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Review of the EU legislation for 21/11/2024

Here’s a concise review of the significant legal acts:

1. Poultry Import Restrictions

New restricted zones established around areas affected by avian influenza in Canada (6 zones), UK (1 zone), and USA (5 zones). The regulation sets 10km restriction zones around infected establishments and suspends poultry imports from these areas. Some previously restricted zones in Florida were reopened for trade.

2. Listeria Control Measures

Stricter controls for ready-to-eat foods regarding Listeria monocytogenes. New requirements include zero detection in 25g of food products and a 100 cfu/g limit where safety can be demonstrated. Implementation deadline is July 2026.

3. Air Quality Standards

New comprehensive framework merging previous directives with stricter limits for pollutants like PM2.5, PM10, and NO2 by 2030. Introduces monitoring ‘supersites’ and compensation mechanisms for health damage from air pollution.

4. Cyber Resilience Act

Establishes mandatory cybersecurity requirements for digital products, including 5-year minimum security updates, vulnerability handling, and incident reporting. Products are classified into risk categories with corresponding assessment procedures.

5. Chemical Classification and Labeling

Updates to CLP regulation including digital labeling requirements, new classification rules for substances, and stricter labeling specifications. Introduces provisions for refill stations and online sales with implementation periods from 2026-2029.

6. Dairy Cattle Feed Regulation

Introduces new feeding options for preventing calcium deficiency in dairy cows, including glycosylated 1,25-dihydroxycholecalciferol from Solanum glaucophyllum extract, with specific dosage and timing requirements.

Review of each of legal acts published today:

Commission Implementing Regulation (EU) 2024/2922 of 20 November 2024 amending Annexes V and XIV to Implementing Regulation (EU) 2021/404 as regards the entries for Canada, the United Kingdom 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

This Commission Implementing Regulation amends the rules for importing poultry, poultry products, and game birds from Canada, the United Kingdom, and the United States into the European Union. The changes are made in response to outbreaks of highly pathogenic avian influenza (HPAI) in these countries.The regulation modifies two annexes of Implementing Regulation (EU) 2021/404: Annex V concerning poultry and poultry germinal products, and Annex XIV regarding fresh meat of poultry and game birds. The changes establish new restricted zones around affected establishments and suspend imports from these areas.The main provisions include:

  • Addition of six new restricted zones in Canada (five in British Columbia and one in Saskatchewan)
  • Creation of a new restricted zone in Cornwall, England
  • Addition of five new restricted zones in the United States (in California, Montana, and Utah)
  • Reauthorization of imports from certain previously restricted zones in Florida, USA, where the situation has improved
  • Detailed geographical coordinates and descriptions of all new restricted zones

The regulation specifies exact coordinates and boundaries for each restricted zone, typically covering a 10km radius around infected establishments. It also sets specific dates for when restrictions begin and, in some cases, when they end. The measures are implemented with immediate effect to prevent the spread of HPAI while maintaining necessary trade flows.

Commission Regulation (EU) 2024/2895 of 20 November 2024 amending Regulation (EC) No 2073/2005 as regards Listeria monocytogenes

This Regulation amends the existing rules on microbiological criteria for foodstuffs, specifically focusing on Listeria monocytogenes control in ready-to-eat foods. The amendment comes as a response to a 15.9% increase in listeriosis cases in the EU in 2022 compared to 2021, with one of the highest death rates in the last decade.The Regulation introduces stricter control measures for ready-to-eat foods that can support the growth of Listeria monocytogenes. The main structural change is in Annex I, Chapter 1, where entry 1.2 is modified to establish new sampling plans, limits, and analytical reference methods for testing Listeria monocytogenes in food products.Key provisions include:

  • A requirement that Listeria monocytogenes must not be detected in 25g of ready-to-eat foods if producers cannot demonstrate that levels will stay below 100 cfu/g throughout shelf-life
  • A limit of 100 cfu/g for products where producers can prove levels will not exceed this threshold during shelf-life
  • New sampling plans requiring 5 samples with zero tolerance for positive results
  • Specific testing methods (EN/ISO 11290-1 and EN/ISO 11290-2) for different situations
  • Implementation deadline set for July 1, 2026, giving food business operators time to adapt their procedures

Commission Implementing Regulation (EU) 2024/2913 of 14 November 2024 laying down rules for the application of Regulation (EU) 2024/1143 of the European Parliament and of the Council as regards the approval of a Union amendment to the product specification of the protected designation of origin Toro

This Regulation approves an amendment to the product specification for the Spanish wine with Protected Designation of Origin (PDO) ‘Toro’. The act represents a technical implementation of the EU’s geographical indications framework for wines and agricultural products.The Regulation consists of two articles: Article 1 approves the amendment to the product specification for ‘Toro’ PDO that was previously published in the Official Journal, while Article 2 sets the standard entry into force provision (twentieth day following publication).The key aspects of this Regulation include:

  • The amendment application was submitted by Spain under the previous regulatory framework (Regulation 1308/2013)
  • No opposition was received during the prescribed period under Article 17 of Regulation 2024/1143
  • The amendment was processed under transitional provisions of the new Regulation 2024/1143 on geographical indications

Commission Regulation (EU) 2024/2899 of 20 November 2024 amending Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes

This Commission Regulation amends the existing list of intended uses of feed intended for particular nutritional purposes, specifically focusing on the reduction of milk fever and subclinical hypocalcaemia in dairy cows. The regulation introduces new feeding options and modifies existing requirements for preventing calcium deficiency-related conditions in dairy cattle.The regulation makes two main changes to Regulation (EU) 2020/354:

  • It adds glycosylated 1,25-dihydroxycholecalciferol from Solanum glaucophyllum extract as a new feeding option
  • It modifies the Dietary Cation Anion Difference (DCAD) requirements, allowing for negative values in the cations-anions balance

Key provisions of the regulation include:

  • Specific dosage requirements for the new Solanum glaucophyllum extract (15-80 μg per day)
  • Detailed timing for administration (from 9 days before calving to immediately before calving)
  • Mandatory calcium supplementation (minimum 60g per cow pre-calving, 84g during lactation)
  • Magnesium supplementation requirements (minimum 18g per cow pre-calving, 26g during lactation)
  • Modified DCAD values ranging from negative values to less than 100 mEq/kg dry matter

Directive (EU) 2024/2881 of the European Parliament and of the Council of 23 October 2024 on ambient air quality and cleaner air for Europe (recast)

This Directive establishes new EU-wide air quality standards and monitoring requirements to protect human health and the environment from air pollution. It aims to progressively improve air quality to levels no longer harmful by 2050, aligning with WHO guidelines.The Directive merges and updates two previous directives (2004/107/EC and 2008/50/EC) into a single comprehensive framework. Key structural elements include: setting limit values and target values for major air pollutants; requirements for air quality assessment and monitoring; obligations for air quality management and planning; and provisions for public information and reporting.The main provisions include:- New stricter limit values for key pollutants like PM2.5, PM10, NO2 to be achieved by 2030- Requirements for extensive air quality monitoring, including new monitoring ‘supersites’- Obligations for Member States to develop air quality plans when standards are exceeded- Enhanced requirements for public information and access to justice- New provisions on compensation for health damage from air pollutionThe Directive introduces several important changes compared to previous legislation:- More stringent air quality standards aligned with WHO guidelines- New monitoring requirements for emerging pollutants like ultrafine particles- Stronger provisions on access to justice and compensation- Enhanced requirements for public information and air quality indices- New focus on protecting sensitive populations and vulnerable groupsThe most significant practical requirements relate to:- Meeting the new limit values for pollutants by specified deadlines- Establishing comprehensive air quality monitoring networks- Developing and implementing air quality plans when standards are exceeded- Providing public information on air quality- Ensuring access to justice and compensation mechanisms

Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) No 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (Text with EEA relevance)

The Cyber Resilience Act (CRA) is a comprehensive EU regulation establishing cybersecurity requirements for products with digital elements (hardware and software) to ensure their security throughout the lifecycle and protect consumers from cyber risks.The regulation introduces mandatory essential cybersecurity requirements for manufacturers, including vulnerability handling, security updates, and incident reporting. It establishes conformity assessment procedures and market surveillance mechanisms to verify compliance.Key provisions include:

  • Mandatory security requirements for digital products before market placement
  • Obligations for manufacturers to handle vulnerabilities and provide security updates during a defined support period (minimum 5 years)
  • Requirements to report serious incidents and actively exploited vulnerabilities
  • Classification of products into different risk categories (regular, important Class I/II, critical) with corresponding conformity assessment procedures
  • Market surveillance framework and penalties for non-compliance

The regulation aims to improve the cybersecurity of digital products in the EU market by setting clear requirements for manufacturers while ensuring transparency for users regarding security properties and updates. It introduces a comprehensive framework covering the entire lifecycle of digital products from design to end-of-support.

Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)

This is a comprehensive amendment to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. The key aspects include:The regulation introduces several major changes to the existing CLP framework:

  • New requirements for digital labeling and online sales of chemicals, including mandatory supplier information and digital label elements
  • Updated rules for classification of multi-constituent substances and mixtures, with specific provisions for plant-derived substances
  • New harmonized classification requirements for endocrine disruptors, persistent/bioaccumulative/toxic substances, and other hazard classes
  • Stricter labeling requirements including minimum font sizes, spacing, and formatting specifications
  • New provisions for refill stations and unpackaged chemicals

The structure includes:

  • 39 amendments to the main regulation text
  • 4 annexes with detailed technical requirements
  • Transitional periods ranging from 2026-2029 for different provisions

Key provisions that may require immediate attention:

  • Requirement for EU-based suppliers for all chemicals placed on the market
  • New mandatory hazard communication elements for advertisements and online sales
  • Updated classification rules requiring review of existing substance classifications
  • Stricter labeling format requirements with specific dimensions and font sizes
  • New provisions for digital labeling and refill stations requiring technical adaptations

Notice concerning the entry into force of the Agreement between the European Union and the European Space Agency on the security and exchange of classified information

This is a notice about the entry into force of the Agreement between the EU and European Space Agency (ESA) regarding the security and exchange of classified information. The Agreement establishes a formal framework for protecting and sharing sensitive information between these two organizations. The Agreement was signed in Brussels on 22 May 2024 and entered into force on 1 November 2024, after completing all necessary procedures by October 30, 2024. The document is registered under reference number 2024/2920 in the Official Journal of the European Union. The main purpose of this Agreement is to establish procedures and standards for the secure exchange of classified information between the EU and ESA, ensuring proper protection of sensitive data shared between these organizations. This creates a legal basis for deeper cooperation in space-related activities where confidential information needs to be exchanged.

EFTA Surveillance Authority communication pursuant to Article 17(5) of Regulation 1008/2008 of the European parliament and of the Council on common rules for the operation of air services in the Community – Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations

This is a communication from EFTA Surveillance Authority regarding a tender for operating scheduled air services on specific routes in Iceland under public service obligations. The document outlines the conditions for operating air services between Reykjavík and two destinations: Gjögur and Bíldudalur.The act is structured as a standard tender announcement, containing essential information about the routes, contract duration, submission deadlines, and contact details for obtaining further documentation. The tender is organized by Vegagerðin (The Icelandic Road and Coastal Administration).Key provisions of the act include:
– Two specific flight routes: Reykjavík-Gjögur-Reykjavík and Reykjavík-Bíldudalur-Reykjavík
– Contract duration of three years (November 1, 2025 – October 31, 2028) with a possible two-year extension
– Two-month submission period from the publication date in the Official Journal
– Detailed tender documentation available through the Icelandic Road and Coastal Administration
– Operation under public service obligations according to Regulation 1008/2008

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