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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:

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

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

  11. 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

Annexes II and III to Regulation (EC) No 396/2005 are 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, 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:

  1. 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

    (***)

    (***)

    (***)

    (***)

    (***)

  2. Annex III is amended as follows:

    1. Part A is amended as follows:

      1. 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

      2. 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

    2. Part B is amended as follows:

      1. 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 (**)