Commission Regulation (EU) 2016/1355 of 9 August 2016 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards thiacloprid (Text with EEA relevance)
Date: 2016-08-09
Institutions: European Commission
Subjects: consumer protection, crop production, food inspection, food safety, foodstuff, honey, pesticide, pesticide residue




L_2016215EN.01000401.xml










10.8.2016   


EN


Official Journal of the European Union


L 215/4








            COMMISSION REGULATION (EU) 2016/1355
of 9 August 2016
         
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards thiacloprid
(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 Article 14(1)(a) thereof,

Whereas:







(1)


For thiacloprid, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005.












(2)


In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance thiacloprid on rapeseed, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRL in honey and other apiculture products.












(3)


In accordance with Article 8 of Regulation (EC) No 396/2005, that application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.












(4)


The European Food Safety Authority, hereinafter ‘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 MRL (2). It forwarded that opinion to the Commission and the Member States and made it available to the public.












(5)


The Authority concluded that all requirements with respect to data were met and that the modification to the MRL requested by the applicant was acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it nor the short-term exposure due to high consumption of the relevant product showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded.












(6)


The Authority proposed several MRLs for honey, to be considered by the risk managers, which were based on, respectively, the field trials submitted by the applicant and Union wide monitoring data. As there is no risk to consumers, the MRL for thiacloprid in honey should be set at the level of 0,2 mg/kg on the basis of the available residue trials. The monitoring data are in a similar range and confirm such level.












(7)


Based on the reasoned opinion of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modification to the MRL fulfils the requirements of Article 14(2) of Regulation (EC) No 396/2005.












(8)


Regulation (EC) No 396/2005 should therefore be amended accordingly.












(9)


In order to minimise the potential market disruptions that may arise from the temporary application of the MRL for honey, set at the limit of determination by Commission Regulation (EU) 2015/1200 (3), this Regulation should enter into force as soon as possible.












(10)


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
Annex II to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 August 2016.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 70, 16.3.2005, p. 1.

(2)  EFSA scientific reports available online: http://www.efsa.europa.eu:
Reasoned opinion on the modification of the existing maximum residue level for thiacloprid in honey. EFSA Journal 2016;14(3):4418 [21 pp.].

(3)  Commission Regulation (EU) 2015/1200 of 22 July 2015 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 amidosulfuron, fenhexamid, kresoxim-methyl, thiacloprid and trifloxystrobin in or on certain products (OJ L 195, 23.7.2015, p. 1).




ANNEX
In Annex II to Regulation (EC) No 396/2005, the column for thiacloprid is replaced by the following:


‘Pesticide residues and maximum residue levels (mg/kg)








Code number


Groups and examples of individual products to which the MRLs apply (1)



Thiacloprid




(1)


(2)


(3)






0100000 



FRUITS, FRESH or FROZEN; TREE NUTS



 






0110000 



Citrus fruits



0,01 (*1)





0110010 


Grapefruits


 




0110020 


Oranges


 




0110030 


Lemons


 




0110040 


Limes


 




0110050 


Mandarins


 




0110990 


Others


 






0120000 



Tree nuts



0,02 (*1)





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


0,3




0130020 


Pears


0,3




0130030 


Quinces


0,7




0130040 


Medlars


0,7




0130050 


Loquats/Japanese medlars


0,7




0130990 


Others


0,01 (*1)







0140000 



Stone fruits



0,5




0140010 


Apricots


 




0140020 


Cherries (sweet)


 




0140030 


Peaches


 




0140040 


Plums


 




0140990 


Others


 






0150000 



Berries and small fruits



 






0151000 








(a)


grapes






0,01 (*1)





0151010 


Table grapes


 




0151020 


Wine grapes


 




0152000 








(b)


strawberries






1






0153000 








(c)


cane fruits






 




0153010 


Blackberries


1




0153020 


Dewberries


1




0153030 


Raspberries (red and yellow)


6




0153990 


Others


0,01 (*1)







0154000 








(d)


other small fruits and berries






1




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


0,01 (*1)





0161020 


Figs


0,5




0161030 


Table olives


4




0161040 


Kumquats


0,01 (*1)





0161050 


Carambolas


0,01 (*1)





0161060 


Kaki/Japanese persimmons


0,01 (*1)





0161070 


Jambuls/jambolans


0,01 (*1)





0161990 


Others


0,01 (*1)







0162000 








(b)


inedible peel, small






 




0162010 


Kiwi fruits (green, red, yellow)


0,2




0162020 


Litchis/lychees


0,01 (*1)





0162030 


Passionfruits/maracujas


0,01 (*1)





0162040 


Prickly pears/cactus fruits


0,01 (*1)





0162050 


Star apples/cainitos


0,01 (*1)





0162060 


American persimmons/Virginia kaki


0,01 (*1)





0162990 


Others


0,01 (*1)







0163000 








(c)


inedible peel, large






 




0163010 


Avocados


0,01 (*1)





0163020 


Bananas


0,01 (*1)





0163030 


Mangoes


0,01 (*1)





0163040 


Papayas


0,5




0163050 


Granate apples/pomegranates


0,01 (*1)





0163060 


Cherimoyas


0,01 (*1)





0163070 


Guavas


0,01 (*1)





0163080 


Pineapples


0,01 (*1)





0163090 


Breadfruits


0,01 (*1)





0163100 


Durians


0,01 (*1)





0163110 


Soursops/guanabanas


0,01 (*1)





0163990 


Others


0,01 (*1)







0200000 



VEGETABLES, FRESH or FROZEN



 






0210000 



Root and tuber vegetables



 




0211000 








(a)


potatoes






0,02






0212000 








(b)


tropical root and tuber vegetables






0,01 (*1)





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


0,05




0213020 


Carrots


0,05




0213030 


Celeriacs/turnip rooted celeries


0,05




0213040 


Horseradishes


0,05




0213050 


Jerusalem artichokes


0,05




0213060 


Parsnips


0,05




0213070 


Parsley roots/Hamburg roots parsley


0,05




0213080 


Radishes


0,05




0213090 


Salsifies


0,05




0213100 


Swedes/rutabagas


0,01 (*1)





0213110 


Turnips


0,01 (*1)





0213990 


Others


0,01 (*1)







0220000 



Bulb vegetables



 




0220010 


Garlic


0,01 (*1)





0220020 


Onions


0,01 (*1)





0220030 


Shallots


0,01 (*1)





0220040 


Spring onions/green onions and Welsh onions


0,15




0220990 


Others


0,01 (*1)







0230000 



Fruiting vegetables



 






0231000 








(a)


solanacea






 




0231010 


Tomatoes


0,5




0231020 


Sweet peppers/bell peppers


1




0231030 


Aubergines/eggplants


0,7




0231040 


Okra/lady's fingers


0,01 (*1)





0231990 


Others


0,01 (*1)







0232000 








(b)


cucurbits with edible peel






0,5




0232010 


Cucumbers


 




0232020 


Gherkins


 




0232030 


Courgettes


(+)




0232990 


Others


 






0233000 








(c)


cucurbits with inedible peel






 




0233010 


Melons


0,2




0233020 


Pumpkins


0,01 (*1)





0233030 


Watermelons


0,2




0233990 


Others


0,01 (*1)





0234000 








(d)


sweet corn






0,01 (*1)





0239000 








(e)


other fruiting vegetables






0,01 (*1)







0240000 



Brassica vegetables (excluding brassica roots and brassica baby leaf crops)



 






0241000 








(a)


flowering brassica






0,3 (+)




0241010 


Broccoli


 




0241020 


Cauliflowers


 




0241990 


Others


 






0242000 








(b)


head brassica






0,3




0242010 


Brussels sprouts


 




0242020 


Head cabbages


 




0242990 


Others


 






0243000 








(c)


leafy brassica






 




0243010 


Chinese cabbages/pe-tsai


1




0243020 


Kales


0,4




0243990 


Others


0,01 (*1)





0244000 








(d)


kohlrabies






0,04






0250000 



Leaf vegetables, herbs and edible flowers



 






0251000 








(a)


lettuces and salad plants






 




0251010 


Lamb's lettuces/corn salads


8




0251020 


Lettuces


1




0251030 


Escaroles/broad-leaved endives


0,15 (+)




0251040 


Cresses and other sprouts and shoots


0,01 (*1)





0251050 


Land cresses


0,7 (+)




0251060 


Roman rocket/rucola


2 (+)




0251070 


Red mustards


0,01 (*1)





0251080 


Baby leaf crops (including brassica species)


2 (+)




0251990 


Others


0,01 (*1)







0252000 








(b)


spinaches and similar leaves






 




0252010 


Spinaches


0,15 (+)




0252020 


Purslanes


0,01 (*1)





0252030 


Chards/beet leaves


0,15 (+)




0252990 


Others


0,01 (*1)





0253000 








(c)


grape leaves and similar species






0,01 (*1)





0254000 








(d)


watercresses






0,01 (*1)





0255000 








(e)


witloofs/Belgian endives






0,01 (*1)







0256000 








(f)


herbs and edible flowers






5




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)


0,4 (+)




0260020 


Beans (without pods)


0,01 (*1)





0260030 


Peas (with pods)


0,2




0260040 


Peas (without pods)


0,2




0260050 


Lentils


0,01 (*1)





0260990 


Others


0,01 (*1)







0270000 



Stem vegetables



 




0270010 


Asparagus


0,01 (*1)





0270020 


Cardoons


0,01 (*1)





0270030 


Celeries


0,7




0270040 


Florence fennels


0,7




0270050 


Globe artichokes


0,01 (*1)





0270060 


Leeks


0,1




0270070 


Rhubarbs


0,02




0270080 


Bamboo shoots


0,01 (*1)





0270090 


Palm hearts


0,01 (*1)





0270990 


Others


0,01 (*1)







0280000 



Fungi, mosses and lichens



0,01 (*1)





0280010 


Cultivated fungi


 




0280020 


Wild fungi


 




0280990 


Mosses and lichens


 




0290000 



Algae and prokaryotes organisms



0,01 (*1)







0300000 



PULSES



 




0300010 


Beans


0,08 (+)




0300020 


Lentils


0,01 (*1)





0300030 


Peas


0,08 (+)




0300040 


Lupins/lupini beans


0,01 (*1)





0300990 


Others


0,01 (*1)







0400000 



OILSEEDS AND OIL FRUITS



 






0401000 



Oilseeds



 




0401010 


Linseeds


0,02 (*1)





0401020 


Peanuts/groundnuts


0,02 (*1)





0401030 


Poppy seeds


0,3




0401040 


Sesame seeds


0,02 (*1)





0401050 


Sunflower seeds


0,02 (*1)





0401060 


Rapeseeds/canola seeds


0,6 (+)




0401070 


Soyabeans


0,02 (*1)





0401080 


Mustard seeds


0,6 (+)




0401090 


Cotton seeds


0,15




0401100 


Pumpkin seeds


0,02 (*1)





0401110 


Safflower seeds


0,02 (*1)





0401120 


Borage seeds


0,02 (*1)





0401130 


Gold of pleasure seeds


0,02 (*1)





0401140 


Hemp seeds


0,02 (*1)





0401150 


Castor beans


0,02 (*1)





0401990 


Others


0,02 (*1)







0402000 



Oil fruits



 




0402010 


Olives for oil production


4




0402020 


Oil palms kernels


0,02 (*1)





0402030 


Oil palms fruits


0,02 (*1)





0402040 


Kapok


0,02 (*1)





0402990 


Others


0,02 (*1)







0500000 



CEREALS



 




0500010 


Barley


0,9




0500020 


Buckwheat and other pseudo-cereals


0,01 (*1)





0500030 


Maize/corn


0,01* (+)




0500040 


Common millet/proso millet


0,01 (*1)





0500050 


Oat


0,9




0500060 


Rice


0,02




0500070 


Rye


0,06




0500080 


Sorghum


0,01 (*1)





0500090 


Wheat


0,1




0500990 


Others


0,01 (*1)







0600000 



TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS



 




0610000 



Teas



10 (+)




0620000 



Coffee beans



0,05 (*1)







0630000 



Herbal infusions from



 






0631000 








(a)


flowers






0,05 (*1)





0631010 


Chamomile


 




0631020 


Hibiscus/roselle


 




0631030 


Rose


 




0631040 


Jasmine


 




0631050 


Lime/linden


 




0631990 


Others


 






0632000 








(b)


leaves and herbs






50 (+)




0632010 


Strawberry


 




0632020 


Rooibos


 




0632030 


Mate/maté


 




0632990 


Others


 






0633000 








(c)


roots






0,02 (+)




0633010 


Valerian


 




0633020 


Ginseng


 




0633990 


Others


 




0639000 








(d)


any other parts of the plant






0,05 (*1)





0640000 



Cocoa beans



0,05 (*1)





0650000 



Carobs/Saint John's breads



0,05 (*1)





0700000 



HOPS



0,05 (*1)







0800000 



SPICES



 






0810000 



Seed spices



0,08 (+)




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



 




0900010 


Sugar beet roots


0,02




0900020 


Sugar canes


0,01 (*1)





0900030 


Chicory roots


0,05




0900990 


Others


0,01 (*1)







1000000 



PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS



 






1010000 



Tissues from



 






1011000 








(a)


swine






 




1011010 


Muscle


0,1




1011020 


Fat tissue


0,01 (*1)





1011030 


Liver


0,5




1011040 


Kidney


0,5




1011050 


Edible offals (other than liver and kidney)


0,5




1011990 


Others


0,01 (*1)







1012000 








(b)


bovine






 




1012010 


Muscle


0,1




1012020 


Fat tissue


0,04




1012030 


Liver


0,5




1012040 


Kidney


0,5




1012050 


Edible offals (other than liver and kidney)


0,5




1012990 


Others


0,01 (*1)







1013000 








(c)


sheep






 




1013010 


Muscle


0,1




1013020 


Fat tissue


0,04




1013030 


Liver


0,5




1013040 


Kidney


0,5




1013050 


Edible offals (other than liver and kidney)


0,5




1013990 


Others


0,01 (*1)







1014000 








(d)


goat






 




1014010 


Muscle


0,1




1014020 


Fat tissue


0,04




1014030 


Liver


0,5




1014040 


Kidney


0,5




1014050 


Edible offals (other than liver and kidney)


0,5




1014990 


Others


0,01 (*1)







1015000 








(e)


equine






 




1015010 


Muscle


0,1




1015020 


Fat tissue


0,04




1015030 


Liver


0,5




1015040 


Kidney


0,5




1015050 


Edible offals (other than liver and kidney)


0,5




1015990 


Others


0,01 (*1)







1016000 








(f)


poultry






 




1016010 


Muscle


0,02




1016020 


Fat tissue


0,01 (*1)





1016030 


Liver


0,02




1016040 


Kidney


0,01 (*1)





1016050 


Edible offals (other than liver and kidney)


0,02




1016990 


Others


0,01 (*1)







1017000 








(g)


other farmed terrestrial animals






 




1017010 


Muscle


0,1




1017020 


Fat tissue


0,04




1017030 


Liver


0,5




1017040 


Kidney


0,5




1017050 


Edible offals (other than liver and kidney)


0,5




1017990 


Others


0,01 (*1)







1020000 



Milk



0,05




1020010 


Cattle


 




1020020 


Sheep


 




1020030 


Goat


 




1020040 


Horse


 




1020990 


Others


 






1030000 



Birds eggs



0,02 (*1)





1030010 


Chicken


 




1030020 


Duck


 




1030030 


Geese


 




1030040 


Quail


 




1030990 


Others


 




1040000 



Honey and other apiculture products




0,2





1050000 



Amphibians and Reptiles



0,01 (*1)





1060000 



Terrestrial invertebrate animals



0,01 (*1)





1070000 



Wild terrestrial vertebrate animals



0,01 (*1)











(**)


Pesticide-code combination for which the MRL as set in Annex III Part B applies.





Thiacloprid







(+)


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 23 July 2017, or, if that information is not submitted by that date, the lack of it.







0232030 




Courgettes






0241000 










(a)



flowering brassica









0241010 




Broccoli






0241020 




Cauliflowers






0241990 




Others






0251030 




Escaroles/broad-leaved endives






0251050 




Land cresses






0251060 




Roman rocket/rucola






0251080 




Baby leaf crops (including brassica species)






0252010 




Spinaches






0252030 




Chards/beet leaves






0260010 




Beans (with pods)






0300010 




Beans






0300030 




Peas






0401060 




Rapeseeds/canola seeds






0401080 




Mustard seeds















(+)


The European Food Safety Authority identified some information on crop metabolism with seed treatment 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 23 July 2017, or, if that information is not submitted by that date, the lack of it.

0500030 

Maize/corn










(+)


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 23 July 2017, or, if that information is not submitted by that date, the lack of it.







0610000 




Teas






0632000 










(b)



leaves and herbs









0632010 




Strawberry






0632020 




Rooibos






0632030 




Mate/maté






0632990 




Others






0633000 










(c)



roots









0633010 




Valerian






0633020 




Ginseng






0633990 




Others






0810000 




Seed spices






0810010 




Anise/aniseed






0810020 




Black caraway/black cumin






0810030 




Celery






0810040 




Coriander






0810050 




Cumin






0810060 




Dill






0810070 




Fennel






0810080 




Fenugreek






0810090 




Nutmeg






0810990 




Others















(+)


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’











(*1)  Indicates lower limit of analytical determination

(1)  For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.