ddrg/super_eurlex huggingface dataset:
4.4.

Regarding the single market, the EESC think it is important for the Commission to define a methodology for the adoption of BOELs in the CMD. This process should involve broad consultation with the social partners, Member States and other stakeholders, including NGOs. In the EESC’s view, two elements require particular consideration: first, the consistency of BOELs with regard to the risk level of the different compounds; second, the need to define BOELs on the basis of scientific evidence, including follow-up of changes in the incidence of work-related diseases. They must take into account different factors, such as feasibility and the possibility of measuring exposure levels. In order to help employers prioritise their prevention measures, they should explicitly refer to the level of risk associated with the exposure level.
2.14.

The EU was a pioneer in the development of regulatory procedures to approve biosimilars: the EMA authorised the first biosimilar in 2006, while the FDA did so only in 2015. However, there are clear signs that Europe is now losing its competitive edge, with its trade partners catching up. Therefore there is an urgent need for the EU to restore the competitiveness of EU-based manufacturers of G/Bs. Doing nothing or postponing an initiative would further weaken the EU industry and unravel the EU’s pioneering effect and competitive advantage in the biosimilar sector in particular.
Opinion of the European Economic and Social Committee on ‘Proposal for a Council Decision on the Association of the Overseas Countries and Territories with the European Union including relations between the European on the one hand, and Greenland and the Kingdom of Denmark on the other (“Overseas Association Decision”)’

(COM(2018) 461 final)

(2019/C 62/53)

Referral Commission, 12.7.2018 Legal basis Article 304 of the Treaty on the Functioning of the European Union Section responsible Section for External Relations Adopted at plenary 17.10.2018 Plenary session No 538 Outcome of vote (for/against/abstentions) 207/0/6

Since the Committee endorses the content of the proposal and feels that it requires no comment on its part, it decided, at its 538th plenary session of 17 and 18 October 2018 (meeting of 17 October 2018), by 207 votes to 0 with 6 abstentions, to issue an opinion endorsing the proposed text.
3.5.

The EESC welcomes the establishment by the Commission of a benchmark for the length of permit granting processes, but would point out that it is important to consult the competent national authorities to ensure that the proposed deadlines are realistic in light of the specific situations in the Member States. On the basis of experience to date, it is possible that the time required to comply with each stage in the procedure — including approval of the technical documents, the technical and economic indicators and the public procurement procedures, and concluding and delivering on the relevant contracts by the deadlines set and in accordance with national legislation — may exceed the deadlines proposed in this regulation by a considerable amount.
3.14.

The Fund is and must be open to supporting cooperation with third countries; however, these resources cannot be allocated directly to the authorities of those countries, but rather to projects and programmes carried out jointly between the authorities of Member States and third countries. Cooperation must be absolutely conditional on monitoring the funding allocated by the Fund; on respect for human rights by the countries benefiting from this cooperation; and, above all, on the acknowledged public character, in terms of state ownership and management, of the collaborating entities that might receive such funding. The resources from the Fund must at all costs be prevented from ultimately financing uncontrolled groups or cells that might even pose a threat to security in their countries or to the Union itself.
4.2.

For the purposes of the Regulation, the proposal lays down the following definitions: ‘hosting service provider’ means a provider of information society services consisting in the storage of information provided by and at the request of the content provider and in making the information stored available to third parties (3); ‘content provider’ means a user who has provided information that is, or that has been, stored at the request of the user by a hosting service provider (4); the EESC proposes that a new point be added including the following: — ‘information providers’: search engines that enable identification of and access to content.
4.1.

It is obvious that people are not largely aware of the opportunities that AI provides to assist them, while concerns related to control over the machine are clearly in evidence. The EESC therefore deems that there is a need for awareness-raising about the opportunities presented by AI for society at large. More knowledge and understanding of the nature and functioning of AI is also necessary to enhance people’s trust based on critical thinking. Moreover, the EESC calls for improved statistical data and more research on the implications of AI for employment and work, including studies on sector-specific impacts.
4.4.

Recalling the tools available in the Regulation on Energy Governance, the EESC proposes that a permanent citizens’ dialogue should be set up and that it should be a compulsory preparatory element of all major political decisions and all EU law-making pertinent to climate change. Transparency and accountability should be significant elements of such a dialogue, meaning that the input into dialogues should be publicly available and that clear information should be provided as to how concerns raised during the dialogue were taken into account. It is key to the success of such a dialogue that it is felt to be close to citizens. Therefore, while an internet dialogue may be useful, it is not sufficient but must be complemented by meetings and direct contact with the general public. It is therefore necessary that the dialogue is visible and that adequate financial and staff resources are available and that it is given a face in the form of a dedicated European Commission vice-president, a Commissioner or other high–level figure.
Opinion of the European Economic and Social Committee on ‘Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 1303/2013 as regards the resources for the specific allocation for the Youth Employment Initiative’

(COM(2019) 55 final — 2019/0027 (COD))

(2019/C 228/15)

Referral European Parliament, 11.2.2019 Council of the European Union, 19.2.2019 Legal basis Articles 177 and 304 of the Treaty on the Functioning of the European Union Section responsible Section for Employment, Social Affairs and Citizenship Adopted at plenary 20.3.2019 Plenary session No 542 Outcome of vote (for/against/abstentions) 132/0/1

Since the Committee unreservedly endorses the content of the proposal and feels that it requires no comment on its part, it decided, at its 542nd plenary session of 20 and 21 March 2019 (meeting of 20 March 2019), unanimously, to issue an opinion endorsing the proposed text.
5.3.

The pilot projects should be implemented as quickly as possible, in conjunction with local elected representatives, universities and research centres, professionals and relevant civil society actors. The projects should enable the key actions and measures to be developed and tested in order to improve the current inadequate situation at the pilot sites. The EESC is recommending a reasonable number of pilot projects to be conducted in the Mediterranean, the Black Sea, the Atlantic coast, the North Sea and the Baltic Sea, as well as in inland water areas with major potential for improvement. These projects could, for instance, entail cleaning nutrient-rich or polluted waters in areas such as ports or tourist zones using specific filtering species such as oysters, sea urchins, mussels or aquatic plants (algae), or restoring migratory pathways and spawning grounds in order to restore the life cycles of migratory fish. At the same time, the capacity to capture CO 2 on a large scale could also be tested in these pilot projects. Pilot projects could also examine the feasibility of new technologies to produce energy from seas and lakes or to find new ways of saving water resources.
3.3.1.

Significant obstacles to the operation of the current SM, as seen by citizens, consumers and enterprises, have been highlighted in terms of: a) complex administrative procedures: SM legislation often includes rules and procedures that are difficult for end-users to understand or follow; b) differing national technical standards: there is a growing body of national technical regulations, as shown by the growing number of regulatory notifications — some 700 each year concerning goods; c) difficulty in accessing information on standards and requirements: the Single Digital Gateway is a step in the right direction in helping enterprises, especially micro and small and medium-sized enterprises, to access the right information, but there are multiple contact points. A one-stop-shop in each Member State could provide better guidance on the rules, procedures and documents required, and on the authorities to be contacted; d) lack of coordination between levels of market surveillance: since surveillance is the responsibility of the Member States and of the regions, this may produce different levels of surveillance, with possible distortions between products on the SM and those entering the market; e) goldplating and lack of transposition and implementation of EU directives in key areas of business regulation, creating a complex regulatory patchwork in the SM, preventing principally micro and SMEs from fully reaping the benefits of the entire SM; f) lack of training and cooperation mechanisms to ensure sound and consistent knowledge of the standards that are (potentially) applicable, by the relevant public authorities, individuals, consumers and the companies concerned; g) failures in ensuring market unity in key sectors, e.g. gas and electricity, and in digital infrastructure and transport.
1.11.

The EESC strongly encourages the European Commission to explore the possibility of having dedicated funding for cross-regional action based on the Blue Bio-economy principles. A number of existing projects have already proven that certain new economic activities can significantly contribute to positive environmental results in the Baltic Sea. Mussel and seaweed farming should be promoted, as they are very efficient nutrient filters. Activities of this kind also help to bring biodiversity, including fish stocks, back to the seashore. The EESC argues that the existing fleet and fishers could be used to realise this potential, as they have both adaptable equipment and skills. The dedicated regional financial program from the EU and Member States themselves is a must.
4.1.

The long history of railways and of rail technology will have many anniversaries in 2021. As underlined by Europalia in the catalogue of its 2021 arts festival, in 2021 the Belgian and French railways will celebrate the 175th anniversary of the rail link between Paris and Brussels. In 1846, these capitals became the first in the world to be linked by a railway line. That same year, Brussels and London were also linked by a rail link through the Ostend-Dover trunk. 2021 will also coincide with the 25th anniversary of Thalys and the 170th anniversary of the first service on the Saxo-Bohemian rail link between Prague and Dresden. Other railway anniversaries in 2021 are the 50th anniversary of the Mulhouse Train Museum and the 75th anniversary of Luxembourg Railways. Remarkably, 2021 will also be the year of the 45th anniversary of the first Pendolino in Italy, the 40th anniversary of the TGV in France and the 30th anniversary of the ICE in Germany. It is also the 20th anniversary of the publication of the European Union’s first white paper on railways in Europe.
4.12.

Given that the ESF+ is geared towards implementing the EPSR, the ESF+ regulation should take account of plans for implementing the EPSR at EU and national level — as core guidance documents with which the partnership agreements and operational programmes should be aligned — and these plans should be monitored as part of the European Semester. The EESC therefore strongly urges the EC and Member States to consider more adequate monitoring of the social situation in the European Semester by including a list of agreed indicators able to provide reliable and adequate information on the social developments in the EU. The EESC has already given its opinion ( 10 ) on this topic, asking for new social indicators in the European Semester process to monitor the implementation of the EPSR and for social country specific recommendations, and will prepare its own proposal for such a list in the near future. To this end, the EC should draw up rules and procedures to verify the correlation between, on the one hand, draft national documents programming ESF+ expenditure for the 2021-2027 period and, on the other, the principles of the EPSR (the policy framework for the labour market, education and training which are primarily laid down in Chapters I and II, whereas the framework for combating poverty and social exclusion should be laid down in Chapter III).
3.2.

Negative impacts or violations of HR and social and environmental standards can be the result of the company's own activities, of the activities of the company's subsidiaries or controlled undertakings, as well as of the company's business relationships, i.e. its supply and subcontracting chain. Accordingly, the UNGP, the OECD Guidelines and the ILO Tripartite Declaration recognise that DD should also cover companies' business relationships, including supply and subcontracting chains. Based on these frameworks, DD requirements should ideally therefore cover all companies' operations, independently of their size, including their own activities, the operations of their subsidiaries and controlled undertakings, and their business relationships, including their whole supply and subcontracting chains, franchise and contract management. They should cover operations, actual and potential impacts and violations both within and outside the EU. However, on the ground, defining the scope for the application of DD is difficult: one of the criteria, for example, chosen in the French law No 2017-399 of 27 March 2017, is the existence of an established business relationship with an entity in the supply chain that implies a certain degree of control. The French Constitutional Court has defined in another judgement what ‘established business relationship’ means: it means a regular, stable and continuous relationship developed, generally, with first tier suppliers and sub-contractors. Of course, it would be more ambitious to cover all the entities without exception, but we have to take into account the complexity of a large numbers of suppliers (up to 100 000 for one multinational company) and at the same time incentivise companies to implement effective DD for the entire value/supply chain.
3.1.7.

The EESC supports the objective of increasing collective bargaining coverage, according to national laws and practice and in full respect of — and compliance with — the division of competences and autonomy of social partners. In this regard, the EESC supports the promotion of the capacity of social partners and promotes their joint actions to engage in collective bargaining on wage-setting, and to encourage constructive, meaningful and informed negotiations on wages ( 11 ) . Article 4 sets out requirements for government intervention in the preparation of frameworks and action plans and the EESC insists that this is done with a tripartite approach in a way that respects the social partners' autonomy and in cooperation with them. In some MS, the coverage of the collective agreements is decided by the social partners, while in other MS, the law or common practice provide for mechanisms to extend collective agreements and these differences shall be respected. The EESC agrees with the proposed target of 70 % and believe that national action plans, agreed and designed with the social partners, could play a crucial role in upwards wage convergence and in establishing fair mechanisms for wage-setting at national level, including in order to close the gender and age pay gaps. They will also allow to take into account national practices and improve systems, where needed. Such action plans should be properly implemented, assessed, reviewed and adapted in order to gradually increase coverage of collective bargaining in the medium term. In some countries, extension mechanisms for collective agreements are in place and aim at increasing the collective bargaining coverage. However, using extension mechanisms is only one of the ways one can promote collective bargaining and increase coverage, in addition to joint actions and capacity-building, anti-union-busting measures, protecting the rights of trade union and employers' organisations to bargain collectively, setting agreed representativeness criteria and countering all forms of discrimination, for example. These elements and targeted proposals should be taken into account in the national action plans, together with other initiatives.
3.5.

The EESC believes that the Next Generation EU initiative has been developed and adopted in the right form and at the right time. By providing financial support, it will ensure the economic recovery and can help the EU emerge from the current crisis stronger and more resilient through public investment in infrastructure, education and measures to overcome the climate crisis. However, it should be borne in mind that loans taken out to finance programmes under the Recovery and Resilience Facility will have to be reimbursed in the future. The Commission document could address a second scenario to finance the plan taking into account the possibility of future crises. However, the EESC also acknowledges, that public investment into infrastructure and education is needed in order to ensure economic, social and environmental sustainability for future generations. Moreover, this is also the base to secure prosperity, income and competitiveness in the long run.
2.10.

In the EESC’s view, it is especially positive that the growing threat of antimicrobial resistance (AMR) is explicitly highlighted in the Pharmaceutical Strategy. In addition to effective measures to reduce the use of antibiotics, the focus must in particular be on alternative incentive models throughout the R & D cycle, as well as on new pricing models. Proven incentives, such as early dialogue with the European Medicines Agency (EMA) and the fee waiver, can also be used here. It will be important in the future to decouple manufacturers’ profits from sales volumes. However, in parallel with the promotion of new antibiotics, other measures, such as advance purchase agreements, could also be taken to provide manufacturers with more predictability.
3.17.

The EESC welcomes the detailed regulation of the notice and internal complaint-handling procedure and the safeguards brought by the proposal. However, the EESC believes that a safe harbour (Article 5) should only be excluded where the content is clearly illegal under national law in the country of origin or under directly applicable EU law or where it has been established by a court of law to be illegal. Otherwise, intermediaries will have an incentive to remove content by default. The legal assessment of certain types of content may be very complex and intermediaries should not be held liable if they have not removed it. This is in line with the duty to suspend established in Article 20, which refers to manifestly illegal content.
Opinion of the European Economic and Social Committee on the proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 1286/2014 as regards the extension of the transitional arrangement for management companies, investment companies and persons advising on, or selling, units of undertakings for collective investment in transferable securities (UCITS) and non-UCITS

(COM(2021) 397 final – 2021/0215 (COD))

(2022/C 105/24)

Referrals Council of the European Union, 29.7.2021 European Parliament, 13.9.2021 Legal basis Article 114 of the Treaty on the Functioning of the European Union Section responsible Economic and Monetary Union and Economic and Social Cohesion Adopted at plenary 20.10.2021 Plenary session No 564 Outcome of vote (for/against/abstentions) 216/0/7

Since the Committee endorses the content of the proposal and feels that it requires no comment on its part, it decided, at its 564th plenary session of 20 and 21 October 2021 (meeting of 20 October 2021), by 216 votes with 7 abstentions, to issue an opinion endorsing the proposed text.
3.5.

The EESC points out that it is necessary to establish common European standards for the collection and standardisation of statistical data — mainly in the area of health. It is also necessary to look at the statistical methodologies applied so far in each area. This is important for proper evidence-based decision making processes in the future. The EESC notes that around the outbreak of the pandemic there were persistent shortcomings in professional and trusted advice and access to epidemic research. It is therefore necessary to coordinate and streamline professional epidemic expertise at EU level. The Committee supports the appointment of a European chief epidemiologist who, acting in an advisory capacity will assist the decision-making process at EU and national level.
Opinion of the European Economic and Social Committee on the proposal for a Directive of the European Parliament and of the Council on uniform procedures for checks on the transport of dangerous goods by road (codification)

(COM(2021) 483 final – 2021/0275 (COD))

(2022/C 105/23)

Referrals European Parliament, 13.9.2021 Council of the European Union, 24.9.2021 Legal basis Articles 91 and 304 of the Treaty on the Functioning of the European Union Section responsible Transport, Energy, Infrastructure and the Information Society Adopted at plenary 20.10.2021 Plenary session No 564 Outcome of vote (for/against/abstentions) 219/0/1

Since the Committee unreservedly endorses the content of the proposal and feels that it requires no comment on its part, it decided, at its 564th plenary session of 20 and 21 October 2021 (meeting of 20 October), by 219 votes with one abstention, to issue an opinion endorsing the proposed text.
1.10.

The EESC calls for support for the most vulnerable communities and for reflection on how to involve as many people as possible in the climate, digital and social transitions. No transition will be possible if local communities are not fully engaged in these changes, as the ORs’ development is based on exceptional but fragile ecosystems. This means anticipating the impact of future policies because the ORs will not escape the changes brought about by the major climate, digital and social transitions. They need to anticipate the total transformation of their economies in order to meet future demands and do this while paying the utmost attention to the social impact of these transitions. Care should therefore be taken to support the most vulnerable communities and to consider ways to get as many people as possible involved in — and if possible enthusiastic about — this shift. No transition will be possible if local communities are not fully engaged in these changes.