Commission Regulation (EU) 2023/1719 of 8 September 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, metaldehyde, Metarhizium brunneum strain Ma 43, paclobutrazol and Straight Chain Lepidopteran Pheromones (SCLP) in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2023/1719 of 8 September 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, metaldehyde, Metarhizium brunneum strain Ma 43, paclobutrazol and Straight Chain Lepidopteran Pheromones (SCLP) in or on certain products (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC OJ L 70, 16.3.2005, p. 1. , and in particular Article 5 and Article 14(1), point (a), thereof, Whereas: (1) For isoxaben, metaldehyde and paclobutrazol, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. For Metarhizium brunneum strain Ma 43 and Straight Chain Lepidopteran Pheromones (SCLP), no specific MRLs were set, nor were those substances included in Annex IV to that Regulation, so the default value laid down in Article 18(1), point (b), thereof applies. (2) As regards metaldehyde, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for flowering brassica and leafy brassica. (3) In addition, in the framework of another application pursuant to Article 6(1) of Regulation (EC) No 396/2005, another applicant had submitted information previously unavailable during the review conducted in accordance with Article 12 of Regulation (EC) No 396/2005 on a hydrolysis study investigating the effect of sterilisation on the nature of residue. This study demonstrated that the existing MRLs for metaldehyde in potatoes, other root and tuber vegetables except sugar beets (except swedes/rutabagas), tomatoes, aubergines/eggplants, brassica vegetables (excluding brassica roots and brassica baby leaf crops), lettuces and salad plants, spinaches and similar leaves, globe artichokes are fully supported by data. (4) As regards paclobutrazol, an applicant submitted information previously unavailable during the review conducted in accordance with Article 12 of Regulation (EC) No 396/2005 on a representative study investigating primary crop metabolism in fruit crops. This study demonstrated that the existing MRLs for that substance in apples, pears, quinces, medlars, loquats/Japanese medlars, apricots and peaches are fully supported by data. (5) In accordance with Article 8 of Regulation (EC) No 396/2005, all those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission and to the European Food Safety Authority (the Authority). (6) The Authority assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs

European Food Safety Authority. Reasoned Opinion on the modification of the existing maximum residue levels for metaldehyde in flowering brassica and leafy brassica. EFSA Journal 2023;21(3):7885. European Food Safety Authority. Reasoned opinion on the modification of the existing MRLs for metaldehyde in certain legume vegetables and pulses. EFSA Journal 2014;12(1):3537. European Food Safety Authority. Reasoned Opinion on the evaluation of confirmatory data following the Article 12 MRL review for paclobutrazol. EFSA Journal 2022;20(11):7651. . It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public. (7) The Authority concluded that all requirements with respect to completeness of data submission were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substances. Neither the long-term exposure to these substances via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded. (8) As regards isoxaben, an application requesting a modification of the existing MRL for isoxaben in gherkins was submitted pursuant to Article 6(1) of Regulation (EC) No 396/2005. (9) For that application, a Member State made a request to use the fast-track procedure, provided for in the Technical Guidelines on the MRL setting procedure Technical guidelines MRL setting procedure in accordance with Articles 6 to 11 of Regulation (EC) No 396/2005 and Article 8 of Regulation (EC) No 1107/2009 (SANTE/2015/10595 Rev. 6.1). , to set an MRL based on residue trials on courgettes. (10) The Authority has assessed residue trials on courgettes in the framework of the review of the existing MRLs for isoxaben and given a reasoned opinion on the proposed MRL European Food Safety Authority. Reasoned opinion on the review of the existing maximum residue levels for isoxaben according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2022;20(1):7062. . That opinion relies on the current scientific and technical knowledge on the subject. As it is appropriate to extrapolate from the residue trials on courgettes to gherkins, as confirmed by the Union guidelines on extrapolation of MRLs Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolation of residue data on products from plant and animal origin (SANTE/2019/12752 – 23 November 2020). , it is unnecessary to request the Authority to provide a reasoned opinion on gherkins specifically. (11) It is therefore appropriate to set the MRL for isoxaben in gherkins at 0,05 mg/kg on the basis of the residue trials performed on courgettes.

(12) Metarhizium brunneum strain Ma 43 and Straight Chain Lepidopteran Pheromones (SCLP) have been renewed as low-risk active substances by Commission Implementing Regulations (EU) 2022/383 Commission Implementing Regulation (EU) 2022/383 of 4 March 2022 renewing the approval of the low-risk active substance Metarhizium brunneum strain Ma 43 (formerly Metarhizium anisopliae var. anisopliae strain BIPESCO 5/F52) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 76, 7.3.2022, p. 1). and (EU) 2022/1251 Commission Implementing Regulation (EU) 2022/1251 of 19 July 2022 renewing the approval of the active substances Straight Chain Lepidopteran Pheromones (acetates) as low-risk active substances, and Straight Chain Lepidopteran Pheromones (aldehydes and alcohols) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 191, 20.7.2022, p. 35). , respectively. The conditions of use of those substances are not expected to lead to the presence of residues in food or feed commodities that may pose a risk to the consumer and, therefore, no MRLs are required. It is therefore appropriate to include those substances in Annex IV to Regulation (EC) No 396/2005. (13) Based on the reasoned opinions of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modifications to the MRLs fulfil the requirements of Article 14(2) of that Regulation. (14) Regulation (EC) No 396/2005 should therefore be amended accordingly. (15) For technical reasons, the amendments to the proposed MRLs should apply later than those of Commission Regulation (EU) 2023/466 Commission Regulation (EU) 2023/466 of 3 March 2023 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, novaluron and tetraconazole in or on certain products (OJ L 68, 6.3.2023, p. 55). . (16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION:

Article 1

Annexes II and IV to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 27 September 2023. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 8 September 2023. For the Commission The President Ursula von der Leyen

Annex

ANNEX Regulation (EC) No 396/2005 is amended as follows: (1) in Annex II, the columns for isoxaben, metaldehyde and paclobutrazol are replaced by the following:

(2) in Annex IV, the following entries are inserted in alphabetical order: Metarhizium brunneum strain Ma 43, Straight Chain Lepidopteran Pheromones (SCLP).

Annex

ANNEX II Pesticide residues and maximum residue levels (mg/kg) Indicates lower limit of analytical determination For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I Isoxaben The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 March 2025, or, if that information is not submitted by that date, the lack of it. 0401090 Cotton seeds The European Food Safety Authority identified some information on residue trials and analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 March 2025, or, if that information is not submitted by that date, the lack of it. 0631000 (a) flowers 0631010 Chamomile 0631020 Hibiscus/roselle 0631030 Rose 0631040 Jasmine 0631050 Lime/linden The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 March 2025, or, if that information is not submitted by that date, the lack of it. 0633000 (c) roots 0633010 Valerian 0633020 Ginseng 0700000 HOPS Metaldehyde The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 14 March 2017, or, if that information is not submitted by that date, the lack of it. 0213000 (c) other root and tuber vegetables except sugar beets 0213010 Beetroots 0213020 Carrots 0213030 Celeriacs/turnip rooted celeries 0213040 Horseradishes 0213050 Jerusalem artichokes 0213060 Parsnips 0213070 Parsley roots/Hamburg roots parsley 0213080 Radishes 0213090 Salsifies 0213110 Turnips 0231010 Tomatoes 0231030 Aubergines/eggplants The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 14 March 2017, or, if that information is not submitted by that date, the lack of it. 1000000 PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS 1010000 Commodities from 1011000 (a) swine 1011010 Muscle 1011020 Fat 1011030 Liver 1011040 Kidney 1011050 Edible offals (other than liver and kidney) 1011990 Others (2) 1012000 (b) bovine 1012010 Muscle 1012020 Fat 1012030 Liver 1012040 Kidney 1012050 Edible offals (other than liver and kidney) 1012990 Others (2) 1013000 (c) sheep 1013010 Muscle 1013020 Fat

1013030 Liver 1013040 Kidney 1013050 Edible offals (other than liver and kidney) 1013990 Others (2) 1014000 d) goat 1014010 Muscle 1014020 Fat 1014030 Liver 1014040 Kidney 1014050 Edible offals (other than liver and kidney) 1014990 Others (2) 1015000 (e) equine 1015010 Muscle 1015020 Fat 1015030 Liver 1015040 Kidney 1015050 Edible offals (other than liver and kidney) 1015990 Others (2) 1016000 (f) poultry 1016010 Muscle 1016020 Fat 1016030 Liver 1016040 Kidney 1016050 Edible offals (other than liver and kidney) 1016990 Others (2) 1017000 (g) other farmed terrestrial animals 1017010 Muscle 1017020 Fat 1017030 Liver 1017040 Kidney 1017050 Edible offals (other than liver and kidney) 1017990 Others (2) 1020000 Milk 1020010 Cattle 1020020 Sheep 1020030 Goat 1020040 Horse 1020990 Others (2) 1030000 Birds eggs 1030010 Chicken 1030020 Duck 1030030 Geese 1030040 Quail 1030990 Others (2) 1050000 Amphibians and Reptiles 1060000 Terrestrial invertebrate animals 1070000 Wild terrestrial vertebrate animals Code numberGroups and examples of individual products to which the MRLs applyIsoxabenMetaldehydePaclobutrazol (sum of constituent isomers)0100000FRUITS, FRESH or FROZEN; TREE NUTS0,050110000Citrus fruits0,010,010110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,010,010120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,010,050130010Apples0130020Pears0130030Quinces0130040Medlars 0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,010140010Apricots0,150140020Cherries (sweet)0,010140030Peaches0,150140040Plums0,010140990Others (2)0,010150000Berries and small fruits0,010151000 (a) grapes 0,010151010Table grapes0151020Wine grapes0152000 (b) strawberries 0,010153000 (c) cane fruits 0,010153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0,010154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0,010,010161000 (a) edible peel 0161010Dates0161020Figs0161030Table olives0161040Kumquats 0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)0162000 (b) inedible peel, small 0162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)0163000 (c) inedible peel, large 0163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,010,010211000

(a) potatoes 0,150212000 (b) tropical root and tuber vegetables 0,050212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2) 0213000 (c) other root and tuber vegetables except sugar beets 0213010Beetroots0,3(+)0213020Carrots0,3(+)0213030Celeriacs/turnip rooted celeries0,3(+)0213040Horseradishes0,3(+)0213050Jerusalem artichokes0,3(+)0213060Parsnips0,3(+)0213070Parsley roots/Hamburg roots parsley0,3(+)0213080Radishes0,3(+)0213090Salsifies0,3(+)0213100Swedes/rutabagas0,050213110Turnips0,3(+)0213990Others (2)0,050220000Bulb vegetables0,010,050,010220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,010231000 (a) Solanaceae and Malvaceae 0,010231010Tomatoes0,15(+)0231020Sweet peppers/bell peppers0,050231030Aubergines/eggplants0,15(+)0231040Okra/lady's fingers0,050231990Others (2)0,050232000 (b) cucurbits with edible peel 0,050232010Cucumbers0,010232020Gherkins0,050232030Courgettes0,050232990Others (2)0,010233000 (c) cucurbits with inedible peel 0,010,050233010Melons 0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0,010,050239000 (e) other fruiting vegetables 0,010,050240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,010,010241000 (a) flowering brassica 0,70241010Broccoli0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 0,40242010Brussels sprouts0242020Head cabbages0242990Others (2)0243000 (c) leafy brassica 60243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 0,150250000Leaf vegetables, herbs and edible flowers0,010251000 (a) lettuces and salad plants 20,010251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2) 0252000 (b) spinaches and similar leaves 20,010252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,050,010254000 (d) watercresses 0,050,010255000 (e) witloofs/Belgian endives 0,050,010256000 (f) herbs and edible flowers 20,020256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010260010Beans (with pods)0,010,40260020Beans (without pods)0,020,30260030Peas (with pods)0,010,40260040Peas (without pods)0,020,30260050Lentils0,010,050260990Others (2)0,010,050270000Stem vegetables0,010,010270010Asparagus0,050270020Cardoons0,050270030Celeries0,050270040Florence fennels0,050270050Globe artichokes0,070270060Leeks1,50270070Rhubarbs0,05 0270080Bamboo shoots0,050270090Palm hearts0,050270990Others (2)0,050280000Fungi, mosses and lichens0,010,050,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010,050,010300000PULSES0,010,20,010300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,010,010401000Oilseeds0401010Linseeds0,60401020Peanuts/groundnuts0,050401030Poppy seeds0,60401040Sesame seeds0,60401050Sunflower seeds0,60401060Rapeseeds/canola seeds0,60401070Soyabeans0,60401080Mustard seeds0,60401090Cotton seeds(+)0,60401100Pumpkin seeds0,60401110Safflower seeds0,60401120Borage seeds0,60401130Gold of pleasure seeds0,60401140Hemp seeds0,60401150Castor beans0,050401990Others (2)0,050402000Oil fruits0,050402010Olives for oil production0402020Oil palms kernels

0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,010,050,010500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050,10,050610000Teas0620000Coffee beans0630000Herbal infusions from0631000 (a) flowers (+)0631010Chamomile(+)0631020Hibiscus/roselle(+)0631030Rose(+)0631040Jasmine(+)0631050Lime/linden(+)0631990Others (2)0632000 (b) leaves and herbs 0632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000 (c) roots (+)0633010Valerian(+)0633020Ginseng(+)0633990Others (2)0639000 (d) any other parts of the plant 0640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,05(+)0,10,050800000SPICES0810000Seed spices0,050,10,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050,10,050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,050,10,050830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050,10,050840020Ginger (10)0840030Turmeric/curcuma0,050,10,050840040Horseradish (11)0840990Others (2)0,050,10,05 0850000Bud spices0,050,10,050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050,10,050860010Saffron0860990Others (2)0870000Aril spices0,050,10,050870010Mace0870990Others (2)0900000SUGAR PLANTS0,010,050,010900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,010,01(+)0,011011000 (a) swine (+)1011010Muscle(+)1011020Fat(+)1011030Liver(+)1011040Kidney(+)1011050Edible offals (other than liver and kidney)(+)1011990Others (2)(+)1012000 (b) bovine (+)1012010Muscle(+)1012020Fat(+)1012030Liver(+)1012040Kidney(+)1012050Edible offals (other than liver and kidney)(+)1012990Others (2)(+)1013000 (c) sheep (+)1013010Muscle(+)1013020Fat(+)1013030Liver(+) 1013040Kidney(+)1013050Edible offals (other than liver and kidney)(+)1013990Others (2)(+)1014000 d) goat (+)1014010Muscle(+)1014020Fat(+)1014030Liver(+)1014040Kidney(+)1014050Edible offals (other than liver and kidney)(+)1014990Others (2)(+)1015000 (e) equine (+)1015010Muscle(+)1015020Fat(+)1015030Liver(+)1015040Kidney(+)1015050Edible offals (other than liver and kidney)(+)1015990Others (2)(+)1016000 (f) poultry (+)1016010Muscle(+)1016020Fat(+)1016030Liver(+)1016040Kidney(+)1016050Edible offals (other than liver and kidney)(+)1016990Others (2)(+)1017000 (g) other farmed terrestrial animals (+)1017010Muscle(+)1017020Fat(+)1017030Liver(+)1017040Kidney(+)1017050Edible offals (other than liver and kidney)(+)1017990Others (2)(+) 1020000Milk0,010,01(+)0,011020010Cattle(+)1020020Sheep(+)1020030Goat(+)1020040Horse(+)1020990Others (2)(+)1030000Birds eggs0,010,01(+)0,011030010Chicken(+)1030020Duck(+)1030030Geese(+)1030040Quail(+)1030990Others (2)(+)1040000Honey and other apiculture products (7)0,050,050,051050000Amphibians and Reptiles0,010,01(+)0,011060000Terrestrial invertebrate animals0,010,01(+)0,011070000Wild terrestrial vertebrate animals0,010,01(+)0,011100000PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)1200000PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)1300000PROCESSED FOOD PRODUCTS (9)