of 21 October 2015
amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for guazatine 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 (1), and in particular Articles 14(1)(a) and 18(1)(b) and Article 49(2) thereof,
Whereas:
(1)
For guazatine, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005.
(2)
The European Food Safety Authority, hereinafter ‘the Authority’, submitted a reasoned opinion on the existing MRLs for guazatine in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). All existing authorisations for plant protection products containing the active substance guazatine have been revoked. Neither were import tolerances reported at Union level nor were Codex MRLs available. In the absence of information on specific good agricultural practices that could be used in a consumer risk assessment, the Authority concluded that a value of 0,05 mg/kg provides a satisfactory level of protection for the European consumers. It is therefore appropriate to set the MRLs at the specific limit of determination. It is also appropriate to change the residue definition.
(3)
Moreover, Belgium indicated that the existing MRLs for guazatine in grapefruit and oranges may raise concerns of consumer protection. In particular, an acute consumer risk could not be excluded even by a refined risk assessment, taking into account a processing factor for citrus fruit. The European Commission and the Member States represented in the Standing Committee on Plants, Animals, Food and Feed considered it an appropriate risk management decision to lower the MRLs to a level that has been demonstrated to be safe for European consumers.
(4)
In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was submitted for guazatine used on citrus fruits. In accordance with Article 8 of Regulation (EC) No 396/2005 this application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. The Authority assessed the application and the evaluation report, examining in particular the risks to the consumer and, where relevant, to animals and gave a reasoned opinion on the proposed MRLs (3). It forwarded this opinion to the Commission and the Member States and made it available to the public. It concluded in the opinion that it does not recommend setting the proposed MRLs since the available data were not sufficient to exclude a risk for European consumers.
(5)
The applicant requested an administrative review of the Authority's reasoned opinion according to Article 13 of Regulation (EC) No 396/2005. This review led to the conclusion that no substantial flaws and errors of assessment on the part of the Authority were identified.
(6)
based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.
(7)
Regulation (EC) No 396/2005 should therefore be amended accordingly.
(8)
In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been lawfully produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.
(9)
The transitional arrangement provided for by this Regulation should take the concerns of consumer protection with the existing MRLs for guazatine in grapefruit and oranges into account.
(10)
A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs.
(11)
Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.
(12)
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 III and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
As regards guazatine, Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to all products which were lawfully produced before 13 May 2016, except grapefruit and oranges.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
However, it shall apply from 13 May 2016.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 October 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 70, 16.3.2005, p. 1.
(2) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels (MRLs) for guazatine according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(5):3239. [20 pp.].
(3) European Food Safety Authority; Reasoned opinion on the modification of the existing MRL for guazatine in citrus fruits. EFSA Journal 2014;12(8):3818. [29 pp.].
ANNEX
Annexes III and V to Regulation (EC) No 396/2005 are amended as follows:
(1)
in Annex III, the column for guazatine is deleted;
(2)
in Annex V, the following column for guazatine is added:
‘Pesticide residues and maximum residue levels (mg/kg)
| Code number | Groups and examples of individual products to which the MRLs apply (2) | Guazatine (guazatine acetate, sum of components) | ||
| (1) | (2) | (3) | ||
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | 0,05 (1) | ||
| 0110000 | Citrus fruits |
| ||
| 0110010 | Grapefruits |
| ||
| 0110020 | Oranges |
| ||
| 0110030 | Lemons |
| ||
| 0110040 | Limes |
| ||
| 0110050 | Mandarins |
| ||
| 0110990 | Others |
| ||
| 0120000 | Tree nuts |
| ||
| 0120010 | Almonds |
| ||
| 0120020 | Brazil nuts |
| ||
| 0120030 | Cashew nuts |
| ||
| 0120040 | Chestnuts |
| ||
| 0120050 | Coconuts |
| ||
| 0120060 | Hazelnuts/cobnuts |
| ||
| 0120070 | Macadamias |
| ||
| 0120080 | Pecans |
| ||
| 0120090 | Pine nut kernels |
| ||
| 0120100 | Pistachios |
| ||
| 0120110 | Walnuts |
| ||
| 0120990 | Others |
| ||
| 0130000 | Pome fruits |
| ||
| 0130010 | Apples |
| ||
| 0130020 | Pears |
| ||
| 0130030 | Quinces |
| ||
| 0130040 | Medlars |
| ||
| 0130050 | Loquats/Japanese medlars |
| ||
| 0130990 | Others |
| ||
| 0140000 | Stone fruits |
| ||
| 0140010 | Apricots |
| ||
| 0140020 | Cherries (sweet) |
| ||
| 0140030 | Peaches |
| ||
| 0140040 | Plums |
| ||
| 0140990 | Others |
| ||
| 0150000 | Berries and small fruits |
| ||
| 0151000 |
|
| ||
| 0151010 | Table grapes |
| ||
| 0151020 | Wine grapes |
| ||
| 0152000 |
|
| ||
| 0153000 |
|
| ||
| 0153010 | Blackberries |
| ||
| 0153020 | Dewberries |
| ||
| 0153030 | Raspberries (red and yellow) |
| ||
| 0153990 | Others |
| ||
| 0154000 |
|
| ||
| 0154010 | Blueberries |
| ||
| 0154020 | Cranberries |
| ||
| 0154030 | Currants (black, red and white) |
| ||
| 0154040 | Gooseberries (green, red and yellow) |
| ||
| 0154050 | Rose hips |
| ||
| 0154060 | Mulberries (black and white) |
| ||
| 0154070 | Azaroles/Mediterranean medlars |
| ||
| 0154080 | Elderberries |
| ||
| 0154990 | Others |
| ||
| 0160000 | Miscellaneous fruits with |
| ||
| 0161000 |
|
| ||
| 0161010 | Dates |
| ||
| 0161020 | Figs |
| ||
| 0161030 | Table olives |
| ||
| 0161040 | Kumquats |
| ||
| 0161050 | Carambolas |
| ||
| 0161060 | Kaki/Japanese persimmons |
| ||
| 0161070 | Jambuls/jambolans |
| ||
| 0161990 | Others |
| ||
| 0162000 |
|
| ||
| 0162010 | Kiwi fruits (green, red, yellow) |
| ||
| 0162020 | Litchis/lychees |
| ||
| 0162030 | Passionfruits/maracujas |
| ||
| 0162040 | Prickly pears/cactus fruits |
| ||
| 0162050 | Star apples/cainitos |
| ||
| 0162060 | American persimmons/Virginia kaki |
| ||
| 0162990 | Others |
| ||
| 0163000 |
|
| ||
| 0163010 | Avocados |
| ||
| 0163020 | Bananas |
| ||
| 0163030 | Mangoes |
| ||
| 0163040 | Papayas |
| ||
| 0163050 | Granate apples/pomegranates |
| ||
| 0163060 | Cherimoyas |
| ||
| 0163070 | Guavas |
| ||
| 0163080 | Pineapples |
| ||
| 0163090 | Breadfruits |
| ||
| 0163100 | Durians |
| ||
| 0163110 | Soursops/guanabanas |
| ||
| 0163990 | Others |
| ||
| 0200000 | VEGETABLES, FRESH or FROZEN | 0,05 (1) | ||
| 0210000 | Root and tuber vegetables |
| ||
| 0211000 |
|
| ||
| 0212000 |
|
| ||
| 0212010 | Cassava roots/manioc |
| ||
| 0212020 | Sweet potatoes |
| ||
| 0212030 | Yams |
| ||
| 0212040 | Arrowroots |
| ||
| 0212990 | Others |
| ||
| 0213000 |
|
| ||
| 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 |
| ||
| 0213100 | Swedes/rutabagas |
| ||
| 0213110 | Turnips |
| ||
| 0213990 | Others |
| ||
| 0220000 | Bulb vegetables |
| ||
| 0220010 | Garlic |
| ||
| 0220020 | Onions |
| ||
| 0220030 | Shallots |
| ||
| 0220040 | Spring onions/green onions and Welsh onions |
| ||
| 0220990 | Others |
| ||
| 0230000 | Fruiting vegetables |
| ||
| 0231000 |
|
| ||
| 0231010 | Tomatoes |
| ||
| 0231020 | Sweet peppers/bell peppers |
| ||
| 0231030 | Aubergines/eggplants |
| ||
| 0231040 | Okra/lady's fingers |
| ||
| 0231990 | Others |
| ||
| 0232000 |
|
| ||
| 0232010 | Cucumbers |
| ||
| 0232020 | Gherkins |
| ||
| 0232030 | Courgettes |
| ||
| 0232990 | Others |
| ||
| 0233000 |
|
| ||
| 0233010 | Melons |
| ||
| 0233020 | Pumpkins |
| ||
| 0233030 | Watermelons |
| ||
| 0233990 | Others |
| ||
| 0234000 |
|
| ||
| 0239000 |
|
| ||
| 0240000 | Brassica vegetables (excluding brassica roots and brassica baby leaf crops) |
| ||
| 0241000 |
|
| ||
| 0241010 | Broccoli |
| ||
| 0241020 | Cauliflowers |
| ||
| 0241990 | Others |
| ||
| 0242000 |
|
| ||
| 0242010 | Brussels sprouts |
| ||
| 0242020 | Head cabbages |
| ||
| 0242990 | Others |
| ||
| 0243000 |
|
| ||
| 0243010 | Chinese cabbages/pe-tsai |
| ||
| 0243020 | Kales |
| ||
| 0243990 | Others |
| ||
| 0244000 |
|
| ||
| 0250000 | Leaf vegetables, herbs and edible flowers |
| ||
| 0251000 |
|
| ||
| 0251010 | Lamb's lettuces/corn salads |
| ||
| 0251020 | Lettuces |
| ||
| 0251030 | Escaroles/broad-leaved endives |
| ||
| 0251040 | Cresses and other sprouts and shoots |
| ||
| 0251050 | Land cresses |
| ||
| 0251060 | Roman rocket/rucola |
| ||
| 0251070 | Red mustards |
| ||
| 0251080 | Baby leaf crops (including brassica species) |
| ||
| 0251990 | Others |
| ||
| 0252000 |
|
| ||
| 0252010 | Spinaches |
| ||
| 0252020 | Purslanes |
| ||
| 0252030 | Chards/beet leaves |
| ||
| 0252990 | Others |
| ||
| 0253000 |
|
| ||
| 0254000 |
|
| ||
| 0255000 |
|
| ||
| 0256000 |
|
| ||
| 0256010 | Chervil |
| ||
| 0256020 | Chives |
| ||
| 0256030 | Celery leaves |
| ||
| 0256040 | Parsley |
| ||
| 0256050 | Sage |
| ||
| 0256060 | Rosemary |
| ||
| 0256070 | Thyme |
| ||
| 0256080 | Basil and edible flowers |
| ||
| 0256090 | Laurel/bay leave |
| ||
| 0256100 | Tarragon |
| ||
| 0256990 | Others |
| ||
| 0260000 | Legume vegetables |
| ||
| 0260010 | Beans (with pods) |
| ||
| 0260020 | Beans (without pods) |
| ||
| 0260030 | Peas (with pods) |
| ||
| 0260040 | Peas (without pods) |
| ||
| 0260050 | Lentils |
| ||
| 0260990 | Others |
| ||
| 0270000 | Stem vegetables |
| ||
| 0270010 | Asparagus |
| ||
| 0270020 | Cardoons |
| ||
| 0270030 | Celeries |
| ||
| 0270040 | Florence fennels |
| ||
| 0270050 | Globe artichokes |
| ||
| 0270060 | Leeks |
| ||
| 0270070 | Rhubarbs |
| ||
| 0270080 | Bamboo shoots |
| ||
| 0270090 | Palm hearts |
| ||
| 0270990 | Others |
| ||
| 0280000 | Fungi, mosses and lichens |
| ||
| 0280010 | Cultivated fungi |
| ||
| 0280020 | Wild fungi |
| ||
| 0280990 | Mosses and lichens |
| ||
| 0290000 | Algae and prokaryotes organisms |
| ||
| 0300000 | PULSES | 0,05 (1) | ||
| 0300010 | Beans |
| ||
| 0300020 | Lentils |
| ||
| 0300030 | Peas |
| ||
| 0300040 | Lupins/lupini beans |
| ||
| 0300990 | Others |
| ||
| 0400000 | OILSEEDS AND OIL FRUITS | 0,05 (1) | ||
| 0401000 | Oilseeds |
| ||
| 0401010 | Linseeds |
| ||
| 0401020 | Peanuts/groundnuts |
| ||
| 0401030 | Poppy seeds |
| ||
| 0401040 | Sesame seeds |
| ||
| 0401050 | Sunflower seeds |
| ||
| 0401060 | Rapeseeds/canola seeds |
| ||
| 0401070 | Soyabeans |
| ||
| 0401080 | Mustard seeds |
| ||
| 0401090 | Cotton seeds |
| ||
| 0401100 | Pumpkin seeds |
| ||
| 0401110 | Safflower seeds |
| ||
| 0401120 | Borage seeds |
| ||
| 0401130 | Gold of pleasure seeds |
| ||
| 0401140 | Hemp seeds |
| ||
| 0401150 | Castor beans |
| ||
| 0401990 | Others |
| ||
| 0402000 | Oil fruits |
| ||
| 0402010 | Olives for oil production |
| ||
| 0402020 | Oil palms kernels |
| ||
| 0402030 | Oil palms fruits |
| ||
| 0402040 | Kapok |
| ||
| 0402990 | Others |
| ||
| 0500000 | CEREALS | 0,05 (1) | ||
| 0500010 | Barley |
| ||
| 0500020 | Buckwheat and other pseudo-cereals |
| ||
| 0500030 | Maize/corn |
| ||
| 0500040 | Common millet/proso millet |
| ||
| 0500050 | Oat |
| ||
| 0500060 | Rice |
| ||
| 0500070 | Rye |
| ||
| 0500080 | Sorghum |
| ||
| 0500090 | Wheat |
| ||
| 0500990 | Others |
| ||
| 0600000 | TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS | 0,05 (1) | ||
| 0610000 | Teas |
| ||
| 0620000 | Coffee beans |
| ||
| 0630000 | Herbal infusions from |
| ||
| 0631000 |
|
| ||
| 0631010 | Chamomile |
| ||
| 0631020 | Hibiscus/roselle |
| ||
| 0631030 | Rose |
| ||
| 0631040 | Jasmine |
| ||
| 0631050 | Lime/linden |
| ||
| 0631990 | Others |
| ||
| 0632000 |
|
| ||
| 0632010 | Strawberry |
| ||
| 0632020 | Rooibos |
| ||
| 0632030 | Mate/maté |
| ||
| 0632990 | Others |
| ||
| 0633000 |
|
| ||
| 0633010 | Valerian |
| ||
| 0633020 | Ginseng |
| ||
| 0633990 | Others |
| ||
| 0639000 |
|
| ||
| 0640000 | Cocoa beans |
| ||
| 0650000 | Carobs/Saint John's breads |
| ||
| 0700000 | HOPS | 0,05 (1) | ||
| 0800000 | SPICES |
| ||
| 0810000 | Seed spices | 0,05 (1) | ||
| 0810010 | Anise/aniseed |
| ||
| 0810020 | Black caraway/black cumin |
| ||
| 0810030 | Celery |
| ||
| 0810040 | Coriander |
| ||
| 0810050 | Cumin |
| ||
| 0810060 | Dill |
| ||
| 0810070 | Fennel |
| ||
| 0810080 | Fenugreek |
| ||
| 0810090 | Nutmeg |
| ||
| 0810990 | Others |
| ||
| 0820000 | Fruit spices | 0,05 (1) | ||
| 0820010 | Allspice/pimento |
| ||
| 0820020 | Sichuan pepper |
| ||
| 0820030 | Caraway |
| ||
| 0820040 | Cardamom |
| ||
| 0820050 | Juniper berry |
| ||
| 0820060 | Peppercorn (black, green and white) |
| ||
| 0820070 | Vanilla |
| ||
| 0820080 | Tamarind |
| ||
| 0820990 | Others |
| ||
| 0830000 | Bark spices | 0,05 (1) | ||
| 0830010 | Cinnamon |
| ||
| 0830990 | Others |
| ||
| 0840000 | Root and rhizome spices |
| ||
| 0840010 | Liquorice | 0,05 (1) | ||
| 0840020 | Ginger | 0,05 (1) | ||
| 0840030 | Turmeric/curcuma | 0,05 (1) | ||
| 0840040 | Horseradish | (+) | ||
| 0840990 | Others | 0,05 (1) | ||
| 0850000 | Bud spices | 0,05 (1) | ||
| 0850010 | Cloves |
| ||
| 0850020 | Capers |
| ||
| 0850990 | Others |
| ||
| 0860000 | Flower pistil spices | 0,05 (1) | ||
| 0860010 | Saffron |
| ||
| 0860990 | Others |
| ||
| 0870000 | Aril spices | 0,05 (1) | ||
| 0870010 | Mace |
| ||
| 0870990 | Others |
| ||
| 0900000 | SUGAR PLANTS | 0,05 (1) | ||
| 0900010 | Sugar beet roots |
| ||
| 0900020 | Sugar canes |
| ||
| 0900030 | Chicory roots |
| ||
| 0900990 | Others |
| ||
| 1000000 | PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS |
| ||
| 1010000 | Tissues from | 0,05 (1) | ||
| 1011000 |
|
| ||
| 1011010 | Muscle |
| ||
| 1011020 | Fat tissue |
| ||
| 1011030 | Liver |
| ||
| 1011040 | Kidney |
| ||
| 1011050 | Edible offals (other than liver and kidney) |
| ||
| 1011990 | Others |
| ||
| 1012000 |
|
| ||
| 1012010 | Muscle |
| ||
| 1012020 | Fat tissue |
| ||
| 1012030 | Liver |
| ||
| 1012040 | Kidney |
| ||
| 1012050 | Edible offals (other than liver and kidney) |
| ||
| 1012990 | Others |
| ||
| 1013000 |
|
| ||
| 1013010 | Muscle |
| ||
| 1013020 | Fat tissue |
| ||
| 1013030 | Liver |
| ||
| 1013040 | Kidney |
| ||
| 1013050 | Edible offals (other than liver and kidney) |
| ||
| 1013990 | Others |
| ||
| 1014000 |
|
| ||
| 1014010 | Muscle |
| ||
| 1014020 | Fat tissue |
| ||
| 1014030 | Liver |
| ||
| 1014040 | Kidney |
| ||
| 1014050 | Edible offals (other than liver and kidney) |
| ||
| 1014990 | Others |
| ||
| 1015000 |
|
| ||
| 1015010 | Muscle |
| ||
| 1015020 | Fat tissue |
| ||
| 1015030 | Liver |
| ||
| 1015040 | Kidney |
| ||
| 1015050 | Edible offals (other than liver and kidney) |
| ||
| 1015990 | Others |
| ||
| 1016000 |
|
| ||
| 1016010 | Muscle |
| ||
| 1016020 | Fat tissue |
| ||
| 1016030 | Liver |
| ||
| 1016040 | Kidney |
| ||
| 1016050 | Edible offals (other than liver and kidney) |
| ||
| 1016990 | Others |
| ||
| 1017000 |
|
| ||
| 1017010 | Muscle |
| ||
| 1017020 | Fat tissue |
| ||
| 1017030 | Liver |
| ||
| 1017040 | Kidney |
| ||
| 1017050 | Edible offals (other than liver and kidney) |
| ||
| 1017990 | Others |
| ||
| 1020000 | Milk | 0,02 (1) | ||
| 1020010 | Cattle |
| ||
| 1020020 | Sheep |
| ||
| 1020030 | Goat |
| ||
| 1020040 | Horse |
| ||
| 1020990 | Others |
| ||
| 1030000 | Birds eggs | 0,05 (1) | ||
| 1030010 | Chicken |
| ||
| 1030020 | Duck |
| ||
| 1030030 | Geese |
| ||
| 1030040 | Quail |
| ||
| 1030990 | Others |
| ||
| 1040000 | Honey and other apiculture products | 0,05 (1) | ||
| 1050000 | Amphibians and Reptiles | 0,05 (1) | ||
| 1060000 | Terrestrial invertebrate animals | 0,05 (1) | ||
| 1070000 | Wild terrestrial vertebrate animals | 0,05 (1) | ||
(2) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
Guazatine (guazatine acetate, sum of components)
(+)
The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.
0840040
Horseradish’
