(1)

The existential threat posed by climate change requires enhanced ambition and increased climate action by the Union and the Member States. The Union is committed to stepping up efforts to tackle climate change and to delivering on the implementation of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (the ‘Paris Agreement’) (4), guided by its principles and on the basis of the best available scientific knowledge, in the context of the long-term temperature goal of the Paris Agreement.

(2)

The Commission has, in its communication of 11 December 2019 entitled ‘The European Green Deal’ (the ‘European Green Deal’), set out a new growth strategy that aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy, where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use. The European Green Deal also aims to protect, conserve and enhance the Union’s natural capital, and protect the health and well-being of citizens from environment-related risks and impacts. At the same time, this transition must be just and inclusive, leaving no one behind.

(3)

The Intergovernmental Panel on Climate Change (IPCC) provides in its 2018 Special Report on the impacts of global warming of 1,5 °C above pre-industrial levels and related global greenhouse gas emission pathways, in the context of strengthening the global response to the threat of climate change, sustainable development, and efforts to eradicate poverty, a strong scientific basis for tackling climate change and illustrates the need to rapidly step up climate action and to continue the transition to a climate-neutral economy. That report confirms that greenhouse gas emissions need to be urgently reduced, and that climate change needs to be limited to 1,5 °C, in particular to reduce the likelihood of extreme weather events and of reaching tipping points. The Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES) has shown in its 2019 Global Assessment Report on Biodiversity and Ecosystem Services a worldwide erosion of biodiversity, with climate change as the third most important driver of biodiversity loss.

(4)

A fixed long-term objective is crucial to contribute to economic and societal transformation, high-quality jobs, sustainable growth, and the achievement of the United Nations Sustainable Development Goals, as well as to reach in a just, socially balanced, fair and cost-effective manner the long-term temperature goal of the Paris Agreement.

(5)

It is necessary to address the growing climate-related risks to health, including more frequent and intense heatwaves, wildfires and floods, food and water safety and security threats, and the emergence and spread of infectious diseases. As announced in its communication of 24 February 2021 entitled ‘Forging a climate-resilient Europe – the new EU Strategy on Adaptation to Climate Change’, the Commission has launched a European climate and health observatory under the European Climate Adaptation Platform Climate-ADAPT, to better understand, anticipate and minimise the health threats caused by climate change.

(6)

This Regulation respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, in particular Article 37 thereof which seeks to promote the integration into the policies of the Union of a high level of environmental protection and the improvement of the quality of the environment in accordance with the principle of sustainable development.

(7)

Climate action should be an opportunity for all sectors of the economy in the Union to help secure industry leadership in global innovation. Driven by the Union’s regulatory framework and efforts made by industry, it is possible to decouple economic growth from greenhouse gas emissions. For example, Union greenhouse gas emissions were reduced by 24 % between 1990 and 2019, while the economy grew by 60 % over the same period. Without prejudice to binding legislation and other initiatives adopted at Union level, all sectors of the economy – including energy, industry, transport, heating and cooling and buildings, agriculture, waste and land use, land-use change and forestry, irrespective of whether those sectors are covered by the system for greenhouse gas emission allowance trading within the Union (‘EU ETS’) – should play a role in contributing to the achievement of climate neutrality within the Union by 2050. In order to enhance involvement of all economic actors, the Commission should facilitate sector-specific climate dialogues and partnerships by bringing together key stakeholders in an inclusive and representative manner, so as to encourage sectors themselves to draw up indicative voluntary roadmaps and to plan their transition towards achieving the Union’s climate-neutrality objective by 2050. Such roadmaps could make a valuable contribution in assisting sectors in planning the necessary investments towards the transition to a climate-neutral economy and could also serve to strengthen sectoral engagement in the pursuit of climate-neutral solutions. Such roadmaps could also complement existing initiatives, including the European Battery Alliance and the European Clean Hydrogen Alliance, which foster industrial collaboration in the transition to climate neutrality.

(8)

The Paris Agreement sets out a long-term temperature goal in point (a) of Article 2(1) thereof, and aims to strengthen the global response to the threat of climate change by increasing the ability to adapt to the adverse impacts of climate change as set out in point (b) of Article 2(1) thereof and by making finance flows consistent with a pathway towards low greenhouse gas emissions and climate-resilient development as set out in point (c) of Article 2(1) thereof. As the overall framework for the Union’s contribution to the Paris Agreement, this Regulation should ensure that both the Union and the Member States contribute to the global response to climate change as referred to in the Paris Agreement.

(9)

The Union’s and Member States’ climate action aims to protect people and the planet, welfare, prosperity, the economy, health, food systems, the integrity of eco-systems and biodiversity against the threat of climate change, in the context of the United Nations 2030 agenda for sustainable development and in pursuit of the objectives of the Paris Agreement, and to maximise prosperity within the planetary boundaries and to increase resilience and reduce vulnerability of society to climate change. In light of this, the Union’s and Member States’ actions should be guided by the precautionary and ‘polluter pays’ principles established in the Treaty on the Functioning of the European Union, and should also take into account the ‘energy efficiency first’ principle of the Energy Union and the ‘do no harm’ principle of the European Green Deal.

(10)

Achieving climate neutrality should require a contribution from all economic sectors for which emissions or removals of greenhouse gases are regulated in Union law.

(11)

In light of the importance of energy production and consumption for the level of greenhouse gas emissions, it is essential to ensure a transition to a safe, sustainable, affordable and secure energy system relying on the deployment of renewables, a well-functioning internal energy market and the improvement of energy efficiency, while reducing energy poverty. Digital transformation, technological innovation, and research and development are also important drivers for achieving the climate-neutrality objective.

(12)

The Union has in place a regulatory framework to achieve the 2030 greenhouse gas emission reduction target agreed in 2014, before the entry into force of the Paris Agreement. The legislation implementing that target consists, inter alia, of Directive 2003/87/EC of the European Parliament and of the Council (5), which establishes the EU ETS, Regulation (EU) 2018/842 of the European Parliament and of the Council (6), which introduced national targets for reduction of greenhouse gas emissions by 2030, and Regulation (EU) 2018/841 of the European Parliament and of the Council (7), which requires Member States to balance greenhouse gas emissions and removals from land use, land use change and forestry.

(13)

The EU ETS is a cornerstone of the Union’s climate policy and constitutes its key tool for reducing greenhouse gas emissions in a cost-effective way.

(14)

The Commission has, in its communication of 28 November 2018 entitled ‘A Clean Planet for all – A European strategic long-term vision for a prosperous, modern, competitive and climate-neutral economy’, presented a vision for achieving net-zero greenhouse gas emissions in the Union by 2050 through a socially-fair and cost-efficient transition.

(15)

Through the ‘Clean Energy for All Europeans’ package of 30 November 2016 the Union has been pursuing an ambitious decarbonisation agenda, in particular by constructing a robust Energy Union, which includes the 2030 goals for energy efficiency and deployment of renewable energy in Directives 2012/27/EU (8) and (EU) 2018/2001 (9) of the European Parliament and of the Council, and by reinforcing relevant legislation, including Directive 2010/31/EU of the European Parliament and of the Council (10).

(16)

The Union is a global leader in the transition towards climate neutrality, and it is determined to help raise global ambition and to strengthen the global response to climate change, using all tools at its disposal, including climate diplomacy.

(17)

The Union should continue its climate action and international climate leadership after 2050, in order to protect people and the planet against the threat of dangerous climate change, in pursuit of the long-term temperature goal set out in the Paris Agreement and following the scientific assessments of the IPCC, IPBES, and the European Scientific Advisory Board on Climate Change, as well as the assessments of other international bodies.

(18)

The risk of carbon leakage remains in respect of those international partners that do not share the same standards of climate protection as those of the Union. The Commission therefore intends to propose a carbon border adjustment mechanism for selected sectors, to reduce such risks in a way which is compatible with the rules of the World Trade Organization. Furthermore, it is important to maintain effective policy incentives in support of technological solutions and innovations which enable the transition to a competitive climate-neutral Union economy, while providing investment certainty.

(19)

The European Parliament called, in its resolution of 15 January 2020 on the European Green Deal, for the necessary transition to a climate-neutral society by 2050 at the latest and for this to be made into a European success story and has, in its resolution of 28 November 2019 on the climate and environment emergency, declared a climate and environment emergency. It has also repeatedly called on the Union to increase its 2030 climate target, and for that increased target to be part of this Regulation. The European Council, in its conclusions of 12 December 2019, has agreed on the objective of achieving a climate-neutral Union by 2050, in line with the objectives of the Paris Agreement, while also recognising that it is necessary to put in place an enabling framework that benefits all Member States and encompasses adequate instruments, incentives, support and investments to ensure a cost-efficient, just, as well as socially balanced and fair transition, taking into account different national circumstances in terms of starting points. It also noted that the transition will require significant public and private investment. On 6 March 2020, the Union submitted its long-term low greenhouse gas emission development strategy and, on 17 December 2020, its nationally determined contribution, to the United Nations Framework Convention on Climate Change (UNFCCC), following their approval by the Council.

(20)

The Union should aim to achieve a balance between anthropogenic economy-wide emissions by sources and removals by sinks of greenhouse gases domestically within the Union by 2050 and, as appropriate, achieve negative emissions thereafter. That objective should encompass Union-wide greenhouse gas emissions and removals regulated in Union law. It should be possible to address such emissions and removals in the context of the review of the relevant climate and energy legislation. Sinks include natural and technological solutions, as reported in the Union’s greenhouse gas inventories to the UNFCCC. Solutions that are based on carbon capture and storage (CCS) and carbon capture and use (CCU) technologies can play a role in decarbonisation, especially for the mitigation of process emissions in industry, for the Member States that choose this technology. The Union-wide 2050 climate-neutrality objective should be pursued by all Member States collectively, and Member States, the European Parliament, the Council and the Commission should take the necessary measures to enable its achievement. Measures at Union level will constitute an important part of the measures needed to achieve the objective.

(21)

In its conclusions of 8 and 9 March 2007 and of 23 and 24 October 2014, the European Council endorsed the Union’s greenhouse gas emission reduction target for 2020 and the 2030 climate and energy policy framework, respectively. The provisions of this Regulation on the determination of the Union’s climate target for 2040 are without prejudice to the role of the European Council, as set out in the Treaties, in defining the Union’s general political direction and priorities for the development of the Union’s climate policy.

(22)

Carbon sinks play an essential role in the transition to climate neutrality in the Union, and in particular the agriculture, forestry and land use sectors make an important contribution in that context. As announced in its communication of 20 May 2020 entitled ‘A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system’, the Commission will promote a new green business model to reward land managers for greenhouse gas emission reductions and carbon removals in the upcoming carbon farming initiative. Furthermore, in its communication of 11 March 2020 entitled ‘A new Circular Economy Action Plan for a cleaner and more competitive Europe’, the Commission has committed itself to developing a regulatory framework for certification of carbon removals based on robust and transparent carbon accounting to monitor and verify the authenticity of carbon removals, while ensuring that there are no negative impacts on the environment, in particular biodiversity, on public health or on social or economic objectives.

(23)

The restoration of ecosystems would assist in maintaining, managing and enhancing natural sinks and promote biodiversity while fighting climate change. Furthermore, the ‘triple role’ of forests, namely, as carbon sinks, storage and substitution, contributes to the reduction of greenhouse gases in the atmosphere, while ensuring that forests continue to grow and provide many other services.

(24)

Scientific expertise and the best available, up-to-date evidence, together with information on climate change that is both factual and transparent, are imperative and need to underpin the Union’s climate action and efforts to reach climate neutrality by 2050. A European Scientific Advisory Board on Climate Change (the ‘Advisory Board’) should be established to serve as a point of reference on scientific knowledge relating to climate change by virtue of its independence and scientific and technical expertise. The Advisory Board should complement the work of the European Environment Agency (EEA) while acting independently in discharging its tasks. Its mission should avoid any overlap with the mission of the IPCC at international level. Regulation (EC) No 401/2009 of the European Parliament and of the Council (11) should therefore be amended in order to establish the Advisory Board. National climate advisory bodies can play an important role in, inter alia, providing expert scientific advice on climate policy to the relevant national authorities as prescribed by the Member State concerned in those Member States where they exist. Therefore, Member States that have not already done so are invited to establish a national climate advisory body.

(25)

The transition to climate neutrality requires changes across the entire policy spectrum and a collective effort of all sectors of the economy and society, as highlighted in the European Green Deal. The European Council, in its conclusions of 12 December 2019, stated that all relevant Union legislation and policies need to be consistent with, and contribute to, the fulfilment of the climate-neutrality objective while respecting a level playing field, and invited the Commission to examine whether this requires an adjustment of the existing rules.

(26)

As announced in the European Green Deal, the Commission assessed the Union’s 2030 target for greenhouse gas emission reduction, in its communication of 17 September 2020 entitled ‘Stepping up Europe’s 2030 climate ambition – Investing in a climate-neutral future for the benefit of our people’. The Commission did so on the basis of a comprehensive impact assessment and taking into account its analysis of the integrated national energy and climate plans submitted to it in accordance with Regulation (EU) 2018/1999 of the European Parliament and of the Council (12). In light of the 2050 climate-neutrality objective, by 2030 greenhouse gas emissions should be reduced and removals enhanced, so that net greenhouse gas emissions, that is emissions after the deduction of removals, are reduced economy-wide and domestically by at least 55 % by 2030 compared to 1990 levels. The European Council endorsed that target in its conclusions of 10 and 11 December 2020. It also provided initial guidance on its implementation. That new Union 2030 climate target is a subsequent target for the purposes of point (11) of Article 2 of Regulation (EU) 2018/1999, and therefore replaces the 2030 Union-wide target for greenhouse gas emissions set out in that point. In addition, the Commission should, by 30 June 2021, assess how the relevant Union legislation implementing the Union 2030 climate target would need to be amended in order to achieve such net emission reductions. In view of this, the Commission has announced a revision of the relevant climate and energy legislation which will be adopted in a package covering, inter alia, renewables, energy efficiency, land use, energy taxation, CO2 emission performance standards for light-duty vehicles, effort sharing and the EU ETS.

The Commission intends to assess the impacts of the introduction of additional Union measures that could complement existing measures, such as market-based measures that include a strong solidarity mechanism.

(27)

According to Commission assessments, the existing commitments under Article 4 of Regulation (EU) 2018/841 result in a net carbon sink of 225 million tonnes of CO2 equivalent in 2030. In order to ensure that sufficient mitigation efforts are deployed until 2030, it is appropriate to limit the contribution of net removals to the Union 2030 climate target to that level. This is without prejudice to the review of the relevant Union legislation in order to enable the achievement of the target.

(28)

Expenditure under the Union budget and the European Union Recovery Instrument established by Council Regulation (EU) 2020/2094 (13) contributes to climate objectives, by dedicating at least 30 % of the total amount of the expenditure to supporting climate objectives, on the basis of an effective methodology and in accordance with sectoral legislation.

(29)

In light of the objective of achieving climate neutrality by 2050 and in view of the international commitments under the Paris Agreement, continued efforts are necessary to ensure the phasing out of energy subsidies which are incompatible with that objective, in particular for fossil fuels, without impacting efforts to reduce energy poverty.

(30)

In order to provide predictability and confidence for all economic actors, including businesses, workers, investors and consumers, to ensure a gradual reduction of greenhouse gas emissions over time and that the transition towards climate neutrality is irreversible, the Commission should propose a Union intermediate climate target for 2040, as appropriate, at the latest within six months of the first global stocktake carried out under the Paris Agreement. The Commission can make proposals to revise the intermediate target, taking into account the findings of the assessments of Union progress and measures and of national measures as well as the outcomes of the global stocktake and of international developments, including on common time frames for nationally determined contributions. As a tool to increase the transparency and accountability of the Union’s climate policies, the Commission should, when making its legislative proposal for the Union 2040 climate target, publish the projected indicative Union greenhouse gas budget for the 2030-2050 period, defined as the indicative total volume of net greenhouse gas emissions that are expected to be emitted in that period without putting at risk the Union’s commitments under the Paris Agreement, as well as the methodology underlying that indicative budget.

(31)

Adaptation is a key component of the long-term global response to climate change. The adverse effects of climate change can potentially exceed the adaptive capacities of Member States. Therefore, Member States and the Union should enhance their adaptive capacity, strengthen resilience and reduce vulnerability to climate change, as provided for in Article 7 of the Paris Agreement, as well as maximise the co-benefits with other policies and legislation. The Commission should adopt a Union strategy on adaptation to climate change in line with the Paris Agreement. Member States should adopt comprehensive national adaptation strategies and plans based on robust climate change and vulnerability analyses, progress assessments and indicators, and guided by the best available and most recent scientific evidence. The Union should seek to create a favourable regulatory environment for national policies and measures put in place by Member States to adapt to climate change. Improving climate resilience and adaptive capacities to climate change requires shared efforts by all sectors of the economy and society, as well as policy coherence and consistency in all relevant legislation and policies.

(32)

Ecosystems, people and economies in all regions of the Union will face major impacts from climate change, such as extreme heat, floods, droughts, water scarcity, sea level rise, thawing glaciers, forest fires, windthrows and agricultural losses. Recent extreme events have already had substantial impacts on ecosystems, affecting carbon sequestration and storage capacities of forest and agricultural land. Enhancing adaptive capacities and resilience, taking into account the United Nations Sustainable Development Goals, help to minimise climate change impacts, to address unavoidable impacts in a socially balanced manner and to improve living conditions in impacted areas. Preparing early for such impacts is cost-effective and can also bring considerable co-benefits for ecosystems, health and the economy. Nature-based solutions, in particular, can benefit climate change mitigation, adaptation and biodiversity protection.

(33)

The relevant programmes established under the Multiannual Financial Framework provide for the screening of projects to ensure that such projects are resilient to the potential adverse impacts of climate change through a climate vulnerability and risk assessment, including through relevant adaptation measures, and that they integrate the costs of greenhouse gas emissions and the positive effects of climate mitigation measures in the cost-benefit analysis. This contributes to the integration of climate change-related risks as well as climate change vulnerability and adaptation assessments into investment and planning decisions under the Union budget.

(34)

In taking the relevant measures at Union and national level to achieve the climate-neutrality objective, Member States and the European Parliament, the Council and the Commission should, inter alia, take into account: the contribution of the transition to climate neutrality to public health, the quality of the environment, the well-being of citizens, the prosperity of society, employment and the competitiveness of the economy; the energy transition, strengthened energy security and the tackling of energy poverty; food security and affordability; the development of sustainable and smart mobility and transport systems; fairness and solidarity across and within Member States, in light of their economic capability, national circumstances, such as the specificities of islands, and the need for convergence over time; the need to make the transition just and socially fair through appropriate education and training programmes; best available and most recent scientific evidence, in particular the findings reported by the IPCC; the need to integrate climate change related risks into investment and planning decisions; cost-effectiveness and technological neutrality in achieving greenhouse gas emission reductions and removals and increasing resilience; and progression over time in environmental integrity and level of ambition.

(35)

As indicated in the European Green Deal, the Commission adopted on 9 December 2020 a communication entitled ‘Sustainable and Smart Mobility Strategy – putting European transport on track for the future’. The strategy sets out a roadmap for a sustainable and smart future for European transport, with an action plan towards an objective to deliver a 90 % reduction in emissions from the transport sector by 2050.

(36)

To ensure that the Union and the Member States remain on track to achieve the climate-neutrality objective and progress on adaptation, the Commission should regularly assess progress, building upon information as set out in this Regulation, including information submitted and reported under Regulation (EU) 2018/1999. In order to allow for a timely preparation for the global stocktake referred to in Article 14 of the Paris Agreement, the conclusions of this assessment should be published by 30 September every five years, starting in 2023. This implies that the reports under Article 29(5) and Article 35 of that Regulation and, in the applicable years, the related reports under Article 29(1) and Article 32 of that Regulation should be submitted to the European Parliament and to the Council at the same time as the conclusions of that assessment. In the event that the collective progress made by Member States towards the achievement of the climate-neutrality objective or on adaptation is insufficient or that Union measures are inconsistent with the climate-neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience or reduce vulnerability, the Commission should take the necessary measures in accordance with the Treaties. The Commission should also regularly assess relevant national measures, and issue recommendations where it finds that a Member State’s measures are inconsistent with the climate-neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience and reduce vulnerability to climate change.

(37)

The Commission should ensure a robust and objective assessment based on the most up-to-date scientific, technical and socioeconomic findings, and representative of a broad range of independent expertise, and base its assessment on relevant information including information submitted and reported by Member States, reports of the EEA, of the Advisory Board and of the Commission’s Joint Research Centre, the best available and most recent scientific evidence, including the latest reports of the IPCC, IPBES and other international bodies, as well as the Earth observation data provided by the European Earth Observation Programme Copernicus. The Commission should further base its assessments on an indicative, linear trajectory linking the Union’s climate targets for 2030 and 2040, when adopted, with the Union’s climate-neutrality objective and serving as an indicative tool to estimate and evaluate collective progress towards the achievement of the Union’s climate-neutrality objective. The indicative, linear trajectory is without prejudice to any decision to determine a Union climate target for 2040. Given that the Commission has committed itself to exploring how the EU taxonomy can be used in the context of the European Green Deal by the public sector, this should include information on environmentally sustainable investment, by the Union or by Member States, consistent with Regulation (EU) 2020/852 of the European Parliament and of the Council (14) when such information becomes available. The Commission should use European and global statistics and data where available and seek expert scrutiny. The EEA should assist the Commission, as appropriate and in accordance with its annual work programme.

(38)

As citizens and communities have a powerful role to play in driving the transformation towards climate neutrality forward, strong public and social engagement on climate action should be both encouraged and facilitated at all levels, including at national, regional and local level in an inclusive and accessible process. The Commission should therefore engage with all parts of society, including stakeholders representing different sectors of the economy, to enable and empower them to take action towards a climate-neutral and climate-resilient society, including through the European Climate Pact.

(39)

In line with the Commission’s commitment to the principles on Better Law-Making, coherence of the Union instruments as regards greenhouse gas emission reductions should be sought. The system of measuring the progress towards the achievement of the climate-neutrality objective as well as the consistency of measures taken with that objective should build upon and be consistent with the governance framework laid down in Regulation (EU) 2018/1999, taking into account all five dimensions of the Energy Union. In particular, the system of reporting on a regular basis and the sequencing of the Commission’s assessment and actions on the basis of the reporting should be aligned to the requirements to submit information and provide reports by Member States laid down in Regulation (EU) 2018/1999. Regulation (EU) 2018/1999 should therefore be amended in order to include the climate-neutrality objective in the relevant provisions.

(40)

Climate change is by definition a trans-boundary challenge and coordinated action at Union level is needed to effectively supplement and reinforce national policies. Since the objective of this Regulation, namely to achieve climate neutrality in the Union by 2050, cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective,

(1)

Chapter V of Regulation (EC) No 1005/2008 lays down procedures for the identification of fishing vessels engaged in illegal, unreported and unregulated (‘IUU’) fishing as well as procedures for establishing a Union list of such vessels (‘the Union list’). Article 37 of that Regulation provides for actions to be taken against fishing vessels included in that list.

(2)

The Union list was established by Commission Regulation (EU) No 468/2010 (2) and subsequently amended by Implementing Regulations (EU) No 724/2011 (3), (EU) No 1234/2012 (4), (EU) No 672/2013 (5), (EU) No 137/2014 (6), (EU) 2015/1296 (7), (EU) 2016/1852 (8), (EU) 2017/2178 (9), (EU) 2018/1883 (10) and (EU) 2020/269 (11).

(3)

According to Article 30(1) of Regulation (EC) No 1005/2008, vessels included in the IUU vessel lists adopted by regional fisheries management organisations are to be included in the Union list.

(4)

All regional fishery management organisations provide for the establishment and regular up-date of IUU vessel lists in accordance with their respective rules (12).

(5)

According to Article 30 of Regulation (EC) No 1005/2008, upon the receipt from regional fisheries management organisations of the lists of fishing vessels presumed or confirmed to be involved in IUU fishing, the Commission is to update the Union list. Since the Commission has received new lists from the regional fisheries management organisations, the Union list should now be updated.

(6)

Considering that the same vessel might be listed under different names and/or flags depending on the time of its inclusion on the regional fisheries management organisations lists, the updated Union list should include the different names and/or flags as established by the relevant regional fisheries management organisations.

(7)

The vessel ‘Bellator’ (13) which is currently included in the Union list, has been removed from the list established by the South Pacific Regional Fisheries Management Organisation (‘SPRFMO’), in line with Conservation and Management Measure (CMM) 04-2020 of that regional fisheries management organisation. As the decision was taken by the relevant regional fisheries management organisation under the terms of Article 30(1) of Regulation (EC) No 1005/2008, this vessel should accordingly be removed from the Union list, despite the fact that it has not yet been deleted from the list established by the Southern Indian Ocean Fisheries Agreement (‘SIOFA’), the Indian Ocean Tuna Commission (‘IOTC’) and the North-East Atlantic Fisheries Commission (‘NEAFC’).

(8)

The vessel ‘Uthaiwan/Wisdom Sea reefer’ (14) which is currently included in the Union list, has been removed from the list established by the Indian Ocean Tuna Commission (‘IOTC’) in line with Resolution 18/03 of that regional fisheries management organisation. As the decision was taken by the relevant regional fisheries management organisation under the terms of Article 30(1) of Regulation (EC) No 1005/2008, this vessel should accordingly be removed from the Union list, despite the fact that it has not yet been deleted from the list established by the Southern Indian Ocean Fisheries Agreement (‘SIOFA’).

(9)

The vessel ‘Nefelin’ (15) has been removed from the list established by the General Fisheries Commission for the Mediterranean (‘GFCM’), in line with Recommendation GFCM/33/209/8 of that regional fisheries management organisation. This vessel should thus not be included in the Union list despite the fact that it has not yet been deleted from the list established by the International Commission for the Conservation of Atlantic Tunas (‘ICCAT’) and the Indian Ocean Tuna Commission (‘IOTC’).

(10)

The vessel referred to in recital 9 was not included in the Union list amended by Implementing Regulation (EU) 2018/1883 as the list of fishing vessels presumed or confirmed to be involved in IUU fishing adopted by the relevant regional fisheries management organisation was received by the Commission after adoption of that Regulation.

(11)

Regulation (EU) No 468/2010 should therefore be amended accordingly.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

(1)

Article 25(6) of Regulation (EU) 2019/1020 requires Member States to submit to the Commission detailed statistical data covering controls performed by the authorities they designated pursuant to Article 25(1) of that Regulation with respect to products subject to Union law entering the Union market. In particular, Regulation (EU) 2019/1020 requires the statistical data to cover the number of interventions in the field of controls on such products with regard to product safety and compliance.

(2)

It is necessary to specify the details of such statistical data.

(3)

Where an intervention by the authorities designated under Article 25(1) of Regulation (EU) 2019/1020 has resulted in a requirement by market surveillance authorities not to release a product for free circulation pursuant to Article 28(1) and (2) of that Regulation, the statistical data on the number of interventions should be complemented with more detailed information about the product concerned in order to better understand issues and trends in product safety and compliance. The statistical data submitted may also contribute to enhancing risk management.

(4)

While the statistical data submitted to the Commission on interventions in the field of controls should cover all controls on products entering the Union market, it should nonetheless cover only those controls where an intervention by the designated authorities has actually taken place. Therefore, the statistical data should not include data on controls carried out exclusively by electronic data-processing techniques.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 43 of Regulation (EU) 2019/1020,

(1)

Benchmarks can be recognised as critical in accordance with Article 20(1), point (a), point (b) or point (c) of Regulation (EU) 2016/1011. Article 20(1), point (b) requires that benchmarks, for such benchmarks to be recognised as critical benchmarks, are based on input data submitted by contributors the majority of which are located in one Member State and are recognised as being critical in that Member State. On 11 August 2016, the Commission adopted Commission Implementing Regulation (EU) 2016/1368 (2), which established a list of critical benchmarks.

(2)

Regulation (EU) 2016/1011 is applicable in the European Economic Area (EEA) and was implemented in Norwegian legislation on 6 December 2019.

(3)

On 3 December 2020, the Norwegian competent authority, the Finanstilsynet, notified the European Securities and Markets Authority (‘ESMA’) of its proposal to recognise the Norwegian Interbank Offered Rate (‘NIBOR’) as a critical benchmark under Article 20(1), point (b), of Regulation (EU) 2016/1011, because the NIBOR is critical in Norway and is based on submissions of contributors, all of which are located in Norway.

(4)

NIBOR is a reference rate based on an average of the interest rates at which banks operating in the Norwegian money market are willing to lend unsecured funds to each other at different maturities. NIBOR is determined on a daily basis for five different maturities: one week and one, two, three, and six months. As of 3 December 2020, six banks participate in the NIBOR panel, all of which are located in Norway.

(5)

In its assessment submitted to ESMA, the Finanstilsynet concluded that the cessation of NIBOR, or its provision on the basis of input data that are, or of a panel of contributors that is, no longer representative of the underlying market or economic reality, could have a significant adverse impact on the functioning of financial markets in Norway.

(6)

The assessment by the Finanstilsynet illustrates that NIBOR is used as a reference in loans to households and non-financial institutions amounting to approximately EUR 418 billion, which corresponds to 94 % of the total of loans granted in Norway to households and non-financial institutions, and to 136 % of Norway’s gross domestic product (GDP). In addition, NIBOR serves as a reference for the coupon payments for around 60 % of the total nominal value of variable rate bonds in Norway, for a total amount of around EUR 130 billion. The Finanstilsynet, based on data from a single central counterparty, also evidenced that NIBOR is used as a reference in over-the-counter (OTC) interest rate derivatives for an outstanding notional amount of at least EUR 1988 billion as of October 2020. Finally, Finanstilsynet indicated that NIBOR is currently referenced in investment funds with a total net asset value of EUR 0,3 billion. The total value of financial instruments and financial contracts referencing NIBOR is therefore at least eight times higher than the gross national product of Norway.

(7)

The assessment by the Finanstilsynet concluded that NIBOR is of vital importance for financial stability and market integrity in Norway, and that NIBOR’s discontinuity or unreliability could have a significant adverse impact on the functioning of financial markets in Norway and on companies and consumers as it is used in loans, consumer credit products, OTC interest rate derivatives and investment funds.

(8)

On 28 January 2021, ESMA transmitted to the Commission its opinion setting out that the assessment by the Finanstilsynet complies with the requirements of Article 20(3) of Regulation (EU) 2016/1011 and that the Finanstilsynet had provided quantitative data to support the case for the recognition of NIBOR as a critical benchmark, as well as analytical reasoning highlighting the crucial role of NIBOR in the Norwegian economy.

(9)

According to Article 20(1) of Regulation (EU) 2016/1011, the Commission is required to review the list of critical benchmarks at least every two years, and those benchmarks are to be provided by administrators located in the Union. On 31 January 2020, the United Kingdom left the Union. Benchmarks provided by an administrator located in the United Kingdom can therefore no longer qualify as critical benchmarks and should be removed from the list of critical benchmarks in the Annex to Implementing Regulation (EU) 2016/1368. The London Interbank Offered Rate (LIBOR) was qualified as a critical benchmark on 19 December 2017, LIBOR should therefore be removed from the list of critical benchmarks in the Annex to Implementing Regulation (EU) 2016/1368.

(10)

Regulation (EU) 2016/1011 was amended by Regulation (EU) 2019/2175 of the European Parliament and of the Council (3), inter alia to appoint ESMA as the competent authority for administrators of critical benchmarks as referred to in Article 20(1), points (a) and (c), of Regulation (EU) 2016/1011 as of 1 January 2022. However, the competence for administrators of critical benchmarks as referred to in Article 20(1), point (b), of Regulation (EU) 2016/1011 will remain with the relevant national competent authority. It is therefore appropriate that the list of critical benchmarks established by the Commission distinguishes between critical benchmarks referred to in Article 20(1). points (a) and (c), of Regulation (EU) 2016/1011 and those referred to in Article 20(1), point (b), of that Regulation.

(11)

Implementing Regulation (EU) 2016/1368 should therefore be amended accordingly.

(12)

In light of the crucial importance of NIBOR, its widespread use and its role in the allocation of capital in Norway, this Regulation should enter into force as a matter of urgency.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the European Securities Committee,

(1)

On 7 November 2020, the Commission adopted Implementing Regulation (EU) 2020/1646 (2) on commercial policy measures concerning certain products from the United States of America (the United States) following the adjudication of a trade dispute under the Dispute Settlement Understanding of the World Trade Organization (WTO) that provides for the application of additional customs duties on imports into the Union of a number of products originating in the United States.

(2)

Recital 9 of Implementing Regulation (EU) 2020/1646 provides that the Commission intends to suspend the application of the Regulation in case of suspension by the United States of the countermeasures against imports of certain products from the European Union, in relation to the WTO disputes on large civil aircraft.

(3)

On 9 March 2021, following an understanding reached with the United States to mutually suspend all measures for a period of four months, the Commission adopted Implementing Regulation (EU) 2021/425 (3) suspending commercial policy measures concerning certain products from the United States of America imposed by Implementing Regulation (EU) 2020/1646 following the adjudication of a trade dispute under the Dispute Settlement Understanding of the World Trade Organization which suspended the application of Implementing Regulation (EU) 2020/1646 until 10 July 2021.

(4)

On 15 June 2021, Executive Vice President Valdis Dombrovskis and U.S. Trade Representative Katherine Tai reached an understanding on a cooperative framework for large civil aircraft, whereby ‘each side intends to suspend application of its countermeasures for a period of 5 year’.

(5)

In accordance with Article 7(3) of Regulation (EU) No 654/2014, ‘where it is necessary to make adjustments to commercial policy measures adopted under the Regulation, subject to Article 4(2) and (3), the Commission may introduce any appropriate amendments in accordance with the examination procedure referred to in Article 8(2)’.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Trade Barriers Committee, established by Regulation (EU) 2015/1843 of the European Parliament and of the Council (4),

(1)

The terms of office of 14 Judges and six Advocates-General of the Court of Justice will expire on 6 October 2021.

(2)

Appointments to these posts should therefore be made for the term of office starting on 7 October 2021 and expiring on 6 October 2027.

(3)

It has been proposed that the term of office of Ms Küllike JÜRIMÄE as Judge of the Court of Justice be renewed.

(4)

It has been proposed that the term of office of Mr Manuel CAMPOS SÁNCHEZ-BORDONA as Advocate-General of the Court of Justice be renewed.

(5)

Ms Maria Lourdes ARASTEY SAHÚN has been nominated for a first term of office as Judge of the Court of Justice.

(6)

Ms Tamara ĆAPETA has been nominated for the post of Advocate-General of the Court of Justice.

(7)

The panel set up under Article 255 of the Treaty on the Functioning of the European Union has given a favourable opinion on the suitability of those candidates to perform the duties of Judge or Advocate-General of the Court of Justice,

(1)

Article 54a(1) of Directive 2001/83/EC provides that medical products subject to prescription are to bear safety features referred to in Article 54, point (o), of that Directive, unless they have been listed in accordance with the procedure pursuant to Article 54a(2), point b, of that Directive. Annex I to Delegated Regulation (EU) 2016/161 sets out a list of medicinal products or product categories subject to prescription that shall not bear the safety features, based on the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products. The medicinal product subject to prescription Zinc-D-gluconate is not included in that list.

(2)

On 15 February 2019, the German competent authority, in accordance with Article 54a(4) of Directive 2001/83/EC and Article 46(2) of Delegated Regulation (EU) 2016/161, informed the Commission by email that they do not deem the medicinal product subject to prescription Zinc-D-gluconate to be at risk of falsification according to the criteria set out in Article 54a(2), point b, of Directive 2001/83/EC. The German competent authority considered that Zinc-D-gluconate should therefore be exempted from the requirement to bear the safety features referred to in Article 54, point (o), of Directive 2001/83/EC.

(3)

The Commission assessed the risk of and the risk arising from falsification relating to the medicinal product concerned, taking into account the criteria listed in Article 54a(2), point (b), of Directive 2001/83/EC. As the medicinal product is authorised for the treatment of severe conditions such as Wilson's disease and Acrodermatitis enteropathica disorder, the Commission assessed, in particular, the severity of the conditions intended to be treated, referred to in Article 54a(2), point (b), subpoint (iv), of that Directive and found that the risks from falsification were not negligible. Therefore, the criteria were not considered to be met.

(4)

It is, therefore, not appropriate to include the medicinal product Zinc-D-gluconate in Annex I to Delegated Regulation (EU) 2016/161 and it should not be exempted from the requirement to bear the safety features referred to in Article 54, point (o), of Directive 2001/83/EC.

(5)

The measures provided for in this Decision are in accordance with the assessment of the European Commission Expert Group ‘Delegated act on safety features for medicinal products for human use’,

(1)

Regulation (EU) 2021/953 lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (‘EU Digital COVID Certificate’) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. It is also to contribute to facilitating the gradual lifting of restrictions to free movement put in place by Member States, in accordance with Union law, to limit the spread of SARS-CoV-2, in a coordinated manner.

(2)

Union citizens and Swiss nationals enjoy reciprocal rights of entry and residence based on the Agreement between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other, on the free movement of persons (2) (the ‘FMOPA’). While the FMOPA does provide, in Article 5(1) of its Annex I, for the possibility to restrict free movement for public health reasons, it does not contain a mechanism of incorporation of Union acts. Switzerland is thus covered by the empowerment in Article 3(10) of Regulation (EU) 2021/953.

(3)

On 4 June 2021, Switzerland adopted an order on COVID-19 certificates (3) (‘the Swiss COVID-19 Certificate Order’), which provides the legal basis for the issuance of COVID-19 vaccination, test and recovery certificates.

(4)

On 23 June 2021, Switzerland informed the Commission that it issues interoperable vaccination certificates only for COVID-19 vaccines authorised in Switzerland. These currently include COVID-19 vaccines Comirnaty, Moderna and Janssen, which correspond to COVID-19 vaccines covered by Article 5(5), first subparagraph, of Regulation (EU) 2021/953. Switzerland further informed the Commission that it issues COVID-19 vaccination certificates after the administration of each dose and clearly indicates whether or not the vaccination course has been completed.

(5)

Switzerland also informed the Commission that it will issue interoperable test certificates only for nucleic acid amplification tests or for rapid antigen tests listed in the common and updated list of COVID-19 rapid antigen tests agreed by the Health Security Committee, established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council (4), on the basis of the Council Recommendation of 21 January 2021 (5).

(6)

Furthermore, Switzerland informed the Commission that it issues interoperable certificates of recovery at the earliest 11 days after a positive test, which are valid for up to 180 days.

(7)

Switzerland also informed the Commission that its system for the issuance of COVID-19 certificates in accordance with the Swiss COVID-19 Certificate Order complies with the technical specifications laid down in Commission Implementing Decision (EU) 2021/1073 (6).

(8)

On 9 June 2021, the Commission had carried out technical tests that demonstrated that COVID-19 certificates issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order are technically capable of being verified by Member States using the trust framework established on the basis of Regulation (EU) 2021/953.

(9)

On 23 June 2021, Switzerland also provided formal assurances that it will accept certificates issued by the Member States in accordance with Regulation (EU) 2021/953.

(10)

In particular, Switzerland informed the Commission that where it accepts proof of vaccination in order to waive restrictions to free movement put in place, in accordance with the FMOPA, to limit the spread of SARS-CoV-2, it will also accept, under the same conditions, vaccination certificates issued by Member States of the Union in accordance with Regulation (EU) 2021/953 for a COVID-19 vaccine that has been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council (7). Switzerland may also accept, for the same purpose, vaccination certificates issued by Member States in accordance with Regulation (EU) 2021/953 for a COVID-19 vaccine that has been granted a marketing authorisation by the competent authority of an Member State pursuant to Directive 2001/83/EC of the European Parliament and of the Council (8), a COVID-19 vaccine the distribution of which has been temporarily authorised pursuant to Article 5(2) of that Directive, or a COVID-19 vaccine that has completed the WHO emergency use listing procedure. Where Switzerland accepts vaccination certificates for such a COVID-19 vaccine, it will also accept, under the same conditions, vaccination certificates issued by Member States in accordance with Regulation (EU) 2021/953 for the same COVID-19 vaccine.

(11)

Switzerland further informed the Commission that where Switzerland requires proof of a test for SARS-CoV-2 infection in order to waive the restrictions to free movement put in place, in accordance with the FMOPA, and taking into account the specific situation of cross-border communities, to limit the spread of SARS-CoV-2, it will also accept, under the same conditions, test certificates indicating a negative result issued by Member States in accordance with Regulation (EU) 2021/953.

(12)

Switzerland also informed the Commission that where Switzerland accepts proof of recovery from SARS-CoV-2 infection in order to waive restrictions to free movement put in place, in accordance with the FMOPA, to limit the spread of SARS-CoV-2, it will accept, under the same conditions, certificates of recovery issued by Member States in accordance with Regulation (EU) 2021/953.

(13)

At the same time, on 9 June 2021, a technical test had demonstrated that EU Digital COVID Certificates issued by Member States are technically capable of being verified by Switzerland using the trust framework established on the basis of Regulation (EU) 2021/953.

(14)

The necessary elements for establishing that COVID-19 certificates issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order are to be treated as equivalent to those issued in accordance with Regulation (EU) 2021/953 are thus present.

(15)

Therefore, COVID-19 certificates issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order should be accepted under the conditions referred to in Article 5(5), Article 6(5) and Article 7(8) of Regulation (EU) 2021/953. Accordingly, where Member States accept proof of vaccination, of recovery from SARS-CoV-2 infection or of a test for SARS-CoV-2 infection in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2, they are also to accept, under the same conditions, vaccination certificates for a COVID-19 vaccine having been granted marketing authorisation pursuant to Regulation (EC) No 726/2004, certificates of recovery, or test certificates indicating a negative result, issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order. Member States could also accept, for the same purpose, vaccination certificates issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order for a COVID-19 vaccine having been granted marketing authorisation by the competent Swiss authority but not having been granted marketing authorisation pursuant to Regulation (EC) No 726/2004.

(16)

In order to protect the Union’s interests, in particular in the area of public health, the Commission may use its powers to suspend or terminate this Decision if the conditions of Article 3(10) of Regulation (EU) 2021/953 are no longer met.

(17)

In order for this Decision to be operational, Switzerland should be connected to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953.

(18)

In the light of the need to connect Switzerland to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953 as rapidly as possible, this Decision should enter into force on the day of its publication in the Official Journal of the European Union.

(19)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 14 of Regulation (EU) 2021/953,