Review of the EU legislation for 07/02/2025

Here’s a concise review of the key legal acts:
1. Authorization for ‘Neporex 2SG’ insecticide:
The EU authorizes this cyromazine-based product for professional use in animal housing to control house fly larvae from 2025 to 2035. The authorization includes specific application rates for different animal facilities and strict safety measures.
2. Technical provisions for insurance companies:
Sets mandatory technical parameters for insurance and reinsurance companies, including risk-free interest rates, fundamental spreads, and volatility adjustments for December 2024 – March 2025.
3. Poultry import restrictions:
Modifies entry authorization for poultry products from Canada, UK, and US due to avian influenza outbreaks. Suspends imports from affected zones in Ontario, England, and nine US states while reauthorizing imports from recovered areas.
4. African swine fever control measures:
Updates restricted zones in EU member states following new ASF outbreaks in Polish regions. Redefines control zones in multiple countries including Germany, Estonia, Latvia, and others.
5. Greek bluefin tuna fishing:
Reopens bluefin tuna fishing for Greek vessels in specific Atlantic and Mediterranean zones, following quota exchanges with other Member States.
6. Late payment ruling:
Court determines that payment periods exceeding 60 days cannot be unilaterally imposed in business transactions and must be expressly agreed by both parties.
7. EU funds limitation periods:
Court rules that limitation periods for EU fund irregularities must start when irregularity occurs, not when discovered, while allowing Member States to set longer periods.
8. EEA marketing authorizations:
Lists new, renewed, extended, and withdrawn marketing authorizations for medicinal products in Iceland, Liechtenstein, and Norway for first half of 2024.
9. Dangerous substances authorizations:
Details authorization decisions for hazardous chemicals in EEA EFTA states, covering substances like chromium compounds and trichloroethylene.
10. Biocidal products authorizations:
Lists authorizations for various biocidal products in EEA EFTA states, including hydrogen peroxide and chlorine-based products.

Review of each of legal acts published today:

Commission Implementing Regulation (EU) 2025/221 of 6 February 2025 granting a Union authorisation for the single biocidal product Neporex 2SG in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

This Commission Implementing Regulation grants a Union authorization for the biocidal product ‘Neporex 2SG’ containing cyromazine as the active substance. The product is authorized for use as an insecticide to control house fly larvae in animal housing facilities. The authorization is valid from February 27, 2025 until January 31, 2035.The regulation consists of two main parts: the authorization decision and a detailed Annex containing the Summary of Product Characteristics (SPC). The SPC provides comprehensive information about administrative details, product composition, hazard statements, and specific use instructions. The authorization was granted following an application by Elanco Animal Health Inc. and evaluation by German competent authorities and the European Chemicals Agency.Key provisions include:

• The product is authorized for professional use only in animal housing facilities
• Specific application rates and frequencies are set for different types of animal facilities (e.g., maximum 5 applications per year for dairy cows, 1 application for pigs)
• Detailed instructions for application in different types of animal housing systems (deep litter, slatted floors, etc.)
• Strict risk mitigation measures including mandatory use of protective equipment
• Environmental protection measures prohibiting discharge into sewage systems or waters
• Storage conditions and shelf-life specifications (60 months)

Commission Implementing Regulation (EU) 2025/216 of 6 February 2025 laying down technical information for the calculation of technical provisions and basic own funds for reporting with reference dates from 31 December 2024 until 30 March 2025 in accordance with Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance

This is a Commission Implementing Regulation laying down technical information for calculating technical provisions and basic own funds for insurance and reinsurance companies under Solvency II directive for the period from December 31, 2024 to March 30, 2025.The regulation provides three key types of technical information that insurance and reinsurance companies must use:

• Risk-free interest rate term structures
• Fundamental spreads for calculating the matching adjustment
• Volatility adjustments for different currencies and national insurance markets

The regulation consists of 2 articles and 3 annexes:
– Article 1 defines the scope and types of technical information to be used
– Article 2 sets the entry into force and application dates
– Annex I contains detailed risk-free interest rate term structures
– Annex II provides fundamental spreads for matching adjustment calculations
– Annex III lists volatility adjustments for different currencies and marketsThe key provisions include:
– Mandatory use of this technical information by all insurance and reinsurance companies for the specified period
– Detailed tables of risk-free rates for different currencies and maturities up to 150 years
– Specific fundamental spreads based on credit quality steps and durations
– Currency and country-specific volatility adjustments

Commission Implementing Regulation (EU) 2025/267 of 4 February 2025 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 Annexes V and XIV to Implementing Regulation (EU) 2021/404 regarding the authorization of entry into the EU of poultry, poultry products and game birds from Canada, the United Kingdom and the United States.The regulation makes changes to the lists of authorized zones in these countries due to outbreaks of highly pathogenic avian influenza (HPAI). It suspends imports from newly affected areas and reauthorizes imports from areas where the disease situation has been resolved.The main changes include:

• Suspension of imports from a new affected zone in Ontario, Canada following an HPAI outbreak confirmed on January 10, 2025
• Suspension of imports from 5 new zones in England (UK) following HPAI outbreaks confirmed between December 31, 2024 and January 28, 2025
• Suspension of imports from 17 new zones across 9 US states following HPAI outbreaks confirmed between January 21-24, 2025
• Reauthorization of imports from previously restricted zones in all three countries where HPAI outbreaks have been successfully controlled

The regulation provides detailed geographical coordinates and descriptions of all affected zones, along with specific dates of restrictions and authorizations. It modifies both the lists of zones authorized for poultry/germinal products (Annex V) and fresh meat (Annex XIV).

Commission Implementing Regulation (EU) 2025/268 of 4 February 2025 amending Annex I to Implementing Regulation (EU) 2023/594 laying down special disease control measures for African swine fever

This is a Commission Implementing Regulation amending Annex I to Regulation (EU) 2023/594 regarding special disease control measures for African swine fever (ASF). The regulation updates the restricted zones I, II and III in various EU member states where special control measures for ASF apply. The main changes include: – New outbreaks of ASF were detected in wild boar in Poland (Pomorskie, Kujawsko-Pomorskie and Świętokrzyskie regions) in January 2025, requiring adjustments to restricted zones The regulation contains detailed lists of municipalities and areas in different member states that are classified as restricted zones I, II or III based on ASF risk level. The main provisions include:

• Redefinition of restricted zone boundaries in Poland to account for new outbreaks
• Detailed geographic descriptions of restricted areas in Germany, Estonia, Latvia, Lithuania, Hungary, Poland, Slovakia, Italy, Czechia, Greece and Croatia
• Classification of areas into three risk zones (I, II, III) with corresponding control measures

Commission Regulation (EU) 2025/262 of 2 February 2025 reopening the fishery for bluefin tuna in the Atlantic Ocean, east of 45° W, and Mediterranean by vessels flying the flag of Greece, by repealing Regulation (EU) 2024/3250

This Regulation reopens the fishery for bluefin tuna in specific areas of the Atlantic Ocean and Mediterranean for Greek vessels. It reverses a previous closure that was implemented in November 2024 due to quota exhaustion, as Greece has obtained additional fishing opportunities through quota exchanges with other Member States.The act consists of two main articles and an annex. Article 1 establishes the reopening of the fishery and repeals the previous closure regulation. Article 2 sets the entry into force and retroactive application from December 9, 2024. The Annex provides specific details about the reopening, including the stock code, species, and geographical zones affected.Key provisions include:
– The reopening applies specifically to vessels flying the flag of Greece
– The affected areas are the Atlantic Ocean east of 45° W and the Mediterranean Sea
– The reopening is retroactively effective from December 9, 2024
– The regulation covers bluefin tuna (Thunnus thynnus) fishing
– Special conditions are included under stock code BFT/AE45WM

Judgment of the Court (Third Chamber) of 6 February 2025.Przedsiębiorstwo Produkcyjno – Handlowo – Usługowe A. v P. S.A.Reference for a preliminary ruling – Combating late payment in commercial transactions – Directive 2011/7/EU – Commercial transactions between undertakings – Article 3(5) – Obligation on Member States to ensure that the period for payment set in the contract concluded between undertakings does not exceed 60 calendar days – Possibility, for contracting parties, to set a longer period for payment – Condition for the express agreement in the contract of such a period – Condition that a contractual term is not grossly unfair to the creditor – Cumulative conditions – Contracts in which the terms are determined unilaterally by one of the parties – Contractual term by which the debtor unilaterally sets the period for payment of 120 days – Unlawfulness.Case C-677/22.

This judgment concerns the interpretation of Directive 2011/7/EU on combating late payment in commercial transactions, specifically regarding payment periods between businesses.The Court ruled on whether a payment period longer than 60 calendar days can be unilaterally imposed by one party. The case involved a dispute between two Polish companies where one party unilaterally set 120-day payment terms.The key provisions analyzed are:

• Article 3(5) of Directive 2011/7 which sets a general 60-day maximum payment period unless otherwise expressly agreed
• Two cumulative conditions for extending beyond 60 days: express agreement in contract and not being grossly unfair to creditor
• Requirements for what constitutes valid ‘express agreement’ between parties

The Court determined that:

• A payment period over 60 days cannot be unilaterally imposed by one party
• There must be clear evidence that both parties expressed their concurrence to be specifically bound by the longer payment term
• This can be satisfied through individual negotiation or clear highlighting of the term in standard contracts
• The term must also not be grossly unfair to the creditor, considering all circumstances

This judgment is particularly significant for protecting smaller businesses from having unfair payment terms imposed on them by larger companies in stronger negotiating positions.

Judgment of the Court (Sixth Chamber) of 6 February 2025.Emporiki Serron AE – Emporias kai Diathesis Agrotikon Proionton v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Agrotikis Anaptyxis kai Trofimon.Reference for a preliminary ruling – Protection of the European Union’s financial interests – Regulation (EC, Euratom) No 2988/95 – Irregularities – Article 3 – Limitation period – Duration and starting point of that period – National legislation providing for a five-year limitation period as from the time the irregularity is discovered.Case C-42/24.

This judgment concerns the interpretation of limitation periods for proceedings related to irregularities affecting the EU’s financial interests under Regulation No 2988/95.The case arose from a dispute in Greece regarding the recovery of EU agricultural funds from a company that received financial support in 2001 but was found to have irregularities during inspections in 2006. The key question was whether national legislation could set different rules about when the limitation period starts running.The Court ruled on two main aspects:

• While Member States can set longer limitation periods than the 4 years provided in EU law, they cannot change the starting point of when the period begins running. The period must start from when the irregularity was committed, not when it was discovered.
• When a Member State sets a longer limitation period, the absolute limitation period (after which no action can be taken) should be twice that longer period, not twice the standard 4-year EU period.

The judgment emphasizes that allowing limitation periods to start only when irregularities are discovered would create excessive legal uncertainty for operators and could encourage administrative inertia. It reinforces that limitation periods must provide legal certainty while allowing reasonable time for authorities to act against irregularities affecting EU funds.

Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the first half of 2024

This document is a comprehensive list of marketing authorizations for medicinal products in the European Economic Area (EEA) EFTA States (Iceland, Liechtenstein, and Norway) for the first half of 2024.The document consists of five annexes listing different categories of marketing authorizations: new authorizations (Annex I), renewed authorizations (Annex II), extended authorizations (Annex III), withdrawn authorizations (Annex IV), and suspended authorizations (Annex V).The main provisions include:

• Detailed listings of medicinal products with their EU registration numbers, product names, countries of authorization, and authorization dates
• Over 60 new marketing authorizations were granted during this period
• About 80 marketing authorizations were renewed
• Around 25 marketing authorizations were extended with new variations
• Approximately 30 marketing authorizations were withdrawn
• No marketing authorizations were suspended during this period

Each entry contains specific information about the product’s registration status in different EEA EFTA countries, allowing for tracking of the authorization status across these jurisdictions.

Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) 1907/2006 (REACH) in the first half of 2024

This document presents a comprehensive list of authorisation decisions for dangerous substances taken by EEA EFTA States (Iceland, Liechtenstein, and Norway) during the first half of 2024, in accordance with Article 64(8) of REACH Regulation. The decisions concern various hazardous chemicals including chromium compounds, trichloroethylene, and other industrial substances.The act is structured as a table listing authorisation decisions, organized by substance name, Commission decision reference number, country of application, and date of decision. Each substance may have multiple entries as the same authorization decision often applies to all three EEA EFTA states separately.Key substances covered by these authorizations include:

• Chromium trioxide and related compounds
• Sodium dichromate
• Trichloroethylene (TCE)
• 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)
• 1,2-dichloroethane (EDC)
• Bis(2-methoxyethyl)ether

Most decisions were taken between January and June 2024, with Iceland typically deciding on February 13, Liechtenstein in January or May-June, and Norway in January or May-June 2024.

Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 44(5) of Regulation (EU) 528/2012 in the first half of 2024

This is a list of authorisation decisions for dangerous substances taken by the EEA EFTA States (Iceland, Liechtenstein, and Norway) during the first half of 2024. The document is based on Article 44(5) of Regulation (EU) 528/2012 concerning the making available on the market and use of biocidal products.The document consists of a single annex containing a detailed table of authorisation decisions. The table includes information about biocidal product names, corresponding Union authorisation decisions, countries that issued the authorizations, and specific dates of decisions.The list covers authorisations for several biocidal products, including:

• Hydrogen peroxide-based products (Evonik’s Product Family)
• Various lime-based products (EuLA hydra-lime, EuLA oxi-lime, Nordkalk products)
• Chlorine-based products (PPC Chlorine liquid, GHC Chlor)
• Other specialized products like AEROCLEAN and Thonhauser PAA

Key aspects of the document include:

• All authorizations were issued between January 1 and June 30, 2024
• Each product received separate authorizations from different EEA EFTA countries
• The decisions are based on existing EU regulations for biocidal products
• Most products received authorizations from all three EEA EFTA states, with some exceptions