[:uk]Review of the EU legislation for 22/10/2024[:]

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Overview of Recent EU Regulations

Commission Implementing Regulation (EU) 2024/2741

This regulation amends the specification for the protected designation of origin (PDO) ‘Chianti’. It confirms the applicability of amendments under the relevant regulations and establishes that there were no objections to the changes proposed by Italy. The regulation will enter into force twenty days post-publication, reinforcing the EU’s commitment to preserving geographical indications.

Commission Implementing Regulation (EU) 2024/2744

This regulation updates the entry requirements for poultry and germinal products from Canada and the United States in response to recent avian influenza outbreaks. It suspends imports from certain areas in the U.S. while allowing reauthorization from previously restricted zones in Canada, thus ensuring strict compliance with animal health standards in the EU.

Commission Implementing Regulation (EU) 2024/2707

This regulation modifies rules related to olive oil marketing standards, mandating that Member States report any instances of non-compliance regarding extra virgin olive oil. It also revises analytical methods for assessing olive oil characteristics and allows flexibility in sampling methodologies, thereby enhancing the regulation’s effectiveness.

Commission Regulation (EU) 2024/2739

This regulation imposes a fisheries closure for Mediterranean albacore specific to Spanish vessels due to the exhaustion of the allocated fishing quota for 2024. It prohibits all fishing activities on this stock, reflecting the EU’s commitment to sustainable fisheries management and compliance with scientific recommendations for fish stock preservation.

Commission Regulation (EU) 2024/2730

This regulation establishes a fisheries closure for Mediterranean albacore for Italian vessels, also due to the exhaustion of the fishing quota for the year 2024. It prohibits any fishing-related activities for this stock, emphasizing the EU’s focus on sustainable fishing practices and protection of vulnerable fish species.

Commission Implementing Regulation (EU) 2024/2699

This regulation outlines procedural rules for cooperation between the Member State Coordination Group on Health Technology Assessment, the European Medicines Agency (EMA), and the HTA secretariat. It covers planning for clinical assessments, data sharing, and expert identification, ensuring a structured and secure exchange of information to enhance health technology evaluations across the EU.

Review of each of legal acts published today:

Commission Implementing Regulation (EU) 2024/2741 of 17 October 2024 approving an amendment to the specification for a protected designation of origin Chianti

Commission Implementing Regulation (EU) 2024/2741

This regulation, adopted by the European Commission on October 17, 2024, approves an amendment to the specification for the protected designation of origin (PDO) ‘Chianti’. The regulation is grounded in the Treaty on the Functioning of the European Union and is specifically linked to Regulation (EU) No 1308/2013, which establishes a common organization of the markets in agricultural products.

Key Provisions

The regulation outlines several critical points:

Applicable Regulations: It references the deletion of certain articles (96 to 99 and 105) from Regulation (EU) No 1308/2013 due to Regulation (EU) 2024/1143, yet states that the provisions concerning applications for amendments to product specifications remain applicable for those published before May 13, 2024.
Examination of Application: The Commission has evaluated the amendment application regarding the ‘Chianti’ PDO, as submitted by Italy, in accordance with the relevant articles of the aforementioned regulations.
Publication Requirement: The application for the amendment was published in the Official Journal of the European Union, fulfilling the transparency requirement set out in the regulation.
No Objections Received: The Commission notes that there were no objections to the proposed amendment, which is a significant factor in the approval process.
Approval of Amendments: The regulation formally approves the amendments to the specification for the ‘Chianti’ PDO, which is recognized for its geographical significance and quality.
Entry into Force: The regulation will enter into force twenty days after its publication in the Official Journal, ensuring a timely implementation of the approved changes.

This regulation is binding in its entirety and directly applicable across all EU Member States, reinforcing the EU’s commitment to protecting geographical indications and maintaining high standards in agricultural products.

Commission Implementing Regulation (EU) 2024/2744 of 21 October 2024 amending Annexes V and XIV to Implementing Regulation (EU) 2021/404 as regards the entries for Canada and 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

Commission Implementing Regulation (EU) 2024/2744 Overview

The Commission Implementing Regulation (EU) 2024/2744, adopted on 21 October 2024, amends Annexes V and XIV of Implementing Regulation (EU) 2021/404 concerning the entry of poultry and germinal products from Canada and the United States into the European Union. This regulation is crucial in the context of animal health and food safety, particularly in response to recent outbreaks of highly pathogenic avian influenza (HPAI) in these countries.

Key Provisions

1. Background and Context

The regulation is grounded in Regulation (EU) 2016/429, which stipulates that consignments of animals and animal products must originate from listed third countries to enter the EU. It specifically addresses the health requirements and lists of countries authorized for such entries.

2. Amendments to Animal Health Lists

The regulation updates the lists of third countries authorized for the entry of poultry and germinal products, particularly in light of HPAI outbreaks:

United States: Following outbreaks in Florida and Idaho, the entry of poultry and related products from the affected zones is suspended to protect the EU’s animal health status.
Canada: The regulation acknowledges improvements in the epidemiological situation in Canada, allowing the reauthorization of product entry from previously restricted zones.

3. Specific Changes to Annexes

Annex V Amendments

The entry for Canada has been updated to reflect the current health status as of 15 November 2023, with specific restrictions noted.
New entries for the United States (zones US-2.681 and US-2.682) have been added, detailing the geographical restrictions following the HPAI outbreaks.

Annex XIV Amendments

Similar updates as in Annex V are made for Canada, specifically for the zone CA-2.219.
The United States entries for zones US-2.681 and US-2.682 have been added, detailing the specific poultry types and restrictions applicable.

4. Urgency and Immediate Effect

The regulation emphasizes the urgency of these amendments, particularly to avoid unnecessary trade disruptions with Canada while addressing the ongoing health risks posed by HPAI in the United States.

Conclusion

This regulation reflects the EU’s proactive approach to managing animal health risks, ensuring that imports of poultry and germinal products from third countries are strictly regulated based on current epidemiological assessments. The updates to the lists in Annexes V and XIV are essential for maintaining the integrity of the EU’s food safety standards.

Commission Implementing Regulation (EU) 2024/2707 of 21 October 2024 amending Implementing Regulation (EU) 2022/2105 laying down rules on conformity checks of marketing standards for olive oil and methods of analysis of the characteristics of olive oil

Overview of Commission Implementing Regulation (EU) 2024/2707

This regulation amends Implementing Regulation (EU) 2022/2105, which sets out rules concerning conformity checks of marketing standards for olive oil and the methods for analyzing its characteristics.

Key Provisions

Notification of Non-Compliance: The regulation introduces a new paragraph in Article 4, mandating that when a sample of extra virgin olive oil fails to meet the organoleptic defect limits outlined in Table A of Annex I to Delegated Regulation (EU) 2022/2104, the involved Member States must report this non-compliance. This notification must be done according to Article 16 of Implementing Regulation (EU) 2019/1715, unless there is suspicion of intentional deceit by businesses or individuals.
Amendments to Annexes: Annexes I and II of Regulation (EU) 2022/2105 are revised. Notably, in Annex I, the method for determining the content of waxes and fatty acid ethyl esters has been updated to ‘COI/T.20/Doc. No 28’ for capillary gas chromatography.
Sampling Methodology Clarification: The regulation provides clearer guidelines on the sampling methodology. For example, it specifies that the primary sample size must consist of olive oil from a minimum number of packages based on their capacity, ensuring that the content is homogenized before analysis.
Increased Sampling Flexibility: Member States are allowed to increase the number of primary samples based on their specific needs and requirements when checking the homogeneity of a batch.

Implementation

The regulation will come 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.

Commission Regulation (EU) 2024/2739 of 17 October 2024 establishing a fisheries closure for Mediterranean albacore in the Mediterranean Sea for vessels flying the flag of Spain

Commission Regulation (EU) 2024/2739 Overview

The Commission Regulation (EU) 2024/2739, adopted on 17 October 2024, establishes a fisheries closure specifically for Mediterranean albacore in the Mediterranean Sea, applicable to vessels flying the flag of Spain. This regulation is a direct response to the depletion of the allocated fishing quota for Spain for the year 2024.

Key Provisions

Article 1: Quota Exhaustion

Article 1 states that the fishing quota assigned to Spain for the Mediterranean albacore stock is considered exhausted. The exhaustion of this quota is effective from the date specified in the Annex of the regulation.

Article 2: Prohibitions

Article 2 outlines prohibitions on fishing activities concerning the Mediterranean albacore stock. It explicitly prohibits vessels registered in Spain from engaging in fishing activities for this stock from the date indicated in the Annex. Furthermore, it is forbidden for these vessels to retain on board, relocate, tranship, or land any fish from this stock caught after the specified date.

Article 3: Entry into Force

According to Article 3, this regulation will come into force the day after its publication in the Official Journal of the European Union. It is binding in its entirety and directly applicable across all Member States.

Annex Details

The Annex includes critical details regarding the regulation:

Member State: Spain
Stock: ALB/MED (including ALB/MED-BC and ALB/MED-SR)
Species: Mediterranean Albacore (Thunnus alalunga)
Zone: Mediterranean Sea
Closing date: 28 June 2024

This regulation reflects the European Commission’s commitment to sustainable fisheries management and compliance with the common fisheries policy, ensuring that fishing activities do not exceed the scientifically recommended limits for fish stocks.

Commission Regulation (EU) 2024/2730 of 17 October 2024 establishing a fisheries closure for Mediterranean albacore in the Mediterranean Sea for vessels flying the flag of Italy

Commission Regulation (EU) 2024/2730 Overview

The Commission Regulation (EU) 2024/2730, adopted on 17 October 2024, establishes a fisheries closure for Mediterranean albacore in the Mediterranean Sea specifically for vessels flying the flag of Italy. This regulation is a response to the reported exhaustion of the allocated fishing quota for this stock for the year 2024.

Key Provisions

Article 1 – Quota Exhaustion

This article declares that the fishing quota assigned to Italy for the Mediterranean albacore stock is considered exhausted as of the date indicated in the Annex of the regulation. This effectively means that Italy can no longer legally catch this species under the established quota for the remainder of the year.

Article 2 – Prohibitions

Under this article, all fishing activities targeting the Mediterranean albacore stock by Italian vessels are prohibited from the specified date in the Annex. This prohibition extends to retaining on board, relocating, transhipping, or landing any fish from this stock caught after the closure date. The intent is to ensure compliance with sustainable fishing practices and to protect the Mediterranean albacore population.

Article 3 – Entry into Force

This regulation enters into force the day after its publication in the Official Journal of the European Union, thereby ensuring prompt implementation of the fishing closure.

Annex Details

The Annex provides essential information regarding the closure, including:

Member State: Italy
Stock: ALB/MED (Mediterranean Albacore)
Species: Mediterranean Albacore (Thunnus alalunga)
Zone: Mediterranean Sea
Closing date: 21 September 2024

Overall, the regulation emphasizes the EU’s commitment to sustainable fisheries management by enforcing strict compliance with fishing quotas and protecting vulnerable fish stocks within its waters.

Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices

Commission Implementing Regulation (EU) 2024/2699 Overview

Article 1: Subject Matter

This Regulation establishes detailed procedural rules for cooperation between the Member State Coordination Group on Health Technology Assessment (the Coordination Group), the Commission acting as the HTA secretariat, and the European Medicines Agency (EMA). The cooperation encompasses:

Planning and forecasting of joint clinical assessments and joint scientific consultations.
Identification of patients, clinical experts, and other relevant experts for participation.
Exchange of information on horizontal scientific and technical matters related to joint activities.
Security measures for sharing and protecting confidential information exchanged between the EMA and the HTA secretariat, and subsequently with the Coordination Group and its subgroups.

Article 2: Information Exchange Related to Planning and Forecast

By April 30 each year, the EMA must provide the HTA secretariat with:

Medicinal Products:
- Upcoming submissions of initial marketing authorization applications, including details such as the active substance name, developer name, therapeutic indication summary, eligibility basis for centralised procedure, priority scheme eligibility, and expected submission dates covering the current and following year.
- Information on variations to existing marketing authorizations for new therapeutic indications planned by holders.
- Estimated number of advice procedures under Article 57(1)(n) of Regulation (EC) No 726/2004.
Medical Devices and In Vitro Diagnostic Medical Devices:
- Number of ongoing and finalized advice procedures initiated by manufacturers, including device type, intended purpose, medical indications, contraindications, target populations, and development phase.
- Estimated number of future advice requests from manufacturers.

Additionally, the EMA must provide updates relevant to the preparation of reports on emerging health technologies.

Article 3: Information Exchange Related to Selection of Medical Devices for Joint Clinical Assessment

The EMA is required to provide the HTA secretariat with information on:

All medical devices for which expert panels under Regulation (EU) 2017/745 have provided or intend to provide scientific opinions, including device name and type, manufacturer, notified body, expert panel decisions, and available scientific opinions.
All in vitro diagnostic medical devices under similar expert panel evaluations, including device name and type, manufacturer, notified body, and available expert panel views.

This information must be submitted no later than 15 days after the end of each quarter, starting from January 1, 2024.

Article 4: Information Exchange with the Coordination Group and Its Subgroups

Upon receiving information from the EMA:

The HTA secretariat must provide the relevant information to the EHT Subgroup or the Coordination Group for analysis and preparation of reports on emerging health technologies and the annual work programme.
The EHT Subgroup may consult the EMA through the HTA secretariat while preparing these reports.
Information related to the selection of medical devices for joint assessments must be provided to the Coordination Group or its relevant subgroups for recommendation purposes.

Article 5: Information Exchange on Identification of Individual Experts

The EMA must provide the HTA secretariat with information on potential experts, including names, contact details, and areas of expertise, upon request. The Regulation ensures:

Recording whether an expert is engaged in evaluations related to the same medicinal product or device within different procedures.
Protection of personal data in compliance with Regulation (EU) 2018/1725, including measures like pseudonymisation and access controls.
Retention of personal data for up to three years for experts not selected for joint work.

Article 6: Information Exchange on Horizontal Scientific and Technical Matters

The Coordination Group and its subgroups are tasked with exchanging scientific and technical information with the EMA on issues that affect joint clinical assessments and consultations, excluding the assessment of specific health technologies. The coordination may involve the HTA stakeholder network to enhance decision-making and knowledge sharing.

Article 7: Secure Exchange of Information

Information between the HTA secretariat and the EMA must be exchanged through the HTA IT platform, a secure system designed for this purpose. The exchange is governed by technical specifications that ensure effective technical and security measures for interfacing, access, and data processing.

Article 8: Protection of Confidential Information

Information received from the EMA must be used exclusively for joint assessments and consultations. The EMA must indicate the protection level of shared information, and the HTA secretariat must maintain at least an equivalent level of protection when sharing with the Coordination Group and its subgroups. Members must implement technical and organizational measures to safeguard confidentiality, limiting access to authorized individuals and reporting any breaches immediately.

Article 9: Failure to Respect Professional Secrecy

If a representative or individual expert breaches professional secrecy:

The Commission will notify the individual and request clarification within 14 days.
Failure to provide clarification may result in exclusion from joint work until the issue is resolved.
If intentional or grossly negligent, exclusion can last up to two years.
The HTA secretariat is responsible for informing relevant parties and enforcing the Commission’s decisions.

Article 10: Entry into Force

This Regulation enters into force 20 days after its publication in the Official Journal of the European Union and applies from January 12, 2025. It is binding and directly applicable in all Member States.[:]