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Review of the EU legislation for 24/02/2025

Here are the key points from the reviewed legal acts:
Plant Pests Regulation:
Removes Leucinodes pseudorbonalis from the EU’s prohibited pest list. Lists four prohibited pests until May 31, 2027: Chloridea virescens, Homona magnanima, Resseliella citrifrugis, and Spodoptera ornithogalli. Each pest now has an EPPO code for clear identification.
Feed Additives Authorization:
Authorizes Lactococcus lactis DSM 34262 as a silage additive for all animal species. Requires minimum concentration of 3 × 10¹¹ CFU/g and specific dose of 1×10⁸ CFU/kg fresh material. Valid until March 2035.
Grapevine Pest Control Areas:
Updates demarcated areas for Grapevine flavescence dorée containment in eight countries. Adds new areas in France and Italy, extends existing zones in Croatia, Portugal, and Slovenia. Creates buffer zones in Austria and Spain.
Feed Additive Renewal:
Renews authorization for Levilactobacillus brevis DSM 16680 as silage additive until March 2035. Requires minimum 2.5 × 10¹⁰ CFU/g concentration and specific dose when used alone.
Food Supplements Amendment:
Adds calcidiol monohydrate to permitted vitamin D sources in food supplements. Must comply with novel food regulations and specific conditions.
Cattle Feed Additive:
Authorizes Saccharomyces cerevisiae CNCM I-4407 for cattle fattening until March 2035. Requires minimum 5 × 109 CFU/g of viable yeast cells.
Health Claim Rejection:
Refuses authorization for health claim linking Appethyl® (spinach extract) to weight reduction due to insufficient scientific evidence.
Plastic Food Contact Materials:
Introduces stricter purity requirements for substances in plastic food contact materials. Updates rules for reprocessing, testing, and documentation requirements.
Food Import Authorization:
Updates third-country authorization lists for fishery and animal product exports to EU. Removes several countries’ authorizations and adds new approvals for specific products.
Border Control Checks:
Modifies frequency rates for plant and agricultural product inspections at EU borders. Sets new rates ranging from 1% to 75% based on risk assessment and product category.

Review of each of legal acts published today:

Commission Implementing Regulation (EU) 2025/356 of 21 February 2025 amending Implementing Regulation (EU) 2022/1941 as regards the prohibition of introduction, movement, holding, multiplication or release of certain pests

The essence of the act:
This Commission Implementing Regulation amends the previous Regulation (EU) 2022/1941 regarding the prohibition of certain plant pests in the EU territory. The main change is the removal of the pest Leucinodes pseudorbonalis from the list of prohibited pests, based on a scientific assessment that showed its very low risk to the EU territory. The regulation also introduces a more structured format for identifying pests by including EPPO (European and Mediterranean Plant Protection Organization) codes and expiry dates for prohibitions.

Structure and main provisions:
1. The regulation consists of two main articles and an annex:
– Article 1 amends the previous regulation by updating the prohibition rules and replacing the annex
– Article 2 sets the entry into force
– The Annex provides a new list of prohibited pests with their EPPO codes and prohibition expiry dates

2. The new annex now lists four prohibited pests:
– Chloridea virescens Fabricius
– Homona magnanima Dyakonov
– Resseliella citrifrugis Jiang
– Spodoptera ornithogalli Guenée
All prohibitions are valid until May 31, 2027

Most important provisions:
1. The prohibition covers multiple aspects of pest handling: introduction, movement, holding, multiplication, and release in the EU territory
2. Each listed pest is now clearly identified with its EPPO code for better reference and identification
3. The regulation establishes specific expiry dates for prohibitions, making it clearer when these measures need to be reviewed
4. The removal of Leucinodes pseudorbonalis demonstrates that prohibitions can be lifted when scientific evidence shows low risk levels
5. The regulation maintains a unified approach to pest control across all EU member states through direct applicability

Commission Implementing Regulation (EU) 2025/359 of 21 February 2025 concerning the authorisation of a preparation of Lactococcus lactis DSM 34262 as a feed additive for all animal species

This Commission Implementing Regulation authorizes the use of Lactococcus lactis DSM 34262 as a feed additive for all animal species. The preparation is classified as a technological additive in the functional group of silage additives, which helps improve the production of silage from fresh plant material.

Structure and main provisions:
1. The regulation consists of two main articles and a detailed annex specifying the conditions of use:
– Article 1 establishes the authorization
– Article 2 sets the entry into force
– The Annex provides detailed technical specifications and conditions

The key provisions include:
– The preparation must contain a minimum of 3 × 10¹¹ CFU/g of Lactococcus lactis DSM 34262
– The minimum dose when used alone is 1×10⁸ CFU/kg fresh material
– The additive is approved for use with plant material having 30% to 35% dry matter content
– The authorization is valid until March 16, 2035
– Specific safety measures for handlers are required due to potential skin and respiratory sensitization risks

Most important provisions for use:
1. The additive is authorized for all animal species without age restrictions
2. It must be used only with easy and moderately difficult to ensile fresh plant material
3. Specific storage conditions must be indicated on the product
4. When used as a cryoprotectant, polyethylene glycol (PEG 4000) is limited to 0.025 mg/kg silage
5. Users must implement safety procedures and use protective equipment when handling the additive

Commission Implementing Regulation (EU) 2025/358 of 21 February 2025 amending Implementing Regulation (EU) 2022/1630 as regards the list of demarcated areas for containment of Grapevine flavescence dorée phytoplasma

Here’s a detailed analysis of Commission Implementing Regulation (EU) 2025/358:

1. Essence of the act (3-5 sentences):
This regulation amends Implementing Regulation (EU) 2022/1630 regarding the list of demarcated areas for containment of Grapevine flavescence dorée phytoplasma, a quarantine pest affecting grapevines. The regulation updates the list of areas where the pest is present and where containment measures must be applied. It extends the geographical scope of containment measures to new areas in France (Nouvelle-Aquitaine), Italy (Tuscany and Lombardy), and modifies existing demarcated areas in Croatia, Portugal, and Slovenia.

2. Structure and main provisions:
– The regulation consists of two main articles and one extensive annex
– Article 1 replaces the entire Annex I of Regulation 2022/1630 with a new version
– Article 2 sets the entry into force
– The new Annex I provides detailed lists of demarcated areas in 8 countries:
* Austria (buffer zones due to Slovenia’s demarcation)
* Croatia (two infected zones and buffer zones)
* France (two infected zones and buffer zones)
* Hungary (buffer zones due to Croatia and Slovenia)
* Italy (two infected zones and buffer zones)
* Portugal (one infected zone and buffer zones)
* Slovenia (three infected zones and buffer zones)
* Spain (buffer zones due to Portugal)

3. Most important provisions:
– The regulation establishes new demarcated areas in France (Nouvelle-Aquitaine region) and Italy (Tuscany and Lombardy) where eradication is no longer possible
– It enlarges existing containment areas in Croatia, Portugal, and Slovenia to include more municipalities
– Buffer zones of demarcated areas in Slovenia are extended to Austria
– Buffer zones of Portuguese demarcated areas in Spain are revised
– The regulation provides precise geographical delimitation of infected zones and corresponding buffer zones for each affected area
– All listed areas must implement containment measures as specified in Regulation 2022/1630

Commission Implementing Regulation (EU) 2025/353 of 21 February 2025 concerning the renewal of the authorisation of a preparation of Levilactobacillus brevis DSM 16680 as a feed additive for all animal species and amending Implementing Regulation (EU) No 399/2014

The act concerns the renewal of authorization for using Levilactobacillus brevis DSM 16680 as a feed additive for all animal species. This is a technological additive specifically used as a silage additive, which has been previously authorized for 10 years under different identification (formerly Lactobacillus brevis DSMZ 16680).

Structure and main provisions:
1. The regulation consists of 4 articles and an annex, which details the specific conditions for the additive’s use.
2. The European Food Safety Authority confirmed the safety of the preparation for animals, consumers, and environment, though noting it should be considered an eye irritant and potential skin/respiratory sensitizer.
3. The authorization is renewed until March 16, 2035, with specific conditions outlined in the Annex.
4. The regulation includes transitional measures allowing products produced and labeled before March 16, 2026, to remain on the market until stocks are exhausted.

Key provisions for implementation:
1. The preparation must contain a minimum of 2.5 × 10¹⁰ CFU/g additive.
2. When used alone (not in combination with other microorganisms), the minimum dose should be 1 × 10⁸ CFU/kg fresh material.
3. Storage conditions must be clearly indicated in the directions for use.
4. Users must implement protective measures due to potential risks, including using personal protective equipment for skin, eyes, and breathing when necessary.
5. Specific analytical methods are prescribed for enumeration and identification of the additive.

Commission Regulation (EU) 2025/352 of 21 February 2025 amending Directive 2002/46/EC of the European Parliament and of the Council as regards calcidiol monohydrate used in the manufacture of food supplements

The Commission Regulation (EU) 2025/352 amends Directive 2002/46/EC by adding calcidiol monohydrate to the list of permitted vitamin and mineral substances that can be used in food supplements. This amendment follows the European Food Safety Authority’s scientific opinion confirming the safety of calcidiol monohydrate as a source of vitamin D in food supplements.

Structure and main provisions:
– The regulation consists of two main articles and an annex
– Article 1 introduces the amendment to Annex II of Directive 2002/46/EC
– Article 2 establishes the entry into force
– The Annex specifically adds calcidiol monohydrate as entry (c) under point A.2. (VITAMIN D) in Annex II of the Directive
– The change adds a new form of vitamin D that can be used in food supplement manufacturing, alongside existing forms like ergocalciferol

Key provisions for practical use:
1. Calcidiol monohydrate becomes a legally permitted source of vitamin D in food supplements
2. Its use must comply with conditions set in Commission Implementing Regulation (EU) 2024/1052
3. The substance must be listed in the Union list of novel foods according to Regulation (EU) 2017/2470
4. The regulation is directly applicable in all EU Member States without need for national implementation
5. Manufacturers can use this new form of vitamin D in food supplements once the regulation enters into force (20 days after publication)

Commission Implementing Regulation (EU) 2025/364 of 21 February 2025 concerning the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle for fattening (holder of authorisation: S.I. Lesaffre) and amending Regulation (EC) No 316/2003

The Commission Implementing Regulation (EU) 2025/364 authorizes the use of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle fattening. This yeast preparation is classified as a zootechnical additive in the functional group of gut flora stabilizers. The regulation grants authorization to S.I. Lesaffre as the holder and amends the previous Regulation (EC) No 316/2003.

Structure and main provisions:
1. The regulation consists of 4 articles and an annex detailing technical specifications:
– Article 1 establishes the authorization
– Article 2 amends previous regulation
– Article 3 sets transitional measures
– Article 4 determines entry into force
2. The annex provides detailed technical requirements including minimum content (4 × 109 CFU/kg), composition requirements, analytical methods, and safety measures.
3. Key changes include updated identification of the strain (previously known as NCYC Sc 47) and new specific requirements for storage, stability, and safety measures.

Most important provisions for practical use:
– The preparation must contain minimum 5 × 109 CFU/g of viable yeast cells
– Specific storage conditions and heat treatment stability must be indicated in usage directions
– Users must implement safety procedures and use protective equipment when handling
– Transitional periods allow using existing stocks: until September 2025 for additives and premixtures, and until March 2026 for compound feed
– The authorization is valid until March 16, 2035
– Regular monitoring of quality and safety parameters is required through specified analytical methods

Commission Regulation (EU) 2025/350 of 21 February 2025 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health

The essence of the act:
This Commission Regulation refuses to authorize a specific health claim related to Appethyl® (a spinach leaf extract) and its alleged ability to help reduce body weight. The decision is based on the European Food Safety Authority’s (EFSA) scientific assessment, which found no established cause-and-effect relationship between the product’s consumption and weight reduction under the proposed conditions of use.

Structure and main provisions:
1. The regulation consists of two articles and an annex:
– Article 1 states that the health claim will not be included in the EU list of permitted claims
– Article 2 establishes the entry into force
– The Annex contains details of the rejected claim

2. The regulation’s preamble includes 10 recitals explaining:
– The legal basis for health claims regulation
– The application process
– The EFSA assessment procedure
– The specific case of Appethyl®
– The consultation process with Member States

Most important provisions for use:
1. The regulation explicitly prohibits the use of the specific health claim “Appethyl® helps your body weight reduction during mild caloric restriction” on food products in the EU market.

2. While EFSA confirmed that Appethyl® itself is sufficiently characterized as a food constituent, the scientific evidence provided did not demonstrate its effectiveness for weight reduction.

3. The decision reinforces the principle that health claims must be scientifically substantiated before they can be used in food marketing within the EU, with scientific evidence being the main aspect considered for authorization.

4. The regulation applies directly in all EU Member States, meaning that food business operators across the EU cannot use this specific health claim in their marketing or labeling.

Commission Regulation (EU) 2025/351 of 21 February 2025 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, amending Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008, and amending Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food as regards recycled plastic and other matters related to quality control and manufacturing of plastic materials and articles intended to come into contact with food

The essence of the act in 3-5 sentences:
This Commission Regulation amends three existing regulations related to plastic materials and articles intended for food contact: Regulation (EU) No 10/2011, Regulation (EU) 2022/1616, and Regulation (EC) No 2023/2006. It introduces more stringent requirements for the purity of substances used in plastic food contact materials, establishes clearer rules for reprocessing plastic manufacturing by-products, and sets detailed requirements for quality control and testing procedures. The regulation also updates provisions regarding repeated use of plastic materials, labeling requirements, and compliance documentation.

Structure and main provisions:
1. Amendments to Regulation (EU) No 10/2011:
– New definitions and clarifications regarding additives and UVCB substances
– Introduction of “high degree of purity” requirements
– Updated rules for reprocessing of plastic materials
– New provisions for repeated use and labeling
– Enhanced requirements for compliance testing and documentation

2. Amendments to Regulation (EU) 2022/1616:
– Clarification of requirements for recycled plastic materials
– Specification of quality control measures

3. Amendments to Regulation (EC) No 2023/2006:
– New requirements for quality assurance systems
– Detailed rules for reprocessing of plastic materials
– Enhanced traceability requirements

Most important provisions for use:
1. High purity requirements: Substances used in plastic food contact materials must meet strict purity criteria, with detailed specifications for assessment and documentation.

2. Reprocessing rules: Clear guidelines for collecting and handling plastic manufacturing by-products, including separation, containment, and traceability requirements.

3. Testing and compliance: Enhanced specifications for migration testing and compliance verification, including detailed mathematical formulas and criteria for evaluating test results.

4. Documentation requirements: Expanded obligations for documentation of compliance, including information about substances used, their purity, and presence of non-intentionally added substances.

5. Labeling obligations: New requirements for providing instructions about repeated use, including guidance on preventing deterioration and identifying signs of material degradation.

Commission Implementing Regulation (EU) 2025/354 of 21 February 2025 amending Implementing Regulation (EU) 2021/405 as regards the lists of third countries with an approved control plan and the lists of third countries authorised for the entry into the Union of certain fishery products

The essence of the act in 3-5 sentences:
This Regulation amends the EU rules regarding the lists of third countries authorized to export certain fishery products and food-producing animals to the EU. It updates the lists of countries that have approved control plans for monitoring pharmacologically active substances, pesticides and contaminants in food products. The act specifically modifies permissions for various countries regarding exports of products like milk, eggs, honey, aquaculture products and other animal-derived foods.

Structure and main provisions:
1. The regulation modifies Implementing Regulation (EU) 2021/405 by:
– Replacing Annex -I with new updated lists of authorized countries
– Amending Annex IX regarding specific provisions for Armenia
2. Key changes include:
– Removal of authorizations for several countries (Belize, Cuba, Honduras, Nigeria, Tunisia) due to failure to submit required evidence
– New approvals (Brazil for eggs, Kazakhstan for honey)
– Modifications of existing authorizations (Singapore for aquaculture products)
– Removal of authorizations for countries no longer interested in exports (UAE and Pitcairn Islands for honey)

Most important provisions for use:
1. The regulation establishes clear marking system for different types of products:
– ‘X’ for approved control plans
– ‘O’ for intention to export composite products
– ‘Δ’ for specific conditions
2. Each country’s authorization is product-specific and can include limitations or specific conditions
3. The changes affect various product categories including:
– Aquaculture products
– Milk and dairy
– Eggs and egg products
– Honey
– Meat products
4. The regulation includes detailed tables specifying exactly which products each country can export to the EU

: The regulation includes specific provisions regarding Ukraine, maintaining its authorization to export various products including bovine, porcine, poultry, aquaculture products, milk, eggs, rabbit, and honey to the EU.

Commission Implementing Regulation (EU) 2025/355 of 21 February 2025 amending Implementing Regulation (EU) 2022/2389 concerning the establishment of frequency rates for identity checks and physical checks on consignments of plants, plant products and other objects entering the Union

The act establishes new rules for checking plants, plant products, and other objects entering the European Union through border control posts. It modifies the frequency rates for identity and physical checks of various agricultural products, focusing on specific categories like cut flowers, fruits, vegetables, and used machinery from different countries of origin. The regulation aims to ensure proper phytosanitary control while optimizing the inspection process based on risk assessment.

The structure of the act consists of two main articles and an annex. Article 1 amends the previous Regulation 2022/2389 by modifying Article 4(4) regarding exceptions to frequency rates and replacing Annex I with new frequency rates. Article 2 sets the entry into force date (20 days after publication) and application date (March 1, 2025). The Annex provides detailed tables with specific frequency rates for different products and their countries of origin.

Key provisions include:
– Reduced frequency rates for certain products like cut flowers from Ecuador, fruits from European third countries, and used machinery
– Increased checks for specific products with higher risk, such as cut flowers from Zimbabwe and fruits from Cameroon
– New approach to frequency rates for plants subject to specific EU entry requirements
– Detailed categorization of products with corresponding inspection frequencies (ranging from 1% to 75%)
– Risk-based methodology considering factors like pest mobility, previous non-compliance cases, and trade patterns
– Special attention to certain categories like Citrus fruits, Malus (apples), and Prunus (stone fruits) from various origins

: The regulation includes specific provisions for products from Ukraine, classifying it among European third countries with specific frequency rates for fruits like Malus (10%), Prunus (3%), Pyrus (10%), and Vaccinium (50%).

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