Review of the EU legislation for 22/01/2025

1. Pesticide MRLs Update

The regulation modifies maximum residue levels for four pesticides in food:
– Fluxapyroxad: New limits for persimmons and cultivated fungi
– Lambda-cyhalothrin: 0.03 mg/kg for poultry products, 0.02 mg/kg for eggs, 0.15 mg/kg for avocados
– Metalaxyl: New limits for pineapples and dried ginseng
– Nicotine: 0.05 mg/kg temporary limit for coffee beans

2. Isomalto-oligosaccharide Authorization

The regulation expands allowed uses of isomalto-oligosaccharide in foods with specific limits:
– Ice cream: 8%
– Breakfast cereals: 10%
– Food supplements: 10g/day maximum (restricted for children under 10)
– New microbiological specifications added
– Mandatory “source of glucose” labeling

3. Grape Seed Extract Approval

Approves grape seed extract as fungicide for:
– Grapevines
– Apples
– Potatoes
– Lettuce
Requires minimum 75% oligomeric proanthocyanidins content

4. Packaging and Waste Regulation

New comprehensive rules requiring:
– All packaging recyclable by 2030
– Minimum recycled content in plastic packaging
– Mandatory reuse/refill targets
– Deposit return systems for beverages
– Harmonized waste sorting labels

5. Active Substances Extension

Extends approval periods for 25 plant protection substances:
– 29 months for 7 substances
– 19.5 months for 12 substances
– 22.5 months for 2 substances
– 15.5 months for 4 substances

6. Anti-dumping Duties on Lever Arch Mechanisms

Maintains duties on Chinese imports:
– 27.1% for DongGuan Humen
– 47.4% for other Chinese companies
Based on findings of potential market disruption if duties were removed.

7. Biocidal Product Correction

Adds missing product characteristics for ClearKlens wipes:
– Contains 63.1% propan-2-ol
– Authorized for professional/industrial use
– Valid until December 31, 2034
– Three specific authorized uses for surface disinfection

8. Poultry Import Restrictions

Modifies import rules due to avian influenza:
– New restrictions for zones in Ontario, UK, and 14 US states
– Lifted restrictions for British Columbia
– Detailed geographical restrictions for affected areas

9. Novel Food Authorization

Review of each of legal acts published today:

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

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, and food supplements. The regulation also establishes specific maximum levels for each food category and adds new microbiological parameters to the specifications.The regulation consists of 4 articles and an annex that modifies Implementing Regulation (EU) 2017/2470. The main changes include:- Adding new food categories where isomalto-oligosaccharide can be used- Setting maximum usage levels for each category (ranging from 2.5% to 100%)- Establishing a 10g/day limit for food supplements- Adding new microbiological specifications- Granting 5-year data protection rights to BioNeutra North America Inc.Key provisions include:- Mandatory labeling requirements indicating it is a ‘source of glucose’- Restriction on food supplements use for children under 10 years- Maximum levels for different food categories (e.g., 8% for ice cream, 10% for breakfast cereals)- Detailed specifications for both powder and syrup forms- Microbiological criteria including limits on total aerobic count, yeasts and molds- Requirements for absence of E.coli and Salmonella- Heavy metals limits for lead and arsenic (≤0.5 mg/kg)

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 specific crops including 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 existing 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
• Usage must comply with specific conditions detailed in the review report PLAN/2024/800 RR rev3
• The substance has been confirmed not to be of concern regarding endocrine disrupting, neurotoxic, or immunotoxic effects
• Scientific evaluations from EFSA’s FEEDAP Panel and NDA Panel have been considered in the approval process

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- Mandatory reuse and refill targets for certain sectors- 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- Reuse targets for transport packaging, beverage packaging and other formats- Bans on certain single-use packaging formats- Mandatory deposit return systems for beverage containers- Requirements for packaging minimization and reduction of empty space- Harmonized labeling system for sorting of packaging waste

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 regulation’s entry into force date or the previous expiry date, whichever is later. For renewed approvals, the Commission will set the earliest feasible application date.

Commission Implementing Regulation (EU) 2025/98 of 14 January 2025 on the registration of the traditional speciality guaranteed Arroz de Sarrabulho à moda de Ponte de Lima (TSG) in the Union register of traditional specialities guaranteed pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council

This Commission Implementing Regulation registers ‘Arroz de Sarrabulho à moda de Ponte de Lima’ as a Traditional Speciality Guaranteed (TSG) in the European Union register. The registration follows Portugal’s application and ensures protection of this traditional dish at the EU level.The regulation consists of two main articles. Article 1 formally enters the ‘Arroz de Sarrabulho à moda de Ponte de Lima’ into the Union register of traditional specialities guaranteed. Article 2 establishes that the regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.The key aspects of this regulation include:

• The application was originally submitted under the previous Regulation (EU) No 1151/2012 but processed under the new Regulation (EU) 2024/1143
• No opposition statements were received during the prescribed period
• The registration provides EU-wide protection for this traditional Portuguese dish
• The regulation is binding in its entirety and directly applicable in all Member States

Commission Implementing Regulation (EU) 2025/100 of 20 January 2025 imposing a definitive anti-dumping duty on imports of lever arch mechanisms originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council

This is a Commission Implementing Regulation imposing definitive anti-dumping duties on imports of lever arch mechanisms (LAM) from China following an expiry review.The regulation maintains existing anti-dumping duties of 27.1% for one Chinese producer (DongGuan Humen) and 47.4% for all other Chinese companies, after finding a likelihood of recurrence of dumping and injury if measures were allowed to lapse.The key findings include:

• Chinese producers have significant spare production capacity that exceeds twice the total EU consumption
• The EU market remains attractive due to its size (45% of world market) and higher prices
• Chinese export prices to third countries were found to be 58% below normal value and would likely undercut EU prices by 27% without duties
• The EU industry remained profitable with the measures in place but would likely suffer material injury if duties were removed

The main provisions include:

• Detailed methodology for calculating normal value using Turkey as an analogue country due to market distortions in China
• Requirements for valid commercial invoices to apply individual duty rates
• Provisions for name changes of companies benefiting from individual rates
• Rules on interest payments for reimbursements following court judgments

The regulation entered into force the day after publication and is binding in its entirety across all EU Member States.

Commission Implementing Regulation (EU) 2025/118 of 14 January 2025 on the registration of the geographical indication Oli de Menorca / Aceite de Menorca (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 ‘Oli de Menorca / Aceite de Menorca’ (olive oil from Menorca) as a Protected Geographical Indication (PGI) in the EU register of geographical indications. The registration follows Spain’s application and ensures legal protection of this product name across the European Union.The regulation consists of two main articles. Article 1 formally enters the geographical indication into the Union register, while Article 2 establishes 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, which replaced the previous Regulation (EU) No 1151/2012.Key aspects of this regulation include:
– The application was originally submitted under the previous regulation but processed under the new rules
– No opposition was received during the prescribed period
– The protection applies immediately across all EU Member States
– The registration grants exclusive rights to use the name ‘Oli de Menorca / Aceite de Menorca’ for olive oil meeting the specified requirements from this geographical area

Commission Implementing Regulation (EU) 2025/86 of 20 January 2025 correcting Implementing Regulation (EU) 2024/2189 as regards the summary of the biocidal product characteristics

This Regulation corrects Commission Implementing Regulation (EU) 2024/2189 by adding the missing Summary of Product Characteristics (SPC) for the biocidal product ‘ClearKlens wipes based on IPA’. The correction is retroactively applicable from September 24, 2024, as the SPC defines essential terms and conditions for market availability and use of this product.The Regulation consists of two articles and an extensive Annex containing the detailed SPC. The first article adds the SPC as an Annex to the previous regulation, while the second article establishes the entry into force and retroactive applicability.The SPC provides comprehensive information about the biocidal product, including:

• Administrative information (trade names, authorization holder, manufacturers)
• Product composition and formulation details
• Hazard and precautionary statements
• Three specific authorized uses with detailed instructions:
  • Hard surface disinfection by wiping
  • Hard surface disinfection by mopping
  • Equipment and small surfaces disinfection by wiping
• General directions for use, including safety measures, storage conditions, and disposal instructions

The product contains 63.1% propan-2-ol as the active substance and is authorized for professional and industrial use in various facilities including laboratories, cleanrooms, pharmaceutical manufacturing facilities, hospitals, and medical practices. The authorization is valid until December 31, 2034.

Commission Implementing Regulation (EU) 2025/125 of 20 January 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 the rules for importing poultry, poultry products, and game birds from Canada, the United Kingdom, and the United States into the European Union due to outbreaks of highly pathogenic avian influenza (HPAI) in these countries.The regulation modifies Annexes V and XIV of Implementing Regulation (EU) 2021/404, which contain lists of third countries and territories authorized to export poultry and poultry products to the EU. The changes reflect new restrictions on imports from specific zones where HPAI outbreaks occurred, as well as the lifting of previous restrictions in certain Canadian regions where the situation has improved.The main changes include:

• Suspension of imports from new restricted zones in Ontario (Canada), Norfolk and Angus (UK), and 24 outbreaks across 14 US states
• Reauthorization of imports from previously restricted zones in British Columbia (Canada) where appropriate control measures were implemented
• Detailed geographical descriptions of all new restricted zones with specific coordinates and affected municipalities
• Updated timelines for restrictions and authorizations for different types of poultry products from each affected zone

The regulation provides precise technical details about the affected geographical areas, including GPS coordinates and municipality names, and specifies exactly which types of poultry and poultry products are subject to restrictions in each zone. It also establishes clear dates for when restrictions begin and, where applicable, when they are lifted.

Commission Regulation (EU) 2025/104 of 14 January 2025 establishing a fisheries closure for common sole in areas 7h, 7j and 7k for vessels flying the flag of Belgium

This Commission Regulation establishes a fisheries closure for common sole in specific areas of EU waters (7h, 7j and 7k) for Belgian vessels. The regulation is enacted because Belgium has exhausted its allocated fishing quota for common sole in these areas for 2024.The regulation consists of three main articles and an annex. Article 1 declares the quota exhaustion, Article 2 sets out specific prohibitions and requirements, and Article 3 deals with the entry into force. The annex provides specific details about the closure, including the affected areas and species.Key provisions include:
– Complete prohibition of fishing for common sole by Belgian vessels in the specified areas from December 19, 2024
– Ban on searching for fish, shooting, setting, or hauling fishing gear for this stock
– Permission to process and land catches taken prior to the closure date
– Requirement to record and count unintended catches against quotas
– Obligation to bring and retain unintended catches on board and land them in accordance with EU regulations

Commission Implementing Regulation (EU) 2025/92 of 20 January 2025 making imports of choline chloride originating in the People’s Republic of China subject to registration

This Commission Implementing Regulation introduces registration requirements for imports of choline chloride from China as part of an ongoing anti-dumping investigation. The regulation aims to enable potential retroactive collection of anti-dumping duties if the investigation concludes they are necessary.The regulation consists of three main sections and two operative articles. The first section defines the product subject to registration – choline chloride in all forms and purities with minimum 30% content. The second section establishes the legal basis and justification for registration, including preliminary dumping margins between 26% and 121%. The third section addresses personal data processing requirements.Key provisions include:
– Registration applies to specific CN codes for choline chloride from China (excluding calcium phosphoryl choline chloride tetrahydrate)
– Registration period is set for 9 months from the regulation’s entry into force
– Customs authorities are directed to implement appropriate registration steps
– The regulation does not set specific duty amounts, which will be determined by the investigation’s findings
– All EU member states are bound by this regulation

Commission Implementing Regulation (EU) 2025/89 of 20 January 2025 authorising the placing on the market of UV-treated powder of whole Tenebrio molitor larvae (yellow mealworm) as a novel food and amending Implementing Regulation (EU) 2017/2470

This Regulation authorizes the placing on the EU market of UV-treated powder made from whole Tenebrio molitor larvae (yellow mealworm) as a novel food. The powder is intended for use in various food products like bread, cakes, pasta, processed potato products, cheese products, and fruit/vegetable compotes, with specific maximum levels for each category.The Regulation consists of 4 articles and an annex that amends the Union list of novel foods. The main provisions include authorization conditions, data protection for the applicant company Nutri’Earth for 5 years, and detailed specifications for the novel food product. Compared to previous regulations on novel foods, this one specifically addresses a new type of insect-based food product with UV treatment.Key provisions include:

• Maximum allowed quantities for different food categories (e.g., 4.0g/100g for bread and rolls)
• Mandatory labeling requirements warning about potential allergic reactions
• Detailed product specifications including composition requirements (protein 50-55%, fat 30-37%, etc.)
• Strict limits for contaminants like heavy metals, mycotoxins, and microbiological criteria
• Special labeling requirements when vitamin D content is significant

Judgment of the Court (Grand Chamber) of 21 January 2025.Land Niedersachsen v Conti 11. Container Schiffahrts-GmbH & Co. KG MS “MSC Flaminia”.Reference for a preliminary ruling – Environment – Shipment of waste – Directive 2006/12/EC – Directive 2008/98/EC – Concept of ‘waste’ – Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal – Article 1(4) – Regulation (EC) No 1013/2006 – Waste subject to the prior written notification and consent procedure – Shipments of waste within the European Union – Article 1(3)(b) – Validity – Interpretation in conformity with the Basel Convention – Waste generated on board a ship following damage sustained by it on the high seas – Concept of ‘offloading of waste’ – Partial offloading of waste in a safe port.Case C-188/23.

This judgment concerns the interpretation of EU regulations on waste shipments, specifically regarding waste generated on ships following accidents. The key points are: The essence of the act is that it clarifies when waste generated on damaged ships falls under EU waste shipment regulations requiring prior notification and consent procedures. The Court ruled that once a ship offloads part of its accident-generated waste at a safe port, any remaining waste on board loses its exemption from these procedures. The main provisions establish that:

• Waste generated from ship accidents is initially exempt from waste shipment regulations until offloading
• After partial offloading at a safe port, remaining waste must follow standard notification procedures
• Ship operators must provide information about quantity, nature and destination of remaining waste
• The goal is to ensure environmentally sound waste management and minimize unnecessary waste shipments

The most important aspects for implementation are:

• The ruling creates clarity on when accident-generated ship waste falls under EU regulations
• It emphasizes environmental protection and proper waste management as key priorities
• Ship operators must follow notification procedures once they have access to a safe port
• The interpretation aligns EU regulations with international Basel Convention requirements