COUNCIL OF THE EUROPEAN UNION,update

 

Press material Thursday, 30 May 2024

● Council of the EU   30/05/2024 11:42 | Press release | Medical devices: Council adopts new measures to help prevent shortages   The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation adopted today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: further extending the transition period for certain IVDs enabling a gradual roll-out of EUDAMED, the new electronic database requiring manufacturers to flag up potential shortages of critical medical devices and IVDs Overview of the key changes In 2017, new rules were introduced to modernise and update the EU framework for IVDs, guaranteeing their safety and effectiveness. The amendment adopted today extends the deadline for transitioning to the new system under certain conditions, to avoid shortages of critical IVDs without compromising on safety. The new regulation also enables a gradual roll-out of the European database on medical devices (EUDAMED) by requiring manufacturers to provide information about their products to existing EUDAMED modules without needing to wait for the remaining modules to be completed. This mandatory registration is expected to take effect as of late 2025. Today’s revision also introduces an obligation for manufacturers to give prior notice about any interruption of supply of certain critical medical devices or IVDs to relevant authorities, health institutions, healthcare professionals and economic operators to whom they supply the device. Next steps The regulation adopted today will enter into force following publication in the EU’s Official Journal. Background The In Vitro Diagnostic Medical Device Regulation (IVDR) entered into force in 2017 and has been applicable since 26 May 2022. It was adopted together with the Medical Devices Regulation (MDR), which has been applicable since 26 May 2021. The aim of these two regulations was to modernise the rules on medical devices, including IVDs, and improve patient safety. Due to the far-reaching nature of the changes set out in the IVDR, a large number of IVDs currently on the market have yet to comply with the new rules; the situation is particularly serious for high-risk IVDs such as certain blood tests. On 23 January 2024 the European Commission published a proposal to update the provisions of the IVDR and MDR with the aim of mitigating shortages of critical medical devices. The EU Council endorsed the compromise agreement reached with the European Parliament on 21 February 2024. Text of the Regulation Text of the Regulation – corrigendum Medical devices: Council endorses new measures to help prevent shortages (press release, 21 February 2024) The EU's role in health policy (background information) EUDAMED database

Press material Thursday, 30 May 2024

● Council of the EU   30/05/2024 11:35 | Press release | Council sets higher tariffs on Russian and Belarusian grain products   The Council today adopted a regulation that aims to levy prohibitive tariffs on grain products imported from Russia and Belarus. The regulation increases duties on cereals, oilseeds and derived products from Russia and Belarus to a point that will in practice halt imports of these products. The new tariffs set today aim to stop the imports of grain from Russia and Belarus into the EU in practice. These measures will therefore prevent the destabilisation of the EU’s grain market, halt Russian exports of illegally appropriated grain produced in the territories of Ukraine and prevent Russia from using revenues from exports to the EU to fund its war of aggression against Ukraine. This is yet another way in which the EU is showing steady support to Ukraine. Vincent Van Peteghem, Belgian minister for finance The regulation increases import tariffs for cereals, oilseeds and derived products as well as beet-pulp pellets and dried peas from the Russian Federation, as well as from the Republic of Belarus, for which, at present, importers pay no or low tariffs. In addition, those goods will be barred from access to the Union’s tariff rate quotas. These measures concern products originating in or exported directly or indirectly from the Russian Federation or the Republic of Belarus to the EU. They will not affect transit through the EU from both countries to other third countries. Next steps The regulation will be published in the EU’s Official Journal. The measures will enter into force on 1 July 2024. Background The EU’s imports of grain products from Russia have significantly increased since Russia’s full-scale invasion of Ukraine on 24 February 2022. While the Russian Federation remains a relatively small supplier of those products to the EU market, it is a leading world-wide producer and exporter of those products. Given its current volumes of exports to the world, the Russian Federation could reorient significant volumes of supplies of those products to the EU, causing a sudden inflow from its large existing stocks, thereby disrupting the EU market. Moreover, there is evidence that the Russian Federation is currently illegally appropriating large volumes of such products in territories of Ukraine, which it illegally occupies, and routing them to its export markets as allegedly Russian products. These measures will therefore prevent the EU market from being destabilised, halt Russian exports of illegally appropriated grain produced in the territories of Ukraine and prevent Russia from using revenues from exports to the EU to fund its war of aggression against Ukraine. The Commission submitted its proposal to the Council on 22 March 2024. The regulation modifies Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff, in order to increase the customs duties applicable to imports of cereals, oilseeds and derived products that are currently classified under Chapters 7, 10, 12, 14, 15 and 23 of the Combined Nomenclature (CN), originating in or exported from the Russian Federation or the Republic of Belarus. Council regulation on the tariff and statistical nomenclature and on the Common Customs Tariff

Press material Thursday, 30 May 2024

● Council of the EU   30/05/2024 11:00 | Press release | Circular economy: Council gives final approval to right-to-repair directive   The Council has today adopted a directive promoting the repair of broken or defective goods, also known as the right-to-repair (or R2R) directive. This legislation will make it easier for consumers to seek repair instead of replacement and repair services will become more accessible, transparent and attractive. The adoption of the directive is the last step in the legislative decision-making process. The directive adopted today enshrines a new right for consumers: the right to have defective products repaired in an easier, cheaper and faster way. It also gives manufacturers the incentive to make products that last longer and can be repaired, reused and recycled. And finally, it makes repairing a more attractive economic activity that can create Europe-based quality jobs. All economic actors win, and so does the environment. Alexia Bertrand, Belgian State Secretary for the Budget and Consumer Protection Repair made easier The directive adopted today creates a set of tools and incentives to make repair more attractive for consumers. These include requiring manufacturers to repair products which are technically repairable under EU law; the availability of a voluntary repair form with clear information about the repair process (deadlines, prices, etc.); a European online platform where consumers can easily find repair services and the extension of the legal guarantee with 12 months if consumers choose repair instead of replacement. The list of repairable products can be increased in the future: whenever the Commission introduces new reparability requirements for certain products, these will be added to the R2R directive. Next steps Following the Council’s approval today, the legislative act has been adopted. After being signed by the President of the European Parliament and the President of the Council, the directive will be published in the Official Journal of the European Union and will enter into force on the 20th day following its publication. Member states will have 24 months from the entry into force to transpose the directive into national law. Background This proposal was presented by the Commission on 22 March 2023 and forms part of the New Consumer Agenda and the Circular Economy Action Plan. It complements other recent EU legislation to promote sustainable consumption, such as the ecodesign for sustainable products regulation (which will promote the production of repairable products) and the directive on empowering consumers for the green transition (which will enable consumers to make better-informed purchasing decisions at the point of sale). Commission proposal Negotiating mandate

Press material Thursday, 30 May 2024

● Council of the EU   30/05/2024 10:56 | Press release | Anti-money laundering: Council adopts package of rules   The Council today adopted a package of new anti-money-laundering rules that will protect EU citizens and the EU's financial system against money laundering and the financing of terrorism. The new and stricter rules will strengthen our systems in the fight against money laundering and terrorist financing. A new agency based in Frankfurt will supervise the work of actors involved. This will ensure that fraudsters, organised crime and terrorists will have no space left for legitimising their proceeds through the financial system. Vincent Van Peteghem, Belgian minister for finance With the new package, all rules applying to the private sector will be transferred to a new directly applicable regulation, while a directive will deal with the organisation of national competent authorities fighting against money laundering and countering the financing of terrorism (AML/CFT). The regulation exhaustively harmonises anti-money laundering rules for the first time throughout the EU, closing loopholes for fraudsters. It extends the anti-money laundering rules to new obliged entities, such as most of the crypto-sector, traders of luxury goods and football clubs and agents. The regulation also sets tighter due diligence requirements, regulates beneficial ownership and sets a limit of € 10.000 to cash payments, among other things.  The directive will improve the organisation of national anti-money laundering systems setting out clear rules on how financial intelligence units (FIUs - the national bodies which collect information on suspicious or unusual financial activity in member states) and supervisors work together. The package sets up a new European Authority for Anti-Money Laundering and Countering the Financing of Terrorism (AMLA) that will have direct and indirect supervisory powers over high-risk obliged entities in the financial sector. Given the cross-border nature of financial crime, the new authority will boost the efficiency of the AML/CFT framework by creating an integrated mechanism with national supervisors to ensure obliged entities comply with AML/CFT-related obligations in the financial sector. AMLA will also have a supporting role with respect to the non-financial sector, and coordinate and support  FIUs. In addition to supervisory powers and in order to ensure compliance, in cases of serious, systematic or repeated breaches of directly applicable requirements, the Authority will impose pecuniary sanctions on the selected obliged entities. The new anti-money laundering directive also prescribes that EU member states make information from centralised bank account registers – containing data on who has which bank account and where – available through a single access point. As the AML directive will provide access to the single access point only to FIUs, the Council today adopted a separate directive to ensure that the national law enforcement authorities will have access to these registers via the single access point. This directive also incudes the harmonisation of bank statement format. Such direct access and use of harmonised formats by the banks is an important instrument in fighting criminal offences and in efforts to trace and confiscate the proceeds of crime. Next steps This is the final step of the adoption procedure. The texts will now be published in the EU’s Official Journal and enter into force. The AML regulation will apply three years after the entry into force. Member states will have two years to transpose some parts of the AML directive and three years for others. AMLA will be based in Frankfurt and start operations in mid-2025. Background On 20 July 2021, the Commission presented its package of legislative proposals to strengthen the EU’s rules on anti-money laundering and countering the financing of terrorism (AML/CFT). This package consists of: a regulation establishing a new EU anti-money laundering authority (AMLA) which will have powers to impose sanctions and penalties a regulation recasting the regulation on transfers of funds which aims to make transfers of crypto-assets more transparent and fully traceable (which was adopted in May 2023) a regulation on anti-money-laundering requirements for the private sector a directive on anti-money-laundering mechanisms at national level The Commission submitted a proposal for a directive on the single access point on 25 November 2021. Regulation establishing the Authority for Anti-Money Laundering and Countering the Financing of Terrorism and amending Regulations (EU) No 1093/2010, (EU) No 1094/2010 and (EU) No 1095/2010 Regulation on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing Directive on the mechanisms to be put in place by Member States for the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Directive(EU) 2019/1937, and amending and repealing Directive (EU) 2015/849 Directive as regards access to centralised bank account registries, 21 May 2024 Regulation on information accompanying transfers of funds and certain crypto-assets

Press material Thursday, 30 May 2024

● Council of the EU   30/05/2024 10:50 | Press release | Serbia: Council gives green light to signing of Frontex cooperation agreement   The Council has today decided that the EU will sign an agreement with the Republic of Serbia on operational activities being carried out by the European Border and Coast Guard Agency (Frontex). The agreement will allow the EU and Serbia to organise joint operations involving Frontex and the Serbian border guards. It also means that Frontex border management teams can be deployed in Serbia, and will allow Frontex to assist Serbia in managing migratory flows, countering illegal immigration and tackling cross-border crime. Background The new agreement will replace the current status agreement between the EU and Serbia. The current agreement is based on the old Frontex regulation and only allows joint operations at Serbia's border with the European Union. Based on the new European Border and Coast Guard Agency regulation of 2019, Frontex can assist countries it signs agreements with throughout their territory and can exercise executive powers, such as border checks and registration of persons. Frontex has border management cooperation agreements in place with Moldova (2022), North Macedonia (2023), Montenegro (2023) and Albania (2024). Next steps After signature, the agreement will go through a ratification or approval process, which, for the EU, involves the European Parliament giving its consent and the Council completing the final conclusion of the agreement. Strengthening the EU’s external border (background information)

Press material Thursday, 30 May 2024

● Council of the EU   30/05/2024 10:44 | Press release | Basel III reforms: new EU rules to increase banks’ resilience to economic shocks   The Council today adopted new rules aimed at making banks operating in the EU more resilient to possible economic shocks. The changes aim to increase the resilience of banks, strengthen their supervision and reinforce risk management. In addition they will strengthen supervision and sustainability in the banking sector. The Basel III standards significantly strengthen the resilience of the banking sector. The rules adopted today will ensure that European banks can continue to operate in the face of economic shocks. They will also make the banking sector more sustainable and better able to deal with the green and digital transitions. This is an important step towards deepening the Banking Union. Vincent Van Peteghem, Belgian minister for finance The new rules update the capital requirements regulation and the capital requirements directive that translate the Basel III standards into EU legislation.   The reforms’ main feature is the introduction of an "output floor" that limits the risk of excessive reductions in banks’ capital requirements and, makes those requirements more comparable. The output floor sets a lower limit on the capital requirements that are determined in accordance with banks’ internal models to 72,5% of the capital requirements that would apply if they used standardised measurements. Beyond the implementation of Basel III standards, the new rules harmonise minimum requirements applicable to the authorisation of branches of third-country banks and the supervision of their activities in the EU. They also set a transitional prudential regime for crypto assets and introduce amendments to enhance banks' management of Environmental, Social and Governance (ESG) risks. Next steps This is the last step of the adoption procedure. The amended capital requirements regulation and capital requirements directive will now be published in the EU’s Official Journal and enter into force 20 days later. Member states will have 18 months to transpose the directive into national legislation. The regulation will apply from 1 January 2025.  Background The Basel III standards were agreed by the Basel Committee on Banking Supervision (BCBS)  to enhance the prudential regulation, supervision and risk management of banks as a response to the global financial crisis of 2007-2008. The capital requirements regulation and the capital requirements directive translate the international Basel standards into EU law. The European Commission presented proposals to implement the Basel III standards through amendments to the capital requirements regulation and the capital requirements directive on 27 October 2021. The Council and the European Parliament reached a provisional political agreement on the proposals on 27 June 2023. Banking sector: Council agrees its position on the implementation of Basel III reforms (press release, 8 November 2022) Banking Union (background information)

Press material Thursday, 30 May 2024

● Council of the EU   30/05/2024 10:28 | Press release | EU-Kenya: Council takes final step to allow the implementation of the Economic Partnership Agreement   The Council today adopted a decision on the conclusion of the EU-Kenya Economic Partnership Agreement (EPA). This will boost trade in goods and create new economic opportunities, with targeted cooperation to enhance Kenya's economic development. This agreement will strengthen our cooperation with Kenya, the economic hub of East Africa. Workers, businesses and traders on both sides will benefit from this shared commitment to sustainable development, including labour rights, the environment and climate action. Belgian minister of Foreign Affairs, European Affairs and Foreign Trade The agreement will provide duty-free, quota-free EU market access to all exports from Kenya (except arms) as soon as it enters into force, as well as partial and gradual opening of the Kenyan market to imports from the EU. The agreement includes binding provisions on trade and sustainable development, such as climate and environmental protection and labour rights, and a transparent dispute resolution mechanism. This is the most ambitious economic partnership agreement the EU will have with a developing country when it comes to sustainability provisions. The EU is Kenya's first export destination and second largest trading partner, totalling €3.3 billion of trade in 2022 - an increase of 27% compared to 2018. Next steps The agreement will enter into force on the first day of the second month following the date on which the parties have notified each other of the completion of their respective internal procedures.  Background  Negotiations on the Economic Partnership Agreement between the East African Community and the EU (EAC-EU EPA) were concluded in 2014. Kenya signed and ratified the Agreement in September 2016. The EU and its Member States also signed it in June 2016. However, implementation of the EPA has not been possible because not all EAC partner countries signed and ratified it. The EAC Summit of 27 February 2021, under the chairmanship of Kenya, reached a decision allowing individual EAC states to implement the EPA. Subsequently, in May 2021, Kenya formally requested to engage with the EU to move forward with the implementation of the Agreement on a bilateral basis. Discussions on the bilateral implementation with sustainability provisions were politically concluded on 19 June 2023. On 28 September 2023, the Commission submitted its proposals for Council Decisions on the signing and the conclusion of the EU-Kenya Economic Partnership Agreement, together with the text of the Agreement. The Council adopted a decision on the signing of the EPA on 12 December 2023. The EU and Kenya signed the agreement in Nairobi, Kenya, on 18 December 2023. The European Parliament gave its consent to the conclusion of the agreement on 29 February 2024 and Kenya ratified the EPA on 24 April 2024. Council decision on the signing of the EPA Council decision on the conclusion of the EPA EU-Kenya EPA EU-Kenya EPA (addendum 1) EU-Kenya EPA (addendum 2) Council and Commission joint statement EU and Kenya conclude negotiations for an ambitious Economic Partnership Agreement with strong sustainability provisions (European Commission) EU-Kenya: Council adopts decision on the signing of the Economic Partnership Agreement (press release, 12 December 2023) The EU and Kenya sign a landmark Economic Partnership Agreement (press release, 19 December 2023)

Meetings Wednesday, 29 May 2024

● Council of the EU   29/05/2024 08:35 | Meetings | Transport, Telecommunications and Energy Council (Energy), 30 May 2024   Background brief - Transport, Telecommunications and Energy Council (Energy), 30 May 2024