Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Commission Regulation (EU) 2016/567 of 6 April 2016 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 chlorantraniliprole, cyflumetofen, cyprodinil, dimethomorph, dithiocarbamates, fenamidone, fluopyram, flutolanil, imazamox, metrafenone, myclobutanil, propiconazole, sedaxane and spirodiclofen in or on certain products (Text with EEA relevance)
Commission Regulation (EU) 2016/567 of 6 April 2016 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 chlorantraniliprole, cyflumetofen, cyprodinil, dimethomorph, dithiocarbamates, fenamidone, fluopyram, flutolanil, imazamox, metrafenone, myclobutanil, propiconazole, sedaxane and spirodiclofen 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 Article 14(1)(a) thereof,
Whereas:
On 18 July 2014, Codex Alimentarius Commission (CAC) adopted Codex maximum residue limits (CXLs) for cyprodinil and flutolanil(2). On 11 July 2015, CAC adopted CXLs for aminocyclopyrachlor, benzovindiflupyr, buprofezin, chlorantraniliprole, clothianidin, cyflumetofen, dichlobenil, dimethomorph, dithiocarbamates, emamectin benzoate, fenamidone, fenpropathrin, fluensulfone, flufenoxuron, fluopyram, glufosinate-ammonium, imazamox, mesotrione, metrafenone, myclobutanil, phosmet, propamocarb, propiconazole, prothioconazole, pyraclostrobin, sedaxane, spirodiclofen, thiamethoxam, triadimefon, triadimenol and triforine(3).
Maximum residue levels (MRLs) are set for those substances in Regulation (EC) No 396/2005 except for cyflumetofen and sedaxane. As cyflumetofen and sedaxane are not included in Annex IV to Regulation (EC) No 396/2005, the default value of 0,01 mg/kg laid down in Article 18(1)(b) applies.
In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council(4), where international standards exist or their completion is imminent, they are to be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Union. Moreover, in accordance with point (e) of Article 13 of that Regulation, the Union is to promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Union is not reduced.
The Union presented a reservation to the Codex Committee on Pesticides Residues (CCPR) on the CXLs proposed for the following pesticide/product combinations: aminocyclopyrachlor (all products); benzovindiflupyr (all products); buprofezin (coffee beans); cyprodinil (berries and other small fruits; brassica leafy vegetables; mammalian edible offal; fruiting vegetables other than cucurbits); dichlobenil (all products); dimethomorph (shelled beans; fruiting vegetables other than cucurbits); dithiocarbamates (cumin seed); fenamidone (flowerhead brassicas; fruiting vegetables other than cucurbits); fenpropathrin (all products); fluensulfone (all products); flufenoxuron (all products); flutolanil (brassica leafy vegetables); myclobutanil (peaches; peppers); propamocarb (leek); prothioconazole (bush berries; cucurbits); pyraclostrobin (peaches) and triforine (all products).
CXLs for chlorantraniliprole, cyflumetofen, cyprodinil, dimethomorph, dithiocarbamates, fenamidone, fluopyram, flutolanil, imazamox, metrafenone, myclobutanil, propiconazole, sedaxane and spirodiclofen, which are not listed in recital 4, should therefore be included in Regulation (EC) No 396/2005 as MRLs except where they relate to products which are not set out in Annex I to that Regulation or where they are set at a lower level than the current MRLs. Those CXLs are safe for consumers in the Union(5).
As regards clothianidin and thiamethoxam, it is appropriate to take the relevant CXLs into account separately, by considering an amendment to Commission Regulation (EU) 2016/156(6). As regards mesotrione, it is appropriate to take the relevant CXLs into account separately, by considering an amendment to Commission Regulation (EU) 2016/53(7). The MRLs for those substances are therefore not modified by the present Regulation.
In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance chlorantraniliprole on cauliflower and ‘other flowering brassica’ of code number 0241990, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.
In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was submitted for chlorantraniliprole used on pomegranate, beans (with pods), peas (with pods), globe artichokes, peanuts and hops. The applicant claims that the authorised uses of that substance on such crops in the United States lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops.
In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.
The European Food Safety Authority, hereinafter ‘the Authority’, assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave a reasoned opinion on the proposed MRLs(8). It forwarded that opinion to the Commission and the Member States and made it available to the public.
The Authority concluded in its reasoned opinion that, as regards the use of chlorantraniliprole on peanuts and hops, the submitted data were not sufficient to set new MRLs. The existing MRLs should therefore be kept.
As regards the other uses covered by the applications, the Authority concluded that all requirements with respect to data 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. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime 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 crops and products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded.
Based on the reasoned opinion 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.
Regulation (EC) No 396/2005 should therefore be amended accordingly.
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
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 April 2016.
For the Commission
The President
Jean-Claude Juncker
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
-
in Annex II, the columns for cyprodinil, dimethomorph, fenamidone, flutolanil, imazamox, metrafenone, myclobutanil and propiconazole are 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(3)
Cyprodinil (F) (R)
Dimethomorph (sum of isomers)
Fenamidone
Flutolanil (R)
Imazamox (Sum of imazamox and its salts, expressed as imazamox)
Metrafenone
Myclobutanyl (R)
Propiconazole
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
0100000
FRUITS, FRESH or FROZEN; TREE NUTS
0,01(*)
0,05(*)
0200000
VEGETABLES, FRESH or FROZEN
0290000
Algae and prokaryotes organisms
0,02(*)
0,01(*)
0,01(*)
0,05(*)
0,01(*)
0300000
PULSES
0,01(*)
0,02(*)
0,01(*)
0,01(*)
0,02(*)
0,05(*)
0300010
Beans
0,2
0,05 (*)
0300020
Lentils
0,02(*)
0,2
0300030
Peas
0,1
0,05 (*)
0300040
Lupins/lupini beans
0,1
0,05(*)
0300990
Others
0,02(*)
0,05(*)
0400000
OILSEEDS AND OIL FRUITS
0,02(*)
0,02(*)
0,01(*)
0,01(*)
0500000
CEREALS
0,01(*)
0,02(*)
0,05(*)
0,02(*)
0500010
Barley
4
0,01(*)
0,6
0,2
0500020
Buckwheat and other pseudo-cereals
0,02(*)
0,01(*)
0,01(*)
0,05(*)
0500030
Maize/corn
0,02(*)
0,01(*)
(+)
0,01(*)
0,05(*)
0500040
Common millet/proso millet
0,02(*)
0,01(*)
0,01(*)
0,05(*)
0500050
Oat
4
0,01(*)
0,6
0,2
0500060
Rice
0,02(*)
2
(+)
0,01(*)
0,7
0500070
Rye
0,5
0,01(*)
0,07
0,05(*)
0500080
Sorghum
0,02(*)
0,01(*)
0,01(*)
0,05(*)
0500090
Wheat
0,5
0,01(*)
0,07
0,05(*)
0500990
Others
0,02(*)
0,01(*)
0,01(*)
0,05(*)
0600000
TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS
0,05(*)
0,05(*)
0,05(*)
0,1(*)
0,05(*)
0,1(*)
0610000
Teas
0,1(*)
0,05
0620000
Coffee beans
0,1(*)
0640000
Cocoa beans
0,1(*)
0650000
Carobs/Saint John's breads
0,1(*)
0700000
HOPS
0,1(*)
80
0,05(*)
0,05(*)
0,1(*)
80
5
0,1(*)
0800000
SPICES
0900000
SUGAR PLANTS
0,02(*)
0,01(*)
0,01(*)
0,05(*)
0,01(*)
0900010
Sugar beet roots
0900020
Sugar canes
0900030
Chicory roots
0900990
Others
1000000
PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS
(+)
1040000
Honey and other apiculture products
0,05(*)
0,05(*)
0,05(*)
0,05 (*)
0,05(*)
1050000
Amphibians and Reptiles
0,02(*)
0,01(*)
0,05(*)
0,01 (*)
0,01(*)
1060000
Terrestrial invertebrate animals
0,02(*)
0,01(*)
0,05(*)
0,01 (*)
0,01(*)
1070000
Wild terrestrial vertebrate animals
0,02(*)
0,01(*)
0,05(*)
0,01 (*)
0,01(*)
-
Annex III is amended as follows:
-
in Part A, the columns for chlorantraniliprole, fluopyram, spirodiclofen and sulfoxaflor are 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(2)
Chlorantraniliprole (DPX E-2Y45) (F)
Fluopyram (R)
Spirodiclofen (F)
(1)
(2)
(3)
(4)
(5)
0100000
FRUITS, FRESH or FROZEN; TREE NUTS
0200000
VEGETABLES, FRESH or FROZEN
0290000
Algae and prokaryotes organisms
0,01(*)
0,01(*)
0,02(*)
0300000
PULSES
0,01(*)
0,4
0,02(*)
0300010
Beans
0300020
Lentils
0300030
Peas
0300040
Lupins/lupini beans
0300990
Others
0400000
OILSEEDS AND OIL FRUITS
0,02(*)
0500000
CEREALS
0,02(*)
0500010
Barley
0,02
0,1 (+)
0500020
Buckwheat and other pseudo-cereals
0,02
0,1 (+)
0500030
Maize/corn
0,02
0,02
0500040
Common millet/proso millet
0,02
0,1 (+)
0500050
Oat
0,02
0,1 (+)
0500060
Rice
0,4
0,01(*)
0500070
Rye
0,02
0,8
0500080
Sorghum
0,02
1,5
0500090
Wheat
0,02
0,8
0500990
Others
0,02
0,1 (+)
0600000
TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS
0,02(*)
0,05(*)
0610000
Teas
0,01(*)
0620000
Coffee beans
0,01(*)
0640000
Cocoa beans
0,01(*)
0650000
Carobs/Saint John's breads
0,01(*)
0700000
HOPS
0,02(*)
3
40
0800000
SPICES
0,05(*)
0900000
SUGAR PLANTS
0,02(*)
0900010
Sugar beet roots
0,02
0,1 (+)
0900020
Sugar canes
0,5
0,01(*)
0900030
Chicory roots
0,02
0,1 (+)
0900990
Others
0,01(*)
0,1 (+)
1000000
PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS
1040000
Honey and other apiculture products
0,05(*)
0,05(*)
0,05 (*)
1050000
Amphibians and Reptiles
0,01(*)
0,02(*)
0,02(*)
1060000
Terrestrial invertebrate animals
0,01(*)
0,02(*)
0,02(*)
1070000
Wild terrestrial vertebrate animals
0,01(*)
0,02(*)
0,02(*)
-
in Part A, the following columns for cyflumetofen and sedaxane are added:
‘Pesticide residues and maximum residue levels (mg/kg)
Code number
Groups and examples of individual products to which the MRLs apply(2)
Cyflumetofen
Sedaxane
(1)
(2)
(3)
(4)
0100000
FRUITS, FRESH or FROZEN; TREE NUTS
0200000
VEGETABLES, FRESH or FROZEN
0290000
Algae and prokaryotes organisms
0300000
PULSES
0,01 (*)
0300010
Beans
0300020
Lentils
0300030
Peas
0300040
Lupins/lupini beans
0300990
Others
0400000
OILSEEDS AND OIL FRUITS
0500000
CEREALS
0,01 (*)
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
0610000
Teas
0620000
Coffee beans
0640000
Cocoa beans
0650000
Carobs/Saint John's breads
0700000
HOPS
0800000
SPICES
0900000
SUGAR PLANTS
0900010
Sugar beet roots
0900020
Sugar canes
0900030
Chicory roots
0900990
Others
1000000
PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS
1040000
Honey and other apiculture products
1050000
Amphibians and Reptiles
1060000
Terrestrial invertebrate animals
1070000
Wild terrestrial vertebrate animals
-
in Part B, the columns for dithiocarbamates, myclobutanil and propiconazole are 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(2)
Dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram)
Myclobutanyl (R)
Propiconazole
(1)
(2)
(3)
(4)
(5)
0620000
Coffee beans
0,1(*)
0,05(*)
0,1(*)
0640000
Cocoa beans
0,1(*)
0,05(*)
0,1(*)
0650000
Carobs/Saint John's breads
0,1(*)
0,05(*)
0,1(*)
0800000
SPICES
0,05(*)
0900000
SUGAR PLANTS
0,02(*)
0,05(*)
1040000
Honey and other apiculture products
0,05(*)
0,05 (*)
0,05(*)
1050000
Amphibians and Reptiles
0,05(*)
0,01 (*)
0,01(*)
1060000
Terrestrial invertebrate animals
0,05(*)
0,01 (*)
0,01(*)
1070000
Wild terrestrial vertebrate animals
0,05(*)
0,01 (*)
0,01(*)
-