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Overview of Recent EU Regulations
Commission Regulation (EU) 2024/2706
This regulation establishes a fisheries closure for Norway lobster in specific areas (8a, 8b, 8d, and 8e) applicable to vessels flagged or registered in Belgium, effective from 1 October 2024. The closure is implemented due to the exhaustion of the fishing quota allocated to Belgium for the year 2024. The regulation prohibits fishing for Norway lobster in the designated areas but allows for certain activities related to previously caught lobster. Any unintended catches must be recorded and counted against the quota. The regulation is binding across all EU Member States.
Commission Implementing Regulation (EU) 2024/2690
This regulation outlines detailed rules for implementing Directive (EU) 2022/2555, focusing on cybersecurity risk-management measures applicable to various service providers, including DNS service providers and cloud computing platforms. It specifies the technical and methodological requirements for these measures and defines criteria for significant incidents, such as financial loss or data breaches. The regulation includes tailored criteria for different service providers and mandates regular compliance assessments. It aims to enhance cybersecurity across the EU by ensuring robust risk-management practices.
Commission Implementing Regulation (EU) 2024/2694
This regulation authorizes magnesium L-threonate as a novel food in the EU and amends Implementing Regulation (EU) 2017/2470. It grants AIDP Inc. exclusive marketing rights for five years starting from November 7, 2024, and protects the scientific data submitted by the company. The regulation includes specific labelling requirements for food supplements containing magnesium L-threonate and establishes safety criteria, ensuring that the product meets defined standards before being available for sale within the EU.
Commission Implementing Regulation (EU) 2024/2692
This regulation amends Annexes I and VIII of Implementing Regulation (EU) 2021/620, addressing the approval or withdrawal of disease-free status for certain Member States regarding transmissible animal diseases. It details the withdrawal of disease-free status for regions in Italy and other Member States due to disease outbreaks and updates the status of several countries. The regulation also approves expanded eradication programmes in Spain, reinforcing the EU’s commitment to managing animal health effectively.
Commission Implementing Regulation (EU) 2024/2686
This regulation initiates an investigation into potential circumvention of anti-dumping measures on graphite electrode systems imported from China. It establishes procedures for registering imports and sets timelines for interested parties to submit evidence and requests. The regulation aims to determine whether existing anti-dumping measures are being circumvented and includes provisions for the investigation process, ensuring compliance and fair practices in trade.
Review of each of legal acts published today:
Commission Regulation (EU) 2024/2706 of 12 October 2024 establishing a fisheries closure for Norway lobster in areas 8a, 8b, 8d and 8e for vessels flying the flag of Belgium
Commission Regulation (EU) 2024/2706 Overview
The Commission Regulation (EU) 2024/2706, adopted on 12 October 2024, establishes a fisheries closure for Norway lobster in specific areas (8a, 8b, 8d, and 8e) for vessels flagged or registered in Belgium. This regulation is a response to the exhaustion of the fishing quota allocated to Belgium for the year 2024, as per the Council Regulation (EU) 2024/257.
Key Provisions
Article 1: Quota Exhaustion
This article states that the fishing quota assigned to Belgium for Norway lobster in the specified areas is considered exhausted from the date indicated in the Annex of the regulation.
Article 2: Prohibitions
- Fishing Prohibition: It is prohibited for vessels flying the Belgian flag or registered in Belgium to fish for Norway lobster in the designated areas from the date specified in the Annex. This includes searching for, shooting, setting, or hauling fishing gear aimed at capturing this stock.
- Other Activities: Activities such as transshipping, retaining on board, processing on board, transferring, caging, fattening, and landing fish and fishery products from Norway lobster caught prior to the closure date are still permitted.
- Unintended Catches: Any unintended catches of Norway lobster by these vessels must be recorded, retained on board, landed, and counted against quotas in accordance with Article 15 of Regulation (EU) No 1380/2013.
Article 3: Entry into Force
This regulation comes into force the day after its publication in the Official Journal of the European Union.
Legal Basis
The regulation is based on the Treaty on the Functioning of the European Union and specifically cites Council Regulation (EC) No 1224/2009, which establishes a control system for compliance with the common fisheries policy.
Annex Details
The Annex outlines specific details regarding the closure, including:
- Member State: Belgium
- Stock: NEP/8ABDE (Norway lobster – Nephrops norvegicus)
- Zones: 8a, 8b, 8d, and 8e
- Closing Date: 1 October 2024
This regulation is binding in its entirety and directly applicable in all Member States of the European Union.
Commission Implementing Regulation (EU) 2024/2690 of 17 October 2024 laying down rules for the application of Directive (EU) 2022/2555 as regards technical and methodological requirements of cybersecurity risk-management measures and further specification of the cases in which an incident is considered to be significant with regard to DNS service providers, TLD name registries, cloud computing service providers, data centre service providers, content delivery network providers, managed service providers, managed security service providers, providers of online market places, of online search engines and of social networking services platforms, and trust service providers
Commission Implementing Regulation (EU) 2024/2690
This regulation, adopted by the European Commission on 17 October 2024, establishes detailed rules for the application of Directive (EU) 2022/2555, specifically addressing the technical and methodological requirements for cybersecurity risk-management measures applicable to various service providers, including DNS service providers, cloud computing service providers, and social networking services platforms, among others. The regulation also specifies the conditions under which an incident shall be deemed significant.
Key Provisions
Article 1: Subject Matter
This article outlines the scope of the regulation, detailing the technical and methodological requirements of cybersecurity risk-management measures as specified in the annex and further clarifying the criteria for determining significant incidents.
Article 2: Technical and Methodological Requirements
The relevant entities are mandated to implement cybersecurity risk-management measures tailored to their specific exposure to risks, size, and incident likelihood. They must document any deviations from the prescribed requirements.
Article 3: Significant Incidents
This article sets forth the criteria for classifying incidents as significant, including thresholds for financial loss, potential harm to individuals, unauthorized access, and exfiltration of sensitive data. Scheduled maintenance interruptions are specifically exempted from this classification.
Incident Criteria
Significant incidents are defined through various criteria, such as:
- Direct financial loss exceeding EUR 500,000
- Death or considerable harm to a natural person
- Unauthorized access capable of causing severe operational disruption
Articles 4-14: Specific Incidents for Various Providers
These articles provide tailored criteria for determining significant incidents for different types of providers, including DNS service providers, cloud computing service providers, and social networking platforms. Each category has specific thresholds related to availability, response time, and data integrity.
Article 15: Repeal
This article repeals the earlier Commission Implementing Regulation (EU) 2018/151, which was previously applicable.
Article 16: Entry into Force and Application
The regulation shall enter into force twenty days following its publication in the Official Journal of the European Union and is binding in its entirety across all Member States.
Annex: Technical and Methodological Requirements
The annex elaborates on the technical and methodological requirements that relevant entities must adhere to, including:
- Establishment of a comprehensive policy on network and information systems security.
- Implementation of a risk management framework.
- Incident handling procedures, including monitoring and logging of activities.
- Business continuity and disaster recovery planning.
- Supply chain security policies.
- Access control management and employee security training.
Compliance and Reporting
Entities are required to regularly assess their compliance with the established cybersecurity measures and report significant incidents to the appropriate authorities within defined timeframes.
Summary
Ultimately, the regulation aims to enhance the cybersecurity posture of entities operating within the European Union by enforcing robust risk-management practices, ensuring a high level of security across various sectors, and providing clear guidelines on incident management and reporting.
Commission Implementing Regulation (EU) 2024/2694 of 17 October 2024 authorising the placing on the market of magnesium L-threonate as a novel food and amending Implementing Regulation (EU) 2017/2470
Commission Implementing Regulation (EU) 2024/2694 Overview
This regulation, adopted by the European Commission on October 17, 2024, authorizes the placing on the market of magnesium L-threonate as a novel food and amends the existing Implementing Regulation (EU) 2017/2470.
Key Provisions
Authorization of Magnesium L-Threonate
- Magnesium L-threonate is officially authorized for sale within the European Union.
- It will be included in the Union list of novel foods as per Implementing Regulation (EU) 2017/2470.
Exclusive Market Rights
- AIDP Inc. is granted exclusive rights to market magnesium L-threonate for a period of five years, starting from November 7, 2024.
- Other applicants may seek authorization for the same novel food, provided they base their applications on legally obtained information and do not reference the proprietary data protected under this regulation.
Protection of Scientific Data
- The scientific data submitted by AIDP Inc., including various studies on safety and bioavailability, are protected from use by other applicants for five years unless AIDP Inc. agrees to allow such use.
Labelling Requirements
- Food supplements containing magnesium L-threonate must include specific labelling stating that they are intended for adults only, excluding pregnant and lactating women.
- The product should be labelled as “Magnesium L-threonate”.
Specifications of Magnesium L-Threonate
- The novel food is produced via chemical synthesis and is characterized as a white powder.
- It must meet specific chemical identity criteria, including a defined molecular formula and weight.
- Microbiological criteria are established to ensure safety, including limits on total aerobic microbial counts and the absence of harmful bacteria such as E. coli and Salmonella.
Conclusion
This regulation establishes the legal framework for the commercialization of magnesium L-threonate within the EU, emphasizing the importance of safety assessments and proprietary rights in the context of novel food products.
Commission Implementing Regulation (EU) 2024/2692 of 17 October 2024 amending Annexes I and VIII to Implementing Regulation (EU) 2021/620 as regards the approval or withdrawal of the disease-free status of certain Member States or zones thereof as regards certain listed diseases and the approval of eradication programmes for certain listed diseases
Analysis of Commission Implementing Regulation (EU) 2024/2692
The Commission Implementing Regulation (EU) 2024/2692, adopted on 17 October 2024, amends Annexes I and VIII of the Implementing Regulation (EU) 2021/620. This regulation addresses the approval or withdrawal of disease-free status for certain Member States or zones regarding specific listed diseases, as well as the approval of eradication programmes for these diseases.
Key Provisions
The regulation primarily focuses on managing the disease-free status related to transmissible animal diseases, as established by Regulation (EU) 2016/429, and outlines the following key provisions:
1. Withdrawal of Disease-Free Status
It details the withdrawal of disease-free status for certain regions in Italy and several Member States due to outbreaks of diseases:
- Brucella abortus, B. melitensis, and B. suis: Following outbreaks in the province of Alessandria, Italy, the disease-free status for this region concerning these infections has been revoked.
- Bluetongue Virus (BTV): Outbreaks reported in Czechia, Denmark, Germany, Luxembourg, Austria, and Sweden have led to the withdrawal of disease-free status from these territories. Specific regions in Italy and Spain also faced similar actions due to BTV serotype outbreaks.
2. Amendments to Disease-Free Status Lists
The regulation amends the entries in Annexes I and VIII to reflect the current epidemiological situation:
- Updates to the disease-free status of Italy, removing the province of Alessandria from the list while maintaining other regions.
- For Czechia, Denmark, Germany, Luxembourg, Austria, and Sweden, the entries reflect the areas that are no longer considered disease-free due to reported outbreaks.
- Spain’s entry is updated to include specific areas affected by BTV, particularly in the autonomous community of Catalonia and the province of Huesca.
3. Approval of Eradication Programmes
Additionally, Spain has expanded its optional eradication programme for BTV to cover new territories, specifically the Balearic Islands and the province of Huesca. This expansion is officially recognized in the amendments to the regulation.
4. Implementation and Enforceability
The amendments take effect three days after publication in the Official Journal of the European Union, establishing immediate applicability across all Member States. This ensures that the measures are binding and enforceable, reinforcing the EU’s commitment to managing animal health and disease prevention effectively.
Conclusion
Commission Implementing Regulation (EU) 2024/2692 represents a crucial step in the ongoing management of animal diseases within the EU framework. By updating disease-free statuses and approving eradication programmes, the regulation aims to maintain the health of livestock and prevent the spread of infectious diseases across Member States.
Commission Implementing Regulation (EU) 2024/2686 of 17 October 2024 initiating an investigation concerning possible circumvention of the anti-dumping measures imposed by Implementing Regulation (EU) 2022/558 on imports of certain graphite electrode systems originating in the People’s Republic of China by imports of artificial graphite in blocks or cylinders originating in the People’s Republic of China and making such imports subject to registration
Commission Implementing Regulation (EU) 2024/2686
Date of Adoption: 17 October 2024
Subject: Investigation on Possible Circumvention of Anti-Dumping Measures on Graphite Electrode Systems from China
Article 1: Initiation of Investigation
An investigation is initiated under Article 13(3) of Regulation (EU) 2016/1036 to determine if imports of artificial graphite in blocks or cylinders from China are circumventing existing anti-dumping measures imposed by Implementing Regulation (EU) 2022/558.
Article 2: Registration of Imports
- Customs authorities of Member States must register the imports identified in Article 1.
- Registration will expire 9 months after the Regulation enters into force.
Article 3: Time-Limits for Interested Parties
- Interested parties must contact the Commission within 15 days from the Regulation’s entry into force.
- Submissions, including questionnaires and exemption requests, must be made within 37 days from publication in the Official Journal.
- Requests to be heard by the Commission must also be submitted within the same 37-day period, with specific provisions for initial stages.
Article 4: Entry into Force
The Regulation becomes effective the day after its publication in the Official Journal of the European Union and is directly applicable across all Member States.
Section A: Request
- The European Commission received a request on 4 September 2024 from the European Carbon and Graphite Association to investigate possible circumvention of anti-dumping measures on certain graphite electrodes from China.
Section B: Product
- Product Concerned: Graphite electrodes used in electric furnaces with specific density and resistivity, classified under CN code ex 8545 11 00.
- Product Under Investigation: Artificial graphite in blocks or cylinders with specified density and resistivity, classified under CN codes ex 3801 10 00 and ex 3801 90 00.
Section C: Existing Measures
- The existing anti-dumping measures are those imposed by Implementing Regulation (EU) 2022/558.
Section D: Grounds for Investigation
- The request provides sufficient evidence that existing measures are being circumvented by the import of the product under investigation.
- There has been a shift in trade patterns, with exports of the targeted product being replaced by the product under investigation due to assembly/completion operations in the Union.
- These practices undermine the remedial effects of the existing measures both in quantity and pricing, with evidence of injurious pricing and increased import volumes.
- Prices of the assembled/completed products in the Union are dumped compared to the normal value of the product concerned.
- The investigation may cover additional circumvention practices identified during its course.
Section E: Procedure
- The Commission has determined that there is sufficient evidence to start the investigation and subject the imports to registration.
- Interested parties must contact the Commission by the deadline set in Article 3(2).
- The authorities of China have been notified about the initiation of the investigation.
Subsection (a): Instructions for Submissions
- Information submitted must be free from third-party copyrights unless permission is obtained.
- All submissions requesting confidential treatment must be labeled ‘Sensitive’ and include non-confidential summaries.
- Parties must use TRON.tdi for submissions and provide accurate contact information for communication.
Subsection (b): Information Collection and Hearings
- All interested parties are invited to submit their views and evidence within the deadline.
- The Commission may hold hearings upon written requests from interested parties.
Subsection (c): Requests for Exemptions
- Importers not engaged in circumvention practices can apply for exemptions within the specified timeframe.
- Questionnaires and exemption forms are available for interested parties to submit their claims.
Section F: Registration
- Imports of the product under investigation must be registered to enable the imposition of anti-dumping duties if circumvention is confirmed.
Section G: Time-Limits
- Sets specific deadlines for interested parties to participate in the investigation process.
- Emphasizes the importance of adhering to time-limits for procedural rights.
Section H: Non-Cooperation
- If parties do not provide necessary information, the Commission may proceed based on available facts.
- Provision of false or misleading information will result in such information being disregarded.
- Partial cooperation may lead to less favorable outcomes for those parties.
Section I: Schedule of the Investigation
- The investigation must be concluded within 9 months from the Regulation’s entry into force.
Section J: Processing of Personal Data
- Personal data collected will be handled according to Regulation (EU) 2018/1725.
- A data protection notice is available on DG Trade’s website.
Section K: Hearing Officer
- Interested parties can request the intervention of a Hearing Officer for trade proceedings.
- The Hearing Officer manages requests related to file access, document confidentiality, time limits, and defense rights.
- Procedures for hearings and mediation are outlined, including requirements for timely and well-reasoned requests.
Conclusion
- All provisions aim to ensure a comprehensive investigation into the potential circumvention of existing anti-dumping measures on specific graphite products imported from China.
- The Regulation outlines detailed procedures, rights, and obligations for all involved parties to facilitate an effective and timely investigation.
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