Review of the EU legislation for 23/01/2025

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

Plant Protection and Active Substances:

• Approval of several low-risk substances for plant protection: Betabaculovirus phoperculellae, Bacillus subtilis RTI477, Bacillus velezensis RTI301, and Pythium oligandrum B301, all valid from February 2025
• Approval of grape seed extract as a basic substance for use as fungicide on specific crops
• Extension of approval periods for 25 active substances used in plant protection products

Geographical Indications:

• Registration of ‘Jidvei’ as a Protected Designation of Origin (PDO)
• Registration of ‘Silifke Yoğurdu’ as a Protected Geographical Indication (PGI)

Major Regulatory Changes:

• New comprehensive regulation on packaging and packaging waste, introducing mandatory recyclability requirements, recycled content targets, and reuse obligations
• New rules for firearms import/export/transit measures, establishing authorization systems and controls
• Amendment to isomalto-oligosaccharide specifications as novel food, extending its authorized uses
• Modification of maximum residue levels for fluxapyroxad, lambda-cyhalothrin, metalaxyl and nicotine in various food products

Financial Ruling:

• Court judgment on calculation of Single Resolution Fund contributions, confirming use of N-2 year financial data

Review of each of legal acts published today:

Commission Implementing Regulation (EU) 2025/103 of 22 January 2025 approving the active substance Betabaculovirus phoperculellae as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011

This Regulation approves Betabaculovirus phoperculellae (formerly known as Phthorimaea operculella granulovirus) as a low-risk active substance for use in plant protection products. The approval is valid from February 12, 2025, to February 12, 2040. The substance belongs to the Baculoviridae family and has been confirmed to have no adverse effects on non-target insects.The Regulation consists of three articles and two annexes. Article 1 approves the active substance, Article 2 amends the list of approved substances in Regulation 540/2011, and Article 3 sets the entry into force. Annex I specifies the conditions for approval, while Annex II adds the substance to the list of approved active substances in Part D of Regulation 540/2011.Key provisions include specific requirements for:

• Protection of operators and workers through mandatory personal protective equipment due to potential sensitizing properties of microorganisms
• Strict maintenance of environmental conditions and quality control during manufacturing
• Adherence to microbiological contamination limits as per OECD standards
• Implementation of risk mitigation measures where necessary

Commission Implementing Regulation (EU) 2025/116 of 16 January 2025 on the registration of the geographical indication Jidvei (PDO) in the Union register of geographical indications pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council

This Regulation registers the geographical indication ‘Jidvei’ as a Protected Designation of Origin (PDO) in the EU register of geographical indications. The registration follows Romania’s application and ensures legal protection of this designation at the EU level.The act consists of two main articles: Article 1 establishes the registration of ‘Jidvei’ as a PDO in the Union register, while Article 2 sets the standard entry into force provision (twentieth day following publication). The regulation is based on the new framework Regulation (EU) 2024/1143 on geographical indications.The key aspects of this regulation are:

• The application was originally submitted by Romania under the previous legal framework (Regulation 1308/2013)
• No opposition was received during the prescribed period
• The registration provides full EU-wide protection for the ‘Jidvei’ geographical indication
• The protection is granted under the PDO category, which is the highest level of geographical indication protection in the EU

Commission Implementing Regulation (EU) 2025/106 of 22 January 2025 approving the active substance Bacillus subtilis strain RTI477 as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

This Commission Implementing Regulation approves Bacillus subtilis strain RTI477 as a low-risk active substance for use in plant protection products within the European Union. The approval is valid from February 12, 2025, until February 12, 2040, and sets specific conditions for its use and implementation.The regulation consists of three main articles and two annexes. Article 1 approves the active substance, Article 2 amends the existing Implementing Regulation (EU) No 540/2011 to include this new substance, and Article 3 establishes the entry into force. Annex I details the specific provisions and conditions for the substance’s use, while Annex II adds the substance to the list of approved active substances.Key provisions include:

• The substance is classified as low-risk as it has not demonstrated multiple resistance to anti-microbials used in human or veterinary medicine
• Special attention must be paid to operator and worker protection, as microorganisms are considered potential sensitizers
• Strict environmental conditions and quality control during manufacturing must be maintained
• Adequate personal protective equipment must be used
• Member States must ensure adherence to microbiological contamination limits as per OECD standards

Commission Implementing Regulation (EU) 2025/112 of 16 January 2025 on the registration of the geographical indication Silifke Yoğurdu (PGI) in the Union register of geographical indications pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council

This Commission Implementing Regulation registers the geographical indication ‘Silifke Yoğurdu’ as a Protected Geographical Indication (PGI) in the European Union register of geographical indications. The registration was requested by the Silifke Chamber of Commerce and Industry from Türkiye.The regulation consists of two articles: Article 1 establishes the registration of ‘Silifke Yoğurdu’ as a PGI, while Article 2 sets the entry into force of the regulation on the twentieth day following its publication in the Official Journal of the EU.The registration process followed the standard procedure where the application was first published in the Official Journal of the EU, and no opposition was received during the designated period. The registration was processed under the new Regulation (EU) 2024/1143, which governs geographical indications for wine, spirit drinks, and agricultural products.The key provision of this regulation is the formal recognition and protection of ‘Silifke Yoğurdu’ as a geographical indication within the EU market. This means that only yogurt produced in the Silifke region according to specified requirements can be marketed under this name in the EU.

Commission Implementing Regulation (EU) 2025/109 of 22 January 2025 approving the active substance Bacillus velezensis strain RTI301 as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011

This Commission Implementing Regulation approves Bacillus velezensis strain RTI301 as a low-risk active substance for use in plant protection products within the European Union. The approval is valid from February 12, 2025, until February 12, 2040, and sets specific conditions for its use and manufacturing.The regulation consists of three articles and two annexes. Article 1 approves the active substance, Article 2 amends the list of approved substances in Regulation 540/2011, and Article 3 sets the entry into force. Annex I details the specific provisions for approval, while Annex II adds the substance to the official list of approved active substances.Key provisions include:
– Confirmation that Bacillus velezensis RTI301 meets safety criteria and qualifies as a low-risk substance
– Special attention must be paid to operator and worker protection due to potential sensitizing properties
– Strict requirements for manufacturing process quality control and environmental conditions
– Mandatory use of adequate personal protective equipment
– Need for adherence to microbiological contamination limits as per OECD standards

Commission Implementing Regulation (EU) 2025/102 of 21 January 2025 approving the active substance Pythium oligandrum B301 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011

This Commission Implementing Regulation approves the active substance Pythium oligandrum B301 for use in plant protection products within the European Union. The approval is valid from February 11, 2025, to February 10, 2035, following an application submitted by Biovitis S.A. and extensive assessment procedures.The regulation consists of three articles and two annexes. Article 1 approves the active substance, Article 2 amends the list of approved substances in Regulation 540/2011, and Article 3 sets the entry into force. Annex I details the conditions of approval, while Annex II adds the substance to the existing list of approved active substances.Key provisions include specific requirements for protecting operators and workers, as microorganisms are considered potential sensitizers. The regulation mandates strict environmental conditions and quality control during manufacturing to ensure compliance with microbiological contamination limits. Producers must maintain adequate personal protective equipment as a condition of use, and Member States must implement appropriate risk mitigation measures.The approval is based on extensive scientific assessment, including evaluation by the European Food Safety Authority and review by Member States. The substance was found to meet all approval criteria for at least one representative use of plant protection products containing it.

Regulation (EU) 2025/41 of the European Parliament and of the Council of 19 December 2024 on import, export and transit measures for firearms, essential components and ammunition, implementing Article 10 of the United Nations Protocol against the illicit manufacturing of and trafficking in firearms, their parts and components and ammunition, supplementing the United Nations Convention against Transnational Organised Crime (UN Firearms Protocol) (recast)

This Regulation establishes rules for import, export and transit measures for firearms, essential components and ammunition in the European Union. It implements Article 10 of the UN Firearms Protocol aimed at preventing illicit manufacturing and trafficking of firearms. The act introduces a comprehensive system of authorizations and controls for civilian firearms trade with non-EU countries.The Regulation consists of 6 chapters and 5 annexes covering: general provisions and definitions; import requirements; export requirements; supervision and controls; administration and cooperation; and final provisions. Key structural elements include detailed procedures for import/export authorizations, marking requirements, deactivation standards, and establishment of an electronic licensing system.The main provisions include:

• Mandatory import and export authorizations for firearms, components and ammunition
• Strict marking and traceability requirements
• Controls on deactivated firearms and alarm/signal weapons
• Creation of an EU-wide electronic licensing system
• Enhanced cooperation between customs and competent authorities
• Detailed record-keeping and statistical reporting obligations
• Post-shipment verification procedures
• Criminal record checks for authorization applicants

Commission Implementing Regulation (EU) 2025/96 of 21 January 2025 approving the basic substance Vitis vinifera L. seed extract (grape seed extract) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

This Commission Implementing Regulation approves grape seed extract (Vitis vinifera L. seed extract) as a basic substance for use in plant protection as a fungicide. The approval allows its use on grapevines, apples, potatoes and lettuce. The substance has been confirmed to meet safety requirements and is already used as a food supplement and feed additive.The regulation consists of three articles and two annexes. Article 1 approves grape seed extract as a basic substance, Article 2 amends the list of approved substances in Regulation 540/2011, and Article 3 sets the entry into force. Annex I specifies the conditions for approval, while Annex II details the amendments to the list of approved substances.Key provisions include:

• The substance must have a minimum content of 75% of Oligomeric proanthocyanidins on the anhydrous basis
• The approval becomes effective from February 11, 2025
• The substance must be used in accordance with specific conditions detailed in the review report PLAN/2024/800 RR rev3
• The approval is based on scientific evaluation by the European Food Safety Authority and multiple safety assessments
• The substance is confirmed not to be of concern regarding endocrine disrupting, neurotoxic, or immunotoxic effects

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (Text with EEA relevance)

This is a comprehensive new EU Regulation on packaging and packaging waste that aims to harmonize requirements across the EU and improve environmental sustainability of packaging. Key aspects include:1. The Regulation establishes requirements for the entire lifecycle of packaging regarding environmental sustainability, labelling, extended producer responsibility, waste prevention, reuse/refill, and waste management. It aims to improve packaging circularity and reduce packaging waste while ensuring free movement of compliant packaging in the EU internal market.2. The Regulation introduces several major changes compared to previous legislation:- Mandatory recyclability requirements for all packaging by 2030- Minimum recycled content targets for plastic packaging- Reuse and refill targets for certain packaging types- Restrictions on unnecessary packaging and certain packaging formats- Harmonized labeling requirements- Deposit return systems for beverage containers- New extended producer responsibility obligations3. Key provisions that will significantly impact packaging include:- All packaging must be recyclable by 2030 and meet minimum recyclability performance grades- Plastic packaging must contain minimum levels of recycled content by 2030/2040- Mandatory reuse targets for transport packaging and certain beverage containers- Restrictions on excessive packaging and certain single-use formats- Requirements for deposit return systems for beverage containers- Harmonized labeling to facilitate proper waste sorting- New producer registration and reporting obligations

Commission Implementing Regulation (EU) 2025/97 of 21 January 2025 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the specifications of the novel food isomalto-oligosaccharide

This Regulation amends the conditions of use and specifications for isomalto-oligosaccharide as a novel food in the EU. It extends the authorized uses of this ingredient to various food categories including ice cream, coffee, tea, sweeteners, baked goods, cereals, sauces, and food supplements. The regulation also establishes specific maximum levels for each food category.The act consists of 4 articles and an annex that modifies Implementing Regulation (EU) 2017/2470. The main changes include new conditions of use, additional specifications including microbiological parameters, and data protection provisions. The regulation grants exclusive marketing rights to BioNeutra North America Inc. for 5 years.Key provisions include:

• Maximum levels for different food categories (e.g., 8% for ice cream, 10% for instant coffee/tea, 20% for cakes)
• 10g/day limit for food supplements for population over 10 years of age
• Mandatory labeling requirements indicating it’s a source of glucose
• Detailed specifications for both powder and syrup forms including purity criteria and microbiological limits
• 5-year data protection period for the scientific studies supporting the authorization

Commission Implementing Regulation (EU) 2025/99 of 21 January 2025 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Aureobasidium pullulans (strains DSM 14940 and DSM 14941), Bacillus amyloliquefaciens subsp. plantarum D747, benalaxyl-M, cyprodinil, dichlorprop-P, formetanate, fosetyl, halosulfuron-methyl, imazamox, milbemectin, phenmedipham, pirimicarb, Pseudomonas sp. strain DSMZ 13134, pyrimethanil, pyriofenone, pyroxsulam, spinosad, sulphur, Trichoderma harzianum Rifai strains T-22 and ITEM 908, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T-25 and TV-1, Trichoderma atroviride (formerly T. harzianum) strain T11, Trichoderma gamsii (formerly T. viride) strain ICC080, triticonazole and ziram

This Commission Implementing Regulation amends Regulation (EU) No 540/2011 regarding the extension of approval periods for multiple active substances used in plant protection products.The regulation extends the approval periods for 25 active substances including various microorganisms, chemical compounds and natural substances used as pesticides, fungicides and plant protection products. The extensions range from 15 to 29 months beyond their current expiration dates.The extensions are needed because the risk assessment and renewal procedures for these substances could not be completed before their approval periods expire. The delays are due to various factors including additional time needed for assessment of approval criteria, pending evaluations, and remaining procedural steps.

Key provisions:

• 29-month extensions are granted for 7 substances where risk assessments are not yet finalized
• 19.5-month extensions are given for 12 substances requiring additional assessment time
• 22.5-month extensions apply to 2 substances needing evaluation of additional information
• 15.5-month extensions are provided for 4 substances awaiting Standing Committee opinions

The regulation specifies that if a substance’s approval is not renewed, the Commission will set the expiry date as either the date of that decision or the original expiry date, whichever is later. For renewed approvals, the Commission will set appropriate application dates based on circumstances.

Commission Regulation (EU) 2025/115 of 21 January 2025 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fluxapyroxad, lambda-cyhalothrin, metalaxyl, and nicotine in or on certain products

This regulation amends the maximum residue levels (MRLs) for four pesticide substances in food products:The regulation modifies existing MRLs for fluxapyroxad, lambda-cyhalothrin, metalaxyl and nicotine in various food products. The changes include both increases and decreases of existing limits based on new scientific data and risk assessments.The key changes include new MRLs for fluxapyroxad in persimmons and cultivated fungi, lambda-cyhalothrin in avocados and poultry products, metalaxyl in pineapples and dried ginseng, and nicotine in coffee beans.

Structure and Main Provisions:

• The regulation consists of 16 recitals explaining the scientific and legal basis for the changes
• Two main articles amending Annexes II and III of Regulation (EC) No 396/2005
• Detailed tables listing new MRLs for hundreds of food products
• Footnotes providing important details about monitoring requirements and data gaps

Key Technical Details:

• Sets temporary MRLs for lambda-cyhalothrin in poultry products at 0.03 mg/kg and eggs at 0.02 mg/kg
• Establishes new import tolerance for lambda-cyhalothrin in avocados at 0.15 mg/kg
• Adopts Codex MRLs for metalaxyl in certain products
• Sets a temporary MRL of 0.05 mg/kg for nicotine in coffee beans
• Includes detailed requirements for additional data submission to address scientific uncertainties

Judgment of the General Court (Tenth Chamber, Extended Composition) of 22 January 2025.Banco Cooperativo Español, SA v Single Resolution Board.Economic and Monetary Union – Banking union – Single Resolution Mechanism for credit institutions and certain investment firms (SRM) – Single Resolution Fund (SRF) – Decision of the SRB on the calculation of the ex ante contributions for the 2019 contribution period – Articles 12 and 14 of Delegated Regulation (EU) 2015/63 – Concept of ‘change of status’ – Institutional protection scheme – Plea of illegality.Case T-498/19.

This judgment concerns a dispute between Banco Cooperativo Español and the Single Resolution Board (SRB) regarding the calculation of ex-ante contributions to the Single Resolution Fund (SRF) for 2019. The key issue was whether the bank’s participation in an Institutional Protection Scheme (IPS) in 2018 should be taken into account when calculating its 2019 contribution. The bank argued that this change in status should be considered, while the SRB maintained it could only use information from approved financial statements from 2017. The Court ruled that under Delegated Regulation 2015/63, the SRB correctly based its calculations on financial information from 2017 (N-2 year) and was not required or permitted to consider the bank’s IPS participation that occurred in 2018. The Court found this approach was justified by the need for reliable calculations based on approved financial statements. The main provisions analyzed were Articles 12 and 14 of Delegated Regulation 2015/63, which establish the reference dates and information requirements for calculating SRF contributions. The Court confirmed these provisions comply with the underlying Directive 2014/59 requirements regarding risk-adjusted contributions and consideration of IPS participation. The Court dismissed the bank’s action entirely and ordered it to pay costs.