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Overview of Recent EU Legal Acts

Commission Implementing Regulation (EU) 2024/2649

This regulation corrects the Swedish language version of Implementing Regulation (EU) 2023/1773, specifically amending an incorrect term used to define a type of gas in Annex II, Section 1 point 39. The correction only affects the Swedish text, with no impact on other language versions. The regulation will enter into force 20 days after publication and is binding across all EU Member States.

Commission Implementing Regulation (EU) 2024/2651

This regulation grants Union authorization to the biocidal product family ‘Taski-Room Care-Suma Family based on Lactic Acid,’ allowing its marketing and use from 31 October 2024 to 30 September 2034. It stipulates specific safety measures, instructions for use, and compliance requirements, ensuring the product meets safety and efficacy standards for disinfectants and hygiene products.

Council Regulation (EU) 2024/2678

This regulation amends Regulation (EU) 2024/257 to establish fishing opportunities in EU waters for 2024 to 2026. It revises total allowable catches (TAC) for certain fish stocks based on scientific advice, addresses ‘choke species’ by increasing TACs for pollack, and suspends fishing for red seabream in critical areas. The measures apply retroactively from 1 January 2024 and aim to ensure sustainable fishing practices.

Commission Implementing Regulation (EU) 2024/2652

This regulation amends Implementing Regulation (EU) 2020/761 regarding tariff quotas in the rice sector and cheese exports to the United States. It establishes new reference quantities for rice quotas, modifies cheese export quotas due to Brexit-related adjustments, and updates certification requirements for dairy product imports from New Zealand to align with international trade standards.

Commission Delegated Regulation (EU) 2024/2684

This regulation updates the protein-related requirements for infant and follow-on formulae made from protein hydrolysates as per Delegated Regulation (EU) 2016/127. It introduces new standards for protein content, processing methods, and amino acid composition, ensuring that these formulations meet the latest safety and nutritional evaluations conducted by the European Food Safety Authority.

Commission Implementing Regulation (EU) 2024/2675

This regulation provides emergency financial support of EUR 119,700,000 to agricultural sectors in Bulgaria, Germany, Estonia, Italy, and Romania affected by climatic events. It outlines distribution criteria, implementation obligations for Member States, and allows for additional national support, aiming to alleviate economic losses and strengthen the viability of agricultural holdings.

Commission Implementing Regulation (EU) 2024/2677

This regulation amends existing regulations concerning the entry of poultry and germinal products from the United States into the EU following an outbreak of highly pathogenic avian influenza. It establishes new zones and specifies the types of products affected, ensuring compliance with EU animal health standards to protect public health and animal welfare.

Commission Regulation (EU) 2024/2640

This regulation modifies maximum residue levels (MRLs) for various active substances in food products, including 1,4-dimethylnaphthalene and fluopyram. It sets new MRLs based on evaluations from member states and the European Food Safety Authority, establishes transitional arrangements for products already on the market, and ensures that the regulation is binding across all EU Member States.

Commission Implementing Regulation (EU) 2024/2639

Review of each of legal acts published today:

Commission Implementing Regulation (EU) 2024/2649 of 10 October 2024 correcting the Swedish language version of Implementing Regulation (EU) 2023/1773 laying down the rules for the application of Regulation (EU) 2023/956 of the European Parliament and of the Council as regards reporting obligations for the purposes of the carbon border adjustment mechanism during the transitional period
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Commission Implementing Regulation (EU) 2024/2649

Date of Adoption

10 October 2024

Purpose

This regulation corrects the Swedish language version of Implementing Regulation (EU) 2023/1773. The correction pertains specifically to Section 1 point 39 in Annex II, where an incorrect term was used to define a type of gas. This error erroneously referred to a different type of gas also covered by the regulation and was present in Annexes II, III, and IV.

Scope of Correction

The correction applies solely to the Swedish language version of Implementing Regulation (EU) 2023/1773. All other language versions of the regulation remain unaffected by this amendment.

Implementation Details

Article 2 of this regulation stipulates that it shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Upon entry into force, the regulation is binding in its entirety and directly applicable in all Member States of the European Union.

Legal Basis and Compliance

The measures outlined in this regulation are in accordance with the opinion of the CBAM Committee, which was delivered prior to the adoption of Implementing Regulation (EU) 2023/1773. This ensures that the correction aligns with the established legal framework governing the Carbon Border Adjustment Mechanism during the transitional period.

Final Provisions

The regulation is officially adopted by the European Commission, with the President Ursula von der Leyen signing on behalf of the Commission on 10 October 2024 in Brussels.

References

• Regulation (EU) 2023/956
• Implementing Regulation (EU) 2023/1773
• Implementing Regulation (EU) 2024/2649

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Commission Implementing Regulation (EU) 2024/2651 of 10 October 2024 granting a Union authorisation for the biocidal product family Taski-Room Care-Suma Family based on Lactic Acid in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
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Commission Implementing Regulation (EU) 2024/2651 Description

The Commission Implementing Regulation (EU) 2024/2651 grants Union authorization for the biocidal product family ‘Taski-Room Care-Suma Family based on Lactic Acid’ under Regulation (EU) No 528/2012. This act follows the procedural requirements of the EU legislation concerning biocidal products.

Key Provisions

Authorization Details

Article 1 establishes that Diversey Europe Operations B.V. is granted a Union authorization with the number EU-0031644-0000 for the marketing and use of the specified biocidal product family. The validity period of this authorization is from 31 October 2024 to 30 September 2034, subject to compliance with the terms laid out in the Annex of the regulation.

Product Characteristics

The ‘Taski-Room Care-Suma Family based on Lactic Acid’ includes L-(+)-Lactic acid as its active substance, which is listed in the Union list of approved active substances. The product family encompasses product types 2, 3, and 4, which correspond to disinfectants, veterinary hygiene products, and those suitable for use in food and feed areas.

Assessment and Evaluation Process

Following the submission of the application on 16 April 2019, the evaluation process involved assessments conducted by the competent authority of Latvia, culminating in a report submitted to the European Chemicals Agency (ECHA). The ECHA provided its opinion on 2 October 2023, declaring that the product family meets the necessary conditions for Union authorization.

Safety Measures and Instructions for Use

The regulation specifies comprehensive safety measures, including protective equipment to be used during handling, as well as detailed instructions for the product’s application. It emphasizes the importance of correct dilution ratios, contact times for effectiveness, and safe disposal practices for both the product and its packaging.

Annex Information

The annex of the regulation contains the summary of product characteristics, detailing formulations, composition, and specific uses of the biocidal product family. It outlines the administrative information, including the authorisation holder’s details, manufacturer information, and the composition of the product family, defining the active and non-active substances involved.

General Directions for Use

Users are instructed to follow the general directions for use, including risk mitigation measures, safe handling, and emergency procedures in case of exposure. The regulation also stipulates the conditions for storage and the shelf life of the product under normal storage conditions.

Legal Binding Nature

Article 2 states that this regulation is binding in its entirety and directly applicable in all Member States, thereby ensuring uniformity in the application of the biocidal product regulations across the EU.

This regulation reflects the EU’s commitment to ensuring that biocidal products available on the market are safe for users and the environment while providing effective solutions for hygiene and disinfection needs.

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Council Regulation (EU) 2024/2678 of 10 October 2024 amending Regulation (EU) 2024/257 fixing for 2024, 2025 and 2026 the fishing opportunities for certain fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2023/194 fixing for 2023 and 2024 such fishing opportunities
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Analysis of Council Regulation (EU) 2024/2678

This regulation amends Regulation (EU) 2024/257, which establishes fishing opportunities for various fish stocks in European Union (EU) waters for the years 2024, 2025, and 2026. The amendments are primarily based on updated scientific advice regarding fish stocks and aim to ensure sustainable fishing practices while addressing the socioeconomic impacts on the fishing sector.

Key Provisions

1. Adjustments to Total Allowable Catches (TAC)

The regulation revises the provisional TAC for anchovy in specified ICES subareas and CECAF division. The definitive TAC for anchovy is set based on scientific advice, allowing a catch limit of 4,997 tonnes for a specified period, with a special condition limiting catches in the southern part of the area to 969 tonnes. Additionally, catches that have already occurred under the provisional TAC are considered, allowing for further fishing under specific conditions.

2. Measures Addressing ‘Choke Species’

To mitigate the risk of ‘choke species’—species that lack sufficient quota to allow for continued fishing—the regulation increases the TACs for pollack in various divisions. This adjustment is based on the Scientific, Technical and Economic Committee for Fisheries (STECF) advice, which highlights the need for certain TAC levels to avoid premature fishery closures. The new TACs for pollack are set at 108 tonnes for ICES division 8c and 132 tonnes for subareas 9 and 10.

3. Fishing Regulations for Red Seabream

The regulation addresses the critical state of the red seabream stock, particularly in the Atlantic part of the Strait of Gibraltar. Based on scientific assessments indicating a significant decline in biomass, the regulation suspends fishing for red seabream in this region to safeguard the stock from overfishing.

4. Amendments to Existing Regulations

Changes are made to existing regulations regarding fisheries management and conservation measures, particularly in relation to the International Commission for the Conservation of Atlantic Tunas (ICCAT). The regulation ensures that there is no overlap in provisions and clarifies the application of fishing measures across different regulations.

5. Implementation Timeline

The provisions of the regulation are set to apply retroactively from 1 January 2024, with specific TACs for anchovy taking effect from 1 July 2024. This retroactive application is deemed necessary to maintain legal certainty and protect legitimate expectations while ensuring the fishing opportunities are either maintained or increased.

6. Immediate Entry into Force

Given the urgency of the situation, particularly concerning the sustainability of fish stocks and the economic stability of fishing communities, the regulation is designed to enter into force immediately upon publication in the Official Journal of the European Union.

Conclusion

The Council Regulation (EU) 2024/2678 represents a critical step towards sustainable fisheries management in the EU, balancing ecological considerations with the needs of the fishing industry. By aligning fishing opportunities with scientific advice, the regulation aims to protect vulnerable species and ensure the long-term viability of fish stocks in EU waters.

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Commission Implementing Regulation (EU) 2024/2652 of 10 October 2024 amending Implementing Regulation (EU) 2020/761 with regard to the management of certain tariff quotas in the rice sector, the adjustment of cheese export tariff quotas for the United States and an update of the technical specifications for the IMA1 certificates for the import of dairy products from New Zealand
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Analysis of Commission Implementing Regulation (EU) 2024/2652

The Commission Implementing Regulation (EU) 2024/2652, adopted on 10 October 2024, introduces several amendments to Implementing Regulation (EU) 2020/761 concerning the management of tariff quotas in the rice sector, adjustments to cheese export tariff quotas for the United States, and updates to technical specifications for IMA1 certificates related to dairy products imported from New Zealand.

Key Provisions

Amendments to Tariff Quotas for Rice

The regulation addresses the over-demand for specific rice tariff quotas (order numbers 09.4112, 09.4117, 09.4118, 09.4119, 09.4130, 09.4154, 09.4166, and 09.4168). It establishes that the maximum quantities available for these quotas will now be defined by a reference quantity, in accordance with Article 9 of Commission Delegated Regulation (EU) 2020/760. Consequently, the tables in Annexes I and III of Regulation 2020/761 will be amended to reflect these changes.

Adjustments to Cheese Export Tariff Quotas for the United States

The regulation also modifies the cheese export tariff quota for the United States due to discrepancies arising from the UK’s withdrawal from the EU. The quantity allocated to the EU must now be aligned with the amount recognized by the United States, necessitating adjustments to Annex XIV.5 of Regulation 2020/761.

Updates to IMA1 Certificates for Dairy Products from New Zealand

For imports of dairy products from New Zealand under specific tariff quotas (order numbers 09.4516, 09.4523, 09.4524, and 09.4525), the IMA1 certificates must adhere to new templates that comply with recent regulations. The templates for cheese and butter imports will be updated, while the templates for certain cheese quotas from Australia will remain unchanged. The transitional period for accepting both old and new certificate formats will last until 30 June 2025.

Implementation Timeline

The new reference quantity requirement will apply to the rice tariff quotas after a transitional period, allowing operators to adapt to the new rules. This will take effect from 23 November 2026, coinciding with the first date operators can apply for licenses valid for the quota period starting 1 January 2027.

Regulatory Compliance

The regulation emphasizes the importance of compliance with the provisions set out in the updated templates for IMA1 certificates and establishes the rules for their completion and verification. It also outlines the circumstances under which these certificates may be canceled or amended.

Conclusion

This regulation represents a significant update to the management of tariff quotas and import certification processes for agricultural products within the EU framework, ensuring better alignment with international trade obligations and operational efficiency for EU operators.

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Commission Delegated Regulation (EU) 2024/2684 of 2 February 2024 amending Delegated Regulation (EU) 2016/127 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates
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Commission Delegated Regulation (EU) 2024/2684 Overview

The Commission Delegated Regulation (EU) 2024/2684, adopted on 2 February 2024, amends Delegated Regulation (EU) 2016/127 concerning the protein-related requirements for infant and follow-on formulae made from protein hydrolysates. The amendments are informed by scientific evaluations regarding the safety and nutritional suitability of specific protein hydrolysates used in these formulae.

Key Provisions

Article 1 – Amendments to Annexes

Annexes I, II, and III of Delegated Regulation (EU) 2016/127 are revised to incorporate new protein-related requirements for infant and follow-on formulas manufactured from protein hydrolysates.

Article 2 – Entry into Force

The Regulation enters into force on the day of its publication in the Official Journal of the European Union, ensuring that the updated requirements can be implemented without unnecessary delay.

Amendments to Specific Requirements

Protein-related Requirements for Infant Formula

The updated Annex I specifies that infant formula manufactured from protein hydrolysates must meet new protein content, source, processing, and amino acid composition standards:

• Protein Content: Minimum and maximum protein content requirements are established for different groups (A, B, C, D), with specific values for grams per 100 kJ and kcal.
• Protein Source: Detailed specifications for the origin and composition of whey proteins, including the percentage breakdown of components and their respective protein content and denaturation levels.
• Protein Processing: Defined processing methods, including temperature and duration of hydrolysis, to ensure the nutritional safety of the formula.
• Amino Acids and L-Carnitine: Requirements for indispensable and conditionally indispensable amino acids and L-carnitine levels, with allowances for certain ratios between amino acids under specified conditions.

Protein-related Requirements for Follow-on Formula

Similar requirements are established for follow-on formula in Annex II, with adjusted parameters that reflect the nutritional needs of older infants:

• Protein Content: Follow-on formulas are subject to similar minimum and maximum protein content regulations as infant formulas.
• Protein Source and Processing: Must adhere to specified protein sources and processing conditions to ensure the suitability of the formula.
• Amino Acids: Follow-on formulas also need to meet specific amino acid composition standards, with similar allowances for calculation ratios as in infant formulas.

Annex III Updates

In Annex III, the introductory sentence regarding the indispensable and conditionally indispensable amino acids in breast milk has been updated to align with the new protein-related requirements for both infant and follow-on formula.

Conclusion

This regulation reflects a proactive approach to ensuring that infant and follow-on formulas made from protein hydrolysates meet the latest safety and nutritional standards, based on scientific evaluations conducted by the European Food Safety Authority. The amendments facilitate the introduction of new formulations that have been deemed safe and suitable for infants and young children.

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Commission Implementing Regulation (EU) 2024/2675 of 10 October 2024 providing for emergency financial support for the agricultural sectors affected by adverse climatic events in Bulgaria, Germany, Estonia, Italy and Romania, in accordance with Regulation (EU) No 1308/2013 of the European Parliament and of the Council
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Detailed Description of Commission Implementing Regulation (EU) 2024/2675

The Commission Implementing Regulation (EU) 2024/2675, adopted on 10 October 2024, provides emergency financial support for the agricultural sectors affected by severe climatic events in Bulgaria, Germany, Estonia, Italy, and Romania. This regulation is framed within the context of Regulation (EU) No 1308/2013, which establishes a common organization of the markets in agricultural products.

Scope of Aid

The regulation allocates a total Union aid of EUR 119,700,000 to the aforementioned Member States to address the economic challenges faced by farmers due to recent adverse climatic conditions. The specific financial allocations are detailed as follows:

• Bulgaria: EUR 10,900,000
• Germany: EUR 46,500,000
• Estonia: EUR 3,300,000
• Italy: EUR 37,400,000
• Romania: EUR 21,600,000

Criteria for Distribution

The aid is intended to compensate the most affected farmers based on objective and non-discriminatory criteria that consider actual economic losses. Member States must ensure that the aid effectively reaches farmers and does not distort the market or competition.

Implementation and Reporting Obligations

Member States are required to notify the European Commission of the measures they plan to implement by 31 December 2024. They must provide a comprehensive description of these measures, the criteria for granting aid, and the anticipated impact on compensating farmers for their economic losses. Additionally, they must report on the total amounts paid and the effectiveness of the measures by 31 October 2025.

Additional National Support

The regulation allows Member States to provide additional national support for the implemented measures, up to a maximum of 200% of the allocated Union aid, ensuring that such payments do not cause market distortions or overcompensation. This additional support must be paid by 31 July 2025.

Final Provisions

The regulation emphasizes the need for timely implementation to ensure farmers receive aid as soon as possible. It enters into force the day after its publication in the Official Journal of the European Union, reflecting the urgent need to address the economic difficulties faced by agricultural producers in the affected regions.

Conclusion

Regulation (EU) 2024/2675 represents a significant step in providing targeted financial support to agricultural sectors in five EU Member States, recognizing the extraordinary climatic challenges they face and aiming to safeguard the economic viability of their agricultural holdings.

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Commission Implementing Regulation (EU) 2024/2677 of 8 October 2024 amending Annexes V and XIV to Implementing Regulation (EU) 2021/404 as regards the entries for the United States in the lists of third countries, territories or zones thereof authorised for the entry into the Union of consignments of poultry and germinal products of poultry, and of fresh meat of poultry and game birds
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Commission Implementing Regulation (EU) 2024/2677

This regulation amends Annexes V and XIV to Implementing Regulation (EU) 2021/404, specifically concerning the entry of consignments of poultry and germinal products of poultry, as well as fresh meat of poultry and game birds from the United States into the European Union.

Key Provisions

Context and Background

The regulation is grounded in the framework of the Treaty on the Functioning of the European Union and the Animal Health Law (Regulation (EU) 2016/429). It stipulates that animal consignments must originate from approved third countries or territories to enter the EU.

Following a recent outbreak of highly pathogenic avian influenza (HPAI) in Idaho, USA, which was confirmed on September 27, 2024, the United States has taken measures to manage the outbreak, including establishing a restricted zone and implementing a stamping-out policy.

Amendments to Annexes

The regulation specifically modifies Annexes V and XIV of Implementing Regulation (EU) 2021/404:

Annex V Modifications

• New row for the United States (zone US-2.680) is added following the previous zone (US-2.679). This zone covers a circular area with a 10 km radius around the affected establishment in Lincoln County, Idaho.
• The updated entry specifies the following codes: BPP, BPR, DOC, DOR, SP, SR, POU-LT20, HEP, HER, HE-LT20, indicating the types of poultry and related products affected.
• The effective date of this amendment is noted as September 27, 2024.

Annex XIV Modifications

• New rows for zone US-2.680 are added, detailing the types of products (POU, RAT) that are impacted by the HPAI outbreak.
• Similar to Annex V, the effective date of these amendments is also set to September 27, 2024.

Implementation and Enforcement

The regulation entered into force the day following its publication in the Official Journal of the European Union and is binding in its entirety across all Member States.

Conclusion

Through these amendments, the European Commission aims to mitigate the risk of HPAI entering the EU from the United States, thereby protecting the animal health status within the Union.

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Commission Regulation (EU) 2024/2640 of 9 October 2024 amending and correcting Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 1,4-dimethylnaphthalene, difluoroacetic acid (DFA), fluopyram and flupyradifurone in or on certain products
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Overview of Commission Regulation (EU) 2024/2640

Commission Regulation (EU) 2024/2640 amends Annex II of Regulation (EC) No 396/2005 regarding maximum residue levels (MRLs) for specific active substances in various food products. The substances affected include 1,4-dimethylnaphthalene, difluoroacetic acid (DFA), fluopyram, and flupyradifurone.

Key Provisions

1. Modifications of MRLs

The regulation establishes new MRLs for the aforementioned substances based on evaluations from member states and the European Food Safety Authority (EFSA). The changes include:

• 1,4-dimethylnaphthalene: MRLs for this substance in various animal products and potatoes have been modified. The MRLs for products from poultry and bird eggs have been raised, while those for certain mammalian products have been lowered.
• Fluopyram: The MRL for fluopyram in pumpkin seeds is set at 0.4 mg/kg, extrapolated from residue trials on rapeseeds/canola seeds.
• DFA and Flupyradifurone: MRLs for these substances have been raised for a range of crops, including citrus fruits and various berries, to align with international standards and avoid trade barriers.

2. Evaluation and Reasoned Opinions

For each application regarding MRL modifications, the following steps were taken:

• Member states evaluated the applications and forwarded reports to the Commission.
• EFSA assessed the risks to consumers and animals, providing reasoned opinions on the proposed MRLs.
• Data gaps identified by EFSA were addressed, allowing for the acceptance of proposed MRLs.

3. Transitional Arrangements

To ensure a smooth transition, a period has been established before the modified MRLs take effect. Products placed on the market before April 30, 2025, will continue to be governed by the previous MRLs until that date.

4. Binding Nature and Applicability

This regulation is binding in its entirety and directly applicable in all EU Member States. It enters into force 20 days after publication, applying from April 30, 2025.

Conclusion

The amendments to Regulation (EC) No 396/2005 through Regulation (EU) 2024/2640 reflect ongoing efforts to ensure food safety and align EU standards with international practices. These changes are essential for maintaining consumer protection while facilitating trade within the EU and with its international partners.

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Commission Implementing Regulation (EU) 2024/2639 of 9 October 2024 laying down rules for the application of Regulation (EU) 2023/988 of the European Parliament and of the Council as regards the roles and tasks of the single national contact points of the Safety Gate Rapid Alert System
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Commission Implementing Regulation (EU) 2024/2639 Overview

The Commission Implementing Regulation (EU) 2024/2639, adopted on 9 October 2024, establishes rules for the application of Regulation (EU) 2023/988 regarding the roles and tasks of the single national contact points within the Safety Gate Rapid Alert System. This regulation aims to enhance the efficiency and effectiveness of the system designed for the rapid exchange of information concerning dangerous products across the European Union.

Key Provisions

Article 1: Roles and Tasks of Safety Gate Contact Points

• Verification and Validation: Safety Gate contact points are responsible for verifying the completeness of notifications received from national authorities before transmitting them to the Commission.
• Check for Duplicates: They must ensure that a product subject to notification has not already been reported in the Safety Gate Rapid Alert System, coordinating follow-ups where necessary.
• National Level Communication: Notifications validated by the Commission must be communicated to relevant national authorities for appropriate follow-up actions.
• Promotion of Tools: Contact points are tasked with promoting the use of the Product Safety eSurveillance Webcrawler and similar tools among national authorities.
• Training and Assistance: They are to train and assist national authorities in utilizing the Safety Gate Rapid Alert System effectively.
• Information Exchange: Safety Gate contact points must cooperate with other contact points and relevant authorities to exchange product safety information.
• Technical Issues Reporting: They are required to inform the Commission promptly about any technical problems with the Safety Gate Rapid Alert System.
• Access Management: Contact points manage requests for access to the Safety Gate applications from users within their National Network.

Article 2: Joint Controllers for Data Processing

The regulation outlines that the Commission and national authorities act as joint controllers for processing data in the Safety Gate Rapid Alert System, detailing their respective roles and responsibilities concerning personal data protection as per EU regulations.

Article 3: Entry into Force

The regulation will enter into force twenty days after its publication, applying from 13 December 2024.

Annex: Joint Controllers’ Responsibilities

The annex elaborates on the responsibilities of the joint controllers, including:

• Data Processing: Joint controllers must ensure the security and confidentiality of personal data processed in the Safety Gate Rapid Alert System.
• Data Subjects’ Rights: Procedures for addressing requests from data subjects regarding their personal data must be established and adhered to.
• Security Incidents Management: The joint controllers are required to document and manage security incidents, including personal data breaches.
• Data Retention: Personal data must not be retained longer than necessary for its intended purpose, with specific timeframes outlined for different categories of data.

This regulation is binding and directly applicable in all Member States, reinforcing the EU’s commitment to product safety and consumer protection through effective communication and rapid response mechanisms.

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