Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Commission Regulation (EU) No 35/2013 of 18 January 2013 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 dimethomorph, indoxacarb, pyraclostrobin and trifloxystrobin in or on certain products Text with EEA relevance
Commission Regulation (EU) No 35/2013 of 18 January 2013 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 dimethomorph, indoxacarb, pyraclostrobin and trifloxystrobin 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:
For indoxacarb, pyraclostrobin and trifloxystrobin maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For dimethomorph MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005.
In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance dimethomorph on leafy brassica, scarole, cress and land cress, an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.
As regards indoxacarb, such an application was made for strawberries, raspberries, Chinese cabbage, lamb’s lettuce, scarole, witloof, beans with pods, cardoons, fennel, rhubarb and soya beans. As regards pyraclostrobin, such an application was made for leafy brassica, sweet corn, maize, millet and sorghum. As regards trifloxystrobin, such an application was made for spring onions and globe artichokes.
In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was made for dimethomorph on flowering brassica, head cabbage, lettuce, celery, garlic, onions and shallots. The applicant claims that the authorised use of dimethomorph on such crops in the United States and Canada leads to residues exceeding the MRLs 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 these 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 reasoned opinions on the proposed MRLs(2). It forwarded these opinions to the Commission and the Member States and made them available to the public.
The Authority concluded in its reasoned opinions that, as regards the use of dimethomorph on flowering brassica, the submitted data are sufficient to set a new MRL for broccoli only. As regards indoxacarb on scarole and soya bean, the submitted data do not show a need to modify the existing MRLs. For witloof, the submitted data are not sufficient to set a new MRL. As regards the use of pyraclostrobin on sweet corn, the submitted data are not sufficient to set a new MRL.
As regards use of dimethomorph on cress and land cress no modification of the MRLs is necessary, since the MRLs set out in Part A of Annex III to Regulation (EC) No 396/2005 are identical with those requested. As regards use of pyraclostrobin on maize, millet and sorghum, no modification of the MRLs is necessary, since the MRLs set out in Annex II to Regulation (EC) No 396/2005 are identical with those requested.
As regards all other 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 these substances, nor the short-term exposure due to extreme consumption of the relevant crops and products showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded.
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.
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 the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
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, 18 January 2013.
For the Commission
The President
José Manuel Barroso
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
-
In Annex II, the columns for indoxacarb, pyraclostrobin and trifloxystrobin 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(1)
Indoxacarb as sum of the isomers S and R (F)
Pyraclostrobin (F)
Trifloxystrobin (F)
(1)
(2)
(3)
(4)
(5)
0100000
FRUIT FRESH OR FROZEN; NUTS
0200000
VEGETABLES FRESH OR FROZEN
0290000
Sea weeds
0,02 (**)
0,02 (**)
0300000
PULSES, DRY
0,3
0,02 (**)
0300010
Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)
0,1
0300020
Lentils
0,02 (**)
0300030
Peas (Chickpeas, field peas, chickling vetch)
0,02 (**)
0300040
Lupins
0,02 (**)
0300990
Others
0,02 (**)
0400000
OILSEEDS AND OILFRUITS
0500000
CEREALS
0,02 (**)
0500010
Barley
0,3
0,3
0500020
Buckwheat (Amaranthus, quinoa)
0,02 (**)
0,02 (**)
0500030
Maize
0,02 (**)
0,02 (**)
0500040
Millet (Foxtail millet, teff)
0,02 (**)
0,02 (**)
0500050
Oats
0,3
0,02 (**)
0500060
Rice
0,02 (**)
0,02 (**)
0500070
Rye
0,1
0,05
0500080
Sorghum
0,02 (**)
0,02 (**)
0500090
Wheat (Spelt, triticale)
0,1
0,05
0500990
Others
0,02 (**)
0,02 (**)
0600000
TEA, COFFEE, HERBAL INFUSIONS AND COCOA
0,05 (**)
0610000
Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis)
0,05 (**)
0,05 (**)
0620000
Coffee beans
0,05 (**)
0,2
0640000
Cocoa (fermented beans)
0,05 (**)
0,05 (**)
0650000
Carob (st johns bread)
0,05 (**)
0,05 (**)
0700000
HOPS (dried), including hop pellets and unconcentrated powder
0,05 (**)
10
30
0800000
SPICES
0,05 (**)
0,05 (**)
0900000
SUGAR PLANTS
0,02 (**)
0900010
Sugar beet (root)
0,1
0900020
Sugar cane
0,02 (**)
0900030
Chicory roots
0,02 (**)
0900990
Others
0,02 (**)
1000000
PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS
1040000
Honey (Royal jelly, pollen)
0,02
0,05 (**)
1050000
Amphibians and reptiles (Frog legs, crocodiles)
0,02
0,05 (**)
1060000
Snails
0,02
0,05 (**)
1070000
Other terrestrial animal products
0,02
0,05 (**)
-
In Part A of Annex III, the column for dimethomorph 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)
Dimethomorph
(1)
(2)
(3)
0100000
FRUIT FRESH OR FROZEN; NUTS
0200000
VEGETABLES FRESH OR FROZEN
0290000
Sea weeds
0,05 (**)
0300000
PULSES, DRY
0,05 (**)
0300010
Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)
0300020
Lentils
0300030
Peas (Chickpeas, field peas, chickling vetch)
0300040
Lupins
0300990
Others
0400000
OILSEEDS AND OILFRUITS
0,05 (**)
0500000
CEREALS
0,05 (**)
0500010
Barley
0500020
Buckwheat (Amaranthus, quinoa)
0500030
Maize
0500040
Millet (Foxtail millet, teff)
0500050
Oats
0500060
Rice
0500070
Rye
0500080
Sorghum
0500090
Wheat (Spelt, triticale)
0500990
Others
0600000
TEA, COFFEE, HERBAL INFUSIONS AND COCOA
0,05 (**)
0610000
Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis)
0620000
Coffee beans
0640000
Cocoa (fermented beans)
0650000
Carob (st johns bread)
0700000
HOPS (dried), including hop pellets and unconcentrated powder
50
0800000
SPICES
0,05 (**)
0900000
SUGAR PLANTS
0,05 (**)
0900010
Sugar beet (root)
0900020
Sugar cane
0900030
Chicory roots
0900990
Others
1000000
PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS
0,05 (**)
1040000
Honey (Royal jelly, pollen)
1050000
Amphibians and reptiles (Frog legs, crocodiles)
1060000
Snails
1070000
Other terrestrial animal products