COMMISSION REGULATION (EU) 2015/1910
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 All existing authorisations for plant protection products containing the active substance guazatine have been revoked.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
(a)
grapes
0151010
Table grapes
0151020
Wine grapes
0152000
(b)
strawberries
0153000
(c)
cane fruits
0153010
Blackberries
0153020
Dewberries
0153030
Raspberries (red and yellow)
0153990
Others
0154000
(d)
other small fruits and berries
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
(a)
edible peel
0161010
Dates
0161020
Figs
0161030
Table olives
0161040
Kumquats
0161050
Carambolas
0161060
Kaki/Japanese persimmons
0161070
Jambuls/jambolans
0161990
Others
0162000
(b)
inedible peel, small
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
(c)
inedible peel, large
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
(a)
potatoes
0212000
(b)
tropical root and tuber vegetables
0212010
Cassava roots/manioc
0212020
Sweet potatoes
0212030
Yams
0212040
Arrowroots
0212990
Others
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
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
(a)
solanacea
0231010
Tomatoes
0231020
Sweet peppers/bell peppers
0231030
Aubergines/eggplants
0231040
Okra/lady's fingers
0231990
Others
0232000
(b)
cucurbits with edible peel
0232010
Cucumbers
0232020
Gherkins
0232030
Courgettes
0232990
Others
0233000
(c)
cucurbits with inedible peel
0233010
Melons
0233020
Pumpkins
0233030
Watermelons
0233990
Others
0234000
(d)
sweet corn
0239000
(e)
other fruiting vegetables
0240000
Brassica vegetables (excluding brassica roots and brassica baby leaf crops)
0241000
(a)
flowering brassica
0241010
Broccoli
0241020
Cauliflowers
0241990
Others
0242000
(b)
head brassica
0242010
Brussels sprouts
0242020
Head cabbages
0242990
Others
0243000
(c)
leafy brassica
0243010
Chinese cabbages/pe-tsai
0243020
Kales
0243990
Others
0244000
(d)
kohlrabies
0250000
Leaf vegetables, herbs and edible flowers
0251000
(a)
lettuces and salad plants
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
(b)
spinaches and similar leaves
0252010
Spinaches
0252020
Purslanes
0252030
Chards/beet leaves
0252990
Others
0253000
(c)
grape leaves and similar species
0254000
(d)
watercresses
0255000
(e)
witloofs/Belgian endives
0256000
(f)
herbs and edible flowers
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
(a)
flowers
0631010
Chamomile
0631020
Hibiscus/roselle
0631030
Rose
0631040
Jasmine
0631050
Lime/linden
0631990
Others
0632000
(b)
leaves and herbs
0632010
Strawberry
0632020
Rooibos
0632030
Mate/maté
0632990
Others
0633000
(c)
roots
0633010
Valerian
0633020
Ginseng
0633990
Others
0639000
(d)
any other parts of the plant
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
(a)
swine
1011010
Muscle
1011020
Fat tissue
1011030
Liver
1011040
Kidney
1011050
Edible offals (other than liver and kidney)
1011990
Others
1012000
(b)
bovine
1012010
Muscle
1012020
Fat tissue
1012030
Liver
1012040
Kidney
1012050
Edible offals (other than liver and kidney)
1012990
Others
1013000
(c)
sheep
1013010
Muscle
1013020
Fat tissue
1013030
Liver
1013040
Kidney
1013050
Edible offals (other than liver and kidney)
1013990
Others
1014000
d)
goat
1014010
Muscle
1014020
Fat tissue
1014030
Liver
1014040
Kidney
1014050
Edible offals (other than liver and kidney)
1014990
Others
1015000
(e)
equine
1015010
Muscle
1015020
Fat tissue
1015030
Liver
1015040
Kidney
1015050
Edible offals (other than liver and kidney)
1015990
Others
1016000
(f)
poultry
1016010
Muscle
1016020
Fat tissue
1016030
Liver
1016040
Kidney
1016050
Edible offals (other than liver and kidney)
1016990
Others
1017000
(g)
other farmed terrestrial animals
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)
(1) Indicates lower limit of analytical determination
(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’
