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Summary of Recent EU Legislation
Commission Implementing Regulation (EU) 2024/2750
This regulation grants a Union authorisation for the ‘LANXESS CMIT/MIT biocidal product family’, allowing its market availability and use, subject to compliance with specified product characteristics. The authorisation is valid from 17 November 2024 until 31 October 2034. It underscores the EU’s regulatory framework for biocidal products, ensuring safety and environmental compliance.
Regulation (EU) 2024/2773
This regulation establishes the Ukraine Loan Cooperation Mechanism, providing exceptional macro-financial assistance to Ukraine in the form of a loan of up to EUR 35 billion. It outlines the terms and conditions for support, including the necessity for Ukraine to uphold democratic principles and human rights while detailing the financial assessment processes and reporting obligations of the Commission. The regulation reflects the EU’s commitment to aid Ukraine amidst its ongoing economic challenges.
Commission Delegated Regulation (EU) 2024/2770
This regulation amends existing rules on the biodegradability of coating agents and water retention polymers in EU fertilising products. It establishes specific criteria for their degradation in soil and aquatic environments, ensuring environmental safety. The regulation includes testing methods, labeling requirements, and transitional provisions for compliance, thereby promoting sustainable agricultural practices.
Commission Delegated Regulation (EU) 2024/2769
This regulation enhances the assessment and verification processes for the performance of construction products relating to environmental sustainability. It introduces a new Assessment and Verification of Constancy of Performance (AVCP) system and mandates compliance assessments for essential characteristics. The regulation aims to promote sustainability within the construction sector, ensuring manufacturers adhere to environmental standards.
Council Implementing Regulation (EU) 2024/2761
This regulation amends existing restrictive measures against Russia, reallocating financial contributions to the Ukraine Loan Cooperation Mechanism to support Ukraine’s economic recovery amidst ongoing conflict. It outlines a structured approach for financial contributions and reinforces the EU’s commitment to assist Ukraine, reflecting the significant recovery needs estimated at EUR 452.8 billion due to the conflict.
Review of each of legal acts published today:
Analysis of Commission Implementing Regulation (EU) 2024/2750
The Commission Implementing Regulation (EU) 2024/2750 pertains to the granting of a Union authorisation for the biocidal product family known as ‘LANXESS CMIT/MIT biocidal product family’. This regulation is established under the framework of Regulation (EU) No 528/2012, which governs the making available on the market and the use of biocidal products.
Key Provisions
Article 1: Granting of Authorisation
Article 1 of the regulation formally grants a Union authorisation, identified by the authorisation number EU-0031652-0000, to Lanxess Deutschland GmbH. This authorisation allows for the making available on the market and the use of the specified biocidal product family, contingent upon compliance with its summary of product characteristics as detailed in the Annex. The validity of the authorisation is set from 17 November 2024 to 31 October 2034.
Article 2: Entry into Force
This regulation will enter into force twenty days after its publication in the Official Journal of the European Union, thus ensuring a timely implementation of its provisions across Member States.
Background and Evaluation Process
The application for the Union authorisation was submitted on 22 June 2017 by Lanxess Deutschland GmbH to the European Chemicals Agency (ECHA). The application was evaluated by the competent authority of the Netherlands, which submitted its assessment report to ECHA on 8 March 2023. Following this, ECHA provided its opinion and final assessment report to the Commission on 2 October 2023, concluding that the ‘LANXESS CMIT/MIT biocidal product family’ meets the regulatory requirements and is eligible for authorisation.
Summary of Product Characteristics
The biocidal product family encompasses several product types, including:
- PT06: Preservatives for products during storage
- PT11: Preservatives for liquid-cooling and processing systems
- PT12: Slimicides
- PT13: Working or cutting fluid preservatives
The active substance in this product family is a mixture of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one, which is included in the Union list of approved active substances.
Safety and Regulatory Compliance
As part of the authorisation process, the biocidal product family has been assessed for safety, efficacy, and environmental impact. The regulation includes specific risk mitigation measures that users must adhere to during handling, application, and disposal, ensuring protection for human health and the environment.
Conclusion
This regulation signifies the European Union’s commitment to regulating biocidal products effectively, balancing the need for such products in various industries with the imperative of safety and environmental protection. The authorisation granted to Lanxess Deutschland GmbH reflects a thorough evaluation process and compliance with established legal standards.
Overview of Regulation (EU) 2024/2773
The Regulation (EU) 2024/2773 establishes the Ukraine Loan Cooperation Mechanism (the ‘Mechanism’) and provides exceptional macro-financial assistance to Ukraine in the form of a loan (the ‘MFA Loan’). This legal act aims to support Ukraine in covering its financing needs, especially in light of the ongoing challenges posed by Russia’s aggression.
Key Provisions
Chapter I: General Provisions
- Article 1: The Regulation sets forth the establishment of the Mechanism and the provision of the MFA Loan to assist Ukraine financially.
- Article 2: Definitions are provided for key terms such as ‘Union support’, ‘bilateral loan’, and ‘MFA Loan’.
Chapter II: Ukraine Loan Cooperation Mechanism
- Article 3: The Mechanism’s purpose is to provide non-repayable financial support to assist Ukraine in repaying the MFA Loan and eligible bilateral loans.
- Article 4: The Mechanism will be financed through contributions from Member States, third countries, and amounts transferred from specific regulations.
- Article 5: Non-repayable financial support will be allocated based on the principal amounts of the MFA Loan and eligible bilateral loans, ensuring proportionality in repayments.
- Article 6: The Commission will assess the eligibility of bilateral loans based on specified criteria and approve them through implementing decisions.
- Article 7: A formal agreement between Ukraine and the Commission will govern the implementation of the Mechanism.
- Article 8: Ukraine may request non-repayable financial support twice a year, which the Commission will assess based on various conditions.
Chapter III: Macro-Financial Assistance
- Article 9: The MFA Loan will be provided to Ukraine, with its release managed by the Commission based on compliance with preconditions.
- Article 10: The maximum amount of the MFA Loan is set at EUR 35 billion, with provisions for adjustments based on other funding sources.
- Article 11: A precondition for the MFA Loan is that Ukraine upholds democratic principles and human rights.
- Article 12: The loan will be linked to a memorandum of understanding detailing policy conditions for Ukraine’s commitments.
- Article 13: Ukraine must submit requests for fund releases, which the Commission will evaluate against preconditions and policy compliance.
- Article 14: The Commission is empowered to borrow funds necessary for the MFA Loan from the capital markets.
- Article 15: The MFA Loan Agreement will detail financial terms, repayment structures, and compliance requirements.
Chapter IV: Final Provisions
- Article 17: The Commission will report regularly to the European Parliament and Council on the implementation of the Regulation and its impact.
- Article 18: The Regulation will enter into force immediately following its publication in the Official Journal of the European Union.
This Regulation underscores the EU’s commitment to providing robust financial support to Ukraine, facilitating its recovery and resilience amidst ongoing economic challenges.
Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups
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Analysis of Commission Delegated Regulation (EU) 2024/2770
The Commission Delegated Regulation (EU) 2024/2770 amends Regulation (EU) 2019/1009, focusing specifically on the biodegradability criteria for coating agents and water retention polymers used in EU fertilising products. This regulation aims to ensure that such polymers do not negatively impact the environment, particularly concerning their degradation in soil and aquatic environments.
Key Provisions
Biodegradability Criteria
The regulation establishes specific biodegradability criteria for polymers used as coating agents and water retention polymers. It requires that these materials demonstrate ultimate degradation or mineralisation within defined timeframes in both soil and aquatic environments.
Soil Biodegradation
Polymers must achieve ultimate degradation (90%) within 48 months after their functionality period when applied to soil. An accelerated testing method at 37°C is permitted under certain conditions, allowing for a reduced testing period while still ensuring adequate biodegradation.
Aquatic Biodegradation
The criteria for aquatic environments are less stringent, allowing for a minimum degradation of 25% after 12 months, depending on the functionality period. This approach acknowledges the primary role of these polymers in slowly releasing nutrients while minimizing the risk of accumulation in water bodies.
Testing Methods
To verify compliance with these biodegradability criteria, specific reliable testing methods, compliant with European or international standards, are outlined. The regulation specifies conditions under which testing may occur, including temperature adjustments if certain criteria are met.
Environmental Considerations
The regulation addresses the potential environmental risks posed by synthetic polymers, particularly concerning their slow degradation and the possibility of ingestion by living organisms. It aims to mitigate these risks through stringent criteria while ensuring the functionality of the polymers in fertilising products.
Labeling Requirements
Products containing these polymers will be subject to labeling requirements, instructing users to avoid application near surface water bodies and to maintain appropriate buffer zones to further limit environmental exposure.
Transitional Provisions
The regulation includes transitional provisions, allowing for a period until 17 October 2028 for compliance with the new biodegradability criteria, facilitating a smooth adaptation for manufacturers and users of EU fertilising products.
Conclusion
Overall, Regulation (EU) 2024/2770 represents a significant step towards enhancing the environmental sustainability of EU fertilising products by establishing clear guidelines for the use of biodegradable polymers. It balances the need for effective agricultural practices with the imperative of protecting environmental and human health.
Commission Delegated Regulation (EU) 2024/2769 Summary
The Commission Delegated Regulation (EU) 2024/2769, adopted on 30 May 2024, introduces new provisions to enhance the assessment and verification of the constancy of performance of construction products, particularly concerning their environmental sustainability. This regulation supplements Regulation (EU) No 305/2011, which governs the marketing of construction products in the European Union.
Key Provisions
Article 1
This article mandates that construction products must be assessed and verified for their constancy of performance regarding essential characteristics related to environmental sustainability. The specific systems for this assessment are outlined in Annex I of the regulation.
Article 2
Article 2 amends Annex V of Regulation (EU) No 305/2011, introducing a new Assessment and Verification of Constancy of Performance (AVCP) system referred to as System 3+. This system is designed to ensure that manufacturers can effectively assess essential characteristics related to environmental sustainability for their construction products.
Article 3
This article states that the regulation will enter into force twenty days after its publication in the Official Journal of the European Union and that it will be binding in its entirety and directly applicable across all Member States.
Annex I: Assessment and Verification Systems
Annex I specifies the systems for assessing and verifying the constancy of performance of construction products based on their essential characteristics related to environmental sustainability. It distinguishes between two categories of products:
- Row 1: Products that have an applicable European legal basis indicating they achieve a certain performance level without further testing or calculation will follow AVCP system 4.
- Row 2: Other products will be subject to the new AVCP system 3+.
Annex II: Amendments to Annex V
Annex II details the amendments to Annex V of Regulation (EU) No 305/2011, including the introduction of System 3+. Key components of System 3+ include:
- The manufacturer must conduct performance assessments based on data collection, assumptions, and modelling.
- Factory production control is required to ensure compliance.
- Notified assessment validation bodies will validate various aspects of the manufacturer’s assessment process, including input values, assumptions, and compliance with applicable rules.
- Initial inspections of manufacturing plants are required to validate any company-specific data.
Additionally, the regulation clarifies the role of notified bodies and manufacturers regarding European Technical Assessments, ensuring that such assessments are recognized as valid performance assessments for construction products.
Overall, this regulation marks a significant step towards promoting environmental sustainability in the construction sector by establishing clear guidelines for assessing and verifying the performance of construction products.
Analysis of Council Implementing Regulation (EU) 2024/2761
The Council Implementing Regulation (EU) 2024/2761, adopted on 24 October 2024, amends Regulation (EU) No 833/2014, which concerns restrictive measures in response to Russia’s destabilizing actions in Ukraine. This regulation is part of the EU’s broader strategy to support Ukraine amidst ongoing conflict and significant economic challenges.
Key Provisions
Amendments to Annex XLI
The regulation specifically modifies Annex XLI of Regulation (EU) No 833/2014. The amendments focus on the allocation of financial contributions that are due to the Union budget, explicitly directing these funds to the newly established Ukraine Loan Cooperation Mechanism. This mechanism is designed to assist Ukraine in repaying macro-financial assistance loans provided by the Union and additional loans from G7 partners.
Financial Contributions
According to the regulation, financial contributions payable to the Union budget, as outlined in Article 1a(11) of Council Decision 2014/512/CFSP, are to be transferred to support the Ukraine Loan Cooperation Mechanism. This mechanism is crucial for facilitating Ukraine’s recovery and reconstruction efforts, particularly in light of the substantial financial gap identified by the International Monetary Fund (IMF).
Continuation of Support
The regulation stipulates that it will apply to the second biannual payment of the financial contribution in the year 2025 and all subsequent payments. This indicates a structured approach to ongoing financial support for Ukraine, reflecting the EU’s commitment to assist in the country’s recovery process.
Legal Framework
This regulation is binding in its entirety and directly applicable across all Member States, ensuring a uniform application of the financial measures intended to support Ukraine. The legal basis for the regulation is rooted in the Treaty on the Functioning of the European Union, specifically Article 215, which allows the Council to implement restrictive measures.
Contextual Background
The regulation comes at a time when Ukraine faces extensive recovery needs, estimated at EUR 452.8 billion due to the ongoing conflict. The Council acknowledges the significant damage caused by Russia’s aggression and emphasizes the necessity for continued financial support to mitigate the impact on Ukraine’s economy and public infrastructure.
Conclusion
In summary, Council Implementing Regulation (EU) 2024/2761 represents a critical step in the EU’s ongoing efforts to bolster Ukraine’s financial stability and recovery. By reallocating financial contributions to the Ukraine Loan Cooperation Mechanism, the regulation aims to provide essential support for Ukraine’s macro-financial assistance needs while reinforcing the EU’s commitment to addressing the humanitarian and economic crises resulting from the conflict.[:]
