Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Commission Regulation (EU) 2015/401 of 25 February 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 acetamiprid, chromafenozide, cyazofamid, dicamba, difenoconazole, fenpyrazamine, fluazinam, formetanate, nicotine, penconazole, pymetrozine, pyraclostrobin, tau-fluvalinate and tebuconazole in or on certain products Text with EEA relevance
Commission Regulation (EU) 2015/401 of 25 February 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 acetamiprid, chromafenozide, cyazofamid, dicamba, difenoconazole, fenpyrazamine, fluazinam, formetanate, nicotine, penconazole, pymetrozine, pyraclostrobin, tau-fluvalinate 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 acetamiprid, cyazofamid, formetanate, pymetrozine, pyraclostrobin and tebuconazole maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. For penconazole MRLs were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For chromafenozide, dicamba, difenoconazole, fenpyrazamine, fluazinam, nicotine and tau-fluvalinate 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 chromafenozide on pome fruit and grapes, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.
As regards cyazofamid, such an application was made for grapes. As regards difenoconazole, such an application was made for peppers and aubergines. As regards fenpyrazamine, such an application was made for apricots, cherries, peaches and plums. As regards formetanate, such an application was made for strawberries. As regards penconazole, such an application was made for blackberries and raspberries. As regards pymetrozine, such an application was made for azarole. As regards pyraclostrobin, such an application was made for chicory roots. As regards tau-fluvalinate, such an application was made for pome fruits, peaches, apricots, grapes, tomatoes, aubergines, melons, broccoli, Brussels sprouts, kohlrabi, globe artichokes, lettuce and other salad plants. As regards tebuconazole, such an application was made for poppy seed.
In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was submitted for acetamiprid on apricots and tree nuts. The applicant claims that the authorised uses of that substance on such crops in the United States lead 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.
Such applications were also submitted as regards dicamba on genetically modified soya bean and as regards fluazinam on ginseng root. The applicants claim that the authorised uses of those substances on such crops in the United States lead 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 fenpyrazamine on peaches, no modification of the existing MRL is required. As regards the use of tau-fluvalinate on pome fruit, apricots, peaches and tomatoes, the submitted data were not sufficient to set new MRLs. The existing MRLs should therefore remain unchanged.
As regards dicamba, no residues were detected at harvest in dicamba-tolerant soya bean. The Authority concluded that the relevant component of the residues identified in dicamba-tolerant soya bean was the metabolite 3,6-dichlorosalicylic acid (DCSA).
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 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 (ADI) or the acute reference dose (ARfD) is exceeded.
As regards nicotine, by Commission Regulation (EU) No 897/2012(3) temporary MRLs were set for wild mushrooms until 30 November 2014 pursuant to Article 16(1)(a) of Regulation (EC) No 396/2005, pending the submission and evaluation of new data and information on the natural occurrence or formation of nicotine in the concerned products. The Commission was informed of a research project which is being carried out to investigate on the sources of nicotine occurring in those crops. In view of the expected duration of the study and in order to provide the necessary time for the Commission to take its decision, it is appropriate to extend the validity of these MRLs until 19 October 2016.
As regards formetanate, several MRLs were modified by Commission Regulation (EU) No 61/2014(4). That Regulation lowers the MRL for strawberries to the limit of determination as of 14 August 2014. In the interest of legal certainty, it is appropriate for the MRL provided for by this Regulation, to apply from the same date.
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 Plants, Animals, Food and Feed,
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.
It shall apply from 1 November 2014. However, it shall apply from 14 August 2014 for the MRL for formetanate in strawberries.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 February 2015.
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 acetamiprid, cyazofamid, formetanate, penconazole, pymetrozine, pyraclostrobin and tebuconazole 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)
Acetamiprid (R)
Cyazofamid
Formetanate: Sum of formetanate and its salts expressed as formetanate(hydrochloride)
Penconazole (F)
Pymetrozine (A) (R)
Pyraclostrobin (F)
Tebuconazole (R)
0100000
FRUIT FRESH OR FROZEN NUTS
0200000
VEGETABLES FRESH OR FROZEN
0290000
Sea weeds
0,01(*)
0,01(*)
0,02(*)
0,02(*)
0,02(*)
0300000
PULSES, DRY
0,02(*)
0,01(*)
0,05(*)
0,05(*)
0300010
Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)
0,07
0,3
0,3
0300020
Lentils
0,01(*)
0,5
0,2
0300030
Peas (Chickpeas, field peas, chickling vetch)
0,07
0,3
0,2
0300040
Lupins
0,01(*)
0,05
0,2
0300990
Others
0,01(*)
0,3
0,2
0400000
OILSEEDS AND OILFRUITS
0,02(*)
0,01(*)
0,05(*)
0500000
CEREALS
0,02(*)
0,01(*)
0,05(*)
0,05(*)
0500010
Barley
0,01(*)
1
2
0500020
Buckwheat (Amaranthus, quinoa)
0,01(*)
0,02(*)
0,02(*)
0500030
Maize
0,01(*)
0,02(*)
0,02(*)
0500040
Millet (Foxtail millet, teff, finger millet, pearl millet)
0,01(*)
0,02(*)
0,02(*)
0500050
Oats
0,01(*)
1
2
0500060
Rice (Indian/wild rice (Zizania aquatica))
0,01(*)
0,02(*)
1 (+)
0500070
Rye
0,01(*)
0,2
0,1
0500080
Sorghum
0,01(*)
0,5
0,02(*)
0500090
Wheat (Spelt, triticale)
0,03
0,2
0,1
0500990
Others (Canary grass seeds (Phalaris canariensis))
0,01(*)
0,02(*)
0,02(*)
0600000
TEA, COFFEE, HERBAL INFUSIONS AND COCOA
0,05(*)
0,05(*)
0,05(*)
0610000
Tea
0,1
0,1(*)
0,1(*)
0,05(*)
0620000
Coffee beans
0,1(*)
0,3 (+)
0,1
0640000
Cocoabeans (fermented or dried)
0,1(*)
0,1(*)
0,05(*)
0650000
Carob (st johns bread)
0,1(*)
0,1(*)
0,05(*)
0700000
HOPS (dried)
0,05(*)
0,05(*)
0,05(*)
0,5
15 (+)
15
40 (+)
0800000
SPICES
0900000
SUGAR PLANTS
0,01(*)
0,01(*)
0,01(*)
0,02(*)
0,02(*)
0900010
Sugar beet (root)
0,2
0900020
Sugar cane
0,02(*)
0900030
Chicory roots
0,08
0900990
Others
0,02(*)
1000000
PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS
(+)
1040000
Honey (Royal jelly, pollen, honey comb with honey (comb honey))
0,05 (*)
0,05(*)
0,05(*)
0,05(*)
0,05(*)
0,05(*)
1050000
Amphibians and reptiles (Frog legs, crocodiles)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0,05(*)
0,1(*)
1060000
Snails
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0,05(*)
0,1(*)
1070000
Other terrestrial animal products (Wild game)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0,05(*)
0,1(*)
-
Annex III is amended as follows:
-
In Part A, the columns for chromafenozide, dicamba, difenoconazole, fenpyrazamine, fluazinam, nicotine and tau-fluvalinate 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)
Chromafenozide
Dicamba
Difenoconazole
Fenpyrazamine
Fluazinam (F)
Nicotine
Tau-Fluvalinate (F)
0100000
FRUIT FRESH OR FROZEN NUTS
0200000
VEGETABLES FRESH OR FROZEN
0,01(*)
0,05(*)
0290000
Sea weeds
0,05(*)
0,05(*)
0,01(*)
0,01(*)
0300000
PULSES, DRY
0,01(*)
0,05(*)
0,01(*)
0,05(*)
0300010
Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)
0,05(*)
0,01(*)
0300020
Lentils
0,05(*)
0,01(*)
0300030
Peas (Chickpeas, field peas, chickling vetch)
0,1
0,02
0300040
Lupins
0,05(*)
0,01(*)
0300990
Others
0,05(*)
0,01(*)
0400000
OILSEEDS AND OILFRUITS
0,01(*)
0,05(*)
0,01(*)
0,05(*)
0500000
CEREALS
0,01(*)
0,01(*)
0,05(*)
0500010
Barley
7
0,05(*)
0,5
0500020
Buckwheat (Amaranthus, quinoa)
0,3
0,05(*)
0,01(*)
0500030
Maize
0,5
0,05(*)
0,1
0500040
Millet (Foxtail millet, teff, finger millet, pearl millet)
0,3
0,05(*)
0,01(*)
0500050
Oats
0,5
0,05(*)
0,5
0500060
Rice (Indian/wild rice (Zizania aquatica))
0,3
3
0,01(*)
0500070
Rye
0,5
0,1
0,05
0500080
Sorghum
4
0,05(*)
0,01(*)
0500090
Wheat (Spelt, triticale)
2
0,1
0,05
0500990
Others (Canary grass seeds (Phalaris canariensis))
0,3
0,05(*)
0,05
0600000
TEA, COFFEE, HERBAL INFUSIONS AND COCOA
0,02(*)
0,01(*)
0,01(*)
0610000
Tea
0,05(*)
0,05(*)
0,05(*)
0,6 (+)
0620000
Coffee beans
0,05(*)
0,05(*)
0,05(*)
0640000
Cocoabeans (fermented or dried)
0,05(*)
0,05(*)
0,05(*)
0650000
Carob (st johns bread)
0,05(*)
0,05(*)
0,05(*)
0700000
HOPS (dried)
0,02(*)
0,05(*)
0,05(*)
0,01(*)
0,05(*)
10
0800000
SPICES
(+)
0900000
SUGAR PLANTS
0,01(*)
0,01(*)
0,05(*)
0,01(*)
0900010
Sugar beet (root)
0,05(*)
0,2
0900020
Sugar cane
1
0,05(*)
0900030
Chicory roots
0,05(*)
0,6
0900990
Others
0,05(*)
0,05(*)
1000000
PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS
0,05(*)
1040000
Honey (Royal jelly, pollen, honey comb with honey (comb honey))
0,05 (*)
0,05(*)
0,05(*)
0,05 (*)
0,05 (*)
1050000
Amphibians and reptiles (Frog legs, crocodiles)
0,01 (*)
0,05(*)
0,05(*)
0,01(*)
0,01(*)
1060000
Snails
0,01 (*)
0,05(*)
0,05(*)
0,01(*)
0,01(*)
1070000
Other terrestrial animal products (Wild game)
0,01 (*)
0,05(*)
0,05(*)
0,01(*)
0,01(*)
-
In Part B, the column for penconazole 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(2)
Penconazole (F)
0620000
Coffee beans
0,1(*)
0639000
Other herbal infusions
0,1(*)
0640000
Cocoabeans (fermented or dried)
0,1(*)
0650000
Carob (st johns bread)
0,1(*)
0800000
SPICES
0900000
SUGAR PLANTS
0,05(*)
1040000
Honey (Royal jelly, pollen, honey comb with honey (comb honey))
0,05 (*)
1050000
Amphibians and reptiles (Frog legs, crocodiles)
0,05 (*)
1060000
Snails
0,05 (*)
1070000
Other terrestrial animal products (Wild game)
0,05 (*)
-