Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Commission Regulation (EU) No 524/2011 of 26 May 2011 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 biphenyl, deltamethrin, ethofumesate, isopyrazam, propiconazole, pymetrozine, pyrimethanil and tebuconazole in or on certain products Text with EEA relevance
Commission Regulation (EU) No 524/2011 of 26 May 2011 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 biphenyl, deltamethrin, ethofumesate, isopyrazam, propiconazole, pymetrozine, pyrimethanil and tebuconazole 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 deltamethrin, ethofumesate, propiconazole, pymetrozine and pyrimethanil maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For tebuconazole, MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For isopyrazam no MRLs were set before in any of the Annexes to Regulation (EC) No 396/2005, so the default value of 0.01 mg/kg applied. Up to now, for biphenyl no specific MRLs were set nor was the substance included in Annex IV to Regulation (EC) No 396/2005. Biphenyl was formerly used as a plant protection product. In accordance with Article 18(1)(b) Regulation (EC) No 396/2005 the default MRL of 0.01 mg/kg is to apply to all products listed in Annex I thereto.
In the context of a procedure, in accordance with Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(2), for the authorisation of the use of a plant protection product containing the active substance pymetrozine on spinach, purslane and beet leaves an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.
As regards deltamethrin, such an application was made for the use on potatoes. As regards ethofumesate, such an application was made for the use in herbal infusions for leaves and flowers and thyme. As regards isopyrazam, such an application was made for the use on several cereals. As regards propiconazole, such an application was made for the use on table and wine grapes, and apples As regards pyrimethanil, such an application was made for the use on peas with pods. As regards tebuconazole, such an application was made for the use on various citrus fruit.
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.
As Regards biphenyl, the Commission received information from Germany and business operators showing the presence of biphenyl on fresh herbs and herbal infusions containing pesticide residues higher than the default MRL. Germany submitted an evaluation report and informed that due to the ubiquitous presence of this substance from various sources it is impossible to produce herbs,tea rose hips, spices and herbal infusions containing residues of biphenyl complying with the MRL. Referring to the procedure described in Article 16(1) (a) of Regulation (EC) No 396/2005 Germany made an application for temporary MRLs to enable the placing on the market of the affected products.
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(3). 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 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 showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded.
For biphenyl the Authority recommended only to raise the MRLs for which data demonstrated that this was necessary. It also advised that because of analytical problems in some cases it might not be possible to enforce the existing MRL and suggested that the lowest limit of analytical determination (LOD) for these crops might be raised. This was confirmed by information obtained from the EU reference laboratory.
Based on the reasoned opinions and statement 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 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, 26 May 2011.
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 deltamethrin, ethofumesate, propiconazole, pymetrozine and pyrimethanil 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)
Deltamethrin (cis-deltamethrin) (F)
Ethofumesate (sum of ethofumesate and the metabolite 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate expressed as ethofumesate)
Propiconazole
Pymetrozine
Pyrimethanil
(1)
(2)
(3)
(4)
(5)
(6)
(7)
0100000
FRUIT FRESH OR FROZEN; NUTS
0,05 (**)
0200000
VEGETABLES FRESH OR FROZEN
0290000
Sea weeds
0300000
PULSES, DRY
1
0,05 (**)
0,05 (**)
0,02 (**)
0,5
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
0500000
CEREALS
2
0,05 (**)
0,02 (**)
0,05 (**)
0500010
Barley
0,2
0500020
Buckwheat (Amaranthus, quinoa)
0,05 (**)
0500030
Maize
0,05 (**)
0500040
Millet (Foxtail millet, teff)
0,05 (**)
0500050
Oats
0,2
0500060
Rice
0,05 (**)
0500070
Rye
0,05 (**)
0500080
Sorghum
0,05 (**)
0500090
Wheat (Spelt, triticale)
0,05 (**)
0500990
Others
0,05 (**)
0600000
TEA, COFFEE, HERBAL INFUSIONS AND COCOA
0,1 (**)
0,1 (**)
0,1 (**)
0610000
Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis)
5
0,1 (**)
0620000
Coffee beans
0640000
Cocoa (fermented beans)
0650000
Carob (st johns bread)
0700000
HOPS (dried) , including hop pellets and unconcentrated powder
5
0,1 (**)
0,1 (**)
15
0,1 (**)
0800000
SPICES
0900000
SUGAR PLANTS
0900010
Sugar beet (root)
0900020
Sugar cane
0900030
Chicory roots
0900990
Others
1000000
PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS
0,1 (**)
0,01 (**)
0,05 (**)
1040000
Honey (Royal jelly, pollen)
1050000
Amphibians and reptiles (Frog legs, crocodiles)
1060000
Snails
1070000
Other terrestrial animal products
-
Annex III is amended as follows:
-
Part A is amended as follows:
-
The column for tebuconazole 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)
Tebuconazole
(1)
(2)
(3)
0100000
FRUIT FRESH OR FROZEN; NUTS
0200000
VEGETABLES FRESH OR FROZEN
0290000
Sea weeds
0,05 (**)
0300000
PULSES, DRY
0300010
Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)
0,2
0300020
Lentils
0,05 (**)
0300030
Peas (Chickpeas, field peas, chickling vetch)
0,05 (**)
0300040
Lupins
0,2
0300990
Others
0,05 (**)
0400000
OILSEEDS AND OILFRUITS
0500000
CEREALS
0500010
Barley
2
0500020
Buckwheat (Amaranthus, quinoa)
0,2
0500030
Maize
0,2
0500040
Millet (Foxtail millet, teff)
0,2
0500050
Oats
2
0500060
Rice
2
0500070
Rye
0,2
0500080
Sorghum
0,2
0500090
Wheat (Spelt, triticale)
0,2
0500990
Others
0,2
0600000
TEA, COFFEE, HERBAL INFUSIONS AND COCOA
0610000
Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis)
0,05 (**)
0620000
Coffee beans
0,1
0640000
Cocoa (fermented beans)
0,05 (**)
0650000
Carob (st johns bread)
0,05 (**)
0700000
HOPS (dried) , including hop pellets and unconcentrated powder
30
0800000
SPICES
0900000
SUGAR PLANTS
0,05 (**)
0900010
Sugar beet (root)
0900020
Sugar cane
0900030
Chicory roots
0900990
Others
1000000
PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS
1040000
Honey (Royal jelly, pollen)
0,05 (**)
1050000
Amphibians and reptiles (Frog legs, crocodiles)
0,05 (**)
1060000
Snails
0,05 (**)
1070000
Other terrestrial animal products
0,1
-
The following columns for isopyrazam and biphenyl are added:
‘Pesticide residues and maximum residue levels (mg/kg)
Code number
Groups and examples of individual products to which the MRLs apply(1)
Biphenyl
Isopyrazam
(1)
(2)
(3)
(4)
0100000
FRUIT FRESH OR FROZEN; NUTS
0,01 (**)
0200000
VEGETABLES FRESH OR FROZEN
0,01 (**)
0290000
Sea weeds
0,01 (**)
0300000
PULSES, DRY
0,01 (**)
0,01 (**)
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
0,01 (**)
0,01 (**)
0500000
CEREALS
0,01 (**)
0500010
Barley
0,6
0500020
Buckwheat (Amaranthus, quinoa)
0,01 (**)
0500030
Maize
0,01 (**)
0500040
Millet (Foxtail millet, teff)
0,01 (**)
0500050
Oats
0,6
0500060
Rice
0,01 (**)
0500070
Rye
0,2
0500080
Sorghum
0,01 (**)
0500090
Wheat (Spelt, triticale)
0,2
0500990
Others
0,01 (**)
0600000
TEA, COFFEE, HERBAL INFUSIONS AND COCOA
0,01 (**)
0610000
Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis)
0,05 (**)
0620000
Coffee beans
0,05 (**)
0640000
Cocoa (fermented beans)
0,05 (**)
0650000
Carob (st johns bread)
0,05 (**)
0700000
HOPS (dried) , including hop pellets and unconcentrated powder
0,05 (**)
0,01 (**)
0800000
SPICES
0,05 (**)
0,01 (**)
0900000
SUGAR PLANTS
0,01 (**)
0,01 (**)
0900010
Sugar beet (root)
0900020
Sugar cane
0900030
Chicory roots
0900990
Others
1000000
PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS
0,01 (**)
0,01 (**)
1040000
Honey (Royal jelly, pollen)
1050000
Amphibians and reptiles (Frog legs, crocodiles)
1060000
Snails
1070000
Other terrestrial animal products
-
-
Part B is amended as follows:
-
The columns for deltamethrin, ethofumesate, propiconazole, pymetrozine and pyrimethanil 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)
Deltamethrin (cis-deltamethrin) (F)
Ethofumesate (sum of ethofumesate and the metabolite 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate expressed as ethofumesate)
Propiconazole
Pymetrozine
Pyrimethanil
(1)
(2)
(3)
(4)
(5)
(6)
(7)
0130040
Medlar
0,1
0,05 (**)
0,05 (**)
0,02 (**)
5
0130050
Loquat
0,1
0,05 (**)
0,05 (**)
0,02 (**)
5
0154050
Rose hips
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
5
0154060
Mulberries (arbutus berry)
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
5
0154070
Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta))
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
5
0154080
Elderberries (Black chokeberry (appleberry), mountain ash, buckthorn (sea sallowthorn), hawthorn, service berries, and other treeberries)
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
5
0161050
Carambola (Bilimbi)
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0161060
Persimmon
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0161070
Jambolan (java plum) (Java apple (water apple), pomerac, rose apple, Brazilean cherry Surinam cherry (grumichama Eugenia uniflora))
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0162040
Prickly pear (cactus fruit)
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0162050
Star apple
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0162060
American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel (yellow sapote), and mammey sapote)
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0163060
Cherimoya (Custard apple, sugar apple (sweetsop), llama and other medium sized Annonaceae)
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0163070
Guava (Red pitaya or dragon fruit (Hylocereus undatus))
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0163090
Bread fruit (Jackfruit)
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0163100
Durian
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0163110
Soursop (guanabana)
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0212040
Arrowroot
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0251050
Land cress
0,5
0,05 (**)
0,05 (**)
2
0,05 (**)
0251070
Red mustard
0,5
0,05 (**)
0,05 (**)
2
0,05 (**)
0252020
Purslane (Winter purslane (miner’s lettuce), garden purslane, common purslane, sorrel, glassworth, Agretti (Salsola soda))
0,5
1
0,05 (**)
0,4
0,05 (**)
0620000
Coffee beans
2
0,1 (**)
0,1 (**)
0,1 (**)
0,1 (**)
0640000
Cocoa (fermented beans)
0,05 (**)
0,1 (**)
0,1 (**)
0,1 (**)
0,1 (**)
0650000
Carob (st johns bread)
0,05 (**)
0,1 (**)
0,1 (**)
0,1 (**)
0,1 (**)
0800000
SPICES
0,05 (**)
0,5
0,1 (**)
0,1 (**)
0,1 (**)
0900000
SUGAR PLANTS
0,05 (**)
0,02 (**)
0,05 (**)
0900010
Sugar beet (root)
0,5
0,5
0,05 (**)
0,02 (**)
0,05 (**)
0900020
Sugar cane
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0900030
Chicory roots
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
0900990
Others
0,05 (**)
0,05 (**)
0,05 (**)
0,02 (**)
0,05 (**)
1040000
Honey (Royal jelly, pollen)
0,03 (**)
0,1 (**)
0,01 (**)
0,01 (**)
0,05 (**)
1050000
Amphibians and reptiles (Frog legs, crocodiles)
0,03 (**)
0,1 (**)
0,01 (**)
0,01 (**)
0,05 (**)
1060000
Snails
0,03 (**)
0,1 (**)
0,01 (**)
0,01 (**)
0,05 (**)
1070000
Other terrestrial animal products
0,03 (**)
0,1 (**)
0,01 (**)
0,01 (**)
0,05 (**)
-
-