Overview of Recent EU Regulations
Commission Regulation (EU) 2024/2789
This regulation establishes a fisheries closure for blue whiting in specified waters due to the exhaustion of the fishing quota allocated to Ireland. It prohibits vessels registered in Ireland from fishing for blue whiting from a designated date, while allowing certain activities related to previously caught fish. The regulation enforces sustainable fisheries management across the Union.
Council Implementing Regulation (EU) 2024/2761
This regulation amends existing measures related to restrictive actions against Russia. It mandates central securities depositories to contribute a significant portion of their profits towards financial assistance for Ukraine, reinforcing the EU’s support amid ongoing geopolitical tensions. It includes provisions for a loan cooperation mechanism aimed at facilitating non-repayable financial support for Ukraine.
Commission Delegated Regulation (EU) 2024/2770
This regulation amends existing regulations concerning the biodegradability criteria for polymers used in EU fertilising products. It sets specific biodegradability benchmarks for soil and aquatic environments, introduces testing methods, and includes labeling requirements to enhance environmental sustainability in agriculture, while allowing manufacturers a transitional period for compliance.
Regulation (EU) 2024/2773
This regulation establishes the Ukraine Loan Cooperation Mechanism, providing a framework for exceptional macro-financial assistance to Ukraine amidst the ongoing conflict. It outlines the conditions for loans and support, ensuring compliance with democratic principles and allowing for structured financial aid aimed at Ukraine’s recovery and stabilization.
Commission Implementing Regulation (EU) 2024/2750
This regulation grants authorization for the ‘LANXESS CMIT/MIT biocidal product family’, detailing the product types it covers and the active substances involved. It stipulates compliance with safety standards and outlines the responsibilities of the manufacturer while reinforcing the harmonization of biocidal product regulations across the EU.
Commission Implementing Regulation (EU) 2024/2745
This regulation focuses on managing conflicts of interest within the Health Technology Assessment framework. It requires representatives to declare their interests, sets assessment procedures for these declarations, and establishes transparency measures to ensure the integrity of health technology assessments across the EU.
Commission Delegated Regulation (EU) 2024/2769
This regulation supplements existing legislation on construction products by introducing new assessment and verification systems that focus on environmental sustainability. It establishes a new AVCP system 3+ and amends related annexes, enhancing the framework for assessing the performance of construction products in the EU market.
Review of each of legal acts published today:
Overview of Commission Regulation (EU) 2024/2789
The Commission Regulation (EU) 2024/2789, adopted on 24 October 2024, establishes a fisheries closure for blue whiting in specific waters. This regulation is a direct response to the exhaustion of the fishing quota allocated to Ireland for the stock of blue whiting in the United Kingdom, Union, and international waters, specifically in areas 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 8d, 8e, 12, and 14.
Key Provisions
Article 1: Quota Exhaustion
This article declares that the fishing quota allocated to Ireland for blue whiting is considered exhausted as of the date specified in the annex of the regulation. This sets the legal basis for the subsequent prohibitions on fishing activities.
Article 2: Prohibitions
The second article outlines specific prohibitions regarding fishing for blue whiting:
- Fishing Prohibition: Vessels flying the flag of or registered in Ireland are prohibited from fishing for blue whiting from the date specified in the annex. This includes searching for, shooting, setting, or hauling fishing gear for this stock.
- Authorized Activities Prior to Closure: Activities such as transshipping, retaining on board, processing on board, transferring, caging, fattening, and landing fish and fishery products from catches taken prior to the closure date are permitted.
- Unintended Catches: Any unintended catches of blue whiting must be retained on board, recorded, landed, and counted against the quotas in accordance with existing regulations.
Article 3: Entry into Force
This regulation enters into force the day following its publication in the Official Journal of the European Union, thereby ensuring that the prohibitions are enacted without delay.
Annex Details
The annex provides detailed information on:
- Member State: Ireland
- Stock: WHB/1X14 (including WHB/*05-F. and WHB/*NZJM1)
- Species: Blue whiting (Micromesistius poutassou)
- Zone: United Kingdom, Union, and international waters of 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 8d, 8e, 12, and 14
- Closing Date: 1 July 2024
This regulation is binding in its entirety and is directly applicable in all Member States, reinforcing the commitment to sustainable fisheries management within the EU framework.
COUNCIL IMPLEMENTING REGULATION (EU) 2024/2761
This regulation, adopted by the Council of the European Union on 24 October 2024, amends Regulation (EU) No 833/2014, which concerns restrictive measures in response to Russia’s actions destabilizing the situation in Ukraine. The regulation is particularly focused on the financial contributions from central securities depositories that manage reserves and assets of the Central Bank of Russia, specifically those exceeding EUR 1 million.
Key Provisions
1. Financial Contributions
The regulation incorporates a requirement for central securities depositories to contribute 99.7% of their net profits that have arisen since 15 February 2024 due to the implementation of restrictive measures against Russia. These contributions are detailed in Annex XLI of Regulation (EU) No 833/2014 and are aimed at addressing the significant financial needs of Ukraine resulting from the ongoing conflict.
2. Ukraine Loan Cooperation Mechanism
The regulation designates the Ukraine Loan Cooperation Mechanism as a Union spending instrument, which is intended to facilitate non-repayable financial support to Ukraine. This mechanism aims to assist Ukraine in repaying macro-financial assistance loans provided by the Union and additional loans from G7 partners.
3. Allocation of Funds
Funds transferred to the Union budget in accordance with Article 1a(11) of Decision 2014/512/CFSP are to be allocated to the Ukraine Loan Cooperation Mechanism. This allocation is intended to support Ukraine in meeting its budgetary needs and to aid in its recovery and reconstruction efforts.
4. Future Payments
The regulation is applicable to the second biannual payment of the financial contribution made in 2025 and all subsequent payments. It establishes a framework for ongoing financial support to Ukraine as it navigates the aftermath of the conflict.
5. Binding Nature
The regulation is binding in its entirety and directly applicable in all Member States, ensuring a unified approach to the implementation of these financial measures across the EU.
Conclusion
The Council Implementing Regulation (EU) 2024/2761 represents a continued commitment by the European Union to provide financial support to Ukraine amidst the ongoing crisis. By mandating financial contributions from Russian central securities depositories and establishing mechanisms for loan support, the regulation aims to bolster Ukraine’s recovery efforts and address its substantial financial needs.
Overview of Commission Delegated Regulation (EU) 2024/2770
The Commission Delegated Regulation (EU) 2024/2770 introduces amendments to Regulation (EU) 2019/1009 regarding the biodegradability criteria for coating agents and water retention polymers used in EU fertilising products.
Key Provisions
1. Background and Context
This regulation addresses the use of polymers in EU fertilising products, particularly those that act as coating agents for controlled release of nutrients and water retention agents. The aim is to reduce nutrient losses and enhance sustainable water use in agriculture while ensuring environmental safety.
2. Biodegradability Criteria
The regulation establishes specific biodegradability criteria for polymers in both soil and aquatic environments:
- Soil Biodegradation: Polymers must achieve ultimate degradation or mineralisation of at least 90% within 48 months, with an option for accelerated testing at 37°C under certain conditions.
- Aquatic Biodegradation: Criteria are set to ensure that polymers degrade sufficiently within 12 months, but at a level that allows them to retain their functional properties during their intended use.
3. Testing Methods
To demonstrate compliance with these biodegradability criteria, specific testing methods are prescribed, including:
- EN ISO 17556:2019 for soil biodegradability.
- EN/ISO 14851:2019 and EN/ISO 14852:2021 for aquatic biodegradability.
4. Environmental Concerns
There are concerns regarding the environmental impact of synthetic polymers that degrade slowly and could accumulate in ecosystems. The regulation aims to mitigate these risks by ensuring that only biodegradable polymers are used in fertilising products.
5. Labelling and Usage Instructions
The regulation mandates labelling requirements to inform users about the safe application of fertilising products, including maintaining buffer zones near water bodies to prevent leaching of polymers into aquatic environments.
6. Transitional Provisions
To allow manufacturers time to adapt to the new requirements, the amendments will come into effect on 17 October 2028, in line with the application timeline for Regulation (EU) 2023/2055.
7. Amendments to Existing Regulations
Annexes II and III of Regulation (EU) 2019/1009 are amended to incorporate the new biodegradability criteria and testing methods, ensuring coherence with the broader regulatory framework for EU fertilising products.
This regulation represents a significant step in aligning agricultural practices with environmental sustainability goals within the EU, particularly in the context of the Farm to Fork Strategy.
Overview of Regulation (EU) 2024/2773
The Regulation (EU) 2024/2773 establishes a framework for the Ukraine Loan Cooperation Mechanism and provides exceptional macro-financial assistance to Ukraine, aimed at addressing the significant financial challenges posed by the ongoing conflict resulting from Russia’s aggression. The key provisions and structure of the Regulation are outlined below.
General Provisions
Article 1 establishes the subject matter of the Regulation, focusing on the creation of the Ukraine Loan Cooperation Mechanism (the ‘Mechanism’) and the provision of exceptional macro-financial assistance to Ukraine through a loan (the ‘MFA Loan’).
Article 2 defines key terms, including ‘Union support’, which encompasses both the MFA Loan and non-repayable financial support provided under the Mechanism, and ‘bilateral loan’, which refers to loans granted by third countries specifically to Ukraine.
Ukraine Loan Cooperation Mechanism
Article 3 articulates the purpose of the Mechanism, which is to provide non-repayable financial support to assist Ukraine in repaying the MFA Loan and eligible bilateral loans. It is designed to ensure equal access to resources for both bilateral lenders and the Union.
Article 4 outlines the financing of the Mechanism, which will be funded through contributions from various sources, including amounts transferred under existing EU regulations and contributions from Member States or third countries.
Article 5 details the available support under the Mechanism, specifying that non-repayable financial support will be proportionally allocated to assist in repaying the MFA Loan and eligible bilateral loans.
Eligibility and Implementation
Article 6 provides the framework for the Commission’s assessment of bilateral loans, setting criteria for eligibility, including the timing of loan agreements and the requirement that they be fully disbursed to Ukraine before a specified date.
Article 7 mandates that non-repayable financial support under the Mechanism is contingent upon the conclusion of an agreement for its implementation (the ‘ULCM Agreement’) with Ukraine, which will outline the obligations and operational details for disbursement.
Article 8 discusses the disbursement process for non-repayable financial support, allowing Ukraine to submit requests for funds twice a year, with the Commission assessing these requests based on compliance with various conditions.
Macro-Financial Assistance
Chapter III addresses the macro-financial assistance, specifying that the MFA Loan aims to cover Ukraine’s financing needs and identifying the conditions under which it will be released (Article 9). The maximum amount of the MFA Loan is set at EUR 35 billion, subject to adjustments based on total loans approved (Article 10).
Article 11 establishes preconditions for receiving support, emphasizing the need for Ukraine to uphold democratic principles and human rights. The Commission will monitor compliance with these preconditions before disbursing funds.
Article 12 outlines a memorandum of understanding (MoU) that will link policy conditions to the MFA Loan, ensuring alignment with broader recovery and modernization goals for Ukraine.
Article 13 describes the process for Ukraine to request fund releases, contingent upon meeting established conditions and satisfactory progress on policy commitments.
Article 14 allows the Commission to borrow funds to finance the MFA Loan, with specific provisions regarding financial management and risk assessments.
Article 15 details the MFA Loan Agreement’s requirements, including the conditions for early repayment and the responsibilities of both parties in managing the loan.
Final Provisions
Article 17 outlines the Commission’s obligation to inform the European Parliament and the Council about the implementation of the Regulation, including annual reports and assessments of the assistance’s effectiveness.
Finally, Article 18 states that the Regulation enters into force immediately upon publication, underscoring the urgency of the situation in Ukraine and the need for immediate support.
This Regulation reflects the European Union’s commitment to providing substantial financial assistance to Ukraine in light of the ongoing crisis, facilitating its recovery and long-term stability.
Commission Implementing Regulation (EU) 2024/2750
This regulation grants a Union authorization for the biocidal product family ‘LANXESS CMIT/MIT biocidal product family’ in accordance with Regulation (EU) No 528/2012. The decision follows an application submitted by Lanxess Deutschland GmbH, which was evaluated by the competent authority of the Netherlands and subsequently assessed by the European Chemicals Agency (ECHA).
Key Provisions:
- Authorization Scope: The regulation authorizes the ‘LANXESS CMIT/MIT biocidal product family’ for specific product types including preservatives for products during storage, liquid-cooling and processing systems, slimicides, and working or cutting fluid preservatives.
- Active Substance: The product family contains a mixture of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (CMIT/MIT) as the active substance, which is included in the Union list of approved active substances.
- Validity of Authorization: The Union authorization, numbered EU-0031652-0000, is valid from 17 November 2024 until 31 October 2034, and is subject to compliance with the summary of biocidal product characteristics provided in the annex.
- Compliance and Evaluation: The regulation states that the product meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012, confirming its eligibility for Union authorization based on the assessments and reports submitted by the competent authority and ECHA.
- Binding Nature: This regulation is binding in its entirety and is directly applicable in all Member States, reinforcing the harmonization of biocidal product regulations across the EU.
Summary of Product Characteristics (SPC):
| Product Type(s) | Authorization Holder | Expiration Date |
|---|---|---|
| PT06, PT11, PT12, PT13 | Lanxess Deutschland GmbH | 31 October 2034 |
Hazard and Precautionary Statements:
The regulation includes specific hazard statements indicating that the product may cause severe skin burns and eye damage, and is very toxic to aquatic life with long-lasting effects. Precautionary measures include wearing appropriate protective equipment and ensuring safe disposal of the product and its packaging.
Conclusion:
This regulation represents a significant step in the approval of biocidal products within the EU, ensuring that the ‘LANXESS CMIT/MIT biocidal product family’ meets the necessary safety and efficacy standards. It outlines the responsibilities of the manufacturer and the conditions under which the product can be marketed and used within the EU.
Overview of Commission Implementing Regulation (EU) 2024/2745
The Commission Implementing Regulation (EU) 2024/2745, adopted on 25 October 2024, establishes the framework for managing conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment (HTA) and its subgroups. This regulation is an essential component of the broader Regulation (EU) 2021/2282, which aims to enhance cooperation among Member States regarding health technologies.
Key Provisions
Declaration of Interests (DOI)
Representatives and individual experts involved in the HTA joint work must submit a signed Declaration of Interests (DOI) and a curriculum vitae (CV). The DOI must detail any financial or other interests related to the health technology developers’ industrial sector. This declaration is crucial for assessing potential conflicts of interest that may affect their impartiality.
Assessment of DOI
The European Commission is responsible for assessing the declared interests in the DOI. If a declared interest is found to constitute a conflict of interest, the relevant representative or expert will be excluded from participation in the joint work. The assessment process includes a timeframe of 15 working days for completion, with the possibility of requesting additional information.
Updating the DOI
DOIs must be updated annually or whenever there is a change in circumstances. Failure to update may result in the individual being barred from participation in the joint work.
Public Availability of DOI
To ensure transparency, the DOI and relevant qualifications of representatives will be publicly accessible on the HTA IT platform for the duration of their involvement, and for one year after the completion of any joint work for individual experts.
Management of Conflicts of Interest
The regulation outlines specific actions to be taken in cases of identified conflicts of interest. This includes the potential exclusion of individuals from participation based on their declared interests, particularly if they have current or recent ties to health technology developers. Cooling-off periods are also established for roles such as chair or co-chair of the Coordination Group and its subgroups.
Responsibilities of the HTA Secretariat
The HTA secretariat is tasked with enforcing compliance with the conflict of interest rules and ensuring that individuals with declared conflicts do not participate in relevant assessments or consultations.
Data Protection Considerations
The regulation mandates that personal data processed through the HTA IT platform must be handled in compliance with data protection laws, including provisions for the retention and review of personal data related to the DOI and CVs.
Entry into Force
This regulation will enter into force on 12 January 2025, aligning with the implementation of Regulation (EU) 2021/2282.
Conclusion
Commission Implementing Regulation (EU) 2024/2745 establishes a structured approach to managing conflicts of interest within the HTA framework, promoting transparency and impartiality in health technology assessments across the European Union.
Commission Delegated Regulation (EU) 2024/2769 Overview
The Commission Delegated Regulation (EU) 2024/2769 supplements Regulation (EU) No 305/2011 by establishing systems for assessing and verifying the constancy of performance of construction products, particularly focusing on their essential characteristics related to environmental sustainability. It introduces a new Assessment and Verification of Constancy of Performance (AVCP) system 3+, which is designed to accommodate advances in technology and modelling approaches in evaluating construction products.
Key Provisions
Article 1: Assessment and Verification
This article mandates that construction products be assessed and verified for their constancy of performance concerning environmental sustainability based on the systems outlined in Annex I of the regulation.
Article 2: Amendment to Annex V
Annex V of Regulation (EU) No 305/2011 is modified to incorporate the new AVCP system 3+. This amendment outlines the tasks necessary for assessing and verifying the constancy of performance of construction products when data collection, assumptions, and modelling techniques are employed.
Article 3: Entry into Force
The regulation comes into effect twenty days after its publication in the Official Journal of the European Union and is binding in its entirety across all Member States.
Annex I: Systems of Assessment and Verification
Annex I specifies the AVCP systems applicable to construction products based on their essential characteristics related to environmental sustainability. The regulation outlines two categories:
- Row 1: Products with an applicable European legal basis that confirm a certain level of performance without the need for testing or calculation fall under AVCP system 4.
- Row 2: Products not included in Row 1 are assessed under the new AVCP system 3+.
Annex II: Detailed Changes to Annex V
Annex II details the amendments made to Annex V of Regulation (EU) No 305/2011:
- Point 1.4a: Introduces AVCP system 3+, which includes requirements for manufacturers to assess product performance through data collection, assumptions, and modelling, alongside factory production control.
- Validation Responsibilities: The notified assessment validation body is tasked with issuing validation reports based on the validation of input values, assumptions, compliance with rules, and validation of the manufacturer’s assessment and processes.
- Point 1.6: Clarifies that construction products with a European Technical Assessment will not require further performance assessment by notified bodies or manufacturers under specific systems.
- New Definitions: The regulation includes definitions for ‘assessment validation body’ and introduces ‘environmental sustainability’ as an essential characteristic.
Overall, this regulation aims to enhance the sustainability of construction products in the European market, ensuring that manufacturers can effectively assess and verify the environmental performance of their products while promoting competitiveness and compliance within the construction sector.
