A&G Newsletter Q1 2024

1. Commission to Expose Hidden Foreign Influence Through ‘Defence of Democracy’

The EU seeks transparency when third countries lobby to influence its democratic processes. The European Commission introduced a Defence of Democracy package before the 2024 European elections, focusing on a law to boost transparency and accountability in foreign interest representations. It also offers two recommendations to ensure elections are free and fair and to increase citizen and civil society engagement in policymaking. This initiative aims to tackle the threat of foreign interference and promote civic participation in democracy. According to a Eurobarometer survey, 81% of Europeans view foreign interference as a significant issue, highlighting the need for action against hidden foreign influence.

The proposal introduces uniform rules for higher transparency and accountability in such lobbying activities across the EU.

The proposal foresees the following transparency requirements:

  • Registration in a Transparency Register: entities lobbying for third countries must join a transparency register, with Member States creating or modifying their own registers accordingly.
  • Public access: key details of lobbying activities, like funding amounts, involved countries, and objectives, will be publicly accessible.
  • Record keeping: lobbyists must maintain records of their activities for four years post-completion.

The proposal sets fair rules to protect fundamental rights:

  • Independent supervisory authorities will be empowered to request limited records in duly justified cases only and in a proportionate manner;
  • Authorities need to ensure that registration does not lead to negative consequences
  • Possibility to derogate from the publicity of information in duly justified cases;
  • It standardizes rules across the EU, preventing extra requirements by Member States.
  • The Commission aims to establish global norms for managing foreign influence, respecting fundamental rights.

The Commission looks forwards for the European Parliament and Council to swiftly advance legislative proposals in democracy before the European parliamentary elections and calls for broad support from national entities to implement the European Democracy Action Plan and the Defence of Democracy package. Ahead of the 2024 European elections, the Commission will enhance dialogues and partnerships with online platforms and signatories of the Disinformation Code, focusing on transparent political ads and tackling AI-driven disinformation. This effort aims to safeguard the integrity of elections and combat disinformation effectively.

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2. Commission Proposes Streamlined ‘One Substance, One Assessment’ Chemicals Reform

The European Commission is introducing three law proposals to make chemical safety checks more consistent and efficient across the EU. This plan, known as the “one substance, one assessment” package, is part of a broader Chemicals Strategy aiming to protect health and the environment better. The plan involves redistributing responsibilities among four EU agencies to ensure clear and unified assessments of chemicals found in everyday items like medical devices, toys, pesticides, and foods.

The benefits of these changes include easier access to information about chemicals for everyone, more uniform processes, and quicker decisions on chemical risks. This means that once a potential hazard is identified, steps can be taken more swiftly to address it, leading to improved safety for people and the environment.

The proposals aim to:

  • Enhance collaboration and consolidate scientific and technical work on chemicals in the European Chemicals Agency, the European Food Safety Authority, the European Environment Agency and the European Medicines Agency. This effort aims to make assessments more consistent and allow for the reuse of data across different regulations.
  • Create a Common Data Platform, and introduce a ‘one-stop shop’ access to data on chemicals.
  • It will include data on hazards, physico-chemical properties, presence in the environment, emissions, uses, environmental sustainability of chemical substances and on ongoing regulatory processes. This platform will incorporate existing platforms such as the Information Platform on Chemical Monitoring (IPCHEM), the Public Activities Coordination Tool (PACT), and the EU chemicals legislation finder (EUCLEF).
  • It will broaden their coverage to nearly all EU chemical laws, adding new tools and databases, such as a repository of human and environmental values.
  • Set up a system to collect data on chemicals in people (like in blood or breast milk) across the EU, helping estimate citizens’ chemical exposure.
  • Create a framework to quickly detect, identify and prevent widespread chemical risks, like PFAS. This system will allow rapid response and track the effects of regulatory measures on chemicals.
  • Empower the European Chemicals Agency to generate data when needed.
  • Guarantee transparency of scientific studies on chemicals, including those contracted by businesses.

These proposals are now waiting for further examination and approval by the European Parliament and the Council.

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3. New Measures to Enhance Access to In Vitro Diagnostics Proposed

The European Commission plans to extend the deadline for companies to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), given certain criteria. This move is designed to boost patient care by increasing the accessibility of crucial healthcare devices. Moreover, the Commission plans to boost Medical Device sector transparency, including hastening certain aspects of the European Database on Medical Devices – EUDAMED.

In vitro diagnostics (IVDs) like HIV, pregnancy, and COVID-19 tests are crucial for health assessments, necessitating the EU’s updated regulatory framework since May 2022 to ensure their safety and effectiveness. Despite this, many IVDs in the market still do not meet these new standards, particularly high-risk devices critical for blood and organ donation testing. To address this, the European Commission proposes extending compliance deadlines to facilitate the transition without sacrificing safety, recognizing the impact on small and medium-sized enterprises (SMEs) that produce these devices. The extension varies by device risk, with high-risk devices (class D) until December 2027, significant risk devices (class C) until December 2028, and lower risk devices (class B and A) until December 2029. Additionally, manufacturers must notify of potential supply interruptions to ensure patient care continuity.

The Commission also aims to enhance medical device transparency through the early mandatory use of the European Database on Medical Devices (EUDAMED) by late 2025, offering a comprehensive view of EU market devices. This initiative, pending approval from the European Parliament and Council, includes a forthcoming evaluation in 2024 to assess the legislation’s impact on device availability, focusing on specific needs and the burden on SMEs.

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4. Commission Unveils AI Package to Support AI Startups and SMEs

The Commission has introduced a support package aimed at European startups and SMEs to foster the development of trustworthy AI, aligning with EU values and the pioneering EU AI Act. This act, agreed upon in December 2023, promotes the use and development of reliable AI across Europe. Following President von der Leyen’s 2023 address, the initiative grants innovative AI startups access to Europe’s supercomputers to develop their AI models. Launching with the Large AI Grand Challenge in November 2023, offering financial and supercomputing support, this package includes measures like privileged supercomputer access for AI startups and innovators, to bolster AI innovation and startup growth.

The proposal includes:
An amendment of the EuroHPC Regulation to set up AI Factories, a new pillar for the EU’s supercomputers Joint Undertaking activities. This includes:

  • Acquiring, upgrading and operating AI-dedicated supercomputers to allow fast machine learning and training of large General Purpose AI (GPAI) models;
  • Enabling access to the AI dedicated supercomputers, contributing to the widening of the use of AI to a large number of public and private users, including startups and SMEs;
  • Offering a one-stop shop for startups and innovators, supporting the AI startup and research ecosystem in algorithmic development, testing evaluation and validation of large-scale AI models, providing supercomputer-friendly programming facilities and other AI enabling services;
  • Enabling the development of a variety of emerging AI applications based on General Purpose AI models.
    The Commission plans to create an AI Office to oversee AI policy development and coordination across Europe, and to monitor the implementation and enforcement of the upcoming AI Act.

The EU outlines key activities for AI Start-Up and Innovation:

  • Financial backing through Horizon Europe and Digital Europe for generative AI, aiming for €4 billion in investments by 2027.
  • Initiatives to enhance the EU’s generative AI talent through education and training.
  • Support for AI start-ups and scale-ups with public and private funding, including venture capital and the EIC accelerator Programme and InvestEU.
  • Speeding up the creation and use of Common European Data Spaces for the AI community to train and refine models. A new report on these data spaces offers the latest developments.
  • Launching ‘GenAI4EU’ to foster new use cases and applications in 14 industrial and public sectors, covering robotics, health, and more.

The Commission, along with several Member States, is setting up two European Digital Infrastructure Consortiums (EDICs):

The ‘Alliance for Language Technologies’ (ALT-EDIC) focuses on creating a shared European infrastructure for language technologies. Its goal is to overcome the lack of data for European languages needed to train AI, promoting linguistic diversity and cultural richness, and aiding in the development of large European language models.

The ‘CitiVERSE’ EDIC will utilize advanced AI tools to improve Local Digital Twins for Smart Communities. This effort aims to assist cities in simulating and optimizing various processes, including traffic and waste management.

In the AI@EC Communication, the Commission outlines its strategic approach to the use of AI, anticipating and preparing internally for the implementation of the EU AI Act.

The European Parliament and the Council will now consider the Commission’s proposed amendments on the Regulation establishing the European High Performance Computing Joint Undertaking.

Alber & Geiger can help organizations voice their interests and concerns to EU policymakers.


5. A European Citizens’ Initiative on Cannabis Got Partially Registered

The Commission has partially approved the ‘European Cannabis Initiative,’ a European Citizens’ Initiative (ECI). The organizers of the initiative proposed three main objectives:

  • To urge the Commission to convene a trans-European citizens’ assembly on cannabis policy, including sanctions and the coherence of member states’ policies.
  • To encourage the Commission to promote access to medical cannabis and facilitate the transport of cannabis and its derivatives prescribed for therapeutic purposes, thereby ensuring the unrestricted exercise of the right to health.
  • To request the Commission provide the necessary resources for researching cannabis for its therapeutic purposes.

The Commission registered only the second and the third objectives. Meanwhile, the request to organize a trans-European assembly on cannabis policy was not registered, as it exceeds the Commission’s authority for legal action. At this point, the Commission has not evaluated the content of the proposals; the registration solely reflects a legal judgment and does not imply the Commission’s final stance or planned actions.

The organizers now have six months to start collecting signatures. If the initiative gathers one million endorsements from at least seven Member States within a year, the Commission must respond, detailing whether it will act on the proposals and the reasons for its decision.

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6. New Rules on Animal Welfare regarding Transport, Home Pets, and Fur Farms

The Commission announced a significant overhaul of EU animal welfare regulations, marking the largest reform in 20 years. This includes introducing, for the first time, regulations for the welfare and traceability of dogs and cats bred, kept, and sold for economic reasons. The reform is in line with the Farm to Fork Strategy part of the European Green Deal for sustainable agriculture and food production.

The reform aims to enhance the welfare of the 1.6 billion animals transported annually within and from the EU, incorporating the latest scientific, technological advances. New standards will set uniform EU requirements for breeding, housing, and managing dogs and cats in various facilities, alongside mandatory identification and registration for these animals to combat illegal trade and improve welfare standards.

Additionally, the Commission is taking steps in response to the ‘Fur Free Europe’ European Citizens’ Initiative, advocating for a ban on fur farming and the sale of fur products in the Single Market, reflecting the ongoing public concern over animal welfare.

Better rules for the transport of animals:
The rules on animal transport are 20 years old. The new rules focus on key areas to guarantee animal welfare in transport:

  • Shorter travel times, access to rest, water and feeding, and special rules for vulnerable animals
  • Allowances to ensure minimum space for the different animals
  • Transport in extreme temperatures will be subject to strict conditions
  • Tightened rules for the exports of live animals from the Union
  • Digital tools to facilitate the enforcement of transport rules

Better welfare for dogs and cats:
The proposal introduces uniform EU standards for the welfare of dogs and cats in breeding establishments, pet shops, and shelters, without imposing new regulations on citizens and pet owners.

Reply to the European citizens’ initiative ‘Fur Free Europe’:
The Commission also responded to a European Citizens’ Initiative “Fur Free Europe”. The Commission has requested EFSA to assess the welfare of fur-farmed animals scientifically. Based on this review and an evaluation of economic and social effects, the Commission will decide on the most suitable course of action.

The legislative proposals will be presented to the European Parliament and the Council. Regarding the European Citizens’ Initiative, EFSA will start its scientific evaluation at the Commission’s request and is expected to provide its findings by March 2025.

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