Summary of Recent EU Legislations
Commission Delegated Regulation (EU) 2024/2795
This regulation amends Regulation (EU) No 575/2013 concerning prudential requirements for credit institutions, particularly focusing on the timeline for applying own funds requirements for market risk in line with the Fundamental Review of the Trading Book (FRTB). It introduces a new Article 520a, mandating institutions to adhere to existing market risk requirements until 1 January 2026, while allowing monitoring of these standards during the deferral period.
Commission Delegated Regulation (EU) 2024/2786
This regulation amends Regulation (EU) 2019/1009 concerning EU fertilising products, specifically addressing Enterococcaceae. It revises maximum limit values for testing enterococci and introduces provisions for compost, digestate, and other materials, allowing for a presumption of compliance without verification under certain conditions, thereby enhancing clarity and compliance processes within the EU market.
Commission Delegated Regulation (EU) 2024/2790
This regulation modifies Annex II of Regulation (EU) 2019/1009, focusing on polymers classified under Component Material Category (CMC) 1. It specifies which polymers pose environmental risks and introduces amendments allowing the inclusion of polymers from CMC 8 and CMC 9, with a strong emphasis on environmental impacts and alignment with existing chemical regulations.
Commission Implementing Regulation (EU) 2024/2766
This regulation addresses the status of caffeine, stating that it is not approved as a basic substance for plant protection products due to health risks identified in assessments by the European Food Safety Authority (EFSA). It highlights significant concerns regarding human health and environmental safety, while also allowing for future applications for caffeine based on new evidence.
Commission Regulation (EU) 2024/2785
This regulation establishes a fisheries closure for the undulate ray in Union waters designated for Portugal following the exhaustion of the fishing quota for 2024. It prohibits fishing activities related to the undulate ray stock from a specified date, while allowing retention and processing of catches made prior to the closure.
Commission Implementing Regulation (EU) 2024/2793
This regulation registers the geographical indication ‘Chistorra de Navarra / Txistorra de Navarra / Nafarroako Txistorra’ as a Protected Geographical Indication (PGI) in the EU, recognizing its quality linked to its geographical origin and providing protection against misuse within the EU.
Commission Implementing Regulation (EU) 2024/2792
This regulation approves an amendment to the specification for the protected designation of origin (PDO) ‘Pico’, ensuring its compliance with EU regulations. It emphasizes the binding nature of the regulation across Member States, reinforcing the EU’s commitment to protecting quality agricultural products.
Commission Implementing Regulation (EU) 2024/2768
This regulation grants protection within the EU to the appellation of origin ‘Tête de Moine / Tête de Moine, Fromage de Bellelay’. It officially recognizes the cheese’s name, ensuring its exclusive use for products meeting specific origin standards.
Commission Implementing Regulation (EU) 2024/2825
This regulation amends special control measures for African swine fever (ASF), updating the classifications of restricted zones in various Member States in response to recent outbreaks. It emphasizes scientific guidance and compliance with international standards for animal health management.
Commission Implementing Regulation (EU) 2024/2817
This regulation makes amendments to the lists of third countries authorized to export poultry and germinal products to the EU. It addresses recent outbreaks of highly pathogenic avian influenza in the U.S., suspending entry from affected areas while allowing reauthorization based on updated health measures.
Commission Delegated Regulation (EU) 2024/2791
This regulation modifies the Annex of Regulation (EU) No 609/2013 regarding food for infants and young children, allowing the use of iron milk caseinate as a source of iron in specified food categories, excluding products intended for infants and young children to ensure safety standards.
Commission Delegated Regulation (EU) 2024/2787
This regulation amends Regulation (EU) 2019/1009 to include mulch films in Component Material Category 9 (CMC 9) for EU fertilising products. It sets specific biodegradability criteria and testing methods to ensure environmental safety, along with requirements for toxicity testing and implementation timelines.
Commission Delegated Regulation (EU) 2024/2788
This regulation modifies Annex II of Regulation (EU) 2019/1009 concerning the use of polymers in fertilising products, excluding certain polymers and aligning with the REACH Regulation. It aims to enhance environmental safety and will be implemented in a transitional period.
Commission Implementing Regulation (EU) 2024/2774
This regulation approves an amendment to the product specification of the PDO ‘Cotnari’, ensuring its compliance with EU standards and underlining the importance of geographical indications in protecting agricultural products.
Commission Implementing Regulation (EU) 2024/2746
This regulation establishes detailed rules for the Farm Sustainability Data Network (FSDN), introducing provisions for the collection, reporting, and management of farm data. It aims to enhance the efficiency of data management and ensure accurate economic assessments of farming holdings within the EU.
Review of each of legal acts published today:
Commission Delegated Regulation (EU) 2024/2795
Overview
This regulation amends Regulation (EU) No 575/2013 concerning prudential requirements for credit institutions, specifically addressing the timeline for the application of own funds requirements for market risk as set out in the Fundamental Review of the Trading Book (FRTB).
Key Provisions
Article 1: Amendment to Regulation (EU) No 575/2013
The regulation introduces a new Article 520a into Regulation (EU) No 575/2013, stipulating that:
- Until 1 January 2026, institutions must continue to apply the existing market risk requirements outlined in Part Three, Title IV, and Articles 430, 430b, 445, and 455 of Regulation (EU) No 575/2013, as they were in force on 8 July 2024.
Article 2: Entry into Force and Application
This regulation will enter into force the day after its publication in the Official Journal of the European Union. Its provisions will apply from 1 January 2025.
Context and Rationale
The amendment is necessary due to the observed delays in the implementation of FRTB standards in various jurisdictions, which poses a risk of competitive distortions in international trading. The deferral ensures that the European Union maintains a level playing field for institutions engaged in trading activities.
During the deferral period, institutions are required to continue reporting their own funds requirements based on the pre-FRTB calculation approaches, allowing competent authorities to monitor the impact of these standards effectively.
Conclusion
The regulation ensures that the implementation timeline for the FRTB standards aligns with broader international practices, thereby preserving market stability and preventing competitive imbalances among credit institutions within the EU.
Overview of Commission Delegated Regulation (EU) 2024/2786
The Commission Delegated Regulation (EU) 2024/2786 amends Regulation (EU) 2019/1009 concerning EU fertilising products, with a particular focus on Enterococcaceae and the presumption of conformity without verification.
Key Provisions
Amendments to Annex I
- Maximum limit values for Enterococcaceae are revised to specify testing for enterococci, addressing public health concerns associated with these bacteria.
- The amendment clarifies the requirements for different product function categories, ensuring that compliance can be evaluated more effectively in practice.
Amendments to Annex II
- Sections related to compost and digestate now include provisions that allow for the presumption of compliance without verification if it can be demonstrated that this compliance follows from the nature of the product or its manufacturing process.
- For precipitated phosphate salts and their derivatives, similar presumption provisions are introduced, enhancing the clarity and ease of conformity assessment.
- New presumption clauses are added for thermal oxidation materials and pyrolysis or gasification materials, further facilitating compliance processes.
Amendments to Annex III
- The tolerance levels for the declared value of inorganic fertilisers are differentiated based on the product size, with a 1% tolerance for larger packages and a 5% tolerance for smaller packages.
- A more flexible tolerance for the content of inhibiting compounds in inhibitors is introduced, allowing for a ±10% deviation of the declared value up to a maximum of ±2% in absolute terms for concentrations exceeding 2%.
Conclusion
This regulation aims to improve the clarity and efficiency of the conformity assessment process for EU fertilising products, thereby enhancing their free movement within the EU internal market while addressing critical health and safety concerns associated with specific pathogens.
Commission Delegated Regulation (EU) 2024/2790
This regulation amends Annex II to Regulation (EU) 2019/1009, which governs the making available on the market of EU fertilising products. The primary focus of this amendment is on the polymers classified under Component Material Category (CMC) 1.
Key Provisions:
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Polymers Regulation:
The regulation specifies that polymers included under CMC 1 must not include certain types of polymers that pose environmental risks. These include:- Polymers resulting from natural polymerisation processes that are not chemically modified.
- Polymers deemed degradable as per the specified guidelines in the existing regulatory framework.
- Polymers with a solubility exceeding 2 g/L.
- Polymers that lack carbon in their chemical structure.
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New Inclusion of CMC 8 and CMC 9 Polymers:
The regulation introduces a new point that allows for the inclusion of polymers covered by CMC 8 and CMC 9 into CMC 1. This reflects the need for alignment across different material categories within the regulation. -
Environmental Impact Considerations:
The regulation acknowledges the environmental concerns associated with synthetic and chemically modified natural polymers, emphasizing the need for careful assessment of their biodegradability and overall impact on ecosystems and human health. -
Alignment with Existing Regulations:
This amendment aims to align the requirements for polymers in CMC 1 with the restrictions set forth in Regulation (EC) No 1907/2006 (REACH), which governs the use of chemicals in the EU. This alignment is intended to ensure coherence in the regulation of similar materials and to uphold the environmental objectives of the EU. -
Transitional Period:
The regulation sets a transitional application period for these new provisions, which will come into effect on 17 October 2028, allowing stakeholders sufficient time to adapt to the updated requirements.
Final Notes:
This regulation is binding in its entirety and directly applicable in all EU Member States. It reflects the European Commission’s ongoing commitment to ensuring that fertilising products on the market are safe for the environment and human health, while also facilitating the use of innovative materials in agricultural practices.
Commission Implementing Regulation (EU) 2024/2522 of 23 September 2024 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff
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Commission Implementing Regulation (EU) 2024/2766
The Commission Implementing Regulation (EU) 2024/2766, adopted on 30 October 2024, addresses the status of 1,3,7-trimethylxanthine, commonly known as caffeine, regarding its potential approval as a basic substance for use in plant protection products.
Key Provisions
Non-Approval of Caffeine
Article 1 states explicitly that 1,3,7-trimethylxanthine (caffeine) is not approved as a basic substance. This decision is based on an assessment of its safety concerning human health and environmental impact, which did not meet the necessary approval criteria established under Regulation (EC) No 1107/2009.
Assessment Process
The evaluation process began with an application from the company Progarein in June 2018. The Commission solicited scientific assistance from the European Food Safety Authority (EFSA), which produced a technical report in January 2021 and a subsequent review report in July 2021. These documents highlighted health risks associated with caffeine, including adverse effects on the cardiovascular system, hydration levels, and central nervous system functioning, particularly concerning children and pregnant women.
Human Health Concerns
The technical assessment pointed to significant health risks, including caffeine’s classification as harmful if swallowed and its potential adverse effects on human health, such as cardiovascular issues and behavioral changes. The EFSA indicated that the available data were insufficient to assess non-dietary risks for individuals exposed to caffeine in agricultural settings.
Environmental Impact
Concerning environmental safety, it was noted that caffeine could exceed the drinking water limit if used as proposed in the application. The assessment indicated that considerable exposure to surface water could occur, and insufficient data were available to confirm an acceptable risk to non-target organisms.
Further Applications
Article 13 of the Regulation clarifies that the non-approval does not preclude the possibility of submitting future applications for caffeine as a basic substance, indicating that further evidence or data could potentially change its status.
Entry into Force
Article 2 specifies that this Regulation will enter into force twenty days after its publication in the Official Journal of the European Union, making it immediately binding and applicable across all Member States.
The decision reflects the Commission’s commitment to ensuring that substances used in agricultural practices meet stringent safety requirements, protecting both human health and the environment.
Commission Regulation (EU) 2024/2785 Overview
The Commission Regulation (EU) 2024/2785, adopted on 24 October 2024, establishes a fisheries closure for the undulate ray (Raja undulata) in Union waters designated as 9 for vessels flying the flag of Portugal. This regulation is a direct response to the exhaustion of the fishing quota for this species allocated to Portugal for the year 2024.
Key Provisions
Article 1: Quota Exhaustion
This article states that the fishing quota assigned to Portugal for the undulate ray stock in Union waters of 9 is considered exhausted as of a specific date outlined in the Annex of the regulation.
Article 2: Prohibitions
Article 2 lays out specific prohibitions regarding fishing activities:
- Paragraph 1: It prohibits fishing for the undulate ray stock by vessels registered in Portugal from the date specified in the Annex. This includes all activities related to fishing such as searching for fish, shooting, setting, or hauling fishing gear.
- Paragraph 2: Certain activities are permitted for catches taken prior to the closure date, including transshipping, retaining on board, processing, transferring, caging, fattening, and landing of fish and fishery products from the stock caught before the closure.
- Paragraph 3: Any unintended catches of undulate ray by these vessels must be brought on board, recorded, landed, and counted against quotas in line with Article 15 of Regulation (EU) No 1380/2013.
Article 3: Entry into Force
This regulation takes effect the day after its publication in the Official Journal of the European Union, ensuring its immediate applicability across Member States.
Conclusion
This regulation underscores the European Commission’s commitment to sustainable fisheries management, particularly in light of overfishing concerns regarding the undulate ray stock in Union waters of 9. The measures outlined aim to prevent further depletion of this species and ensure compliance with the established fishing quotas.
Commission Implementing Regulation (EU) 2024/2793
The Commission Implementing Regulation (EU) 2024/2793, adopted on 24 October 2024, establishes the procedure for registering the geographical indication (GI) ‘Chistorra de Navarra / Txistorra de Navarra / Nafarroako Txistorra’ as a Protected Geographical Indication (PGI) within the European Union.
Key Provisions:
Article 1: Registration of the Geographical Indication
This article officially enters the GI ‘Chistorra de Navarra / Txistorra de Navarra / Nafarroako Txistorra’ into the Union register of geographical indications as stipulated in Article 22 of Regulation (EU) 2024/1143. This indicates that the product is recognized for its quality and reputation linked to its geographical origin, thereby affording it protection against misuse and imitation within the EU.
Article 2: Entry into Force
Article 2 specifies that the regulation will come into force twenty days after its publication in the Official Journal of the European Union. Furthermore, it emphasizes that this regulation is binding in its entirety and is directly applicable in all Member States, ensuring uniform implementation across the EU.
Background Context:
The regulation is based on the provisions of Regulation (EU) 2024/1143, which governs geographical indications for agricultural products, including traditional specialties. The application for the GI was initially submitted by Spain prior to the new regulation’s entry into force, and it did not receive any opposition as per Article 17 of the same regulation. This lack of opposition allowed for the smooth registration of the geographical indication.
By registering ‘Chistorra de Navarra / Txistorra de Navarra / Nafarroako Txistorra’, the EU aims to protect the authenticity of this traditional product and support local producers in maintaining its unique characteristics linked to the Navarra region.
Commission Implementing Regulation (EU) 2024/2792
This regulation, adopted by the European Commission on 24 October 2024, approves an amendment to the specification for the protected designation of origin (PDO) ‘Pico’. The regulation is grounded in the Treaty on the Functioning of the European Union and specifically references Regulation (EU) No 1308/2013, which establishes a common organization of the markets in agricultural products.
Key Provisions
Article 1
Article 1 of the regulation confirms the approval of the amendment to the specification for the PDO ‘Pico’. This indicates that the changes proposed to the product specification have been reviewed and accepted by the Commission.
Article 2
Article 2 stipulates that the regulation shall enter into force twenty days following its publication in the Official Journal of the European Union. This provision ensures that there is a clear timeline for the implementation of the approved amendment.
Binding Nature
The regulation is binding in its entirety and directly applicable in all Member States of the European Union. This means that once it enters into force, all Member States must comply with its provisions without the need for further national legislation.
Procedural Background
The regulation notes that the application for the amendment was forwarded by Portugal and was published in the Official Journal, as required by previous regulations. The Commission did not receive any objections to the proposed amendment, which facilitated its approval. Furthermore, the examination of the application followed the procedures established under Regulation (EU) No 1308/2013, ensuring compliance with the necessary legal framework.
Committee Opinion
The measures outlined in this regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets, reflecting a consensus on the amendment’s appropriateness within the context of EU agricultural policy.
In summary, this regulation formalizes the approval of an amendment to the PDO for ‘Pico’, reinforcing the EU’s commitment to protecting the quality and authenticity of its agricultural products.
Commission Implementing Regulation (EU) 2024/2768
This regulation, adopted by the European Commission on 30 October 2024, grants protection within the European Union to the Appellation of Origin ‘Tête de Moine / Tête de Moine, Fromage de Bellelay’. This name has been registered in the International Register of Appellations of Origin and Geographical Indications under the Geneva Act, as notified by the International Bureau of the World Intellectual Property Organization on 29 November 2023.
Key Provisions
- Article 1: The name ‘Tête de Moine / Tête de Moine, Fromage de Bellelay’ is officially recognized and protected within the European Union. It specifically identifies a type of cheese, ensuring that this designation can only be used for products that meet the defined standards of origin.
- Article 2: The regulation will enter into force twenty days after its publication in the Official Journal of the European Union, making it a binding and directly applicable regulation across all Member States.
Background Context
The regulation stems from the provisions of Regulation (EU) 2019/1753 which outlines the action of the Union following its accession to the Geneva Act of the Lisbon Agreement. This framework allows for the protection of geographical indications and appellations of origin, promoting the integrity and quality of products within the EU market.
As part of the process, the international registration of the appellation was published to allow for any potential opposition, but none was received. The measures were also aligned with the opinion of the Quality Policy Committee for agricultural products, wine, and spirit drinks, further validating the decision for protection.
Conclusion
This regulation exemplifies the EU’s commitment to protecting high-quality agricultural products and their unique characteristics linked to geographical origins, thereby supporting producers and enhancing consumer trust in authentic products.
Analysis of Commission Implementing Regulation (EU) 2024/2825
The Commission Implementing Regulation (EU) 2024/2825, adopted on October 29, 2024, amends Annex I to Implementing Regulation (EU) 2023/594 regarding special control measures for African swine fever (ASF). The regulation addresses the epidemiological situation of ASF in various Member States and updates the listings of restricted zones based on recent outbreaks and improvements in certain areas.
Key Provisions
Context of African Swine Fever
African swine fever is a highly contagious viral disease that affects both domestic and wild pigs. It poses significant risks to animal health and the economic stability of farming operations. The regulation emphasizes the need for specific control measures to manage the disease’s spread within the EU and to third countries.
Amendments to Restricted Zones
The regulation modifies the existing classifications of restricted zones I, II, and III in response to evolving epidemiological data. Key changes include:
- Areas in Latvia previously classified as restricted zone II are reclassified to restricted zone III due to a new outbreak in Dobeles county.
- In Italy, the Lombardy Region sees a reclassification of certain municipalities from restricted zone I to restricted zone III following an outbreak.
- Poland’s Zachodniopomorskie Region experiences changes as areas transition from restricted zone I to zone II due to proximity to outbreaks.
- The Panevezio Region in Lithuania is upgraded from restricted zone II to restricted zone I, reflecting effective disease control measures.
- Additional amendments are made in various regions across Germany, Italy, Latvia, Poland, and Slovakia to ensure that the boundaries of restricted zones accurately reflect the current ASF situation.
Scientific Basis and International Standards
The amendments are guided by scientific principles and criteria for zoning as outlined in the ASF guidelines developed collaboratively by the Commission and Member States. Compliance with international standards, such as those from the World Organisation for Animal Health (WOAH), is also prioritized.
Urgency and Implementation
The regulation stresses the urgency of these amendments in light of the dynamic nature of the ASF situation within the EU. As such, the changes to Annex I are set to take effect immediately upon publication in the Official Journal of the European Union, ensuring swift action to mitigate risks associated with the disease.
Binding Nature
The regulation is binding in its entirety and is directly applicable in all Member States, reinforcing the EU’s commitment to collective animal health management.
Conclusion
Commission Implementing Regulation (EU) 2024/2825 represents a proactive approach to managing African swine fever across the EU, reflecting a responsive regulatory framework that adapts to the evolving epidemiological landscape. The regulation’s focus on scientific guidance and international standards underscores the EU’s dedication to maintaining high animal health and biosecurity standards.
Overview of Commission Implementing Regulation (EU) 2024/2817
The Commission Implementing Regulation (EU) 2024/2817, adopted on 29 October 2024, makes specific amendments to Annexes V and XIV of Implementing Regulation (EU) 2021/404. These changes pertain to the entries for the United States in the lists of third countries authorized for the entry into the European Union of consignments related to poultry and germinal products, as well as fresh meat of poultry and game birds.
Key Provisions
- Regulatory Framework: The regulation is grounded in the legal framework provided by Regulation (EU) 2016/429, which governs the entry of animals and animal products into the EU from third countries based on animal health standards.
- Recent Health Incidents: The regulation addresses three outbreaks of highly pathogenic avian influenza (HPAI) reported in the United States, specifically in California, Utah, and Washington in October 2024. Following these outbreaks, the U.S. veterinary authority established restricted zones and implemented control measures, including a stamping-out policy.
- Suspension of Entry: Due to the outbreaks, the Commission decided to suspend the entry of consignments from the affected areas to protect the EU’s animal health status.
- Reevaluation of Risk: The United States provided updated information on the epidemiological situation and the measures implemented to control the outbreaks. Following an evaluation, the Commission determined that the animal health risks had been mitigated sufficiently, allowing for the reauthorization of entry for specific consignments from the previously restricted zones.
- Amendments to Annexes: The regulation amends Annexes V and XIV to reflect the current epidemiological situation. This includes detailed updates on specific zones (e.g., US-2.649, US-2.650, US-2.683, US-2.684, and US-2.685) and the relevant health status, indicating the species and products allowed entry, as well as the dates of validity and health guarantees.
- Urgency of Implementation: The amendments are deemed urgent to prevent unnecessary trade disruptions with the United States, emphasizing the need for swift action based on the evolving health situation.
- Binding Effect: The regulation is binding in its entirety and directly applicable in all EU Member States, reinforcing the uniformity of animal health standards across the Union.
Conclusion
This regulation serves to ensure that the EU maintains stringent animal health standards while allowing for the resumption of trade with the United States, contingent on the assessed risks and the effectiveness of control measures implemented by U.S. authorities.
Overview of Commission Delegated Regulation (EU) 2024/2791
The Commission Delegated Regulation (EU) 2024/2791, adopted on 29 January 2024, introduces modifications to the Annex of Regulation (EU) No 609/2013. This regulation pertains to food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. The key change allows the use of iron milk caseinate as a source of iron in specific food categories, notably excluding products for infants and young children.
Key Provisions
- Union List of Substances: The regulation amends the Annex of Regulation (EU) No 609/2013, which contains a Union list of substances permitted for addition to certain food categories. The amendment specifically includes iron milk caseinate as an authorized source of iron.
- Scientific Opinion: The inclusion of iron milk caseinate follows a scientific assessment by the European Food Safety Authority (EFSA), which concluded that the substance is safe for use as a source of iron and that the iron derived from it is bioavailable. This assessment was pivotal in justifying the amendment.
- Exclusions: The regulation explicitly states that the use of iron milk caseinate is not permitted in food products intended for infants and young children. This precaution aligns with existing safety protocols for vulnerable populations.
- Implementation Date: The regulation will come into force twenty days after its publication in the Official Journal of the European Union, making it binding and directly applicable across all Member States.
Summary of Changes
The amended Annex now includes iron milk caseinate under the category of ‘Minerals’ as a source of iron, following the entry for ‘ferrous L-pidolate’. This addition reflects the Commission’s commitment to ensuring that food for special medical purposes and total diet replacements can utilize effective iron sources while maintaining safety standards for sensitive groups.
Overall, this regulation represents a significant update to the existing legal framework governing food safety and nutritional standards within the EU, particularly in relation to dietary products designed for weight control and specific medical needs.
Commission Delegated Regulation (EU) 2024/2787
The Commission Delegated Regulation (EU) 2024/2787 amends Regulation (EU) 2019/1009 regarding the inclusion of mulch films in Component Material Category 9 (CMC 9) for EU fertilising products. This regulation is significant as it focuses on the biodegradability criteria for mulch films, a type of polymer used in agriculture.
Key Provisions
1. Inclusion of Mulch Films
The regulation establishes that EU fertilising products belonging to PFC 3 may include polymers in the form of mulch films, thereby expanding the scope of CMC 9 to incorporate these materials.
2. Biodegradability Criteria
Mulch films must meet specific biodegradability criteria in both soil and aquatic environments. In soil, the mulch films must demonstrate a minimum of 90% ultimate degradation or mineralisation within 24 months, while in aquatic environments, at least 30% degradation must be achieved within 12 months, with the potential for 90% degradation within 24 months following the functionality period.
3. Testing Methods
The regulation specifies acceptable testing methods to assess biodegradability, referring to various European and international standards. These tests ensure reliability and reproducibility in measuring the environmental impact of these polymers.
4. Environmental Considerations
To mitigate environmental risks, the regulation requires labelling that advises users to maintain a minimum buffer zone of 3 meters from surface water bodies and to incorporate mulch films into the soil after their functionality period to prevent leaching.
5. Toxicity Testing
Polymers used in mulch films must undergo stringent toxicity tests, including acute and chronic toxicity tests on earthworms and plant growth toxicity tests, ensuring that they do not adversely affect soil health and environmental quality.
6. Amendments to Existing Regulations
The regulation amends Annexes II and III of Regulation (EU) 2019/1009 to integrate these new provisions, thereby aligning the legislative framework with current environmental and agricultural practices.
7. Implementation Timeline
The regulation will enter into force twenty days after its publication in the Official Journal of the European Union, making it binding and directly applicable in all EU Member States.
Conclusion
This regulation represents a proactive approach by the European Commission to enhance the sustainability of agricultural practices by regulating the use and biodegradability of mulch films, thereby contributing to environmental protection and promoting the use of biodegradable materials in EU fertilising products.
Analysis of Commission Delegated Regulation (EU) 2024/2788
The Commission Delegated Regulation (EU) 2024/2788, adopted on 23 July 2024, amends Annex II of Regulation (EU) 2019/1009, which governs the market availability of EU fertilising products. This amendment specifically addresses the polymers included in Component Material Category 11 (CMC 11), with a focus on ensuring environmental safety and alignment with existing chemical regulations.
Key Provisions
1. Definition and Exclusions of Polymers
Article 1 of the regulation modifies the definition of polymers within CMC 11. It stipulates that certain polymers are excluded from this category, specifically:
- Polymers resulting from natural polymerisation processes that are not chemically modified.
- Polymers that are deemed degradable according to specified appendices of the REACH Regulation (Regulation (EC) No 1907/2006).
- Polymers with solubility greater than 2 g/L as defined in the REACH Regulation.
- Polymers that do not contain carbon atoms in their structure.
Additionally, a new point (ba) is introduced to clarify that polymers covered by CMC 8 and CMC 9 are also included in the regulations governing CMC 11.
2. Environmental Concerns
The regulation reflects a growing concern regarding the environmental impact of synthetic and chemically modified natural polymers, particularly those that are insoluble in water and degrade slowly. This concern extends to polymers that may be intentionally added to fertilising products and subsequently released into the environment.
3. Alignment with REACH Regulation
The amendment aims to align the requirements for polymers in CMC 11 with the general restrictions established under Regulation (EC) No 1907/2006, which governs the registration, evaluation, authorisation, and restriction of chemicals. This alignment is crucial to ensure that similar materials are subject to the same regulatory standards, thereby enhancing coherence across different product categories.
4. Transitional Period
The regulation stipulates that it will apply from 17 October 2028, providing a transitional period to allow stakeholders to adapt to the new requirements. This is consistent with the implementation timeline of the general restriction in Regulation (EC) No 1907/2006.
Conclusion
The Commission Delegated Regulation (EU) 2024/2788 represents a significant step towards tightening the regulations surrounding the use of polymers in EU fertilising products. By amending the definitions and aligning with existing chemical regulations, the European Commission aims to mitigate potential environmental risks associated with these materials.
Commission Implementing Regulation (EU) 2024/2774
The Commission Implementing Regulation (EU) 2024/2774, adopted on 23 October 2024, establishes the approval of a Union amendment to the product specification of the protected designation of origin (PDO) ‘Cotnari’. This regulation operates under the framework provided by Regulation (EU) 2024/1143, which concerns geographical indications for various agricultural products, including wines and spirit drinks.
Key Provisions
Article 1 of the regulation formally approves the amendment to the product specification of the PDO ‘Cotnari’. This signifies that the changes proposed by Romania regarding the product specification have been accepted without any opposition from other Member States, as no statements of opposition were received by the Commission, in accordance with Article 17 of Regulation (EU) 2024/1143.
Article 2 outlines the entry into force of this regulation, stating that it will take effect twenty days after its publication in the Official Journal of the European Union. Moreover, it emphasizes that the regulation is binding in its entirety and directly applicable across all Member States, ensuring uniform implementation of the product specification amendment without the need for further national legislation.
Background Context
The regulation follows the process set out in previous regulations concerning the common organisation of the markets in agricultural products, particularly Regulation (EU) No 1308/2013. It highlights the procedural steps taken by Romania to seek approval for the amendment to the PDO ‘Cotnari’, including the necessary publication of the application prior to the enactment of Regulation (EU) 2024/1143.
This regulation is part of the ongoing efforts by the European Union to protect and promote the quality and reputation of agricultural products through geographical indications, thereby supporting local producers and preserving traditional production methods.
Commission Implementing Regulation (EU) 2024/2746 Overview
The Commission Implementing Regulation (EU) 2024/2746, adopted on 25 October 2024, lays down detailed rules for the application of Council Regulation (EC) No 1217/2009, which establishes the Farm Sustainability Data Network (FSDN). This act repeals the previous Commission Implementing Regulation (EU) 2015/220 and introduces various provisions to ensure the effective functioning of the newly established framework.
Key Provisions
Field of Survey and Selection Plan
Article 1 sets out thresholds for the economic size of holdings, which vary by Member State and FSDN division. Article 2 details the number of returning holdings required from each Member State, and Article 3 mandates the creation of a selection plan to ensure a representative sample for the survey.
Union Typology for Holdings
Articles 4 to 8 establish the Union typology for holdings, including methods for calculating economic size and standard output coefficients. The regulation also emphasizes the importance of non-agricultural activities related to holdings.
Farm Return and Data Delivery
Articles 9 through 12 outline the reporting year structure, definitions of variables, and deadlines for data transmission to the Commission. Specific provisions are included for the submission of farm returns, ensuring they are completed accurately and in a timely manner.
Amount Payable to Member States
Articles 13 to 17 specify the conditions under which Member States are eligible for payments based on the delivery of duly completed farm returns. The regulation establishes a clear framework for the calculation of these payments, including adjustments based on the number of returns submitted.
Data Sharing and Storage
Articles 18 to 22 focus on the technical specifications for data transmission, storage, and processing. These include provisions for the sharing of data from various datasets to reduce the administrative burden on Member States and to improve the efficiency of data management.
Transitional and Final Provisions
Articles 23 to 25 cover transitional provisions to ensure continuity during the transition from the previous FADN to the FSDN framework. The regulation is set to apply from the reporting year 2025, with specific provisions for the completion of previous accounting years.
Annexes
The regulation includes multiple annexes that detail the economic size thresholds, the number of returning holdings, models for the selection plan, and the definitions of variables necessary for compliance. It also outlines the methods for calculating standard outputs and provides a comprehensive timetable for data submissions.
Implementation Timeline
The regulation will come into force the day after its publication and will be applicable starting from the reporting year 2025. Member States are required to prepare promptly for the new selection plan as part of the transition to the FSDN.
Agreement Between the European Union and the Republic of Armenia on Judicial Cooperation
Overview
This Agreement aims to enhance judicial cooperation between the European Union Agency for Criminal Justice Cooperation (Eurojust) and the competent authorities of Armenia in combating serious crime, particularly organized crime and terrorism. It establishes a framework for the transfer of personal data to support investigations and prosecutions while ensuring the protection of individual rights, particularly concerning personal data privacy.
Key Provisions
Objectives and Scope (Articles 1-2)
The main objective is to strengthen cooperation against serious crime, allowing Eurojust to share personal data with Armenian authorities to facilitate investigations and prosecutions. The scope includes activities defined under the Eurojust Regulation and related to judicial cooperation in criminal matters.
Definitions (Article 3)
This section provides definitions for key terms used in the Agreement, such as ‘Eurojust’, ‘serious crime’, and ‘competent authority’. It establishes clarity regarding the parties involved and the types of crimes addressed, including terrorism, organized crime, and various other serious offenses.
Communication and Cooperation (Articles 4-6)
Armenia is required to designate contact points for communication with Eurojust, including a Liaison Prosecutor who will be seconded to Eurojust. This Liaison Prosecutor will facilitate operations and maintain direct communication with Armenian authorities. The Agreement also allows for joint investigation teams to be formed with Eurojust’s assistance.
Data Protection and Personal Data Processing (Articles 9-20)
Personal data transferred under this Agreement must be processed for specific purposes related to criminal investigations. The Agreement outlines general data protection principles, including fairness, legality, and transparency in data processing. It establishes strict guidelines for the handling of sensitive data, including additional safeguards for data related to vulnerable individuals, and prohibits automated decisions that adversely affect individuals.
There are provisions for onward transfers of personal data, requiring prior authorization from Eurojust and adherence to the same conditions as the original transfer. The rights of data subjects, including access, rectification, and erasure of data, are also guaranteed.
Supervisory Authority (Article 21)
Each Party must establish independent public authorities to oversee the implementation of the Agreement and ensure compliance with data protection standards. These authorities have the power to investigate complaints and enforce rights related to personal data processing.
Liability and Compensation (Article 24)
The Agreement stipulates liability for damages caused by errors in information exchanged, establishing that neither Eurojust nor Armenian authorities can claim inaccuracies from one another as a defense against liability. Compensation mechanisms are outlined for instances where one authority causes harm through erroneous information provided by the other.
Final Provisions (Articles 25-35)
This section includes provisions on expenses, working arrangements for cooperation, relations with other international agreements, and procedures for notification and amendments to the Agreement. It also outlines the conditions for entry into force, review, evaluation, and termination of the Agreement.
Conclusion
This Agreement represents a significant step in fostering judicial cooperation between the EU and Armenia, with a strong emphasis on data protection and the safeguarding of individual rights in the context of combating serious crime.
