Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Commission Regulation (EU) 2019/552 of 4 April 2019 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 azoxystrobin, bicyclopyrone, chlormequat, cyprodinil, difenoconazole, fenpropimorph, fenpyroximate, fluopyram, fosetyl, isoprothiolane, isopyrazam, oxamyl, prothioconazole, spinetoram, trifloxystrobin and triflumezopyrim in or on certain products (Text with EEA relevance.)
Commission Regulation (EU) 2019/552 of 4 April 2019 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 azoxystrobin, bicyclopyrone, chlormequat, cyprodinil, difenoconazole, fenpropimorph, fenpyroximate, fluopyram, fosetyl, isoprothiolane, isopyrazam, oxamyl, prothioconazole, spinetoram, trifloxystrobin and triflumezopyrim 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 6 July 2018, the Codex Alimentarius Commission adopted new Codex maximum residue limits (CXLs) for azoxystrobin, bicyclopyrone, chlormequat, cyprodinil, difenoconazole, fenazaquin, fenpropimorph, fenpyroximate, flonicamid, fluopyram, flupyradifurone, fosetyl, imazamox, imazapyr, isoprothiolane, isopyrazam, oxamyl, picoxystrobin, prothioconazole, quinclorac, saflufenacil, spinetoram, tebuconazole, trifloxystrobin and triflumezopyrim(2).
Maximum residue levels (MRLs) had been set for those substances in Annexes II and III to Regulation (EC) No 396/2005, except for bicyclopyrone and triflumezopyrim for which no specific MRLs were set nor were those substances included in Annex IV to that Regulation, so the default value of 0,01 mg/kg laid down in Article 18(1)(b) thereof applies.
In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council(3), 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(4) to the Codex Committee on Pesticides Residues on the CXLs proposed for the following pesticide/product combinations: bicyclopyrone (mammalian edible offal); difenoconazole (pome fruit; rice); fenazaquin (all products); fenpropimorph (banana); fenpyroximate (pears; cucumbers; melons; peppers; coffee beans; citrus fruits; animal products); flonicamid (all products); fluopyram (milk; rice; dry peas); flupyradifurone (all products); imazamox (all products); imazapyr (all products); oxamyl (cucumber; summer squash); picoxystrobin (all products); quinclorac (all products); saflufenacil (all products); spinetoram (avocado; plums; animal products); tebuconazole (all products); trifloxystrobin (head cabbages).
The CXLs for azoxystrobin, bicyclopyrone, chlormequat, cyprodinil, difenoconazole, fenpropimorph, fenpyroximate, fluopyram, fosetyl, isoprothiolane, isopyrazam, oxamyl, prothioconazole, spinetoram, trifloxystrobin and triflumezopyrim, 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 referred to in Annex I to that Regulation or where they are at a lower level than the current MRLs. Those CXLs are safe for consumers in the Union(5).
In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance potassium phosphonates on blackberries, raspberries, blueberries, currants, gooseberries and elderberries, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs for fosetyl.
In accordance with Article 8 of Regulation (EC) No 396/2005, that application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.
The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report, examining in particular the risks to the consumer and, where relevant, to animals and gave a reasoned opinion on the proposed MRLs(6). It forwarded that opinion to the applicant, the Commission and the Member State and made it available to the public.
The Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicant 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 substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant 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, 4 April 2019.
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 azoxystrobin, chlormequat, cyprodinil, fenpropimorph, fenpyroximate, oxamyl, prothioconazole 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(2)
Azoxystrobin
Chlormequat (sum of chlormequat and its salts, expressed as chlormequat-chloride)
Cyprodinil (F) (R)
Fenpropimorph (sum of isomers) (F) (R)
Fenpyroximate (A) (F) (R)
Oxamyl
Prothioconazole: prothioconazole-desthio (sum of isomers) (F)
Trifloxystrobin (F) (R)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
0100000
FRUITS, FRESH or FROZEN; TREE NUTS
0,01(*)
0200000
VEGETABLES, FRESH or FROZEN
0290000
Algae and prokaryotes organisms
0,01(*)
0,01(*)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0,01(*)
0,01(*)
0300000
PULSES
0,15
0,01(*)
0,01(*)
0,01(*)
0,01(*)
0,2
0300010
Beans
0,2
0,05 (+)
0300020
Lentils
0,02(*)
1 (+)
0300030
Peas
0,1
1 (+)
0300040
Lupins/lupini beans
0,1
1 (+)
0300990
Others (2)
0,02(*)
0,01(*)
0400000
OILSEEDS AND OIL FRUITS
0,01(*)
0,01(*)
0,01(*)
0500000
CEREALS
0,01(*)
0,01(*)
0500010
Barley
1,5
3
4
0,4
0,2 (+)
0,5
0500020
Buckwheat and other pseudocereals
0,01(*)
0,01(*)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0500030
Maize/corn
0,02
0,01(*)
0,02(*)
0,01(*)
0,1
0,02
0500040
Common millet/proso millet
0,01(*)
0,01(*)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0500050
Oat
1,5
15
4
0,4
0,05 (+)
0,4 (+)
0500060
Rice
5
0,01(*)
0,02(*)
0,01(*)
0,01(*)
5
0500070
Rye
0,5
8
0,5
0,15
0,05 (+)
0,3
0500080
Sorghum
10
0,01(*)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0500090
Wheat
0,5
7
0,5
0,15
0,1 (+)
0,3
0500990
Others (2)
0,01(*)
0,01(*)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0600000
TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS
0,05(*)
0,05(*)
0,05(*)
0,05(*)
0,05(*)
0610000
Teas
0,05(*)
0,1(*)
8
0620000
Coffee beans
0,03
0,1(*)
0,05(*)
0640000
Cocoa beans
0,05(*)
0,1(*)
0,05(*)
0650000
Carobs/Saint John's breads
0,05(*)
0,1(*)
0,05(*)
0700000
HOPS
30
0,05(*)
0,1(*)
0,05(*)
15 (+)
0,05(*)
0,05(*)
40
0800000
SPICES
0900000
SUGAR PLANTS
0,01(*)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0900010
Sugar beet roots
0,2
0,03
0,02
0900020
Sugar canes
0,05
0,01(*)
0,01(*)
0900030
Chicory roots
0,09
0,01(*)
0,01(*)
0900990
Others (2)
0,01(*)
0,01(*)
0,01(*)
1000000
PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS
(+)
1040000
Honey and other apiculture products (7)
0,05(*)
0,05(*)
0,05(*)
0,05(*)
0,05(*)
0,05(*)
0,05(*)
0,05(*)
1050000
Amphibians and Reptiles
0,01(*)
0,01(*)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0,01(*)
0,02(*)
1060000
Terrestrial invertebrate animals
0,01(*)
0,01(*)
0,02(*)
0,01(*)
0,01(*)
0,01(*)
0,01(*)
0,02(*)
1070000
Wild terrestrial vertebrate animals
0,01(*)
0,3
0,02(*)
0,04
0,01(*)
0,01(*)
0,01
0,02(*)
1100000
PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)
1200000
PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)
1300000
PROCESSED FOOD PRODUCTS (9)
-
Part A of Annex III is amended as follows:
-
the columns for difenoconazole, fluopyram, fosetyl, isoprothiolane, isopyrazam and spinetoram 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)
Difenoconazole
Fluopyram (R)
Fosetyl-Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl)
Isoprothiolane
Isopyrazam
Spinetoram (XDE-175)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
0100000
FRUITS, FRESH or FROZEN; TREE NUTS
0,01(*)
0200000
VEGETABLES, FRESH or FROZEN
0,01(*)
0290000
Algae and prokaryotes organisms
0,05(*)
0,01(*)
2(*)
0,01(*)
0,05(*)
0300000
PULSES
0,4
2(*)
0,01(*)
0,01(*)
0,05(*)
0300010
Beans
0,06
0300020
Lentils
0,06
0300030
Peas
0,15
0300040
Lupins/lupini beans
0,06
0300990
Others (2)
0,06
0400000
OILSEEDS AND OIL FRUITS
2(*)
0,01(*)
0,05(*)
0500000
CEREALS
2(*)
0,05(*)
0500010
Barley
0,3
0,2
0,01(*)
0,6
0500020
Buckwheat and other pseudocereals
0,05(*)
0,2
0,01(*)
0,01(*)
0500030
Maize/corn
0,05(*)
0,02
0,01(*)
0,01(*)
0500040
Common millet/proso millet
0,05(*)
0,01(*)
0,01(*)
0,01(*)
0500050
Oat
0,05(*)
0,2
0,01(*)
0,6
0500060
Rice
3
0,01(*)
6
0,01(*)
0500070
Rye
0,1
0,9
0,01(*)
0,2
0500080
Sorghum
0,05(*)
1,5
0,01(*)
0,01(*)
0500090
Wheat
0,1
0,9
0,01(*)
0,2
0500990
Others (2)
0,05(*)
0,01(*)
0,01(*)
0,01(*)
0600000
TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS
0,01(*)
0,01(*)
0610000
Teas
0,05(*)
0,05(*)
5(*)
0,1(*)
0620000
Coffee beans
0,05(*)
0,05(*)
5(*)
0,1(*)
0640000
Cocoa beans
0,05(*)
0,05(*)
2(*)
0,1(*)
0650000
Carobs/Saint John's breads
0,05(*)
0,05(*)
2(*)
0,1(*)
0700000
HOPS
0,05(*)
50
2 000
0,01(*)
0,01(*)
0,1(*)
0800000
SPICES
0900000
SUGAR PLANTS
0,01(*)
0,01(*)
0,05(*)
0900010
Sugar beet roots
0,2
0,1
2(*)
0900020
Sugar canes
0,05(*)
0,01(*)
2(*)
0900030
Chicory roots
0,6
0,1
75
0900990
Others (2)
0,05(*)
0,01(*)
2(*)
1000000
PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS
1040000
Honey and other apiculture products (7)
0,05(*)
0,05(*)
0,5(*)
0,05(*)
0,05(*)
0,05(*)
1050000
Amphibians and Reptiles
0,05(*)
0,02(*)
0,5(*)
0,01(*)
0,01(*)
0,01(*)
1060000
Terrestrial invertebrate animals
0,05(*)
0,02(*)
0,5(*)
0,01(*)
0,01(*)
0,01(*)
1070000
Wild terrestrial vertebrate animals
0,05(*)
1,5
0,5(*)
0,01(*)
0,01(*)
0,01(*)
1100000
PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)
1200000
PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)
1300000
PROCESSED FOOD PRODUCTS (9)
-
the following columns for bicyclopyrone and triflumezopyrim are added:
‘Pesticide residues and maximum residue levels (mg/kg)
Code number
Groups and examples of individual products to which the MRLs apply(2)
Bicyclopyrone (sum of bicyclopyrone and its structurally related metabolites determined as the sum of the common moieties 2-(2- methoxyethoxymethyl)-6-(trifluoromethyl) pyridine-3-carboxylic acid (SYN503780) and (2-(2-hydroxyethoxymethyl)-6- (trifluoromethyl)pyridine-3-carboxylic acid (CSCD686480), expressed as bicyclopyrone)
Triflumezopyrim
(1)
(2)
(3)
(4)
0100000
FRUITS, FRESH or FROZEN; TREE NUTS
0200000
VEGETABLES, FRESH or FROZEN
0290000
Algae and prokaryotes organisms
0300000
PULSES
0300010
Beans
0300020
Lentils
0300030
Peas
0300040
Lupins/lupini beans
0300990
Others (2)
0400000
OILSEEDS AND OIL FRUITS
0500000
CEREALS
0500010
Barley
0,04
0500020
Buckwheat and other pseudocereals
0,02 (*)
0500030
Maize/corn
0,02 (*)
0500040
Common millet/proso millet
0,02 (*)
0500050
Oat
0,02 (*)
0500060
Rice
0,02 (*)
0,01
0500070
Rye
0,02 (*)
0500080
Sorghum
0,02 (*)
0500090
Wheat
0,04
0500990
Others (2)
0,02 (*)
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
0,02 (*)
0900010
Sugar beet roots
0900020
Sugar canes
0900030
Chicory roots
0900990
Others (2)
1000000
PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS
1040000
Honey and other apiculture products (7)
0,05 (*)
0,05 (*)
1050000
Amphibians and Reptiles
0,02 (*)
0,01 (*)
1060000
Terrestrial invertebrate animals
0,02 (*)
0,01 (*)
1070000
Wild terrestrial vertebrate animals
0,02 (*)
0,01 (*)
1100000
PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)
1200000
PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)
1300000
PROCESSED FOOD PRODUCTS (9)
-