needs of learners; and

(b) promoting initial and continued education, exchanges and peer learning and peer counselling activities as well as guidance and mentoring for educational staff;

Implementing measures 8. review and, where necessary, improve existing policies and practices in the field of education, training and non- formal learning with a view to acting on these recommendations;

9. identify needs and enhance public engagement, using existing data or, if necessary, collecting new data with a view to improving evidence-informed policy making on the social and civic dimensions of education and training;

10. continue collaborating in EU strategic cooperation frameworks in the fields of education and training, youth, sport and culture through peer learning, peer counselling and exchange of good practices with a view to promoting com­ mon values;

11. make effective use of EU funding instruments, in particular Erasmus+, European Structural and Investment Funds, Creative Europe, Europe for Citizens, the Rights, Equality and Citizenship Programme and Horizon 2020 with a view to implementing these recommendations;

WELCOMES THE COMMISSION’S INTENTION TO: 12. support the Member States in implementing the provisions of this Recommendation through the available tools and funding instruments, such as the Erasmus+ programme, particularly through learning mobility at all levels of edu­ cation, with a focus on schools, transnational projects, the e-Twinning network as well as Jean Monnet activities;

13. support national and regional policy reforms and practice improvements through the ET2020 framework for Euro­ pean cooperation in education and training and any successor framework; 7.6.2018 EN Official Journal of the European Union C 195/5

14. where necessary, develop and regularly review practical reference tools and guidance documents for policymakers and practitioners and support research and stakeholder engagement to meet knowledge needs;

15. assess and evaluate the action taken in response to this Recommendation, in particular through the ET2020 frame­ work, including the Education and Training Monitor.

Done at Brussels, 22 May 2018.

For the Council The President K. VALCHEV C 195/6 EN Official Journal of the European Union 7.6.2018

II (Information)

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

EUROPEAN COMMISSION

Non-opposition to a notified concentration (Case M.8887 — Platinum Equity/LifeScan) (Text with EEA relevance) (2018/C 195/02)

On 4 June 2018, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available: — in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, — in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32018M8887. EUR-Lex is the online access to European law.

(1) OJ L 24, 29.1.2004, p. 1.

Non-opposition to a notified concentration (Case M.8771 — Total/Engie (Part of Liquefied Natural Gas Business)) (Text with EEA relevance) (2018/C 195/03)

On 11 April 2018, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available: — in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, — in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32018M8771. EUR-Lex is the online access to European law.

(1) OJ L 24, 29.1.2004, p. 1. 7.6.2018 EN Official Journal of the European Union C 195/7

IV (Notices)

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

COUNCIL

Council conclusions on moving towards a vision of a European Education Area (2018/C 195/04)

THE COUNCIL OF THE EUROPEAN UNION,

recalling the political background to this issue as set out in Annex to these conclusions,

RECALLING THAT: 1. the social dimension of education as stated in the first principle of the European Pillar of Social Rights states that everyone has the right to quality and inclusive education, training and lifelong learning in order to main­ tain and acquire skills that allow full participation in society and successful transitions in the labour market.

2. in the context of the Social Summit in Gothenburg on 17 November 2017, the Leaders’ Agenda was devoted to education and culture. Political support was established for a number of specific work strands, mainly on the basis of the Commission communication on ‘Strengthening European Identity through Education and Culture’ that presented the idea to work together, in full respect of subsidiarity, towards a shared vision of a European Education Area based on trust, mutual recognition, cooperation and exchange of best practices, mobility and growth, to be established by 2025.

3. as a follow-up to the Gothenburg Summit, the European Council conclusions of 14 December 2017 placed education high on the European political agenda and created momentum for achieving significant progress in this field.

CONSIDERS THAT: 4. education and culture are crucial in bringing Europeans together and for the future of individuals as well as for the Union as a whole. All Europeans should be able to benefit from the diverse common cultural and educa­ tional heritage.

5. a European Education Area should be underpinned by the life-long learning continuum, from early childhood education and care through school and vocational education and training to higher education and adult education.

6. a European Education Area should promote and foster mobility and cooperation in education and training and support Member States in modernising their education and training systems.

7. UNDERLINES that the Strategic Framework for European Cooperation in Education and Training (ET 2020) has provided a valuable basis for setting up common priorities and supporting Member States in modernising their education and training systems.

8. INVITES Member States to continue reflecting on a shared vision of a European Education Area, including its possible goals, objectives and scope, and its links with the post-2020 strategic framework for cooperation in education and training. The follow-up to ET 2020, through increased cooperation between Member States and with the support of the Commission, should promote mutual learning and support further efforts and steps towards making the vision of a European Education Area a reality. In order to progress the vision of a European Education Area, particular attention should be paid to the following topics: C 195/8 EN Official Journal of the European Union 7.6.2018

9. ERASMUS+

9.1. STRESSES that the Erasmus+ programme is a highly successful flagship initiative of the EU, which boosts learning mobility throughout Europe and beyond, and makes a significant contribution to improving personal develop­ ment and intercultural competences and strengthening the European identity; it underpins EU-wide cooperation between education and training institutions of all levels; it also increases the EU’s competitiveness; and enhances the promotion of common European values.

9.2. WELCOMES the results of the mid-term evaluation of Erasmus+ and CALLS for measures to strengthen and widen participation, continue focusing on the impact and quality of projects, foster high quality education and training and make access to the next-generation Erasmus+ programme more inclusive and equitable, for exam­ ple by reinforcing equal opportunities and enhancing access to the programme for underrepresented regions and groups, first time applicants and organisations with smaller capacity throughout all parts of the pro­ gramme. Synergies with other European Union funding sources could be reinforced, while overlaps should be avoided.

9.3. CALLS for further simplification of the rules and procedures in order to further reduce the administrative bur­ den at all levels.

10. DIGITAL SKILLS AND EDUCATION

10.1. UNDERLINES the importance of improving learning and teaching in the digital age and of promoting the devel­ opment of digital competence, one of the key competences for lifelong learning, by paying special attention to the Sofia Call for Action on Digital Skills and Education and to the Commission communication on the Digital Education Action Plan.

10.2. HIGHLIGHTS that the next-generation Erasmus+ programme and other relevant Union funding programmes should support the adaptation of education and training systems and infrastructure to the digital age.

10.3. CALLS UPON THE MEMBER STATES AND THE COMMISSION, ACTING WITHIN THEIR RESPECTIVE COMPETENCES, TO:

10.3.1. Support the modernisation of education and training systems through innovation, including by making a peda­ gogical and innovative use of digital technologies and approaches that support the quality and inclusive nature of education and training and through appropriate use of relevant EU funding programmes and tools, including the voluntary SELFIE self-assessment tool, encourage initiatives and cooperation of all relevant stakeholders to further develop education and training, to include digital skills in all teaching and learning.

10.3.2. Take concrete measures to promote the development of digital competences and media literacy skills among all Europeans in order to build resilience to disinformation, propaganda and filter bubbles and to equip all citizens, including those from disadvantaged backgrounds, with the skills they need to use digital technologies and the internet for their own well-being and for civic participation.

10.3.3. Stimulate education that fosters creativity and entrepreneurship as well as, where appropriate and in accordance with existing legal provisions, foster cooperation between education and business and the civil society for the upskilling and reskilling of learners and educators including for example the development of digital skills train­ ing programmes. Acknowledges the work by the Intellectual Property in Education network managed by the European Union Intellectual Property Office.

11. HIGHER EDUCATION

11.1. RECALLS specific challenges for Europe’s higher education sector as set out in the November 2017 Council Conclusions on a renewed EU agenda for higher education.

11.2. RECOGNISES the proven added value of Erasmus+ learning mobility and strategic partnerships across the Union, in fostering higher education cooperation as well as initiatives such as the European Institute of Technology and Innovation and the Marie Skłodowska-Curie actions.

11.3. RECOGNISES the importance of strengthening strategic collaboration between higher education institutions in Europe through a bottom-up, flexible, unbureaucratic, inclusive, open and transparent approach. 7.6.2018 EN Official Journal of the European Union C 195/9

11.4. SUPPORTS the emergence of ‘European Universities’, consisting of sustainable bottom-up networks that are geo­ graphically and socially inclusive and work seamlessly across borders, and which could play a flagship role in the creation of a European Education Area as a whole, contributing to empower new generations of European citizens and to strengthen the international competitiveness of higher education in Europe. CONSIDERS that ‘European Universities’ have the potential to significantly enhance mobility and foster high quality and excel­ lence in education and research, by strengthening the link between teaching, research and innovation and knowledge transfer, by demonstrating the benefits of multilingual learning, the recognition of qualifications and by developing joint education and research programmes and projects.

11.5. INVITES THE COMMISSION, WITH DUE REGARD FOR THE SUBSIDIARITY PRINCIPLE, AND IN CLOSE COOPERATION WITH THE MEMBER STATES to develop and establish the key objectives and concept of ‘European Universities’ as well as support their development. TAKES NOTE that the Commission has set up an Ad hoc Expert Group com­ posed of experts from the Member States for this purpose. TAKES NOTE that the selection criteria for the pilot phase of ‘European Universities’ will be developed following the procedures stipulated in the Erasmus+ Regulation (1).

11.6. INVITES the Commission to report regularly to the Council on the progress in developing the selection criteria for piloting ‘European Universities’. CALLS on the Commission together with the Member States and based on the outcomes of the pilot project, to reflect on the future shape of ‘ European Universities’.

11.7. STRESSES that university-business cooperation is instrumental in fostering the EU’s competitiveness, as well as its economic and social growth. ACKNOWLEDGES the contribution of the European University-Business Forum. HIGHLIGHTS the need for continuous support to university-business partnerships to fuel their potential to inno­ vate, research and develop innovative pedagogies.

11.8. INVITES the Member States to foster measures, with the support of the Commission, to enhance the entrepreneurial and innovative capabilities of higher education institutions, including through the use of the HEInnovate self-assessment tool.

11.9. CALLS on the Commission in close cooperation with the Member States and based on the outcomes of the pilot project, to explore the possibility of creating a voluntary European Student Card, which should contribute to improved learning mobility by ensuring better services for students and reduced administration for higher edu­ cation institutions.

12. HIGH QUALITY AND INCLUSIVE EDUCATION

12.1. RECALLS that the European Pillar of Social Rights states that all children have the right to affordable and good quality early childhood education and care. UNDERLINES that the efforts should be intensified towards reaching the priorities set out in the 2011 Council conclusions on early childhood education and care and towards pro­ viding all children, including those from socioeconomically disadvantaged regions, as well as those from all socioeconomic backgrounds, access to early childhood education and care systems.

12.2. UNDERLINES the need to ensure high quality and inclusive education to support the development of all learners, including by focussing on the priorities set out in the November 2017 Council conclusions on school develop­ ment and excellent teaching.

12.3. HIGHLIGHTS the need to promote the attractiveness and importance of the teacher profession and that of other educational staff and support their continuous upskilling. Even though many of the jobs of the future are still unknown, this profession is among those that will retain its central role for society in an era of crosscutting technological innovation and artificial intelligence. In this regard, mobility of teachers and educational staff, as well as better communication between the responsible bodies for their training, should be promoted.

12.4. STRESSES that it is key to join forces to reduce early school leaving in Europe and increase the opportunities for equal access to education and basic skills for all vulnerable groups, including the children of workers who relo­ cate to another Member State for shorter or longer periods.

(1) Regulation (EU) No 1288/2013 of the European Parliament and of the Council of 11 December 2013 establishing ‘Erasmus+’: the Union programme for education, training, youth and sport and repealing Decisions No 1719/2006/EC, No 1720/2006/EC and No 1298/2008/EC (OJ L 347, 20.12.2013, p. 50). C 195/10 EN Official Journal of the European Union 7.6.2018

12.5. NOTES the difficulties children and pupils could encounter when returning to their home country’s education system after periods abroad in cases of insufficient communication between the national educational systems.

12.6. INVITES the Member States, with the support of the Commission, where appropriate, to explore ways of improving the exchange of information on pupils’ educational status in cases of mobility, while respecting Union law on protection of personal data.

13. LANGUAGE LEARNING

13.1. RECOGNISES multilingual competence as an important building block of a European Education Area. STRESSES that languages play a key role in fostering understanding and diversity, as well as promoting European values, and are essential for personal development, mobility and participation in society and employability.

13.2. RECALLS the ambition expressed by the European Council in its conclusions of December 2017 with respect to language learning.

13.3. RECALLS the May 2014 Council conclusions on multilingualism and the development of language competences that called on Member States to adopt and improve measures aimed at promoting multilingualism and at enhancing the quality and efficiency of language learning and teaching.

14. RECOGNITION OF QUALIFICATIONS (1)

14.1. CONSIDERS the recognition of higher education and secondary level education qualifications, including VET qualifications, as well as the recognition of the outcomes of learning periods abroad, as important building blocks of a European Education Area through their contribution to the seamless mobility of learners across the Union as a whole.

14.2. EMPHASISES the importance of cooperation between education and training systems, education and training providers and other stakeholders for developing and implementing policies, as well as contributing to trust through quality assurance and improved evaluation procedures.

14.3. RECALLS that the second indent of Article 165(2) of the Treaty on the Functioning of the European Union calls upon the Union to encourage the academic recognition of diplomas and periods of study building upon the Lisbon Convention on the Recognition of Qualifications concerning Higher Education in the European Region and its subsidiary texts with a view to fostering mobility of students and teachers; FULLY RESPECTS the responsi­ bilities and competences of the Member States in this area and STRESSES that the proposed solutions at Union level should be based on transparency and trust, and should take into account the specificities of the educa­ tional systems of the Member States.

Additionally STRESSES:

15. that initiatives included in the concept and future actions to be proposed and undertaken as a part of a European Education Area need to ensure complementarity and coherence with respect to national education and training systems and should include all levels and types of education and training, including adult educa­ tion and vocational education and training.

(1) Qualifications as defined in Article I of the Lisbon Convention on the Recognition of Qualifications concerning Higher Education in the European Region (i.e. higher education qualification; and qualification giving access to higher education). 7.6.2018 EN Official Journal of the European Union C 195/11

ANNEX

POLITICAL BACKGROUND

1. Council conclusions on preparing young people for the 21st century: an agenda for European cooperation on schools (21 November 2008). 2. Council conclusions on a strategic framework for European cooperation in education and training (‘ET2020’) (12 May 2009). 3. Conclusions of the Council and of the Representatives of the Governments of the Member States, meeting within the Council, on developing the role of education in a fully-functioning knowledge triangle (26 November 2009). 4. Council conclusions on early childhood education and care: providing all our children with the best start for the world of tomorrow (19 and 20 May 2011). 5. Council conclusions on the modernisation of higher education (28 and 29 November 2011). 6. Council conclusions on the social dimension of higher education (16 and 17 May 2013). 7. Council conclusions on the global dimension of European higher education (25 and 26 November 2013). 8. Council conclusions on effective leadership in education (25 and 26 November 2013). 9. Council conclusions on multilingualism and the development of language competences (20 May 2014). 10. Declaration on promoting citizenship and the common values of freedom, tolerance and non-discrimination through education (Paris, 17 March 2015). 11. Council conclusions on the role of early childhood education and primary education in fostering creativity, innova­ tion and digital competence (18 and 19 May 2015). 12. 2015 Joint Report of the Council and the Commission on the implementation of the strategic framework for Euro­ pean cooperation in education and training (ET 2020) — New priorities for European cooperation in education and training (23 and 24 November 2015). 13. Council conclusions on reducing early school leaving and promoting success in school (23 and 24 November 2015). 14. Resolution of the Council and of the Representatives of the Governments of the Member States, meeting within the Council, on promoting socioeconomic development and inclusiveness in the EU through education: the contribu­ tion of education and training to the European Semester 2016 (24 February 2016). 15. Council conclusions on developing media literacy and critical thinking through education and training (30 May 2016). 16. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – A n ew skills agenda for Europe: working together to strengthen human capital, employability and competitiveness (10 June 2016). 17. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – Improving and modernising education (7 December 2016). 18. Council Recommendation on Upskilling Pathways: New Opportunities for Adults (19 December 2016) 19. Report from the Commission to the European Parliament, the Council, the European Economic and Social Commit­ tee and the Committee of the Regions on the Mid-term evaluation of the Erasmus+ programme (2014-2020) (31 January 2018). 20. Conclusions of the Council and of the Representatives of the Governments of the Member States, meeting within the Council, on inclusion in diversity to achieve a high quality education for all (17 February 2017). 21. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Strengthening European Identity through Education and Culture: The European Commission’s contribution to the Leaders’ meeting in Gothenburg, 17 November 2017. 22. Council Recommendation on tracking graduates (20 November 2017). 23. Council conclusions on a renewed EU agenda for higher education (20 November 2017). 24. Council conclusions on school development and excellent teaching (20 November 2017). 25. Conclusions of the European Council (14 December 2017). C 195/12 EN Official Journal of the European Union 7.6.2018

26. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the Digital Education Action Plan (17 January 2018).

27. Council Recommendation on a European framework for quality and effective apprenticeships (15 March 2018).

28. Council Recommendation on promoting common values, inclusive education, and the European dimension of teaching (22 May 2018).

29. Council Recommendation on Key Competences for Lifelong Learning (22 May 2018). 7.6.2018 EN Official Journal of the European Union C 195/13

Council conclusions on the role of young people in building a secure, cohesive and harmonious society in Europe (2018/C 195/05)

THE COUNCIL OF THE EUROPEAN UNION,

RECALLING: 1. The political background to this issue as set out in the Annex to these conclusions.

TAKES NOTE OF: 2. The Youth, Peace and Security agenda, as set out in UN Security Council Resolution 2250 (2015), which recognises the important and positive contribution of young people in efforts for the maintenance and promotion of peace and security, and affirms the important role young people can play in the prevention and resolution of conflicts.

3. The 2030 Agenda for Sustainable Development (2030 Agenda) adopted by the United Nations in September 2015 and the Sustainable Development Goals (SDGs), which constitute, at their core, a transformative political framework to eradicate poverty and achieve sustainable development. They balance the economic, social and environmental dimensions, including the key issues of governance and peaceful, harmonious and inclusive societies, and recognise the essential interlinkage between their goals and targets.

4. The Global Strategy for the European Union’s Foreign And Security Policy, which envisages nurturing societal resilience also by deepening work on education, culture and youth to foster pluralism, coexistence and respect.

5. The European Consensus on Development, which provides that young people are agents of development and change and, as such, are essential contributors to the 2030 Agenda, including through their ability to innovate, and asserts that the EU and its Member States will also aim to strengthen the rights of young people and their empow­ erment in the conduct of public affairs, including by promoting their participation in local economies, societies and decision-making, notably through youth organisations.

6. The White Paper on the future of Europe (1), emphasising the important role of ‘European values’.

7. The European Regional Consultation on ‘Youth, peace and security’ held in Brussels, Belgium, from 25 -27 September 2017, organized by the European External Action Service in partnership with the United Nations Population Fund, the United Nations Peacebuilding Support Office and key civil society stakeholders.

RECOGNISING THAT: 8. The number of young people in the world is rising — there are 1,8 billion children and young people (aged 15-24) in the world today, and there will be 72 million more by [2025].

9. The number of young people in the European Union is currently 88,9 million (2016).

10. ‘Participation’ and ‘youth and the world’, among other subjects, were included as two priority areas of action in the renewed framework for European cooperation in the area of youth policy (2010-2018).

11. The ‘Youth, peace and security’ ( 2) agenda, as set out in UN Security Council Resolution 2250 (2015) has relevance at both global and European level. Europe is one of the most secure parts of the world. Nevertheless, structural issues, such as climate change, natural disasters, human trafficking, limited employment opportunities, and marginalisation, that affect young people in the European Union — together with the growing threat of violent radicalisation — challenge the idea that Europe is a secure and peaceful continent.

12. There is a need to recognise young people as key actors in building democracy, creating peaceful narratives, building social cohesion, and promoting European values. It is important to engage and recognise young people and stakehold­ ers in the field of youth as key allies in building the resilience to combat such issues, to sustain peace and prevent violence, and to work towards an inclusive and peaceful society. In this context, youth work can play an important role in highlighting young people’s potential to play a positive role in building a secure, cohesive and peaceful society.

(1) Doc. 6952/17 (2) United Nations Development Programme, UNDP Youth Strategy 2014-2017: Empowered Youth, Sustainable Future (New York, 2014). C 195/14 EN Official Journal of the European Union 7.6.2018

STRESSING THAT: 13. Throughout the world today, more than 600 million young people live in fragile and conflict-affected contexts (1). They are among the most affected by the multiple and often interlinked forms of violence — from minor acts of violence to the organised crime and violent extremism terrorist attacks that plague their communities — and suffer enormous and long-lasting human, social and economic consequences. Therefore it is of the highest importance to design and implement policies and programs that give them opportunities to develop resilience and help their inclusion in society.

14. Many European countries have recently experienced high youth unemployment rates and issues related to social exclusion. As a result groups of young people are increasingly embracing outlets such as negative expressions of populism, propaganda, hate speech, and xenophobia, that have the potential to lead to violent extremism, damaging our multicultural identity as Europeans. Therefore, it is crucial that young people are supported in embracing new opportunities such as new technologies and digitalisation, and tackling new challenges such as fake news and globalisation.

15. It is crucial to bear in mind that Youth, Peace and Security is not just a global agenda — it is also a European agenda. In general young people have a holistic understanding of sustaining peace and thus they have a crucial role in addressing the different types of violence, discrimination and injustice that affect them, including domestic vio­ lence, gender-based violence, propaganda, all forms of bullying, early and forced marriage, ethnic discrimination and disrespect, through different instruments such as intercultural dialogue through mobility, youth work, volun­ teering and non-formal and informal learning.

16. Young people are valuable innovators and agents of change, and their contributions should be actively supported, solicited and regarded as essential in building a peaceful society and supporting democratic governance. Moreover, young people’s participation promotes civic engagement and active citizenship. In addition, education for demo­ cratic citizenship, including digital citizenship along with human rights education, including education for peace and critical thinking, play a key role in their development. In that context, the cooperation between the European Union and the Council of Europe can make a valuable contribution.

UNDERLING THAT: 17. Youth mobility is crucial for exchanging ideas, spreading innovation, tackling unemployment and social issues, establishing strong relationships between people, assisting personal development, encouraging the acquisition of soft and transversal skills, as well as promoting intercultural competences and fighting prejudices and discrimina­ tion. Therefore, it should be promoted to achieve inclusive, cohesive and secure society for all.

18. Youth work and non-formal and informal learning have a significant role to play in addressing youth marginalisa­ tion and radicalisation. In addition, youth work helps to combat youth marginalisation and radicalisation and enable young people to better understand human rights and democratic values in practice.

19. It is of great importance to further develop and promote the international cooperation of all stakeholders including young people, youth workers, youth leaders and youth organisations from the European Union and beyond, as this constitutes a contribution to building confidence and shaping future relations in and outside Europe.

STRESS THE FOLLOWING AREAS FOR ACTION: A. Cross-sectorial cooperation based on innovative methods of communication, sharing of good practices and effective dialogue 20. The youth, peace and security agenda cuts across the EU’s internal and external policies on promoting sustainable development, peace and security and human rights. Optimising synergies and ensuring coherence between policy responses to challenges straddling the internal and external policies of the Union can only be achieved through the combined efforts of many different stakeholders.

(1) Council of Europe charter on education for democratic citizenship and human rights education. 7.6.2018 EN Official Journal of the European Union C 195/15

IN THIS CONTEXT THE COUNCIL INVITES MEMBER STATES, THE EUROPEAN COMMISSION AND THE EUROPEAN EXTERNAL ACTION SERVICE WITHIN THEIR RESPECTIVE SPHERES OF COMPETENCE TO: 21. Promote cross-sectorial cooperation based on innovative methods of communication, sharing of good practices and effective dialogue between the youth sector and different policy fields and relevant authorities so that they consider including young people, youth organisations and organisations working for youth as valuable partners in reinforc­ ing societal and state resilience and building cohesive society.

22. Mobilise expertise, promote innovation, and deepen multi-stakeholder partnerships between the EU institutions, Member States, civil society, young people and stakeholders in the field of youth and beyond by strengthening the young people’s role in sustaining peace.

Promote dialogue, cooperation and good practices exchange related to the Youth, Peace, Security agenda between key stakeholders, through reinforcing the global cooperation chapter of the Erasmus+ Programme, and other mech­ anisms to exchange good practices. This should also mobilise young people and create a link between decision- making authorities, youth organisations and organisations for youth that work to sustain peace and build a cohe­ sive and harmonious society.

B. Striving for cohesive and harmonious societies: building on the evidence-based approach 23. At a time when Europe is attempting to address hate speech and reduce all forms of violence it is important to develop peaceful discourse that promotes common values ( 1) of the EU of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights.

IN THIS CONTEXT THE COUNCIL INVITES THE EUROPEAN COMMISSION AND THE EUROPEAN EXTERNAL ACTION SERVICE WITHIN THEIR RESPECTIVE SPHERES OF COMPETENCE TO: 24. Promote, review and highlight good practices regarding young people’s role in sustaining peace and preventing violence as a source of knowledge production and a valuable tool with which to change ‘negative narratives’ on young people. Qualitative results and evidence-based examples of young people’s contributions to sustaining peace and solidarity should be mapped and systematically collected in Europe, including in cooperation with Member States within the Youth Wiki.

C. Ensure active and meaningful youth participation in building peaceful and inclusive societies 25. Active and equal participation (supported through capacity building) of young people, especially the ones with fewer opportunities at all levels of civil and political life is an essential condition for building peaceful, cohesive and equal societies. It is also important to eradicate poverty and social exclusion leading to marginalisation of young people.

26. There is a growing recognition that young people are agents of change in conflict prevention, promoting inclusion and social justice, and sustaining peace. Promoting peace and stability requires a global partnership between all stakeholders, young people and organisations for youth have a vital role to play in this respect. Youth work also has an important role to play in building peace and promoting solidarity.

IN THIS CONTEXT THE COUNCIL INVITES MEMBER STATES, THE EUROPEAN COMMISSION AND THE EUROPEAN EXTERNAL ACTION SERVICE WITHIN THEIR RESPECTIVE SPHERES OF COMPETENCE TO: 27. Increase opportunities for meaningful participation of young people in maintaining and promoting peace and secu­ rity at all levels, when and where possible, through participatory mechanisms.

28. Facilitate easier access to data and knowledge from the recent studies and research outputs on youth participation in democratic life in Europe among young people, youth organisations and other stakeholders.

29. Promote active participation of young people in society, including young people with fewer opportunities, and cross-border mobility and contacts between people, thereby facilitating the exchange of ideas and the spreading of innovation through the current and future programmes.

(1) See Article 2 of the Treaty on European Union. C 195/16 EN Official Journal of the European Union 7.6.2018

IN THIS CONTEXT THE COUNCIL INVITES THE EUROPEAN EXTERNAL ACTION SERVICE TO: 30. Take forward work on EU engagement with the youth, peace and security agenda, as well as key inter-regional engagements (1), in partnership with the United Nations and other international organisations, including the pro­ gressive framing of a strategic EU-UN partnership on youth in peacebuilding.

D. Maintain and foster the intercultural dialogue between youth in and beyond Europe 31. Intercultural dialogue has multiple functions and may be recognised as contributing to peace and security in the EU and neighbouring countries. Participating in intercultural dialogue provides various opportunities for young people to take a leadership position, to advance reconciliation processes and reduce prejudice, misunderstandings and discrimination among diverse groups as well as to combat hate speech and violent extremism using a human-rights based approach.

IN THIS CONTEXT THE COUNCIL INVITES MEMBER STATES, THE EUROPEAN COMMISSION AND THE EUROPEAN EXTERNAL ACTION SERVICE WITHIN THEIR RESPECTIVE SPHERES OF COMPETENCE TO: 32. Support international youth cooperation, dialogue and mutual understanding between young people, youth work­ ers, youth leaders and youth organisations and organisations for youth (2) from the EU and beyond as an important tool in supporting European citizenship and the democratisation processes.

E. Building resilience and critical thinking through non-formal and informal learning and the peer-to-peer approach 33. Young people’s awareness and understanding of the common values of the EU (3) such as respect for democracy, equality, human rights, solidarity, citizenship and diversity should be supported as well as their media and informa­ tion literacy. This contributes to critical thinking and to an awareness of and knowledge about how information can be biased and exploited by violent extremist groups in order to spread propaganda.

34. As agreed and introduced within the Council of Europe, Education for democratic citizenship and human rights education is closely interrelated and mutually supportive (4). This non-formal method of education and training is an instrument that focuses primarily on promoting democratic rights and responsibilities and active participation, in relation to the civic, political, social, economic, legal and cultural spheres of society.

IN THIS CONTEXT THE COUNCIL INVITES MEMBER STATES, THE EUROPEAN COMMISSION AND THE EUROPEAN EXTERNAL ACTION SERVICE WITHIN THEIR RESPECTIVE SPHERES OF COMPETENCE TO: 35. Consider promoting and reinforcing, when and where relevant, the concept of ‘Education for democratic citizenship and human rights education’, which could be implemented in formal and non-formal learning environments and the peer-to-peer approach, respecting subsidiarity and freedom of education.

36. Enhance further cooperation with the Council of Europe within the partnership agreement.

(1) The Youth Track of the 5th AU-EU Summit and the Young Mediterranean Voice Initiative. (2) By ‘Youth Organisations’ is meant civil-society organisations for which the coordination body is comprised mainly of young people. By ‘Organisations for Youth’ is meant civil-society organisations who provide services for young people but their coordinating bodies do not consist of only young people. (3) See Article 2 of the Treaty on European Union. (4) Council of Europe Charter on Education for Democratic Citizenship and Human Rights Education (Adopted in the framework of Rec­ ommendation CM/Rec(2010)7 of the Committee of Ministers). 7.6.2018 EN Official Journal of the European Union C 195/17

ANNEX

In adopting these conclusions, the Council RECALLS in particular the following:

1. EU Global Strategy on Foreign and Security Policy, with special emphasis on resilience

2. European Consensus on Development/Council conclusions on sustainable development (2016).

3. EU Comprehensive Approach on Gender, Peace and Security.

4. Revised Guidelines for the EU Strategy for Combating Radicalisation and Recruitment to Terrorism (9640/16 and 14276/16).

5. Council conclusions on the role of youth work in supporting young people’s development of essential life skills that facilitate their successful transition to adulthood, active citizenship and working life (9624/17).

6. Council conclusions on the role of the youth sector in an integrated and cross-sectoral approach to preventing and combating violent radicalisation of young people (9640/16).

7. EU Action Plan on Human Rights and Democracy 2015-2019 (2015)

8. The informal meeting of the Heads of States or Government of 12 February 2015 at which the members of the European Council called for a comprehensive approach, including initiatives regarding social integration, among others, which are of great importance to prevent violent radicalisation.

9. The Declaration adopted by EU education ministers at their informal gathering in Paris on 17 March 2015 in which they provide guidance on how to cooperate at European level. The importance of efforts to prevent and tackle marginalisation, intolerance, racism and radicalisation, to promote citizenship of young people and to preserve a framework of equal opportunities for all were highlighted.

10. The Council conclusions on the renewed internal security strategy of 17 June 2015, which prioritise the specific issues of disengagement, rehabilitation and de- or anti-radicalisation as a p riority for action in the coming years (9416/15).

11. The EU Work Plan for Youth 2016-2018 which focuses on increasing the social inclusion of all young people, taking into account underlying European values, and the role of youth work both in the non-digital and the digital world.

12. The 2015 Joint EU Youth Report of the Council and the Commission on ‘the implementation of the renewed framework for European cooperation in the youth field (2010-2018)’ which underlined that young people should be able to grow up in inclusive and pluralist societies based on democratic, European values. The joint EU Youth Report also illustrates the need to empower young people from all backgrounds even more, especially those at risk of exclusion.

13. Cooperation between the European Commission and the Council of Europe within the Partnership Agreement.

14. The European Agenda on Security, of 28 April 2015, in which the Commission considers participation of young people to be a k ey factor in preventing radicalisation by promoting European values and fostering social inclusion, also mentioning the Radicalisation Awareness Network (RAN), an EU-wide umbrella which enables the exchange of experience and practices facilitating early detection of radicalisation and the design of preventive and disengagement strategies at local level.

15. The European Parliament Resolution of 25 November 2015 on the prevention of radicalisation and recruitment of European citizens by terrorist organisations.

16. UN Security Council Resolution 2250 (2015) on youth, peace and security.

17. 125th session of the Committee of Ministers — The Action Plan of the Committee of Ministers (Brussels, 19 May 2015), CM(2015)74 final, on ‘The fight against violent extremism and radicalisation leading to terrorism’ , and the United Nations Plan of Action to Prevent Violent Extremism. C 195/18 EN Official Journal of the European Union 7.6.2018

18. The UN Inter-Agency Working Group on Youth and Peacebuilding’s ‘Guiding principles for young people’s partici­ pation in peacebuilding’. 7.6.2018 EN Official Journal of the European Union C 195/19

EUROPEAN COMMISSION

Euro exchange rates (1) 6 June 2018 (2018/C 195/06)

1 euro =

Currency Exchange rate Currency Exchange rate USD US dollar 1,1765 CAD Canadian dollar 1,5150 JPY Japanese yen 129,57 HKD Hong Kong dollar 9,2328 DKK Danish krone 7,4436 NZD New Zealand dollar 1,6702 GBP Pound sterling 0,87683 SGD Singapore dollar 1,5685 SEK Swedish krona 10,2760 KRW South Korean won 1 255,45 ZAR South African rand 15,0421 CHF Swiss franc 1,1629 CNY Chinese yuan renminbi 7,5230 ISK Iceland króna 123,70 HRK Croatian kuna 7,3878 NOK Norwegian krone 9,5238 IDR Indonesian rupiah 16 300,41 BGN Bulgarian lev 1,9558 MYR Malaysian ringgit 4,6704 CZK Czech koruna 25,648 PHP Philippine peso 61,697 HUF Hungarian forint 318,64 RUB Russian rouble 72,9345 PLN Polish zloty 4,2753 THB Thai baht 37,530 RON Romanian leu 4,6534 BRL Brazilian real 4,4924 TRY Turkish lira 5,4078 MXN Mexican peso 23,9686 AUD Australian dollar 1,5365 INR Indian rupee 78,7310

(1) Source: reference exchange rate published by the ECB. C 195/20 EN Official Journal of the European Union 7.6.2018

COMMISSION IMPLEMENTING DECISION of 6 June 2018 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2022, 2023 and 2024 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (Text with EEA relevance) (2018/C 195/07)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 18 thereof,

Whereas:

(1) A large number of active substances approved under Regulation (EC) No 1107/2009 and listed in Parts B and E of the Annex to Commission Implementing Regulation (EC) No 540/2011 (2) have an expiry date set between 1 January 2022 and 31 December 2024. Part C of the Annex to Commission Implementing Regulation (EU) No 686/2012 (3) lists those active substances and allocates to the Member States the evaluation of those active substances, naming for each active substance a rapporteur and a co-rapporteur Member State for the purposes of the renewal procedure.

(2) In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals of the active substances concerned by the Member States and by the European Food Safety Authority (the Authority), it is necessary to establish a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.

(3) It is appropriate to provide for the identification of substances, for which, given their properties, it is expected that they may fail to satisfy the approval criteria set out in points 3.6.2 to 3.6.5 and point 3.7 of Annex II to Regula­ tion (EC) No 1107/2009 and to prioritise their assessment.

(4) Among the active substances listed in Part C of the Annex to Implementing Regulation (EU) No 686/2012 it is appropriate to identify those substances that are listed in Part E of the Annex to Implementing Regulation (EC) No 540/2011 as candidates for substitution, for which, given their properties, the approval periods do not exceed seven years. It is also appropriate to identify substances that are listed in the Annex to Commission Implementing Regulation (EU) 2015/408 (4) as candidates for substitution. The programme should prioritise their assessment.

(5) Active substances fluxapyroxad, bixafen, sedaxane, penflufen and penthiopyrad share similar properties. Active substances disodium phosphonates and potassium phosphonates share similar properties. The active substances eugenol, geraniol and thymol share similar properties. The active substances Trichoderma atroviride (strain I-1237) and Trichoderma asperellum (strain T34) share similar properties. The active substances benzovindiflupyr and isopy­ razam also share similar properties. As it is appropriate to align the timing of the assessment and the peer-review process carried out by the Authority of substances with similar properties, the dossiers for these substances should be submitted to their respective rapporteur Member States within the same time frame.

(6) Given the available resources of the authorities conducting the assessment of applications for the renewal of approvals, it cannot be excluded that as a result of the prioritisation of the assessment of substances provided for by this Decision the approval of some other active substances may expire before a decision has been taken on the renewal of the approval of such substances. In such cases, the approval period of such active substances should be extended in due time in accordance with Article 17 of Regulation (EC) No 1107/2009.

(1) OJ L 309, 24.11.2009, p. 1. (2) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1). (3) Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances whose approval expires by 31 December 2018 at the latest (OJ L 200, 27.7.2012, p. 5). (4) Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ L 67, 12.3.2015, p. 18). 7.6.2018 EN Official Journal of the European Union C 195/21

(7) In addition to providing for the grouping together of similar active substances based on priorities for their assess­ ment, Article 18 of Regulation (EC) No 1107/2009 also provides that the work programme is to include specific elements. Implementing Regulations (EU) No 844/2012 and (EU) No 686/2012 are, respectively, implementing points (a) to (e) and point (f) of the second paragraph of Article 18 of Regulation (EC) No 1107/2009,

HAS DECIDED AS FOLLOWS:

Sole Article The work programme as set out in the Annex to this Decision is hereby adopted.

Done at Brussels, 6 June 2018.

For the Commission Vytenis ANDRIUKAITIS Member of the Commission C 195/22 EN Official Journal of the European Union 7.6.2018

ANNEX

(1) The work programme concerns active substances approved under Regulation (EC) No 1107/2009 which are listed in Part C of the Annex to Implementing Regulation (EU) No 686/2012. (2) The priorities for the assessment of applications for the renewal of approvals of the active substances and grouping together similar active substances, as provided for in Article 18 of Regulation (EC) No 1107/2009, are as follows: (a) The assessment of applications for the renewal of approvals of active substances for which, given their proper­ ties, it is expected that they may fail to satisfy the approval criteria set out in points 3.6.2 to 3.6.5 and point 3.7 of Annex II to Regulation (EC) No 1107/2009, shall be prioritised. Accordingly, such assessments shall be car­ ried out without delay or with as little delay as possible. (b) The assessment of applications for the renewal of approvals of active substances listed in Part E of the Annex to Regulation (EC) No 540/2011 as candidates for substitution which, given their properties, are approved for no more than seven years, shall be prioritised. Also the assessment of applications for the renewal of approvals of active substances listed in the Annex to Implementing Regulation 2015/408 shall be prioritised. Accordingly, such assessments shall be carried out without delay or with as little delay as possible. (c) Taking into account the similarities in their respective properties, where the dates of dossier submission are different, the approval period shall be extended where appropriate and in due time in accordance with Article 17 of Regulation (EC) No 1107/2009 in order to align the timing of their assessment and the peer- review process carried out by the Authority for the following substances: (i) fluxapyroxad, bixafen, sedaxane, penflufen and penthiopyrad; (ii) disodium phosphonates and potassium phosphonates; (iii) eugenol, geraniol and thymol; (iv) Trichoderma atroviride (strain I 1237) and Trichoderma asperellum (strain T34); (v) benzovindiflupyr and isopyrazam. (d) Where the approval of some active substances not covered by points (a) and (b) i s likely to expire before a decision has been taken on the renewal of the approval of such substances for reasons beyond the control of the applicant, the approval period of those active substances shall be extended in due time in accordance with Article 17 of Regulation (EC) No 1107/2009. 7.6.2018 EN Official Journal of the European Union C 195/23

COURT OF AUDITORS

Special Report No 12/2018 ‘Broadband in the EU Member States: despite progress, not all the Europe 2020 targets will be met’ (2018/C 195/08)

The European Court of Auditors hereby informs you that Special Report No 12/2018 ‘Broadband in the EU Member States: despite progress, not all the Europe 2020 targets will be met’ has just been published. The report can be accessed for consultation or downloading on the European Court of Auditors’ website: http://eca.europa.eu C 195/24 EN Official Journal of the European Union 7.6.2018

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

STANDING COMMITTEE OF THE EFTA STATES

Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the first half of 2016 (2018/C 195/09)

Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee With reference to EEA Joint Committee Decision No 25/2008 of 14 March 2008, the EEA Joint Committee is invited to note the following lists concerning authorisation decisions adopted on the basis of Article 64(8) of Regulation (EC) No 1907/2006 (REACH) for the period 1 January – 30 June 2016, at their meeting on 2 December 2016.

ANNEX

List of authorisation decisions

The following authorisation decisions in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) have been taken in the EEA EFTA States during the period 1 January – 30 June 2016:

Commission decision under Article 64(8) of Substance name Country Date of decision Regulation (EC) No 1907/2006 Trichloroethylene C(2015) 8093 Iceland 14 January 2016 Hexabromocyclododecane (HBCDD) C(2015) 9812 Liechtenstein 19 January 2016 Hexabromocyclododecane (HBCDD) C(2015) 9812 Norway 2 February 2016 Dibutyl phthalate (DBP) C(2016) 2003 Liechtenstein 18 April 2016 Dibutyl phthalate (DBP) C(2016) 2003 Norway 26 April 2016 7.6.2018 EN Official Journal of the European Union C 195/25

Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the second half of 2016 (2018/C 195/10)

Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee With reference to EEA Joint Committee Decision No 25/2008 of 14 March 2008, the EEA Joint Committee is invited to note the following lists concerning authorisation decisions adopted on the basis of Article 64(8) of Regulation (EC) No 1907/2006 (REACH) for the period 1 July-31 December 2016, at their meeting on 17 March 2017.

ANNEX

List of authorisation decisions

The following authorisation decisions in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) have been taken in the EEA EFTA States during the period 1 July-31 December 2016:

Commission decision under Substance name Article 64(8) of Regulation (EC) Country Date of decision No 1907/2006 Hexabromocyclododecane C(2015) 9812 Iceland 29 August 2016 Dibutyl phthalate (DBP) C(2016) 2003 Iceland 29 August 2016 Bis(2-ethylhexyl) phthalate (DEHP) C(2016) 3549 Iceland 29 August 2016 Bis(2-ethylhexyl) phthalate (DEHP) C(2016) 3549 Liechtenstein 11 July 2016 Bis(2-ethylhexyl) phthalate (DEHP) C(2016) 3549 Norway 5 July 2016 Lead sulfochromate yellow & Lead C(2016) 5644 Liechtenstein 3 October 2016 chromate molybdate sulphate red Lead sulfochromate yellow & Lead C(2016) 5644 Norway 4 October 2016 chromate molybdate sulphate red Trichloroethylene C(2016) 7581 Iceland 29 December 2016 Trichloroethylene C(2016) 7581 Liechtenstein 14 December 2016 Trichloroethylene C(2016) 7581 Norway 16 December 2016 Trichloroethylene C(2016) 7607 Iceland 29 December 2016 Trichloroethylene C(2016) 7607 Liechtenstein 14 December 2016 Trichloroethylene C(2016) 7607 Norway 16 December 2016 Trichloroethylene C(2016) 7609 Iceland 29 December 2016 Trichloroethylene C(2016) 7609 Liechtenstein 14 December 2016 Trichloroethylene C(2016) 7609 Norway 16 December 2016 C 195/26 EN Official Journal of the European Union 7.6.2018

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2016 (2018/C 195/11)

Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee With reference to EEA Joint Committee Decision No 74/1999 of y28 Ma 1999 , the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1y Jul -31 December 2016, at their meeting on 17 March 2017: Annex I List of new marketing authorisations Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations 7.6.2018 EN Official Journal of the European Union C 195/27

ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1y- 31Jul December 2016:

EU Number Product Country Date of authorisation

EU/1/12/793 Xalkori (Switch to non-conditional) Liechtenstein 31.12.2016

EU/1/13/848 Erivedge (Switch to non-conditional) Liechtenstein 31.12.2016

EU/1/15/1066 Ongentys Iceland 13.7.2016

EU/1/15/1066 Ongentys Norway 4.7.2016

EU/1/16/1091 Atazanavir Mylan Iceland 29.8.2016

EU/1/16/1091 Atazanavir Mylan Norway 2.9.2016

EU/1/16/1091 Atazanavir Mylan Liechtenstein 31.8.2016

EU/1/16/1094 Ninlaro Liechtenstein 31.12.2016

EU/1/16/1094 Ninlaro Iceland 7.12.2016

EU/1/16/1094 Ninlaro Norway 28.11.2016

EU/1/16/1102 Bortezomib SUN Iceland 11.8.2016

EU/1/16/1102 Bortezomib SUN Norway 12.8.2016

EU/1/16/1102 Bortezomib SUN Liechtenstein 31.8.2016

EU/1/16/1103 Neparvis Iceland 4.7.2016

EU/1/16/1105 EndolucinBeta Iceland 25.7.2016

EU/1/16/1105 EndolucinBeta Norway 27.7.2016

EU/1/16/1105 EndolucinBeta Liechtenstein 31.8.2016

EU/1/16/1107 ZINBRYTA Iceland 14.7.2016

EU/1/16/1107 Zinbryta Norway 7.7.2016 C 195/28 EN Official Journal of the European Union 7.6.2018

EU Number Product Country Date of authorisation

EU/1/16/1107 Zinbryta Liechtenstein 31.8.2016

EU/1/16/1108 Qtern Iceland 25.7.2016

EU/1/16/1108 Qtern Norway 4.8.2016

EU/1/16/1108 Qtern Liechtenstein 31.8.2016

EU/1/16/1109 ZAVICEFTA Iceland 12.7.2016

EU/1/16/1109 Zavicefta Norway 1.7.2016

EU/1/16/1112 Odefsey Iceland 12.7.2016

EU/1/16/1113 Enzepi Iceland 14.7.2016

EU/1/16/1113 Enzepi Norway 26.7.2016

EU/1/16/1113 Enzepi Liechtenstein 31.8.2016

EU/1/16/1114 Bortezomib Hospira Iceland 10.8.2016

EU/1/16/1114 Bortezomib Hospira Norway 12.8.2016

EU/1/16/1114 Bortezomib Hospira Liechtenstein 31.8.2016

EU/1/16/1115 Pemetrexed Fresenius Kabi Iceland 16.8.2016

EU/1/16/1115 Pemetrexed Fresenius Kabi Norway 11.8.2016

EU/1/16/1116 Epclusa Iceland 12.7.2016

EU/1/16/1116 Epclusa Norway 11.7.2016

EU/1/16/1116 Epclusa Liechtenstein 31.8.2016

EU/1/16/1119 Zepatier Iceland 11.8.2016

EU/1/16/1119 Zepatier Norway 4.8.2016

EU/1/16/1119 Zepatier Liechtenstein 31.8.2016

EU/1/16/1121 Zalmoxis Iceland 7.9.2016 7.6.2018 EN Official Journal of the European Union C 195/29

EU Number Product Country Date of authorisation

EU/1/16/1121 Zalmoxis Norway 16.9.2016

EU/1/16/1121 Zalmoxis Liechtenstein 31.10.2016

EU/1/16/1122 Aerivio Spiromax Iceland 2.9.2016

EU/1/16/1122 Aerivio Spiromax Norway 8.9.2016

EU/1/16/1122 Aerivio Spiromax Liechtenstein 31.10.2016

EU/1/16/1123 Airexar Spiromax Iceland 2.9.2016

EU/1/16/1123 Airexar Spiromax Norway 13.9.2016

EU/1/16/1123 Airexar Spiromax Liechtenstein 31.10.2016

EU/1/16/1124 Nordimet Iceland 7.9.2016

EU/1/16/1124 Nordimet Norway 30.8.2016

EU/1/16/1124 Nordimet Liechtenstein 31.8.2016

EU/1/16/1125 Cinqaero Iceland 7.9.2016

EU/1/16/1125 Cinqaero Norway 31.8.2016

EU/1/16/1125 Cinqaero Liechtenstein 31.8.2016

EU/1/16/1126 Truberzi Iceland 7.10.2016

EU/1/16/1126 Truberzi Norway 6.10.2016

EU/1/16/1126 Truberzi Liechtenstein 31.10.2016

EU/1/16/1127 Tenofovir disoproxil Zentiva Iceland 6.10.2016

EU/1/16/1127 Tenofovir disoproxil Zentiva Liechtenstein 31.10.2016

EU/1/16/1127 Tenofovir disoproxil Zentiva Norway 13.10.2016

EU/1/16/1128 Kisplyx Iceland 7.9.2016

EU/1/16/1128 Kisplyx Norway 31.8.2016 C 195/30 EN Official Journal of the European Union 7.6.2018

EU Number Product Country Date of authorisation

EU/1/16/1128 Kisplyx Liechtenstein 31.8.2016

EU/1/16/1129 Tenofovir disoproxil Mylan Iceland 16.12.2016

EU/1/16/1129 Tenofovir disoproxil Mylan Norway 21.12.2016

EU/1/16/1130 Onivyde Iceland 1.11.2016

EU/1/16/1130 Onivyde Norway 4.11.2016

EU/1/16/1130 Onivyde Liechtenstein 31.10.2016

EU/1/16/1131 Thorinane Iceland 6.10.2016

EU/1/16/1131 Thorinane Norway 23.9.2016

EU/1/16/1131 Thorinane Liechtenstein 31.10.2016

EU/1/16/1132 Inhixa Iceland 7.10.2016

EU/1/16/1132 Inhixa Norway 5.10.2016

EU/1/16/1132 Inhixa Liechtenstein 31.10.2016

EU/1/16/1134 Mysildecard Iceland 6.10.2016

EU/1/16/1134 Mysildecard Norway 29.9.2016

EU/1/16/1134 Mysildecard Liechtenstein 31.10.2016

EU/1/16/1135 Sialanar Iceland 7.10.2016

EU/1/16/1135 Sialanar Norway 14.10.2016

EU/1/16/1135 Sialanar Liechtenstein 31.10.2016

EU/1/16/1136 Cabometyx Iceland 6.10.2016

EU/1/16/1136 CABOMETYX Norway 20.9.2016

EU/1/16/1136 CABOMETYX Liechtenstein 31.10.2016

EU/1/16/1137 Granpidam Liechtenstein 31.12.2016 7.6.2018 EN Official Journal of the European Union C 195/31

EU Number Product Country Date of authorisation

EU/1/16/1137 Granpidam Iceland 6.12.2016

EU/1/16/1137 Granpidam Norway 28.11.2016

EU/1/16/1138 Venclyxto Iceland 8.12.2016

EU/1/16/1138 Venclyxto Norway 13.12.2016

EU/1/16/1139 Ocaliva Iceland 19.12.2016

EU/1/16/1139 OCALIVA Norway 12.12.2016

EU/1/16/1141 SomaKit TOC Iceland 15.12.2016

EU/1/16/1141 SomaKit TOC Norway 15.12.2016

EU/1/16/1142 Parsabiv Liechtenstein 31.12.2016

EU/1/16/1142 Parsabiv Iceland 1.12.2016

EU/1/16/1142 Parsabiv Norway 22.11.2016

EU/1/16/1143 Lartruvo Liechtenstein 31.12.2016

EU/1/16/1143 Lartruvo Iceland 1.12.2016

EU/1/16/1143 Lartruvo Norway 18.11.2016

EU/1/16/1144 Ivabradine Zentiva Liechtenstein 31.12.2016

EU/1/16/1144 Ivabradine Zentiva Iceland 2.12.2016

EU/1/16/1144 Ivabradine Zentiva Norway 28.11.2016

EU/1/16/1145 Ivabradine JensonR Liechtenstein 31.12.2016

EU/1/16/1145 Ivabradine JensonR Iceland 2.12.2016

EU/1/16/1145 Ivabradine JensonR Norway 5.12.2016

EU/1/16/1146 Glyxambi Liechtenstein 31.12.2016

EU/1/16/1146 Glyxambi Iceland 5.12.2016 C 195/32 EN Official Journal of the European Union 7.6.2018

EU Number Product Country Date of authorisation

EU/1/16/1146 Glyxambi Norway 9.12.2016

EU/1/16/1147 IBRANCE Liechtenstein 31.12.2016

EU/1/16/1147 Ibrance Iceland 1.12.2016

EU/1/16/1147 IBRANCE Norway 15.11.2016

EU/1/16/1148 Emtricitabin/Tenofovir disoproxil Zentiva Liechtenstein 31.12.2016

EU/1/16/1148 Emtricitabine/Tenofovir disoproxil Zentiva Iceland 1.12.2016

EU/1/16/1148 Emtricitabine/Tenofovir disoproxil Zentvia Norway 15.11.2016

EU/1/16/1151 Emtricitabine/Tenofovir disproxil Krka Norway 21.12.2016

EU/1/16/1151 Emtricitabine/Tenofovir disoproxil Krka Iceland 14.12.2016

EU/2/16/196 Sevocalm Norway 11.7.2016

EU/2/16/196 Sevocalm Liechtenstein 31.8.2016

EU/2/16/196 Sevocalm Iceland 12.7.2016

EU/2/16/198 Sedadex Iceland 22.8.2016

EU/2/16/198 Sedadex Norway 30.8.2016

EU/2/16/198 Sedadex Liechtenstein 31.8.2016

EU/2/16/199 Eravac Iceland 10.10.2016

EU/2/16/199 ERAVAC Norway 5.10.2016

EU/2/16/199 ERAVAC Liechtenstein 31.10.2016

EU/2/16/200 Cepedex Iceland 19.12.2016 7.6.2018 EN Official Journal of the European Union C 195/33

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1y- Jul 31 December 2016:

EU Number Product Country Date of authorisation

EU/1/06/347 Sutent Liechtenstein 31.12.2016

EU/1/06/347 Sutent Iceland 1.12.2016

EU/1/06/347 Sutent Norway 15.11.2016

EU/1/06/355 ATryn Iceland 26.7.2016

EU/1/06/355 ATryn Norway 10.8.2016

EU/1/06/355 ATryn Liechtenstein 31.8.2016

EU/1/06/360 Champix Iceland 13.7.2016

EU/1/06/360 Champix Norway 7.7.2016

EU/1/06/360 Champix Liechtenstein 31.8.2016

EU/1/06/361 Luminity Iceland 26.7.2016

EU/1/06/361 Luminity Norway 6.8.2016

EU/1/06/361 Luminity Liechtenstein 31.8.2016

EU/1/06/362 Byetta Iceland 18.8.2016

EU/1/06/363 Sprycel Iceland 18.8.2016

EU/1/06/363 Sprycel Norway 12.8.2016

EU/1/06/363 Sprycel Liechtenstein 31.8.2016

EU/1/06/364 Adrovance Iceland 16.10.2016

EU/1/06/365 Elaprase Iceland 16.10.2016

EU/1/06/366 Tandemact Iceland 16.10.2016 C 195/34 EN Official Journal of the European Union 7.6.2018

EU Number Product Country Date of authorisation

EU/1/06/374 Lucentis Liechtenstein 31.12.2016

EU/1/06/374 Lucentis Iceland 2.12.2016

EU/1/06/374 Lucentis Norway 22.11.2016

EU/1/06/379 Cystadane Iceland 7.12.2016

EU/1/06/379 Cystadane Norway 29.11.2016

EU/1/11/699 Fampyra Norway 8.7.2016

EU/1/11/701 Levatiracetam Teva Norway 4.8.2016

EU/1/11/701 Levetiracetam Teva Iceland 26.7.2016

EU/1/11/701 Levetiracetam Teva Liechtenstein 31.8.2016

EU/1/11/706 Levodopa/Carbidopa/Entacapone Orion Norway 15.9.2016

EU/1/11/711 Matever Iceland 14.7.2016

EU/1/11/711 Matever Norway 7.7.2016

EU/1/11/711 Matever Liechtenstein 31.8.2016

EU/1/11/712 Levetiracetam Accord Iceland 10.8.2016

EU/1/11/712 Levetiracetam Accord Norway 11.8.2016

EU/1/11/712 Levetiracetam Accord Liechtenstein 31.8.2016

EU/1/11/713 Levetiracetam Actavis Iceland 5.10.2016

EU/1/11/713 Levetiracetam Actavis Norway 30.9.2016

EU/1/11/713 Levetiracetam Actavis Liechtenstein 31.10.2016

EU/1/11/715 Plenadren Iceland 15.8.2016

EU/1/11/715 Plenadren Norway 15.8.2016

EU/1/11/715 Plenadren Liechtenstein 31.8.2016 7.6.2018 EN Official Journal of the European Union C 195/35

EU Number Product Country Date of authorisation

EU/1/11/716 Eurartesim Iceland 15.9.2016

EU/1/11/716 Eurartesim Norway 15.9.2016

EU/1/11/716 Eurartesim Liechtenstein 31.10.2016

EU/1/11/717 Vyndaqel Iceland 10.8.2016

EU/1/11/717 Vyndaqel Norway 11.8.2016

EU/1/11/717 Vyndaqel Liechtenstein 31.8.2016

EU/1/11/719 Telmisartan Teva Pharma Iceland 12.7.2016

EU/1/11/722 Pioglitazone Accord Iceland 13.12.2016

EU/1/11/722 Pioglitazone Accord Norway 21.12.2016

EU/1/11/727 Xaluprine Liechtenstein 31.12.2016

EU/1/11/727 Xaluprine Iceland 6.12.2016

EU/1/11/727 Xaluprine Norway 5.12.2016

EU/1/11/728 Pramipexole Accord Iceland 26.7.2016

EU/1/11/728 Pramipexole Accord Norway 4.8.2016

EU/1/11/728 Pramipexole Accord Liechtenstein 31.8.2016

EU/1/11/731 Komboglyze Iceland 26.7.2016

EU/1/11/731 Komboglyze Norway 11.8.2016

EU/1/11/731 Komboglyze Liechtenstein 31.8.2016

EU/1/11/732 Desloratadine Teva Iceland 15.8.2016

EU/1/11/732 Desloratadine Teva Norway 22.8.2016

EU/1/11/733 Dificlir Iceland 29.8.2016

EU/1/11/733 Dificlir Norway 30.8.2016 C 195/36 EN Official Journal of the European Union 7.6.2018

EU Number Product Country Date of authorisation

EU/1/11/733 Dificlir Liechtenstein 31.8.2016

EU/1/11/734 Edarbi Liechtenstein 31.12.2016

EU/1/11/734 Edarbi Iceland 2.12.2016

EU/1/11/734 Edarbi Norway 22.11.2016

EU/1/11/736 EDURANT Iceland 10.8.2016

EU/1/11/736 EDURANT Norway 11.8.2016

EU/1/11/736 EDURANT Liechtenstein 31.8.2016

EU/1/11/737 Eviplera Iceland 10.8.2016

EU/1/11/737 Eviplera Norway 11.8.2016

EU/1/11/737 Eviplera Liechtenstein 31.8.2016

EU/1/11/738 Levetiracetam Actavis Group Iceland 15.8.2016

EU/1/11/738 Levetiracetam Actavis Group Norway 2.9.2016

EU/1/11/738 Levetiracetam Actavis Group Liechtenstein 31.8.2016

EU/1/11/739 Dasselta Iceland 22.8.2016

EU/1/11/739 Dasselta Norway 5.9.2016

EU/1/11/739 Dasselta Liechtenstein 31.8.2016

EU/1/11/740 Ameluz Liechtenstein 31.12.2016

EU/1/11/740 Ameluz Iceland 7.12.2016

EU/1/11/740 Ameluz Norway 5.12.2016

EU/1/11/741 Levetiracetam SUN Liechtenstein 31.12.2016

EU/1/11/741 Levetiracetam Sun Iceland 5.12.2016

EU/1/11/741 Levetiracetam SUN Norway 23.11.2016 7.6.2018 EN Official Journal of the European Union C 195/37

EU Number Product Country Date of authorisation

EU/1/11/742 Efavirenz Teva Iceland 16.10.2016

EU/1/11/742 Efavirenz Teva Norway 21.10.2016

EU/1/11/743 Repaglinide Accord Iceland 14.10.2016

EU/1/11/743 Repaglinide Accord Norway 21.10.2016

EU/1/11/745 Desloratadin Actavis Liechtenstein 31.12.2016

EU/1/11/745 Desloratadine Actavis Iceland 2.12.2016

EU/1/11/745 Desloratadine Actavis Norway 25.11.2016

EU/1/11/746 Desloratadine ratiopharm Iceland 15.8.2016

EU/1/11/746 Desloratadine ratiopharm Norway 22.8.2016

EU/1/11/746 Desloratadine ratiopharm Liechtenstein 31.8.2016

EU/1/11/747 Colobreathe Iceland 10.10.2016

EU/1/11/747 Colobreathe Norway 13.10.2016

EU/1/11/747 Colobreathe Liechtenstein 31.10.2016

EU/1/12/750 Esmya Liechtenstein 31.12.2016

EU/1/12/750 Esmya Iceland 5.12.2016

EU/1/12/750 Esmya Norway 29.11.2016

EU/1/12/751 Zelboraf Norway 6.10.2016

EU/1/12/751 Zelboraf Iceland 10.10.2016

EU/1/12/751 Zelboraf Liechtenstein 31.10.2016

EU/1/12/753 Signifor Liechtenstein 31.12.2016

EU/1/12/753 Signifor Iceland 6.12.2016

EU/1/12/753 Signifor Norway 24.11.2016 C 195/38 EN Official Journal of the European Union 7.6.2018

EU Number Product Country Date of authorisation

EU/1/12/755 Pioglitazone Actavis Liechtenstein 31.12.2016

EU/1/12/755 Pioglitazone Actavis Norway 9.12.2016

EU/1/12/755 Pioglitazone Actavis Iceland 2.12.2016

EU/1/12/756 Glidipion Norway 9.12.2016

EU/1/12/756 Glidipion Liechtenstein 31.12.2016

EU/1/12/756 Glidipion Iceland 2.12.2016

EU/1/12/763 Ecansya Norway 23.12.2016

EU/1/12/793 XALKORI Iceland 10.8.2016

EU/1/12/793 XALKORI Norway 12.8.2016

EU/1/12/793 XALKORI Liechtenstein 31.8.2016

EU/1/12/794 ADCETRIS Liechtenstein 31.10.2016

EU/1/12/794 ADCETRIS Iceland 2.11.2016

EU/1/12/794 ADCETRIS Norway 8.11.2016

EU/1/15/1047 Blincyto Iceland 10.10.2016

EU/1/15/1047 Blincyto Norway 29.9.2016

EU/1/15/1047 Blincyto Liechtenstein 31.10.2016

EU/1/16/1086 Tagrisso Iceland 19.12.2016

EU/2/06/061 Nobilis Influenza H5N2 Iceland 13.7.2016

EU/2/11/128 Emdocam Iceland 13.7.2016

EU/2/11/132 Nobivac Myxo-RHD Iceland 25.8.2016

EU/2/11/132 Nobivac Myxo-RHD Norway 30.8.2016

EU/2/11/132 Nobivac Myxo-RHD Liechtenstein 31.10.2016 7.6.2018 EN Official Journal of the European Union C 195/39

EU Number Product Country Date of authorisation

EU/2/11/133 Recocam Iceland 17.8.2016

EU/2/11/133 Recocam Norway 25.8.2016

EU/2/11/133 Recocam Liechtenstein 31.8.2016

EU/2/11/134 Inflacam Liechtenstein 31.12.2016

EU/2/11/134 Inflacam Iceland 2.12.2016

EU/2/11/134 Inflacam Norway 25.11.2016

EU/2/11/135 Panacur AquaSol Liechtenstein 31.8.2016

EU/2/11/135 Panacur AquaSol Iceland 2.9.2016

EU/2/11/135 Panacur AquaSol Norway 5.9.2016

EU/2/11/137 Activyl Tick Plus Norway 23.12.2016

EU/2/12/139 Zulvac 1+8 Bovis Iceland 19.12.2016 C 195/40 EN Official Journal of the European Union 7.6.2018

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period y1 Jul -31 December 2016:

EU Number Product Country Date of authorisation

EU/1/03/267/012 Reyataz Iceland 13.7.2016

EU/1/08/494/005 Stelara Norway 24.11.2016

EU/1/08/494/005 Stelara Iceland 5.12.2016

EU/1/11/714/002-003 Zytiga Iceland 1.12.2016

EU/1/11/714/003 Zytiga Norway 25.11.2016

EU/1/12/776/024 Fycompa Iceland 11.10.2016

EU/1/12/776/024 Fycompa Norway 10.10.2016

EU/1/14/939/005-006 Daklinza Iceland 13.7.2016

EU/1/14/939/005-006 Daklinza Norway 4.7.2016

EU/1/15/1024/002 KEYTRUDA Iceland 24.8.2016

EU/1/15/1024/002 KEYTRUDA Norway 26.8.2016

EU/2/97/004/050-053 Metacam Norway 29.8.2016 7.6.2018 EN Official Journal of the European Union C 195/41

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July-31 December 2016:

EU Number Product Country Date of withdrawal

EU/1/00/137 Avandia Iceland 12.8.2016

EU/1/03/258 Avandamet Iceland 12.8.2016

EU/1/07/385 Focetria Iceland 12.8.2016

EU/1/08/489 Opgenra Iceland 14.7.2016

EU/1/08/489 Opgenra Norway 11.8.2016

EU/1/08/489 Opgenra Liechtenstein 31.8.2016

EU/1/08/500 Fablyn Iceland 12.8.2016

EU/1/08/506 Celvapan Iceland 7.12.2016

EU/1/08/506 Celvapan Liechtenstein 31.12.2016

EU/1/08/506 Celvapan Norway 21.12.2016

EU/1/09/518 PANTECTA Control Iceland 7.10.2016

EU/1/09/518 PANTECTA Control Norway 20.10.2016

EU/1/09/518 PANTECTA Control Liechtenstein 31.10.2016

EU/1/09/563 ChondroCelect Liechtenstein 31.8.2016

EU/1/09/563 ChondroCelect Iceland 15.8.2016

EU/1/09/563 ChondroCelect Norway 11.8.2016

EU/1/10/657 Prepandemic Influenza vaccine (H5N1) (surface Iceland 12.8.2016 antigen, inactivated, adjuvanted) Novartis Vaccines and Dia

EU/1/11/721 Paglitaz Iceland 12.8.2016 C 195/42 EN Official Journal of the European Union 7.6.2018

EU Number Product Country Date of withdrawal

EU/1/12/810 Krystexxa Iceland 14.7.2016

EU/1/12/810 Krystexxa Norway 6.7.2016

EU/1/12/810 Krystexxa Liechtenstein 31.8.2016

EU/1/13/831 Capecitabine SUN Iceland 13.7.2016

EU/1/13/831 Capecitabine SUN Norway 6.7.2016

EU/1/13/883 Vitekta Iceland 10.11.2016

EU/1/13/883 Vitekta Liechtenstein 31.12.2016

EU/1/13/883 Vitekta Norway 15.12.2016

EU/1/14/942 Clopidogrel/Acetylsalicylic acid Teva Iceland 26.7.2016 7.6.2018 EN Official Journal of the European Union C 195/43

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July-31 December 2016:

EU Number Product Country Date of suspension

EU/2/15/192 Velactis Iceland 30.8.2016

EU/2/15/192 Velactis Norway 29.8.2016

EU/2/15/192 Velactis Liechtenstein 31.8.2016 C 195/44 EN Official Journal of the European Union 7.6.2018

V (Announcements)

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

EUROPEAN COMMISSION

Prior notification of a concentration (Case M.8954 — BPEA/PAI/WFC) Candidate case for simplified procedure (Text with EEA relevance) (2018/C 195/12)

1. On 31 May 2018, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1).

This notification concerns the following undertakings:

— Baring Asia Private Equity Fund VI (‘BPEA’, Cayman Islands), controlled by Baring Asia (Hong Kong),

— PAI Partners SAS (‘PAI’ , France),

— GB WFC International SARL (‘WFC’ , Luxembourg).

BPEA and PAI acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of the whole of WFC.

The concentration is accomplished by way of purchase of shares.

2. The business activities of the undertakings concerned are:

— for BPEA: private equity fund focused on capital preservation and post-investment value creation investments in Asian countries. BPEA is under common control with other private equity funds that as a whole comprise Baring Asia,

— for PAI: private equity firm that manages and advises a number of funds that own companies active in a variety of business sectors, such as business services, food and consumer goods, general industries, healthcare, and retail and distribution,

— for WFC: air cargo general sales and service agent providing outsourced air cargo management services to airlines.

3. On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved.

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4. The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.8954 — BPEA/PAI/WFC

(1) OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’). (2) OJ C 366, 14.12.2013, p. 5. 7.6.2018 EN Official Journal of the European Union C 195/45

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below: Email: [email protected] Fax +32 22964301 Postal address: European Commission Directorate-General for Competition Merger Registry 1049 Bruxelles/Brussel BELGIQUE/BELGIË C 195/46 EN Official Journal of the European Union 7.6.2018

Prior notification of a concentration (Case M.8928 — Francisco Partners/VeriFone) Candidate case for simplified procedure (Text with EEA relevance) (2018/C 195/13)

1. On 30 May 2018, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1). This notification concerns the following undertakings: — Francisco Partners Management LP (‘Francisco Partners’, United States), — VeriFone Systems, Inc. (‘VeriFone’, United States). Francisco Partners acquires within the meaning of Article 3(1)(b) of the Merger Regulation sole control of the whole of VeriFone. The concentration is accomplished by way of purchase of shares. 2. The business activities of the undertakings concerned are: — Francisco Partners: a private equity firm exclusively focused on investments in software and technology-enabled businesses, — VeriFone: primarily active in the design, manufacture and supply of point of sale (‘POS’) payment devices and related services. 3. On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. 4. The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission. Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified: M.8928 — Francisco Partners/VeriFone Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below: Email: [email protected] Fax +32 22964301 Postal address: European Commission Directorate-General for Competition Merger Registry 1049 Bruxelles/Brussel BELGIQUE/BELGIË

(1) OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’). (2) OJ C 366, 14.12.2013, p. 5. 7.6.2018 EN Official Journal of the European Union C 195/47

OTHER ACTS

EUROPEAN COMMISSION

Publication of an amendment in accordance with Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (2018/C 195/14)

This publication opens the opportunity to raise objections against the amendment in accordance with Article 51 of Regulation (EU) No 1151/2012 of the European Parliament and of the Council (1).

APPLICATION FOR APPROVAL OF AN AMENDMENT TO THE PRODUCT SPECIFICATION OF PROTECTED DESIGNATIONS OF ORIGIN/PROTECTED GEOGRAPHICAL INDICATIONS WHICH IS NOT MINOR Application for approval of an amendment in accordance with Article 53(2)(1) of Regulation (EU) No 1151/2012 ‘GAILTALER SPECK’ EU No: PGI-AT-0192-AM01 — 5.4.2017 PDO ( ) PGI ( X ) 1. Applicant group and legitimate interest Gailtaler Speck — Naturarena Kärnten c/o Albert Jank Götzing 4 9624 Egg ÖSTERREICH Tel. +43 6504282000 Email: [email protected]

The applicant is the original applicant group and represents all current producers of Gailtaler Speck g.g.A.

2. Member State or Third Country

3. Heading in the product specification affected by the amendment(s) — Name of product — Description of product — Geographical area — Proof of origin — Method of production — Link with the geographical area — Labelling — Other [Contacts of the competent authority and the applicant group, type of product, control body, national legislation, list of references and sources]

4. Type of amendment(s) — Amendment to the product specification of a registered PDO or PGI which is not minor in accordance with Article 53(2)(3) of Regulation (EU) No 1151/2012.

(1) OJ L 343, 14.12.2012, p. 1. C 195/48 EN Official Journal of the European Union 7.6.2018

— Amendment — which is not minor — to the product specification of registered PDO or PGI for which a Single Document (or equivalent) has not been published in accordance with Article 53(2)(3) of Regula­ tion (EU) No 1151/2012.

5. Amendment(s) The former specification, which consisted of several separate documents (summary, specification), has been com­ bined into a single document and revised for improved transparency and at the same time to update the require­ ments for the method of production and the proof of origin. In addition, production regulations (e.g. the ‘Gailtaler Speck Guidelines’/Production Guidelines for Gailtaler Speck) from the chapter on materials, which were earlier referenced in the specification, are now integrated into the specification and are therefore subject to the requirements for amendments stipulated by Community law. Information previously provided on the associa­ tion's internal quality assurance and control system is no longer included. Generally applicable requirements for animal husbandry (e.g. the ban on feeding meat-and-bone meal or commercial kitchen waste) or for the produc­ tion of bacon have also not been repeated in the specification. The remaining appendices to the specification therefore serve solely as evidence.

In particular:

Product description: The following Section 4.2 of the summary

‘The following pig breeds are used to produce Gailtaler Speck: landrace, large white, crosses between landrace and large white, Duroc, cross-breeds from approved Carinthian breeding programmes.

The pigs must be fattened under the conditions specified in the production guidelines for Gailtaler Speck.

Fresh pork with a maximum pH of 5,8 is used in the production of Gailtaler Speck. Whole bacon sides are used, and if necessary the individual parts of a side — belly, loin, loin belly, leg and shoulder.

Gailtaler Speck is marinated, cold smoked and matured in special maturing rooms. The external colour of Gailtaler Speck is golden yellow and the cut is bright red with a w hite fat portion. Gailtaler Speck has a well-developed cured, smoky and meaty taste, which is only slightly spicy and mildly salty. It is of firm consistency, tender to bite and melts gently in the mouth.’

and Section 4.2 of the specification (product description and type of product):

‘Gailtaler Speck is a c ured pork product. The quality characteristics of Gailtaler Speck are set out in Chapter 3 of the Gailtaler Speck Guidelines. It is distinguished by the following characteristics (see Gailtaler Speck Association — 's Natural Arena, 1999b, Annex to Section 4.2):

— Basic materials: Gailtaler Speck is produced from pork from the following pig breeds: landrace, large white, crosses between landrace and large white, Duroc and cross-breeds from approved Carinthian breeding programmes.

— Constituents, recipe and ingredients: Fresh pork with a maximum pH of 5,8 is used to produce Gailtaler Speck. Gailtaler Speck is produced from the following cuts of meat: whole sides of bacon or if necessary the individual parts of a side: belly, loin, loin belly, leg, shoulder. The meat pieces are processed in their natural form and are never pressed. Cooking or curing salt, pepper, garlic and mixtures of spices from traditional recipes are used in the curing process. The main spices used are ginger, coriander, caraway, bay leaves, all­ spice, paprika, rosemary, juniper and sugar. Smoking is carried out using the process of “cold smoking” (smoking temperature maximum 22 °C).

— Appearance: The external colour of Gailtaler Speck is golden yellow, the fat is white and the muscle meat is bright red. Gailtaler Speck is free from external defects and defects in the cut.

— Flavour: Gailtaler Speck has a mildly salty, well-developed cured, smoky and meaty flavour. It has no off-taste.

— Consistency: Gailtaler Speck is of a firm consistency, tender to bite and melts gently in the mouth. 7.6.2018 EN Official Journal of the European Union C 195/49

— Distinctive characteristics: The method of “cold smoking” , the processing mainly of whole bacon sides and the processing of the meat in an unpressed state constitute a combination of product characteristics that are typical of the Valley.’

are replaced by the following text:

‘4.2. Product description Gailtaler Speck is a raw cured product made of unpressed, boneless pork distinguished by the following characteristics:

— Basic materials: Gailtaler Speck is produced exclusively from the meat of the following pig breeds: landrace, large white, Duroc, Swabian Hall Saddleback and crosses of these breeds. In addition, crosses of these breeds with Pietrain pigs (as sires) are also admissible.

— Constituents, recipe and processing method: For the production of Gailtaler Speck only fresh, boneless meat in its natural form without being pressed is used for processing. Gailtaler Speck can in principle be produced from any cuts of meat, including from whole sides of bacon. The belly, loin, loin belly, leg and shoulder are preferred, however. The half-carcasses are checked for their suitability for human consumption by the veteri­ nary service before being cut and are marinated, smoked and matured (dried) with a traditional salt and spice mixture in accordance with the procedure described in Section 4.5.2.

— Appearance: The external colour of Gailtaler Speck is golden yellow, the fat portion is pure white and clearly distinguishable, and the muscle meat is bright red.

— Flavour and consistency: Gailtaler Speck tastes slightly spicy (without a dominant juniper note) and mildly salty and is characterised by a well-developed cured, smoky and meaty taste; despite the greater firmness of the fat portion compared to other types of bacon, Gailtaler Speck dissolves softly on the tongue and is tender to bite. Gailtaler Speck is free from external defects and defects in the cut and has no off-taste.

— Marketing: Gailtaler Speck can be sold unpackaged or packaged, in whole sides, in chunks or sliced.’

Reasons:

The list of pig breeds approved for the production of Gailtaler Speck has been specified more precisely and in particular the reference to ‘acknowledged breeding programmes in Carinthia’ (anerkannte Kärntner Zuchtprogramme) has been removed. As the origin of piglets is no longer limited to Carinthia (see the section ‘Geographical area’), the breeds and crossing options are specifically listed in the current version of the specifications. Only the pig breed ‘Schwäbisch Hällische Sattelschwein’ (Swabian Hall Saddleback) has been added to the list of admissible pig breeds, as this breed offers good-quality meat and fat, and owing to its weather resistance it is suitable for free-range farming, which in turn is essential for potential organic production. Crosses — as was previously consistent with breeding programmes in Carinthia — are allowed between all admissible breeds and also with Pietrain pigs as sires. How­ ever, crosses between pure meat breeds do not produce the desired clearly visible fat content.

The previous requirement of a maximum pH value of 5,8 could be omitted because suitability for human con­ sumption has to be ensured and controlled, and also confirmed by the veterinary service (veterinary inspector). In addition, the party processing the bacon recognises on the basis of their experience whether the meat is suit­ able for bacon processing.

Whereas earlier whole bacon sides were regularly used and cuts only when necessary, this ratio has now been reversed, which is due to demand from customers and the different forms of marketing. These have been incor­ porated into the specifications for clarification.

A slightly more specific description of the appearance and consistency of the bacon was given; it was stipulated that Gailtaler Speck should have a ‘clearly recognisable’ fat content. A more precise definition is not possible in relation to a natural product, in particular as the fat content differs between castrated males and female animals and between different cuts of meat. Due to the longer lifespan of the pigs used for the production of Gailtaler Speck and their higher minimum live weight at the time of slaughter (which is 120 k g instead of the European average of 85 kg in normal bacon production), the fat content of Gailtaler Speck is, however, recognisably higher than in comparable products. The particular firmness of the fat contained in Gailtaler speck is due to the special feeding of the pigs with a very small amount of maize (max. 10 % instead of max. 70 % as is usual in Europe), which is also referred to in the text now. C 195/50 EN Official Journal of the European Union 7.6.2018

For the purpose of clarification and in line with current trade practices, information on the permissible market­ ing forms has been added, stating that Gailtaler Speck can be sold unpackaged or packaged, in whole sides (that is as uncut sides of bacon or uncut sections), as separated belly, loin, loin belly, leg and shoulder portions or cut into slices, chunks, etc.

The previous information concerning ‘cold smoking’ and the list of permissible spices used to attain the tradi­ tional character of the product are moved to the section ‘Method of production’.

Geographical area: — Section 4.3 of the summary, first sentence: ‘The production area comprises the municipalities Kötschach-Mauthen, , Kirchbach, , Hermagor, St. Stefan im Gailtal, Nötsch im Gailtal, Feistritz an der Gail and .’

and Section 4.3.1 of the specification (‘Indication of the area of production’):

‘ Due to features of the natural landscape (see Section 4.6) and also to historical developments (see Section 4.4) a special culture of bacon production developed in the Gail Valley. Based on historical documents and sources attesting to the historical development of the bacon production, an area delimitation for the region in which Gailtaler Speck can be produced is set out below.

The example of a l ist of production costs compiled by servants around 1830 clearly shows the importance of Gailtaler Speck in the diet of the people of the Gail Valley (see Carinthian Regional Archive, Stabile Cadastre (Kärntner Landesarchiv, Stabiler Kataster) Annex A to Section 4.3.1).

The importance of bacon in the diet of the Gail Valley inhabitants compared to that of other regions in Carinthia is clear from other historical documents (see Carinthian Regional Archive, Stabile Cadastre, Annex B to Section 4.3.1). The reasons for this lie in the particular natural conditions in the Gail Valley that make the area ideal for the production of high-quality cured products (see Section 4.6).

The area is delimited to the north and south by the conventional delimitation of the Gail Valley according to general opinion by its mountain ranges lying to the north and south, the Carnic , belonging to the Southern Calcareous Alps, in the south along the border with , and the in the north, along which the borders of the political municipalities of the Gail Valley also run. The area is delimited to the east and west by natural conditions, in particular climatic conditions, which also constitute a crucial prerequisite for production of the bacon.

The following section now provides a more detailed description, with reference to the relevant annexes, of the delimitation of the area for the location of production facilities in order for these facilities to be entitled to pro­ duce Gailtaler Speck PGI. The location of the Gail Valley within Europe at NUTS 2 level and within the Republic of Austria is described in the account in Annex C to Section 4.3.1 (see Civil Engineers Office Blechl & Piechl, 1999a, Annex C to Section 4.3.1). The area is thus delimited by a combination of the municipalities in which the production facilities for Gailtaler Speck are located and the topographical situation, which determines the climatic conditions. The municipalities concerned are Kötschach-Mauthen, Dellach, Kirchbach, Hermagor, Gitschtal, St. Stefan im Gailtal, Nötsch im Gailtal, Feistritz an der Gail and Hohenthurn (See Civil Engineers Office Blechl & Piechl, 1999b, Annex D to Section 4.3.1).’

are reworded as follows:

‘4.3 Geographical area 4.3.1 Delimitation The geographical area lies in the Austrian province of Carinthia.

Due to natural conditions as well as to historical developments a special culture of bacon production developed in the Gail Valley. Based on historical documents and sources attesting to the historical development of the bacon production, an area delimitation for the region in which Gailtaler Speck can be produced is set out below.

The area is delimited according to convention by the in the south along the border with Italy and the Gailtal Alps in the north, along which the borders of the political municipalities of the Gail Valley also run. The area is delimited to the east and west by natural conditions, in particular climatic conditions, which also constitute a crucial prerequisite for production of the bacon (see Steinhauser 1958). The production area has developed from traditional roots (see Carinthian Regional Archive, Analysis of Land Register Estimates, 1832).

The defined geographical region (referred to below as “defined region” or “ the region”) is made up of the following municipalities: Dellach, Feistritz an der Gail, Gitschtal, Hermagor, Hohenthurn, Kirchbach, Kötschach-Mauthen, Nötsch im Gailtal and St. Stefan im Gailtal. 7.6.2018 EN Official Journal of the European Union C 195/51

For the purpose of illustration and precise delimitation of the area, the defined region is marked in red on the graphic below.

Reasons:

The information is reduced to the essential points and the text has been streamlined; delimitation of the area by naming the municipalities remains unchanged, however, as do the details of the delimitation of the area by means of natural conditions. New, clearer maps have been added.

— Section 4.3 of the summary, second sentence: ‘The pigs which are used to produce Gailtaler Speck originate from the Gail Valley and, if necessary, from other regions of the province of Carinthia.’

and Section 4.3.2 of the specification (‘Indication of the area of origin of the basic products’):

‘For the production of Gailtaler Speck it is essential that meat from pigs originating from the Gail Valley is used in accordance with Sections 1.2 and 1.3 of the Gailtaler Speck Guidelines. If it is not possible to meet the demand for piglets or fattening pigs from the stock originating from the Gail Valley, pigs from other regions within Carinthia listed in Annex A to Section 4.3.2 may be used (see Gailtaler Speck Association — Carinthia's Natu­ ral Arena, 1999b, Annex to Section 4.2 and Civil Engineers Office Blechl & Piechl, 1999c, Annex to Section 4.3.2). In this regard, only those basic products that have been produced in compliance with the production, quality and con­ trol standards set out in the Gailtaler Speck Guidelines or equivalent guidelines in accordance with Sections 1.2 and 1.3 of the Gailtaler Speck Guidelines may be used. Suitable basic products are produced, for example, by members of the Carinthian pig production consortium.’

are replaced by the following text:

‘4.3.2 Origin of the basic materials For the production of Gailtaler Speck, meat from pigs originating from the defined region, that is to say that were born, reared and fattened there, is to be used. However, the purchase of piglets of a different origin up to a maximum weight of 31 kg is admissible, provided they belong to the breeds stated in this specification.’

Reasons:

The previous restriction of the admissible purchase of pigs, where necessary, to animals reared in the province of Carinthia only in accordance with the specified feeding guidelines has been removed in accordance with changes in Union law. Controlling compliance with the feeding guidelines outside the Gail Valley (Gailtal) also encoun­ tered organisational difficulties. C 195/52 EN Official Journal of the European Union 7.6.2018

Instead it was stipulated that only piglets (i.e. not older animals) of the admissible breeds or crosses up to a m aximum weight of 31 k g may be purchased and used in the production process, which must subsequently take place in a controlled manner within the defined region. Above that weight — which approximately corre­ sponds to 10 weeks of age — pigs are no longer classed as ‘piglets’.

— The following new section is added: ‘4.3.3 Steps that must take place within the defined region The fattening of the piglets, cutting of the meat and production of the bacon itself (marinating, smoking and maturing) must take place at registered establishments in the defined region.’

Reasons:

The purpose of this section is to specify the steps that definitely must take place within the defined region. The term ‘registered establishments’ refers to the establishments registered by the ‘central registration body’ of the applicant group (see the section ‘Proof of origin’).

Proof of origin: The information previously contained in this section (essentially a description of the historical development of the product and its economic importance for the region) has been moved to the section ‘Link with the geograph­ ical area’ and revised. In its place, provisions to ensure traceability have been included:

‘4.4 Proof of origin The following measures serve to ensure the authenticity and traceability of the Gailtaler Speck PGI — over and above the general relevant documentation requirements:

— Central registration body The applicant group maintains a registration body, with which, irrespective of their formal membership, all establishments involved in rearing/fattening, processing, bacon production and trade within the framework of the specification must be registered. Sales outlets selling the prepacked commodity are not included, provided they carry out no further processing. This register contains the address and contact details of the registered establish­ ments and their area of activity. Each establishment receives a registration number by which it and its labelled products can be identified. The application for registration must be made in writing (email, fax, letter) to the registration body before fattening, processing, etc. can be started for the first time.

— A special system of sealing meat During the cutting process, the (still green) meat cuts that come from the slaughterhouse are provided with green or red pull-up seals that are issued exclusively by the applicant group, including to non-member establishments. These seals contain an eight-figure serial number that is recorded in a seal register kept by the applicant group and can be assigned to the relevant seal recipient. Only sealed meat cuts may be used to produce the bacon.

Only single-use, tamper-evident pull-up security seals (2 mm thick, 10 mm wide) are admissible, and next to the image of the head of a laughing pig, they must contain the words “Gailtaler Speck”. 7.6.2018 EN Official Journal of the European Union C 195/53

The different colours of the seals indicate different production chains:

— Green makes it clear that the fattening and jointing of the animals and their further processing take place at the same agricultural establishment,

— Red, on the other hand, indicates that basic materials complying with the specification are being processed by a b acon producer (farmer or meat-cutting plant) who has purchased the basic materials (i.e. animals not fat­ tened on the bacon producer's own farm).

— Compulsory reporting of purchased piglets Any registered establishment that purchases piglets must notify the registration body of that fact within 5 working days, stating the number of piglets, their origin (LFBIS (Agriculture and Forestry Holding Information System) No and name of the producer) and the weight of the individual animals.

The following documents/evidence are of relevance for checking the proof of origin:

Registration body:

— Register of establishments

— Seal register: contains the names of the bacon producers and the quantity and numbers of the seals issued to those producers

— Reports of piglet intake.

In the event of discrepancies between reports and actual stock, the registration body must be granted access to the veterinary information system (VIS database).

Producer (rearing/fattening):

— Ear tags

— Animal husbandry records (a template is produced by the registration body): contain the name of the animal keeper, fattening period, serial number, establishment number for the establishment of origin according to the ear tag, establishment of origin, start of fattening, place of slaughter, date of slaughter, cutting/bacon record number, bacon producer or purchaser

— Transfer note (in the case of the purchase of piglets): contains the name and address of the supplier and purchaser, LFBIS No of the breeding establishment, identity of the pigs, number of fattening pigs, establish­ ment number of the establishment of origin according to the ear tag, signature of both parties, date.

Processing establishment:

— Pull-up seal: seal number and colour

— Label on the packaged product

— Registration number of the bacon producer

— Slaughter record or other approval by a veterinary surgeon (e.g. on the transfer note): number of slaughters inspected and checked, date, stamp and signature of the official veterinary surgeon

— Transfer note: see above

— Cutting or bacon record: contains the serial number, bacon producer, date of slaughter, place of slaughter, number of pieces, fattening establishment, animal keeper, animal husbandry record number, establishment number of the establishment of origin according to the ear tag, list of meat cuts and associated seal numbers used.

Seller:

— Pull-up seal in the case of unpackaged goods

— Label on the packaged product

— Delivery note: reference to the protected geographical indication (PGI) of the Gailtaler Speck, article descrip­ tion, number of pieces/quantity, date, name of the processor and purchaser C 195/54 EN Official Journal of the European Union 7.6.2018

— Invoice: reference to the protected geographical indication (PGI) of the Gailtaler Speck, quantity, date, name of the processor and purchaser

— Registration number of the bacon producer.’

Reasons:

The new provisions, which are intended to ensure traceability of the product, provide for a central registration body, to be run by the applicant group, for all establishments involved in rearing/fattening, processing, bacon production and sales, a special system for the sealing of meat and, for establishments purchasing additional pigs, the compulsory reporting of purchased piglets. In addition, the documentation and records to be kept by the individual groups of actors are mentioned.

Pull-up seals of different colours are stipulated for the sealing of all cuts of meat to be used in processing, which identify whether the whole production process from fattening to the final product — with the exception of the slaughter — took place at one and the same establishment (green seal) or whether the bacon producer processed animals fattened elsewhere (red seal). This is intended to make a clear distinction between traditional farm-based production and more industrialised production. The seals are recorded in a central seal register and can be assigned to the recipient of the seal by a number visible on the seal.

Production process and packaging: Section 4.5 of the summary (Method of production):

‘The method of production is set out in the Gailtaler Speck Guidelines. These guidelines govern the basic prod­ ucts' origin and quality and the production process, define the product characteristics and contain provisions on safeguarding quality, whereby all producers of Gailtaler Speck are responsible for ensuring complete verifiability in accordance with these guidelines.

The cuts, whose pH must not exceed 5,8 , are marinated in an unpressed state by means of a dry-curing process during which cooking or curing salt, pepper, garlic and other spices and herbs are added in accordance with traditional recipes which have been handed down.

This extracts water from the meat and inhibits the growth of harmful micro-organisms. Marination takes place preferably on traditional wooden marination tables or in curing tubs made of plastic or high-grade steel at 4 °C to 0 °C and approximately 70 % humidity for 1 to 4 weeks. The marinated material is then hung up until com­ pletely dry.

The dry-marinated material is hung up in the smoking chamber where it is smoked at temperatures not exceed­ ing 22 °C. The only fuel used is beechwood, to which juniper branches are added to obtain the distinctive smoke aroma. The smoking process is interrupted several times. In these pauses in the smoking process, fresh air is let in. This gives the bacon its particular aroma. Each producer's experience and acquired skill determine the exact juncture at which fresh air is let in and the exact length of each smoking interval. After the smoking process, the bacon is taken to the ripening room, where temperatures of 8 °C to 16 °C and relative humidity of 60 % to 80 % must be maintained. Depending on the cuts used, it remains there for at least 4 to 12 weeks to mature fully.

At 25 % fat content, dehydration leads to 30 % to 40 % of fresh weight being lost.’

and Section 4.5 to 4.5.4 of the specification:

‘Section 4.5 Method of production The components of the method of production described in Sections 4.5.1 to 4.5.4 and set out in detail in the Gailtaler Speck Guidelines have been developed and agreed by the association “Gailtaler Speck — Carinthia's Natural Arena” with the involvement of experts and the relevant specialist officials of the national food inspec­ tion authority and the national veterinary office (see Gailtaler Speck Association — Carinthia's Natural Arena, 1999b, Annex to Section 4.3).

The Gailtaler Speck Guidelines are not limited to the production process of Gailtaler Speck in a restricted sense, but also include the origin and quality of the basic products and contain a detailed product description, measures to safeguard quality with an implemented control system as well as rules on penalties and labelling. 7.6.2018 EN Official Journal of the European Union C 195/55

Section 4.5.1 Production of the basic products Animal keepers are required to keep a stock list and to mark the animals in order for the origin of each individ­ ual batch of bacon to remain traceable. Animal keepers are also required to give the animals high-quality feed only, in particular feed that promotes the slow growth of the animals, and to avoid the use of fattening aids, anabolic agents, hormones and chemical and antibiotic growth promoters. They are also required to keep an “animal husbandry record/pig record” in accordance with Annex 2 to the Gailtaler Speck Guidelines or an equiv­ alent record.

Bacon producers are required to allocate and use for bacon production pigs that have reached a minimum age of 6 months, a minimum slaughter weight of 120 kg and a maximum average daily live weight gain of 750 g only, as only the meat from slow-growing pigs exhibits the quality necessary for production of the bacon.

Operators of slaughterhouses are required to ensure that the slaughter premises and slaughter equipment are in perfect working order and that the required personal and operational hygiene standards are maintained. Slaugh­ terhouse operators and bacon producers undertake to store the carcass in a proper manner until it undergoes further processing.

4.5.2 Processing method The process of refining the pork to become Gailtaler Speck is described below. The side of bacon is marinated in a dry-curing process. Cooking or curing salt, pepper, garlic and a v ariety of other spices and herbs are added to the meat in accordance with recipes which have been handed down (see Section 4.2). The action of the salt extracts water from the meat and inhibits the growth of harmful micro-organisms. Marination takes place prefer­ ably on traditional wooden marinating tables or in curing tubs made of plastic or high-grade steel at a tempera­ ture of 4 °C to 10 °C and a relative humidity of approximately 70 %. Depending on the thickness of the mari­ nated material, this process takes from 1 to 4 weeks.

Once the marinating process is finished, excess salt is brushed off and the marinated material is hung up until completely dry. Once this is complete, the meat cuts are hung up in the smoking chamber at distances that are sufficiently large to obtain an even effect of the smoke. The smoking method used is cold smoking. With this method, a temperature of 22 °C must not be exceeded. The only fuel used is beechwood, to which juniper branches are added to obtain the distinctive smoke aroma of Gailtaler Speck. The smoking process is interrupted several times. In these pauses in the smoking process, fresh air is let in. This gives the bacon its particular aroma. Each producer's experience and acquired skill determine the exact juncture at which fresh air is let in and the exact length of each smoking interval.

Once the smoking process is complete, the bacon is placed in a well-ventilated ripening room with temperatures between 8 °C and 16 °C and a relative humidity of 60 % to 80 %. Depending on the cuts used, the bacon must remain in the ripening room for between at least 4 and at least 12 weeks until mature. At 25 % fat content, dehydration leads to 30 % to 40 % of fresh weight being lost.

4.5.3 Quality assurance and quality control process The bacon producers undertake to carry out quality assurance and self-monitoring in their bacon production. The following detailed provisions apply in this regard:

— Fresh meat with a pH higher than 5,8 is not used to produce Gailtaler Speck, as this would decrease the ability of the meat to release water and take up salt and reduce the shelf life of the final product.

— The marinating room must be clean, ventilated and equipped with devices to measure temperature and humidity. The plant must also be kept to impeccable hygiene standards.

— The smoking room must be clean, ventilated and equipped with devices to measure temperature. The plant must also be kept to impeccable hygiene standards.

— When the marinated material is hung up in the smoking room it must be completely dry; otherwise it will result in the increased accumulation of soot particles.

— The products to be smoked must be hung up in such a way as to obtain even smoke generation.

— When the smoking fire is reignited, the products to be smoked must not come into contact with the initial smoke that arises.

— The drying and ripening room must be clean, ventilated and equipped with devices to measure temperature and humidity. The plant must also be kept to impeccable hygiene standards. In particular, undesirable mould growth in the ripening room is to be avoided or removed. C 195/56 EN Official Journal of the European Union 7.6.2018

The bacon producers also undertake to keep a production record equivalent to the “bacon record” in accordance with Annex 3 to the Gailtaler Speck Guidelines (see Gailtaler Speck Association — Carinthia's Natural Arena, 1999b, Annex to Section 4.2).

Section 4.5.4 Special supervisory mechanisms Section 11 of the articles of association of the association “Gailtaler Speck — Carnic Region” stipulates the estab­ lishment of a supervisory committee for the internal supervision of the guidelines that are to be complied with by the individual producers of Gailtaler Speck (see Gailtaler Speck Association — Carinthia's Natural Arena, 1999a, Annex to Section 2). The supervisory committee is responsible for the regular monitoring of compliance with the guidelines set out by the Association and inspection of all members who produce Gailtaler Speck. To assist with its work, a “Good Manufacturing Practice Chart” (Annex 1 to the Gailtaler Speck Guidelines) and a s upervision flowchart (Annex 4 to the Gailtaler Speck Guidelines) are available to the supervisory committee (see Gailtaler Speck Association — Carinthia's Natural Arena, 1999b, Annex to Section 4.2.2).

The supervisory committee must report the results of its supervisory activities at regular intervals to the execu­ tive board of the Association “Gailtaler Speck — Carnic Region”. The executive board must receive the reports of the supervisory committee and in the event of a b reach of the mandatory provisions of the Gailtaler Speck Guidelines it must apply the penalties provided for to the members concerned. If a delay could pose a risk, the executive board can put the relevant decisions into force with immediate effect. The final decision on penalties is reserved for the general meeting of the Association “Gailtaler Speck — Carinthia's Natural Arena”.

Future producers of Gailtaler Speck PGI who do not belong to the Association “Gailtaler Speck — Carinthia's Natural Arena” must meet the supervision requirements by applying equivalent supervisory mechanisms.’

are replaced by the following:

‘4.5 Production process and packaging 4.5.1 Production of the basic products Gailtaler Speck is produced from meat from the breeds listed in Section 4.2 only.

Pig fattening:

For complete traceability, the entire fattening of a pig, i.e. from piglet to slaughter, must be carried out at only one (1) registered establishment in the defined region, that is to say the fattening of the individual pig cannot be divided between several establishments.

These animals may only be reared on feed that is conducive to their slow growth. Liquid feeding (e.g. wet maize or soya) is forbidden. Maize and soya may only be given in small amounts of less than 20 % of the dry matter for soya and less than 10 % of the dry matter for maize. A maximum daily weight gain of 750 grams, determined over the entire fattening period, must not be exceeded. When feeding the pigs, under no circumstances may growth promoters, anabolic agents or hormones be added to the feed. From the beginning of fattening (i.e. from a live weight of 31 kg), the use of chemical and antibiotic growth promoters must also cease. The pigs are ready for slaughter once they reach a live weight of at least 120 kg.

4.5.2 Processing method Cutting, curing, smoking and drying must all be carried out at the same establishment.

Slaughter and cutting:

Slaughter may only be carried out at the nearest slaughterhouse to the relevant fattening establishment with the necessary capacity for the particular case and which is properly equipped and complies with the statutory hygiene, veterinary and animal protection provisions. The half-carcasses are cut, boned, trimmed and immedi­ ately provided with the defined seals (pull-up seals) by the establishment producing the bacon. Only sealed meat cuts may be used to produce the Gailtaler Speck PGI bacon.

Marinating:

The meat cuts are marinated in an unpressed state at temperatures up to a maximum of 10 °C using a dry-curing process. For this purpose, salt (cooking, curing or sea salt or mixtures of these), pepper, garlic and juniper are added to the meat. Further spices and herbs may be added, which may include ginger, coriander, caraway, bay leaf, allspice, paprika, rosemary and sugar. 7.6.2018 EN Official Journal of the European Union C 195/57

The action of the salt extracts water from the meat and inhibits the growth of harmful micro-organisms. Marina­ tion is carried out in curing tubs and on plastic or high-grade-steel tables. The meat can be marinated in a cold or warm state and it stays in the salt until it has a strong salty taste, which can take 1 to 4 weeks, depending on the thickness of the marinating material. Recognition of the correct time is part of the learned skills of the bacon producers, handed down through the generations.

Once the marinating process is finished, excess salt is removed and the marinated material is hung up in prepara­ tion for smoking, that is to say until it is completely dry. Injection marinating and tumbling methods and press­ ing of the marinated material are not permitted.

Smoking:

Gailtaler Speck is always cold smoked (8 °C to 24 °C). The fuel used is beechwood or hardwood chips to which juniper berries are added to give an aroma to the generated smoke. The smoking chambers, built according to traditional farming models and operating methods, are heated to produce smoke intermittently, that is to say the smoking process is interrupted several times to cool the bacon and ventilate the chamber. In order to avoid the formation of benzopyrene, it must be ensured that, during this process, the initial smoke generated during igni­ tion and reignition of the smoking fire does not come into contact with the products to be smoked.

If there is no cooling in the smoking chambers, when the external temperature is 25 °C or higher it must be ensured by repeated checks that the core temperature of the bacon cuts does not exceed 24 °C over the entire smoking process. If the outside temperature during the interruptions in the smoking process does not contribute to cooling, the products to be smoked must be removed from the smoking chamber and cooled in order to achieve an end result comparable to conventional cold smoking. The duration of the interruptions in the smok­ ing process in this type of production must be dependent on the core temperature of the bacon cuts.

During the interruptions in the smoking process, the smoking chamber is ventilated with fresh air. Ventilation promotes the aroma formation and is intended to prevent the formation of condensation and contamination of the products to be smoked with resin. Ventilation is achieved by opening the chamber door, by air flaps or, in modern installations, by automatic ventilation systems.

Each producer's experience and acquired skill determine the exact juncture at which fresh air is let in, the number of smoking intervals and the exact length of each one, and these timings are important for the aroma of the Gailtaler Speck.

In modern smoking chambers the smoking process can also run continuously, as the temperature is kept constant by the technology and the ventilation intervals are implemented automatically. In these modern installations, the smoking process, from ignition, smoke dosing and temperature to ventilation, is set using a program. This pro­ gram is based on smoking in traditional smoking chambers. In these installations, the formation of condensation is eliminated and filters are installed to prevent resin contamination.

Maturing:

Once the smoking process is complete, the bacon is hung up in a well-v entilated ripening room with tempera­ tures between 8 °C and 16 °C and a relative humidity of 60 % to 80 %. Continual checks must be carried out to ensure that there is no undesirable mould growth. Where necessary, this must be removed by brushing the bacon and renewed mould growth prevented by putting it through a further smoking process. For the ideal degree of ripening, the loss on drying at 25 % fat content should be 30 % to 40 % of the fresh weight.

The following ripening times must be complied with for the different cuts (among other things, depending on the thickness of the meat):

— Belly bacon: at least 4 weeks

— Loin bacon: at least 8 weeks

— Loin belly: at least 6 weeks

— Shoulder bacon: at least 4 weeks

— Leg bacon or Schinkenspeck: at least 12 weeks

— Whole sides of bacon: at least 12 weeks.’ C 195/58 EN Official Journal of the European Union 7.6.2018

Reasons:

The contents of the Gailtaler Speck Guidelines which have so far also been applicable to the method of produc­ tion of Gailtaler Speck have been — where continued application was foreseen — incorporated into the revised version of the specifications (see the general comments under ‘Amendments’ above). Neither this measure nor the amendments to the production method described below will result in a reduction in product quality:

— It is stipulated that the entire fattening period for an animal may only take place at a single (1) establishment within the defined region, i.e. may not be distributed among several establishments. This is intended to make the complete traceability of this stage of the production easier in the area, this stage being essential for the quality of the final product. For the same reason, all of the actual processing steps for a carcass (cutting, curing, smoking and drying) must also take place at the same establishment.

— Where previously only liquid feeding with pure maize was prohibited, the specification now contains a blan­ ket ban on the feeding of liquids, as during liquid feeding animals consume more feed, which would unfavourably speed up the growth of the animals.

— The dry matter content may now consist of a maximum of 20 % soya, increased from 10 %, for the improved protein supply of the animals where necessary. Protein need was earlier covered by feeding whey and milk produced on the farm. This is no longer permitted, however.

— In order to avoid uncertainties in connection with the supervision, it is clarified that the maximum permissi­ ble daily weight gain of 750 g is calculated ‘over the entire fattening period’, that is to say the entire weight gain is divided by the entire fattening period.

— The limit for any use of chemical or antibiotic growth promoters is now lowered from 35 kg to 31 kg of live weight of the piglets, i.e. the time when their fattening begins in the Gail Valley. Up to that weight, the pur­ chase of piglets of other origin is admissible, over the rearing of which the applicant group has no reliable control.

— The minimum live weight at the time of slaughter of 120 kg is retained, but the minimum age at slaughter of 6 m onths is removed, as it is not the observation of an exact age at slaughter, but that of a m inimum live weight which is decisive for the quality of carcasses intended for bacon production or the fat content.

— As regards the slaughter, it is stipulated that it must be carried out at a slaughterhouse of suitable capacity located closest to the fattening farm and appropriately equipped, so that the transportation routes and the related stress for the animals are reduced to a minimum. The hygiene requirements contained in Section 4.5.1 of the previous specification and requirements for rest times, slaughter, slaughter equipment and slaughter rooms have been dispensed with in the new specification, as they do not go beyond the relevant generally applicable provisions that must be complied with anyway.

— The half-carcasses or the cuts removed from these by the establishment producing the bacon must be marked by the bacon producer with the required pull-up seals recorded in the seal register of the central registration body (see point ‘Proof of origin’).

— Due to statutory requirements, the traditional wooden marinating tables are no longer used. It was not possi­ ble to clean (disinfect) them sufficiently to meet the prescribed hygiene standards. Salting is now carried out only in curing tubs and on tables made of plastic or high-grade steel. No demonstrable effect on meat quality is associated with this change.

— Instead of ‘cooking or curing salt’ the wording now is ‘cooking, curing or sea salt, or a mixture of these’, as the effect and taste is the same and therefore no restrictions are necessary.

— In addition to the spices already mentioned (see Section 4.5 of the summary and Sections 4.2 and 4.5.2 of the specification) the use of juniper (branches or berries) is also now mandatory. This — together with the below specified addition of juniper berries to the heating medium during the smoking process — is intended to compensate for the fact that juniper branches no longer have to be used as a c ompulsory requirement in the smoking process, as they are increasingly difficult to source in the region. 7.6.2018 EN Official Journal of the European Union C 195/59

— The mandatory use of juniper branches stipulated previously in Section 4.5 of the summary and Section 4.5.2 of the previous specification to give an aroma to the smoke has been removed. For the reason, see above. To retain the juniper note of the Gailtaler Speck, juniper berries — if no juniper branches are used — are added to the heating medium.

— Previously only beechwood was permitted as fuel in the smoking process, but in future, for reasons of flexi­ bility, other hardwood chips will be permitted (even beechwood chips are now subject to supply shortages) without this having any effects on quality or taste. Softwood chips, however, are not suitable for the smoking process as they produce too much heat.

— The previously stipulated minimum temperature in the marinating room of 4 °C is omitted, as the definition of this limit value is not essential for the quality of the bacon and if retained would lead to unnecessary control requirements. Any lower temperatures actually only result in a slower penetration of the salt into the meat. The reference value of 70 % for air humidity in the marinating room is also removed, as humidity has no influence on the complete curing of the meat.

— Gailtaler Speck is essentially smoked cold. The previously specified highest temperature of 22 °C for smoking Gailtaler Speck is now replaced by the temperature band ‘8 °C to 24 °C’ defined in the Austrian Codex Ali­ mentarius for cold smoking.

— As no cooling is usually installed, particularly in older smoking chambers, establishments are now permitted to carry out the process of smoking Gailtaler Speck even at higher outside temperatures (from about 25 °C) to cover demand. However, the core temperature of the bacon cuts must never exceed 24 °C, which must be ensured by repeated controls. If the outside temperature during the interruptions in the smoking does not contribute to cooling, the products to be smoked must be removed from the smoking chamber and cooled in order to achieve an end result comparable to conventional cold smoking. The duration of the interruptions in the smoking process in this type of production must be dependent on the core temperature of the bacon cuts.

— The ripening times of Gailtaler Speck are now defined separately for different cuts of meat for more clarity.

— The general requirements pertaining to the equipping and hygiene of the production rooms (see parts of Section 4.5.3 of the previous specification) to be complied with during the production of food or meat prod­ ucts have been dispensed with. This makes the new specification more concise and also avoids the need for the specification to be revised as a result of amendments to the statutory framework conditions that cannot be controlled by producers of Gailtaler Speck.

— Information on the association's internal quality assurance and control system (Section 4.5.4 of the previous specification) has been removed. Measures relating to control and quality assurance have been outsourced to the approved control body.

Link with the geographical area: The essentially historical description and information concerning the economic importance of Gailtaler Speck previously contained in the section ‘Proof of origin’, specifically

Section 4.4 of the summary (Proof of origin):

‘The production of bacon in the Gail Valley area has been documented from as long ago as the fifteenth century. Travel reports, farm inventories and servants' food lists testify to the bacon's importance in the diet of the Gail Valley's inhabitants. That importance was attained particularly because smoking and air-drying enabled it to be kept for long periods.’

and Sections 4.4 to 4.4.2.2.4 of the specification:

‘Section 4.4 Proof of origin Section 4.4.1 Historical developments Section 4.4.1.1 Historical developments in ancient times The earliest evidence for the importance of animal husbandry in the Gail Valley stems from the Celtic period (200 BC to 100 AD). Cattle and horses were most commonly kept, but pigs were also present. Bronze statues of a p ig and horse, which were found in Gurina, an ancient mining settlement in the Gail Valley north-east of Dellach, bear witness to this (see Dinklage 1966, Annex to Section 4.4.1.1). C 195/60 EN Official Journal of the European Union 7.6.2018

Section 4.4.1.2 Historical developments in the Middle Ages The first known reference to an awareness of bacon production is found in an ordinance (Capitulare de villis) issued by Charlemagne in 812, which was also applicable in Carinthia. It concerns, among other things, mainte­ nance of the utmost cleanliness when handling foodstuffs. The preparation of bacon, sausage and smoked and salted meat is emphasised in particular — foods that have therefore been documented for the duchy of Carinthia.

An imperial diploma of Otto II from 977 in which he grants farmers permission for acorn grazing throughout the Lavant Valley suggests that pig farming flourished in the High Middle Ages. Pigs kept at mills were particularly sought after, as they were usually well fattened. Therefore, in the land register records of the Ducal administrative office in from 1267 mention was made of mills in Höfling near St. Daniel, which were particularly suitable for keeping pigs and also had to pay pig taxes (see Dinklage 1966, Annex A to Section 4.4.1.2).

A definite indication that the bacon was already an important part of the diet in the Gail Valley by the 15th century is provided by the translation of the travel diaries of Paolo Santonino, the private secretary to the patri­ arch of Aquileia and travel companion of the Bishop of Caorle from 1485 to 1487. The first of his three jour­ neys took him into the Gail Valley and to East Tirol and his later ones into the Rosen Valley, to and to former Lower Styria. Santonino describes in detail the way of life of the people of the Gail Valley, in particular their cuisine. During his stay in the Gail Valley, bacon, mostly served with beets or cabbage, was an integral part of the lavish meals that were served to him and the Bishop. This dish is mentioned no fewer than seven times, these being in connection with the visits to Goldenstein Castle near Mauthen and to Dölsach/Osttirol, St. Daniel, Tröpolach, Hermagor, St. Laurenzen, St. Michael near Egg and finally Berg im Drautal. This dish was not served to him again throughout the rest of the journey or during his later journeys (see Egger, 1947, Annex B to Section 4.4.1.2). The fact that Paolo Santonino does not mention bacon as an important part of the meals and dishes served to him in his descriptions of other destinations during his travels indicates that bacon was already a typical staple food of the Gail Valley in the Late Middle Ages.

Section 4.4.1.3 Historical developments in modern times In the oldest land register of the lordship of Aichelburg from 1504 it states that many taxpayers had to provide two shoulders of pork, which was usually smoked, to the lordship annually, in addition to other natural produce. Similar contributions evident from the tax registers also date from the subsequent period (see Carinthian Regional Archive, Dinklage 1948, Annex A to Section 4.4.1.3).

The land register for the castle of Waydenburg, situated south-west of Dellach, from 1523 also mentions contri­ butions that were to be paid to the castle in the form of two shoulders that had to be provided smoked and dried. This was a type of Schinkenspeck obtained from the fattening pig and prepared as prescribed by the admin­ istrative office of and Mauthen. Fresh meat was freely available to the lordship, as all kinds of wild game could be hunted and prepared. What was needed, however, was food that was available at any time and that therefore had to be preserved by the kind of smoking and air-drying methods used in the Gail Valley (see Carinthian Regional Archive, Waydenburg land register 1523, Annex B to Section 4.4.1.3).

Numerous farm inventories from the time around 1700, in which all of the belongings found in the house were meticulously listed, forming the tax base for the relevant lordship, also reveal that “bacon in the box” or “smoked pork” was a valued long-life product in the farming households of the Gail Valley (see Carinthian Regional Archive, Aichelburg Archive, Annex C to Section 4.4.1.3). In the inventories of the Carinthian lowlands at the same time we find “chopped bacon”, that is to say probably a type of minced bacon (Verhackert).

The food source for the pigs has always been the focus of attention through the ages: the land register of the Bamberg administrative office in Künburg in the centre of the Gail Valley from 1586 mentions a royal hunting forest around the castle of Künegg, north-west of Lake Pressegg, which consisted mainly of oak trees. No wood was permitted to be taken from these forests by the farmers. If the oaks bore plentiful acorns the farmers were permitted to herd their pigs into the forest for acorn feeding (see Dinklage, 1966, Annex D to Section 4.4.1.3). Furthermore, in a long-running dispute between several Gail Valley neighbourhoods concerning their grazing rights, Georg Friedrich von Aichelburg ruled in 1608 that, in addition to their dairy cattle, the four neighbour­ hoods of Emmersdorf, Michelhofen, St. Paul and Dragantschach could also graze three horses and their pigs on the Osternig mountain and in the Rießen (see Carinthian Regional Archive, Dinklage 1948, Annex to Section 4.4.1.3). 7.6.2018 EN Official Journal of the European Union C 195/61

Section 4.4.1.4 Historical developments in the 19th century The municipal estimates of livestock numbers for the Gail Valley in 1832 indicate that, although pig fattening was not practised on a large scale, it was nevertheless carried out with expertise. Cattle farming was more impor­ tant due to the terrain and associated dominance of grassland as the main land use. Within the valley there was a distinct incline from the lower Gail Valley, where more feedingstuffs, in particular maize, were cultivated, up to the upper Gail Valley. If we look at the livestock from neighbouring regions, e.g. the Kanal Valley, however, pig numbers there are much lower than in the Gail Valley.

In the Gail Valley, at least a few pigs were found in most households, and around 1830 these were mainly pigs of the Friulian breed, which were black, large and elongated and ideal for fattening. They mainly served to meet the population's requirement for fat. The bacon was particularly suitable for that purpose, as it could be preserved for a l ong time by smoking and air drying and was therefore a nutritious and pleasant-tasting energy source which, in contrast to fresh meat, was available at any time (see Carinthian Regional Archive, Analysis of Land Register Estimates, 1832, Annex A to Section 4.4.1.4).

The diet was also considerably enriched. Rules for the provision of food for servants, with weekly meal plans, are known from the Stabile Cadastre records. If the diets of different Carinthian regions are compared, those from the Gail Valley are significantly more varied than other diets (see Carinthian Regional Archive, Stabile Cadastre, Annex B to Section 4.4.1.4). On workdays in the Gail Valley they received bacon served with polenta and sweet or sour milk in the mornings and evenings, whereas in the Drau Valley or even in the of Ossiach servants had to make do with Sterz and milk. Meat, bacon or lard were also an integral component of the other meals in the Gail Valley. After a particularly hard day's work, “frigga”, a rich timber worker's meal consisting of polenta, cheese and bacon, was on the menu.

In connection with the transfer of a farm from father to son in Vordernberg in 1885 the old farmer secured the right in writing, in the event of the poor provision of food by the son, to be able to demand 40 kilograms of bacon and meat or half a p ig of that weight and 10 kilograms of salt annually instead of a diet of cereals (see Carinthian Regional Archive, Dinklage 1948, Annex C to Section 4.4.1.4). These details emphasise the impor­ tance of bacon as a staple in the diet of the Gail Valley inhabitants.

Section 4.4.1.5 Historical developments in the 20th century In the years following the First World War, the objective was to use funding programmes to restrengthen agriculture, which had been badly affected by the war. In the Gail Valley, in addition to soil improvement and the acquisition of fertilisers and seed, they sought to achieve the meaningful control of the sale of surplus slaughter animals. At that time, 2 000 pigs a year were exported from the Gail Valley and in turn many tonnes of maize were brought in to be used for feed, as yields per hectare in arable farming were well below the regional average (see Picker 1947, Annex A to Section 4.4.1.5).

During the years of the Second World War pig stocks declined to their lowest level due to a lack of feed and an increased number of slaughters, but by 1950 pig stocks had returned to their pre-war density. Up until the late 1940s there was also an obligation for farmers to provide bacon if they slaughtered their own pigs at home in order to ensure that the population had a basic supply of food. This was abolished as late as 1949 by an order of the Federal Minister for Agriculture, Forestry and Nutrition (see Kärntner Bauer (Carinthian Farmer) 1950, No 3, Annex B to Section 4.4.1.5).

In agricultural reference books from this period, “air-cured” bacon from Upper Carinthia was clearly distin­ guished from all other types of bacon. In addition to the description of its very particular production method, these books also reveal that the durations of the individual processing stages are determined to a significant extent by the weather conditions (see Faltnitzer 1949, Annex C to Section 4.4.1.5).

In one edition of the Kärntner Bauer from 1984 it was stated that the rightly deserved good reputation of the Upper Carinthian long-life product is probably due to its unusual production conditions, in particular the pigs being fed with only small proportions of maize (see Kärntner Bauer 1984, No 2, Annex D to Section 4.4.1.5).

In the 1980s and 1990s the Gail Valley experienced an economic upturn, explained primarily by the developing winter tourism in the valley. Under these general conditions, the Gail Valley was also able to establish itself as a “culinary region” (see Section 4.4.2).

An age-old Gail Valley custom, which is still practised today in Kreuth near Kötschach, is “bacon hunting”. The single young men of the village make music to gain entry to homes, where they have to be served with bread and bacon. The housewife must ensure that only the nicest pieces are put on the table; otherwise she will be certain to gain a bad reputation (see Wassermann 1998, Annex E to Section 4.4.1.5). C 195/62 EN Official Journal of the European Union 7.6.2018

Section 4.4.2 Economic importance of the product for the region Section 4.4.2.1 Economic importance in the past The conditions for agricultural production in the floor of the Gail Valley were rather poor due to a high propor­ tion of very waterlogged “acid” meadows. The focus of agriculture in the Gail Valley has therefore always been on grassland management with horse and cattle rearing and in particular alpine dairy farming. As a result of the low level of arable farming and the resulting lack of fodder, pig production has never been practised on a large scale in the Gail Valley, but it has been carried out throughout the region and to particularly high standards. Almost every household had several pigs, used mainly to meet the household's own meat and fat requirements. As preservation by means of refrigeration or freezing was unknown, preservation by curing, smoking and drying was essential. Bacon, which is an important source of energy, was therefore available at all times.

Therefore, even during the wars and in the post-war years of this century, visits to the Gail Valley were used to supplement the meagre supply of food in the central areas of Carinthia with the agricultural products produced there. These days Gailtaler Speck is no longer needed to supplement the diet due to there no longer being food shortages, but this makes it an even more tasty and welcome reminder of days spent in the Gail Valley.

During the 1960s and 1970s, summer tourism in the Carnic region, as the Gail Valley was also called, increased in importance. In the surrounding area, the gastronomic and culinary delights experienced by visitors during their stay became ever more important. In that respect, Gailtaler Speck as well as Gailtaler Almkäse (Gail Valley alpine cheese) PDO are definitely among the flagship products of the region.

Section 4.4.2.2 Economic importance today Section 4.4.2.2.1 Tourism Tourism is a very important economic factor in the Carnic region, which often also acts as an impetus for devel­ opments in other economic sectors. Whereas winter tourism is focused mainly on skiing in the Nassfeld area, in summer more varied forms of tourism are encountered, for example the mountain pastures in the Gail Valley are a popular destination for mountain hiking. For these activities, the overall experience is becoming increasingly important due to the increased quality demands of the visitors. Visitors wish to travel through a landscape that is as intact and attractive as possible and want to return from their holiday to their everyday lives feeling both physically and mentally refreshed.

This general trend for quality tourism is also satisfied in the Gail Valley with the natural and traditional speciali­ ties of the regional gastronomy. Visitors demand products with a regional identity, “delicacies” which have a clear link to the region. The points of sale for regional products on the mountain pastures and farms and in small shops in the Gail Valley provide a v ery significant addition to the attractions for tourists. The traditional nature of the production method for Gailtaler Speck and the presence of another speciality in the form of Gailtaler Almkäse, which already has a protected designation of origin, increase the marketing opportunities for both products.

Section 4.4.2.2.2 Processing of a natural product and cross-sector cooperation The processing of agricultural raw products by the producer ensures that producers receive higher revenues and also satisfies the desire of today's consumers for transparency and traceability of the production process. The delimitation of the area of production, the specified production process and quality control ensure the high qual­ ity of Gailtaler Speck and a limit to the quantity. Cooperation with the regional butcher establishments enables additional customer groups to be reached, as the product Gailtaler Speck can also be found on the shelves of food retailers. In the light of the above, the sale of the product is safeguarded for the future, too. Together with Gailtaler Almkäse, Gailtaler Speck has developed into an initiator for the marketing of other regional products, for tourist attractions in the region, such as the “Speckfest” (bacon festival) and for tourist infrastructure with a more long-term period of use, such as the “Speckmuseum” (bacon museum) (see press reports 1993 to 1999, Annex to Section 4.4.2.2.2).

Section 4.4.2.2.3 Cooperation with top regional restaurants Cooperation between the producers of quality regional products and top restaurants is increasingly forming the basis for the image portrayed by local tourism undertakings. The internationally renowned and multi-award-winning Sissy Sonnleitner (Kellerwand country hotel, Kötschach-Mauthen) also prefers to use Gailtaler Speck to refine her cuisine because, as she says, “it gives the dishes a particular richness and a pleasant smoky flavour” (see Sonnleitner 1999, Annex to Section 4.4.2.2.3). Ensuring a high and consistent quality by means of the provisions in the Gailtaler Speck Guidelines is intended to allow this cooperation to develop in a way that is positive for both sides. 7.6.2018 EN Official Journal of the European Union C 195/63

Section 4.4.2.2.4 Positioning of the region The liberalisation of the markets and altered legal requirements have exerted increased economic pressure on the agricultural products of the Gail Valley. With the obligation of all producers of Gailtaler Speck PGI to comply with the Gailtaler Speck Guidelines developed and standardised by the association “Gailtaler Speck — Carinthia's Natural Arena” the foundations are laid for Gailtaler Speck to position itself as a quality, branded product in the long term and for it to have a favourable outlook in terms of price.

Since the Gail Valley experiences difficult conditions as a business location and there are only a f ew new jobs being created in the production sector by the establishment of existing businesses and the setting up of new ones, job retention in the existing farming establishments and small businesses is an important objective of Carinthian regional policy. Cooperation in the form of production collectives like the association “Gailtaler Speck — Carinthia's Natural Arena” as well as the “Association of the Collective of Gailtaler Alpine Cheese Dairies”, and extensive mea­ sures for quality assurance and control in food production are improving the regional supply of produce and focus­ ing marketing activities. Prioritisation in the area of countryside, food, cuisine and culture with effects on tourism therefore makes an important contribution to maintaining and developing the Gail Valley as a flourishing rural region.’

are moved to the section ‘ Link with the geographical area’ and, along with the information currently included here, i.e.

Section 4.6 of the summary (Link with the geographical area):

‘In the past, the main reason for producing bacon was so that meat could be kept for a long time. Gailtaler Speck developed into a w idely known and regionally distinctive product through the special climate-based maturing conditions, the exclusive use of pigs grown slowly and fattened on high-quality feed, and the use of traditional production methods and handed-down recipes. Experience historically handed down from one generation to the next determines the length of each stage in turning fresh pork into a culinary high-quality processed product. The producers' knowledge and experience concerning seasonal and climatic variations in production conditions enable them to optimise the timing of production. The key to this optimal and, within Carinthia at least, unique bacon production is to utilise the Gail Valley's specific climatic conditions: steady temperature and humidity, long hours of sunshine, limited fog formation in winter and clearing southerly winds. Stable air movement and only slight variations in temperature and humidity enable the product to dry evenly. The slow maturing process gives the bacon its special aroma and means that it can be kept for a long time.’

and Sections 4.6 to 4.6.5 of the specification:

‘Section 4.6 Link with the geographical area Section 4.6.1 Climate Carinthia belongs to the temperate climate zone of Central Europe, but this is frequently modified by each of its neighbouring regions, by its relief and by local conditions. The mountains of Carinthia stretch from west to east and therefore result in the formation of pronounced sunny and shady sides and windward and leeward sides, a phenomenon that is also typical of the Gail Valley.

The Central Alps, located in the north, in particular the massif, just like the southern chains of the Carnic mountain range, shield the valleys and basins from approaching disturbances and act to weaken the pre­ vailing westerly weather conditions. This forms a barrier to the main streams along the mountain chains, which leads to heavy rain over the summit regions and a reduction in cloud cover from the border mountains to the basin regions.

The Vb cyclone track, which is the Baltic branch of the winds tracking from the Bay of Biscay and from Spain, determines the specific weather conditions in the Gail Valley. Winds blowing from the Gulf of Genoa towards the north-east try to divert around the fringe of the Alps in the direction of the Baltic, hit the southern alpine chain and find their way into the Carinthian area via the Fella Valley and the hollows of Nassfeld. The moist warm air masses collide with cold air lying there and, in addition to the summer maximum usual for the whole of Carinthia, also cause the second precipitation maximum encountered in south Carinthia in autumn. The intensity of the precipitation is therefore high in the summit region of the Carnic Alps, but it peters out much too quickly towards the north. C 195/64 EN Official Journal of the European Union 7.6.2018

The winds accompanying the Vb front on its route from the south reach the Gail Valley and dispel the cold air masses from there. This largely exhausts their energy and they therefore no longer have any effect beyond the mountains to the north of the Gail Valley (see Tschada 1962, Annex A to Section 4.6.1). As a r esult of the shielding lee effect of the southern , in particular the Carnic Alps, the Gail Valley and the area around Villach experience above-average periods of sunshine of more than 50 % over the year as a whole com­ pared with other regions of Carinthia. The Gail Valley is particularly favourable in autumn and winter, however, when in the central basins of Carinthia fog formation substantially limits the amount of radiation received there (see Steinhauser 1958, Annex B to Section 4.6.1 and Paschinger 1976).

Consequently, air humidity in the Gail Valley over the year as a whole is also very steady, whereas the air in the basins is relatively moister in winter and drier in summer. Thus, the variability in the mean relative humidity in the Gail Valley over the course of a year is only half the value of the central region of Carinthia. The essential natural prerequisite for good maturing of the bacon, i.e. consistent humidity, is therefore present in the Gail Valley.

Temperatures are also on average slightly lower than in the basin, for example, but they are more consistent, i.e. with fewer marked temperature extremes, due to the higher position of the Gail Valley (see Central Institute for Meteorology and Geodynamics 1999).

Total precipitation in the Gail Valley is high, but at the same time the number of days with measurable precipita­ tion is fairly low, as shown by comparisons with monitoring stations from neighbouring regions. This indicates heavy and extensive precipitation events, which are nevertheless followed quickly by clear weather (Central Hydrographical Bureau 1999, Annex C to Section 4.6.1).

The west to east orientation of the valley, the even temperatures and humidities, the long periods of sunshine and associated low cloud cover percentage and fog-free conditions in the winter and the characteristic clearing southerly winds as a result of the strong influence of the Vb weather front create ideal conditions in the Gail Valley for the production and, in particular, the maturing of bacon. High-quality cured products can only be produced in regions with even air movement and with small variations in temperature and humidity, as only there is it possible for the product to dry evenly (see Aichwalder 1997, Annex D to Section 4.6.1). The special aroma and long shelf life of the bacon is a result of the long and undisturbed maturing process. The prerequisites for successful bacon production are therefore present in particular abundance in the Gail Valley.

4.6.2 The tradition of bacon production In the past, the main reason for producing bacon was so that meat as a r aw material could be kept for a long time. In that way, meat and fat were available all through the year to complete and enrich the diet. In recent decades, however, it is the high quality of the bacon that can be achieved through the special production and maturing conditions in the Gail Valley that makes it a sought-after culinary speciality.

Marination on traditional wooden marinating tables using handed-down recipes, smoking and interruptions in the smoking process during which the bacon comes into contact with fresh air, which gives the bacon its typical flavour, and the slow maturation under the climatic conditions that are typical of the Gail Valley are additional important factors that determine the quality of the bacon (see Gailtaler Speck Association — Carinthia's Natural Arena, 1999b, Annex B to Section 2).

4.6.3 The special reputation of Gailtaler Speck Gailtaler Speck has an excellent reputation in the other regions of the province of Carinthia as well as beyond the Carinthian borders. Particularly in the Lower Carinthian regions, where a completely different type of bacon is produced, if it is produced at all, Gailtaler Speck is held in high regard and is appreciated for its unique taste. The popularity enjoyed by Gailtaler Speck manifests itself every year at the Speckfest (bacon festival), now in its 7th year, held in the town of Hermagor, which is centrally located in the Gail Valley, where tens of thousands of visitors from Austria and from abroad take the opportunity to come to the Gail Valley to try Gailtaler Speck and to take some home with them (see press reports 1993 to 1999, Annex to Section 4.6.3).

4.6.4 The importance of Gailtaler Speck for the regional diet As already mentioned in Section 4.6.2, Gailtaler Speck was an essential nutritional resource due to its method of production, which enabled the preservation of meat at a time when technical refrigeration methods were largely unknown. Even today, Gailtaler Speck, as part of the traditional “Brettljausen” (Austrian cold platters), which are considered to be complete meals and in which Gailtaler Speck forms a main element, plays a s ignificant role in the diet of the inhabitants of, as well as visitors to, the Gail Valley (see Speckfestjournal (Bacon Festival Journal) 1998, Annex A to Section 4.6.4). 7.6.2018 EN Official Journal of the European Union C 195/65

A second element to the importance of Gailtaler Speck in the diet is its use in the preparation of traditional dishes and also in the development of new local cuisine. The top restaurateur Sissy Sonnleitner, who was men­ tioned above in Section 4.4.2.2.3, as well as the gourmet chef Walter Trupp and chef of the year 1997 Harald Fritzer, all value Gailtaler Speck, as it gives dishes a v ery distinctive flavour (see Lexe 1997, Annex B to Section 4.6.4).

4.6.5 Maintaining traditional forms of agriculture Production of Gailtaler Speck takes account of the local traditions of the agricultural sector. These are evident in the following processes: use of whole sides of bacon to produce cured products, curing on traditional wooden marinating tables, the method of cold smoking with several interruptions during the smoking process and finally the individually distinct spice recipes, which have been handed down from generation to generation exclusively within families (see Gailtaler Speck Association — Carinthia's Natural Arena, 1999b, Annex to Section 4.2).’

are replaced with the following text:

‘4.6 Link with the geographical area 4.6.1 Climate The Gail Valley belongs — with certain exceptions — to the temperate climate zone of Central Europe. The mountains of Carinthia run in a west-east direction, which results in the formation of pronounced sunny and shady sides and windward and leeward sides. This is the case in the Gail Valley, too. The Central Alps, located in the north, in particular the High Tauern massif, just like the southern chains of the Carnic mountain range, shield the valleys and basins from approaching disturbances and act to weaken the prevailing westerly weather conditions. This forms a b arrier to the main streams along the mountain chains, which leads to heavy rain over the summit regions and a reduction in cloud cover from the border mountains to the basin regions.

The Vb cyclone track, which is the Baltic branch of the winds tracking from the Bay of Biscay and from Spain, determines the specific weather conditions in the Gail Valley. Winds blowing from the Gulf of Genoa towards the north-east try to divert around the fringe of the Alps in the direction of the Baltic, hit the southern alpine chain and find their way into the Carinthian area via the Fella Valley and the hollows of Nassfeld. The moist warm air masses collide with cold air lying there and, in addition to the summer maximum usual for the whole of Carinthia, also cause the second precipitation maximum encountered in south Carinthia in autumn. The intensity of the precipitation is therefore high in the summit region of the Carnic Alps, but it peters out much too quickly towards the north.

As a r esult of the shielding lee effect of the , in particular the Carnic Alps, the Gail Valley and the area around Villach experience above-average periods of sunshine of more than 50 % over the year as a whole compared with other regions of Carinthia. However, the Gail Valley is particularly favourable in autumn and winter (see Steinhauser 1958 and Pachinger 1976).

Consequently, air humidity in the Gail Valley over the year as a whole is also very steady, whereas the air in the basins is relatively moister in winter and drier in summer. Thus, the variability in the mean relative humidity in the Gail Valley over the course of a year is only half the value of the central region of Carinthia. The essential natural prerequisite for good maturing of the bacon, i.e. consistent humidity, is therefore present in the Gail Valley. Temperatures are also on average slightly lower than in the Klagenfurt basin, for example, but they are more consistent, i.e. with fewer marked temperature extremes, due to the higher position of the Gail Valley (see Central Institute for Meteorology and Geodynamics 1999).

Total precipitation in the Gail Valley is high, but at the same time the number of days with measurable precipita­ tion is fairly low, as shown by comparisons with monitoring stations from neighbouring regions. This indicates heavy and extensive precipitation events, which are nevertheless followed quickly by clear weather (see Central Hydrographical Bureau 1999).

The west to east orientation of the valley, the even temperatures and humidities, the long periods of sunshine and associated low cloud cover percentage and fog-free conditions in the winter and the characteristic clearing southerly winds as a r esult of the strong influence of the Vb weather front create ideal conditions in the Gail Valley for the production and, in particular, the maturing of bacon. High-quality cured products can only be produced in regions with even air movement and with small variations in temperature and humidity, as only there is it possible for the product to dry evenly (see Aichwalder 1997). C 195/66 EN Official Journal of the European Union 7.6.2018

4.6.2 Human expertise Knowledge gained from experience handed down from one generation to the next determines the length of each stage in turning fresh pork into a culinary high-quality processed product. The producers' knowledge and experi­ ence concerning seasonal and climatic variations in production conditions enable them to optimise the timing of production and to ensure the quality of the product even under less-favourable weather conditions. Utilising these specific climatic conditions in the Gail Valley is key to the optimum and, within Carinthia, unique produc­ tion of the bacon.

4.6.3 The history and tradition of bacon production The preparation of Gailtaler Speck is mentioned in documents dating as far back as 812. The bacon has been considered an essential component of the diet since the Late Middle Ages and is today classed as one of the traditional dishes of the region.

In the past, the main reason for producing bacon was so that meat as a raw material could be kept for a long time. In that way, meat and fat were available all through the year to complete and enrich the diet. Although marination was previously still carried out on traditional wooden marinating tables, today modern or high-grade- steel tubs and marinating tables are used for that purpose. What remain the same, however, are the high quality of the raw materials resulting from the feeding and fattening methods, the handed-down recipes and the gentle smoking process, which together with the slow maturing process under the climatic conditions typical of the Gail Valley are considered to be the additional essential factors determining the quality of Gailtaler Speck.

4.6.4 The special reputation of Gailtaler Speck Gailtaler Speck has an excellent reputation in the other regions of the province of Carinthia as well as beyond the borders of the province. Particularly in the Lower Carinthian regions, where a completely different type of bacon is produced, if it is produced at all, Gailtaler Speck is held in high regard and is appreciated for its unique taste and its distinctly different consistency, which is due mainly to the conditions under which the animals are fed.

The popularity enjoyed by Gailtaler Speck manifests itself at the Speckfest (bacon festival), which takes place every year in the town of Hermagor, located in the centre of the Gail Valley. The festival is attended by tens of thou­ sands of visitors from Austria and abroad, always on the first weekend in June, who take the opportunity to visit the Gail Valley to taste Gailtaler Speck in the area where it is produced and also to take some home with them. The importance of this key Carinthian product was recognised in 2005, when its area of origin was declared a Genussregion in Austria, which is associated with regular marketing and tourism initiatives (see http://www.genuss-region.at/genussregionen/kaernten/gailtaler-speck-g-g-a/region.html).’

Reasons:

The essential information related to this point contained in the various individual documents of the original specification (e.g. the detailed description of the prevailing weather conditions in the Gail Valley, historical details or the description of the special reputation of Gailtaler Speck, etc.) has been incorporated into the new specifica­ tion in a more concise format to comply with the objectives of the new specification described at the beginning (see ‘Amendments’). The only thing that has been added is that human expertise among other things allows a consistently high-quality product to be produced even under less-favourable weather conditions (e.g. at higher outside temperatures; see the information on cold smoking).

Labelling: Section 4.8 of the summary (Labelling):

‘Labelling is done by means of a badge or ribbon attached at an appropriate place to the individual sides or cuts of bacon, or by equivalent product labels which show legibly and unalterably the producer and inspection num­ ber. The inspection number must be entered in a production record (“bacon record”) maintained by the producer for submission to the inspection body, documenting that each batch of bacon has been produced in accordance with the production method and providing the basis for checking compliance with the production method at any time. The use of company or proper names in product labelling is permitted, provided that it does not mislead consumers.’ 7.6.2018 EN Official Journal of the European Union C 195/67

and Section 4.8 of the specification (Labelling):

‘Labelling of the cuts intended for marketing as Gailtaler Speck is carried out by means of a badge or ribbon attached at an appropriate place to the individual sides or cuts of bacon, or by equivalent product labels which show legibly and unalterably the producer and inspection number. Inspection numbers are made up of the health mark that is specific to each production establishment, the date of slaughter and the veterinary approval number, which is in turn specific to each slaughterhouse. The inspection number must be entered in a p roduction record (“bacon record”) maintained by the producer for submission to the inspection body, documenting that each batch of bacon has been produced in accordance with the production method and providing the basis for the inspec­ tion body's check for compliance with the production method at any time. The association “Gailtaler Speck — Carinthia's Natural Arena” has developed a “bacon record” to document the production method (see Gailtaler Speck Association — Carinthia's Natural Arena, 1999b, Annex to Section 4.2). Producers of Gailtaler Speck PGI are required to use this or an equivalent method to document the production method.

The labelling must be easily visible right up to the last portion of the relevant bacon batch that is sold. A label containing the inspection number must be attached to Gailtaler Speck that is packaged ready for sale. The bacon must be packaged in suitable materials that ensure that the shelf life and quality of the product are maintained. The label must meet all other statutory labelling requirements.

A uniform product presentation is intended to be put together in future consisting of a figurative mark contain­ ing word elements that is to be developed containing the designation “Gailtaler Speck” and, provided the pro­ tected geographical indication is recognised, the designation “PGI”. This is to be used along with the Community symbol made available by the European Commission.’

are replaced by the following text:

‘A l abel is to be applied to the packaged product, in the window of which, in addition to the required EU mark, the words “Gailtaler Speck — PGI” and the registration number of the bacon producer are also to be specified.’

Reasons:

In view of the system for ensuring traceability that has been extended with the new version of the specification (see the section ‘Proof of origin’), the labelling media previously required (badge, ribbon or equivalent product labels and specification of the producer and inspection number) can be dispensed with.

The previous information on packaging can also be deleted without being replaced, particularly as it has been treated exhaustively in the specification of the general objectives (maintaining quality and shelf life), without lay­ ing down detailed requirements relating to the quality of the packaging materials or special forms of packaging.

The use of company names or proper names in product labelling shall continue to be permitted; however, no explicit ‘approval’ is required in the specification. The previous passage relating to this is considered to be super­ fluous regulatory content and therefore has not been included in the new specification.

Other — The contact details of the competent authority and the applicant group have changed since the indication was declared protected and have been updated as follows:

1. Competent authority of the Member State: Name: Austrian Patent Office (Österreichisches Patentamt) Address: Dresdner Straße 87 1200 Vienna ÖSTERREICH Telephone: +43 1534240 Fax +43 153424535 Email: [email protected] C 195/68 EN Official Journal of the European Union 7.6.2018

2. Association: Name: ‘Gailtaler Speck — Naturarena Kärnten’ Address: c/o Albert Jank, Götzing 4, A-9620 Egg Tel. +43 6504282000 Email: [email protected]

— Type of product:

With this formal change, the exact description of the product class, i.e. ‘Class 1.2 Meat products (cooked, cured, smoked, etc.)’, has been adopted.

— Control body:

The modification in the area of the control body is necessary due to changes in national legislation, which foresee a change in the system from public controls by the Governor to controls by accredited private control bodies. The following control body will now carry out the controls:

agroVet GmbH Königsbrunnerstrasse 8 2202 Enzersfeld ÖSTERREICH Mobile phone: +43 6648487991 Fax +43 2262672213-33 Email: [email protected]

The specification states that its particular tasks are:

‘Inspection of the product characteristics and checking of the documents and evidence specified in Section 4.4 Proof of origin for plausibility and compliance with the specification.’

— The listing of relevant, but generally applicable, national legislation under the previous point ‘National legisla­ tion’ has been deleted, as this point is no longer regarded as a necessary content of specifications.

— List of references and sources

The following appendices have been deleted or removed, as their content has either been directly included in the text of the specification or become obsolete on account of new provisions:

— Gailtaler Speck Association — Carinthia's Natural Arena (1999b): Gailtaler Speck Guidelines. Hermagor

— Civil Engineers Office Blechl & Piechl (1999): Map entitled ‘ Origin of the basic products for Gailtaler Speck’. Klagenfurt.

SINGLE DOCUMENT ‘GAILTALER SPECK’ EU No: PGI-AT-0192-AM01 — 5.4.2017 PDO ( ) PGI ( X ) 1. Name(s) ‘Gailtaler Speck’

2. Member State or Third Country Austria

3. Description of the agricultural product or food product 3.1. Type of product Class 1.2 Meat products (cooked, cured, smoked, etc.) 7.6.2018 EN Official Journal of the European Union C 195/69

3.2. Description of the product, to which the name given under point 1 applies Gailtaler Speck is a raw cured product made of unpressed, boneless pork.

Gailtaler Speck can in principle be produced from any cuts of meat, including from whole sides of bacon. The belly, loin, loin belly, leg and shoulder are preferred, however.

Gailtaler Speck is sold unpackaged or packaged, in whole sides, in chunks or sliced. Whole pieces of bacon always bear a r ed or green numbered pull-up seal independent of whether they are packaged or not, which can be traced back to the user of the seal, and shows a laughing pig's head and the lettering ‘Gailtaler Speck’.

Organoleptic characteristics: Gailtaler Speck has a g olden yellow external colour, the fat content is clearly recognisable and pure white upon cutting and the muscle meat has an intense red colour. The bacon tastes slightly spicy without a dominant juniper note, is mildly salty and is characterised by a well-developed cured, smoky and meaty taste; despite the greater firmness of the fat content compared to other types of bacon, Gailtaler Speck dissolves softly on the tongue and has a tender bite.

3.3. Feed (only for products of animal origin) and raw materials (only for processed products) The raw material consists of pigs born, reared and fattened in the delineated region, of the following breeds: landrace, large white, Duroc, Swabian Hall Saddleback and crosses of these breeds. In addition, crosses of these breeds with Pietrain pigs as sires are also admissible. The purchase of piglets of these breeds of a different origin is allowed up to a maximum weight of 31 kg.

These animals may only be reared on feed that is conducive to their slow growth. A maximum daily weight gain of 750 grams, determined over the entire fattening period, must not be exceeded. Liquid feeding (e.g. wet maize or soya) is forbidden. Maize and soya may only be given in small amounts of less than 20 % of the dry matter for soya and less than 10 % of the dry matter for maize. When feeding the pigs, under no circumstances may growth promoters, anabolic agents or hormones be added. From the beginning of fattening, the use of chemical and antibiotic growth promoters also has to stop. The pigs are ready for slaughter only above a live weight of at least 120 kg.

3.4. Particular production measures to be taken in the delineated geographical area Fattening of the pigs, cutting of the meat and production of the bacon itself (marinating, smoking and maturing) must be carried out within the defined geographical area that is covered by the central registration body of the applicant group.

3.5. Particular requirements for measures such as cutting, rubbing, packaging, etc. of the product with the registered name —

3.6. Particular requirements for the labelling of the product with the registered name A label has to be applied on the packaged product, in the window of which, in addition to the required EU mark, the words ‘Gailtaler Speck — PGI’ and the registration number of the bacon producer also have to be specified.

4. Short description of the delineation of the geographical area The geographical area lies in the Austrian province of Carinthia and consists of the following administrative municipalities: Dellach, Feistritz an der Gail, Gitschtal, Hermagor, Hohenthurn, Kirchbach, Kötschach-Mauthen, Nötsch im Gailtal and St. Stefan im Gailtal.

5. Link with the geographical area Particular characteristics of the area: Natural factors The Gail Valley in Carinthia is — with certain exceptions — part of the temperate climate zone of Central Europe. The surrounding mountains run in a west-east direction, which results in the formation of pronounced sunny and shady sides and windward and leeward sides. At the same time, the mountains protect the Gail Valley from incoming weather disturbances and dampen the prevailing weather fronts arriving from the west. As a result, sunshine duration in the Gail Valley is above average in comparison with other areas in Carinthia at more than 50 % of the entire year. However, the Gail Valley is most advantageous in the autumn and winter. Accordingly, the humidity conditions are also very balanced in the Gail Valley throughout the year. C 195/70 EN Official Journal of the European Union 7.6.2018

The average temperatures in the delineated area are usually slightly lower than in, e.g. the Klagenfurt basin; due to the higher altitude of the Gail Valley, they also tend to fluctuate less, e.g. show less-pronounced extremes.

Altogether the west-to-east orientation of the valley, the balanced, constant temperatures and humidity condi­ tions, the high sunshine duration and the related low cloud cover percentage and fog-free conditions in the win­ ter and also the characteristic winds from the south clearing up the weather create ideal conditions in the Gail Valley for the production and particularly the ripening of bacon.

Human factors The inhabitants of the Gail Valley have a documented tradition of producing bacon extending back to the 9thy centur , and possess comprehensive knowledge rooted in experience on how, by observing certain proce­ dures for the production of raw materials (admissible animal breeds, feeding aimed at slow growth), and when, making use of the regional climatic characteristics, such a high-quality and unmistakable refined product as the Gail­ taler Speck can be produced. This centuries-old practical experience regarding the various factors influencing the quality of Gailtaler Speck (among others the knowledge of adverse influences, the reasons for fluctuations in quality and the changing characteristics of the raw materials, depending on environmental factors, and how these have to be handled) is decisive in producing a product of a constant high quality.

Particular nature of the product Gailtaler Speck has a relatively high fat content of characteristic firmness, which, when consumed, nevertheless provides for a pleasant, smooth feel in the mouth and dissolves softly on the tongue. Together with the taste as described under point 3.2., this results in an unmistakeable product for connoisseurs.

Causal correlation between the area and the characteristics of the product This correlation shows primarily in the effects of the regional production process handed down through the generations, which gives the Gailtaler Speck its particular character, which in turn brought it its current good reputation.

The knowledge developed in the region and preserved and refined for centuries has an effect on all stages of production:

— Selection and rearing of the animals Only pig breeds which, according to experience, ensure the desired, relatively higher fat content in conjunction with slow fattening and the admissible types of feed are allowed for production. This higher fat content cannot be determined in terms of measurements in cm, as Gailtaler Speck is a natural product, and the fat content differs between castrated males and females, and also the different cuts of meat. However, due to the longer lifespan (limitation of the daily weight gain) of the pigs used for the production of Gailtaler Speck and their higher minimum live weight at the time of slaughter (which is at least 120 kg instead of the European average of 85 kg in normal bacon production), the fat content of Gailtaler Speck is recognisably higher than in comparable products.

The particular firmness of the fat contained in Gailtaler Speck is due to the special feeding of the pigs with a very small amount of maize (max. 10 % instead of up to 70 % as is usual in Europe). Feeding a higher ratio of maize would raise the linoleic acid content (= polyunsaturated fatty acid) of the meat, which would make the bacon more susceptible to oxidisation and cause it to turn rancid, and would also change its melting point. This in turn would have an effect on its consistency, its typical graininess.

— Production process The choice of spices, the determination of the length of the curing phase and the method of the smoking process dynamically adjusted to the prevailing temperature and humidity conditions are responsible for the appearance of the product, the typical mildly salty and slightly spicy aroma, and also the characteristic cured, smoky and meaty taste of Gailtaler Speck. The already mentioned special firmness of the fat content in Gailtaler Speck — in addi­ tion to traditional cold smoking — is what makes the admissible smoking process at higher outside temperatures in smoking chambers without cooling possible in the first place. Softer fat would sweat increasingly at higher temperatures, which would lead to a higher solubility of smoke, and as a result variations in taste.

Ventilation, drying and ripening take place making use of the above advantages of the regional climate and are — together with the experience-based knowledge of local bacon producers in relation to identifying the ideal level of ripeness of the individual, unpressed and therefore varyingly thick cuts of bacon — decisive for the consistency and shelf-life of the product. 7.6.2018 EN Official Journal of the European Union C 195/71

When Gailtaler Speck is produced in modern air-conditioned smoking chambers, this experience is incorporated into the programming of process control in these, and ensures results comparable to the processing procedure controlled by humans.

Its taste and consistency distinguish Gailtaler Speck from other bacon products in neighbouring regions and lead to a rapidly increasing popularity.

This, e.g. manifests in the annual ‘Speckfest’ (bacon festival) in the town of Hermagor, which is centrally located in the Gail Valley. The festival is attended by tens of thousands of visitors from Austria and abroad, always on the first weekend in June, who take the opportunity to visit the Gail Valley to taste Gailtaler Speck where it is pro­ duced and also to take some home with them.

The significance of Gailtaler Speck as a leading product of the province of Carinthia was acknowledged in 2005, when its area of origin was declared a Genussregion in Austria, which is linked with regular marketing and tourism initiatives.

Reference to the publication of the product specification (Article 6(1) of the Regulation)

The full text of the specification is available under

https://www.patentamt.at/herkunftsangaben/gailtalerspeck/

ISSN 1977-091X (electronic edition) ISSN 1725-2423 (paper edition)

EN