2003L0113 — EN — 31.12.2003 — 000.001 — 1
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►B COMMISSION DIRECTIVE 2003/113/EC
of 3 December 2003
amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards
the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal
origin and certain products of plant origin, including fruit and vegetables
(Text with EEA relevance)
(OJ L 324, 11.12.2003, p. 24)
Corrected by:
►C1 Corrigendum, OJ L 98, 2.4.2004, p. 61 (2003/113/EC)
►C2 Corrigendum, OJ L 104, 8.4.2004, p. 135 (2003/113/EC)
▼B
COMMISSION DIRECTIVE 2003/113/EC
of 3 December 2003
amending the Annexes to Council Directives 86/362/EEC, 86/363/
EEC and 90/642/EEC as regards the fixing of maximum levels forcertain pesticide residues in and on cereals, foodstuffs of animalorigin and certain products of plant origin, including fruit and
vegetables
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 86/362/EEC of 24 July 1986 on the
fixing of maximum levels for pesticide residues in and on cereals (1), as
last amended by Commission Directive 2003/62/EC (2), and in parti-
cular Article 10 thereof,
Having regard to Council Directive 86/363/EEC of 24 July 1986 on the
fixing of maximum levels for pesticide residues in and on foodstuffs ofanimal origin (
3), as last amended by Commission Directive 2003/60/
EC (4), and in particular Article 10 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990
on fixing of maximum levels for pesticide residues in and on certainproducts of plant origin including fruit and vegetables (
5), as last
amended by Commission Directive 2003/69/EC (6), and in particular
Article 7 thereof,
Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the market (7),
as last amended by Commission Directive 2003/84/EC (8), and in parti-
cular Article 4(1)(f) thereof,
Whereas:
(1) The existing active substances 2,4-DB linuron and pendi-
methalin, were included in Annex I to Council Directive 91/414/EEC by Commission Directive 2003/31/EC (
9).
(2) The new active substances imazamox, oxasulfuron, ethoxysul-furon, foramsulfuron, oxadiargyl and cyazofamid were includedin Annex I to Council Directive 91/414/EEC by CommissionDirective, 2003/23/EC (
10).
(3) The inclusion in Annex I to Directive 91/414/EEC of the activesubstances concerned was based on the assessment of the infor-
mation submitted concerning the proposed use. Information
relating to this use has been submitted by certain Member Statesin accordance with Article 4(1)(f) of Directive 91/414/EEC. Theinformation available has been reviewed and is sufficient toallow certain maximum residue levels (MRLs) to be fixed.
(4) Where no Community MRL or provisional MRL exists, MemberStates are to establish a national provisional MRL in accordance
with Article 4(1)(f) of Directive 91/414/EEC before plant protec-
tion products containing these active substances may beauthorised.2003L0113 — EN — 31.12.2003 — 000.001 — 2
(1) OJ L 221, 7.8.1986, p. 37.
(2) OJ L 154, 21.6.2003, p. 70.
(3) OJ L 221, 7.8.1986, p. 43.
(4) OJ L 155, 24.6.2003, p. 15.
(5) OJ L 350, 14.12.1990, p. 71.
(6) OJ L 175, 15.7.2003, p. 37.
(7) OJ L 230, 19.8.1991, p. 1.
(8) OJ L 247, 30.9.2003, p. 20.
(9) OJ L 101, 23.4.2003, p. 3.
(10) OJ L 81, 28.3.2003, p. 39.
▼B
(5) With respect to the inclusion in Annex I to Directive 91/414/
EEC of the active substances concerned, the related technical
and scientific evaluations were finalised in the form of Commis-sion review reports. The assessment reports for the substancesmentioned were finalised on the dates as mentioned in theCommission Directives cited under (1) and (2). These reportsfixed the Acceptable Daily Intake (ADI) and if necessary, the
Acute Reference Dose (ARfD) for the substances concerned.
The exposure of consumers of food products treated with theactive substance concerned has been assessed and evaluated inaccordance with Community procedures. Account has also beentaken of guidelines published by the World Health Organisa-
tion (
1) and the opinion of the Scientific Committee for
Plants (2) on the methodology employed. It is concluded that
MRLs proposed will not lead to those ADIs or ARfD beingexceeded.
(6) In order to ensure that the consumer is adequately protectedfrom exposure to residues resulting from unauthorised uses ofplant protection products, provisional MRLs should be set forthe relevant product/pesticide combinations at the lower limit ofanalytical determination.
(7) The setting at Community level of such provisional MRLs doesnot prevent the Member States from establishing provisional
MRLs for the substances in this Directive in accordance with
Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto.It is considered that a period of four years is sufficient to permitfurther uses of the active substance concerned. The provisionalMRL should then become definitive.
(8) It is therefore necessary to add all of the pesticide residuesarising from use of these plant protection products to theAnnexes to Council Directives 86/362/EEC, 86/363/EEC and
90/642/EEC to allow for proper surveillance and control of the
prohibition of their uses and to protect the consumer. TheAnnexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.
(9) This Directive is in accordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The maximum pesticide residue levels for 2,4-DB, linuron, pendi-
methalin, imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron,
oxadiargyl and cyazofamid as shown in Annex I to this Directive areadded to Part A of Annex II to Directive 86/362/EEC.
Article 2
The maximum pesticide residue levels for pendimethalin, as shown in
Annex II to this Directive are added to Annex IIA to Directive 86/363/
EEC. The maximum pesticide residue levels for 2,4-DB and oxasul-
furon as shown in Annex III to this Directive are added to Annex IIBto Directive 86/363/EEC.2003L0113 — EN — 31.12.2003 — 000.001 — 3
(1) Guidelines for predicting dietary intake of pesticide residues (revised),
prepared by the GEMS/Food Programme in collaboration with the Codex
Committee on Pesticide Residues, published by the World Health Organisa-tion 1997 (WHO/FSF/FOS/97.7).
(
2) Opinion of the Scientific Committee on Plants regarding questions relating
to amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC
and 90/642/EEC (Opinion expressed by the Scientific Committee on Plants,
14 July 1998) (http://europa.eu.int/comm/food/fs/sc/index_en.html).
▼B
Article 3
The maximum pesticide residue levels for 2,4-DB, linuron, pendi-
methalin, imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron,
oxadiargyl and cyazofamid as shown in Annex IV to this Directive
are added to Annex II to Directive 90/642/EEC.
Article 4
Member States shall bring into force the laws, regulations and admin-
istrative provisions necessary to comply with this Directive six monthsafter publication of this Directive in the Official Journal of the
European Union at the latest. They shall forthwith inform the Commis-
sion thereof.
They shall apply these provisions with effect from 4 June 2005.When Member States adopt those provisions, they shall contain a refer-
ence to this Directive or be accompanied by such a reference on the
occasion of their official publication. Member States shall determine
how such reference is to be made.
Article 5
This Directive shall enter into force on the 20th day following that of
its publication in the Official Journal of the European Union .
Article 6
This Directive is addressed to the Member States.2003L0113 — EN — 31.12.2003 — 000.001 — 4
ANNEX I
Groups and examples of individual
products to which the MRLs applyPesticide residues and maximum residue levels (mg/kg)
2,4-DB linuron imazamox pendimethalin oxasulfuron ethoxysulfuron foramsulfuron oxadiargyl cyazofamid
CEREALS 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,01 (*) (p) 0,01 (*) (p) 0,02 (*) (p)
Barley
BuckwheatMaizeMillet
Oats
RiceRyeSorghumTriticale
Wheat
Cereals others
(*) indicates lower limit of analytical determination
(p) indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become de finitive with effect from (four years from date of coming into force of the
Directive introducing this amendment)▼B2003L0113 — EN — 31.12.2003 — 000.001 — 5
▼B
ANNEX II
Pesticide residuesMaximum levels in mg/kg (ppm)
Of fat contained in meat,
preparations of meat,
offal and animal fats
listed in Annex I under
heading Nos ex 0201,
0202, 0203, 0204,
0205 00 00, 0206, 0207,
ex 0208, 0209 00, 0210,
1601 00 and 1602 (1)(4)for cow's milk and whole
cream cow's milk listed in
Annex I under headings
No 0401: for other food-
stuffs in heading Nos
0401, 0402, 0405 00 and
0406 in accordance
with (2)(4)of shelled fresh eggs, for
bird's eggs and egg yolks
listed in Annex I under
heading Nos 0407 00 and
0408 (3)(4)
Pendimethalin 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p)
(*) Indicates lower limit of analytical determination
(p) indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless
amended, this level will become definitive with effect from 31 December 2007.
(1) In the case of foodstuffs with a fat content of 10 % or less by weight, the residue is related to the total weight of
the boned foodstuff. In such cases, the maximum level is one-tenth of the value related to fat content, but mustbe no less than 0,01 mg/kg.
(
2) In determining the residues in raw cow's milk and whole cream cow's milk, a fat content of 4 % by weight
should be taken as a basis.
For raw milk and whole cream milk of another animal origin the residues are expressed on the basis of the fat.
For the other foodstuffs listed in Annex I under heading Nos 0401, 0402, 0405 00, and 0406:
— with a fat content of less than 2 % by weight, the maximum level is taken as half that set for raw milk and
whole cream milk,
— with a fat content of 2 % or more by weight, the maximum level is expressed in mg/kg of fat. In such cases,
the maximum level is 25 times that set for raw milk and whole cream milk.
(3) For eggs and egg products with a fat content higher than 10 %, the maximum level is expressed in mg/kg fat.
In this case, the maximum level is 10 times higher than the maximum level for fresh eggs.
(4) Footnotes (1), (2) and (3) do not apply in cases where the lower limit of analytical determination is indicated.2003L0113 — EN — 31.12.2003 — 000.001 — 6
▼B
ANNEX III
Pesticide residuesMaximum levels in mg/kg (ppm)
Of meat, including fat,
preparations of meat,
offal and animal fats
listed in Annex I under
heading Nos ex 0201,
0202, 0203, 0204,
0205 00 00, 0206, 0207,
ex 0208, 0209 00, 0210,
1601 00 and 1602for milk and milk
products listed in Annex I
under heading Nos 0401,
0402, 0405 00 and 0406of shelled fresh eggs, for
bird's eggs and egg yolks
listed in Annex I under
heading Nos 0407 00 and
0408
2,4-DB 0,05 (*) (p) meat
0,1 (p) liver, kidney0,01 (*) (p) 0,05 (*) (p)
oxasulfuron 0,05 (*) (p)
(*) indicates lower limit of analytical determination.
(p) indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless
amended, this level will become definitive with effect from 31 December 2007.2003L0113 — EN — 31.12.2003 — 000.001 — 7
ANNEX IV
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
1. Fruit, fresh, dried or uncooked, preserved
by freezing, not containing added sugar;
nuts0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,01 (*) (p) 0,01 (*) (p)
(i) CITRUS FRUIT 0,05 (*) (p) 0,01 (*) (p)
Grapefruit
Lemons
LimesMandarins (including clementines and
other hybrids)
OrangesPomelos
Others
(ii) TREE NUTS (shelled or unshelled) 0,05 (*) (
p) 0,01 (*) (p)
Almonds
Brazil nuts
Cashew nutsChestnutsCoconuts
Hazelnuts
Macadamia▼C22003L0113 — EN — 31.12.2003 — 000.001 — 8
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
Pecans
Pine nutsPistachios
Walnuts
Others
(iii) POME FRUIT 0,05 (*) (
p) 0,01 (*) (p)
ApplesPearsQuincesOthers
(iv) STONE FRUIT 0,05 (*) (
p) 0,01 (*) (p)
ApricotsCherriesPeaches (including nectarines and similar
hybrids)
Plums
Others
(v) BERRIES AND SMALL FRUIT 0,05 (*) (
p)
(a) Table and wine grapes 0,5 (p)
Table grapes▼C22003L0113 — EN — 31.12.2003 — 000.001 — 9
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
Wine grapes
(b) Strawberries (other than wild) 0,01 (*) (p)
(c) Cane fruit (other than wild) 0,01 (*) (p)
Blackberries
DewberriesLoganberriesRaspberriesOthers
(d) Other small fruit and berries (other
than wild)0,01 (*) (
p)
Bilberries
CranberriesCurrants (red, black and white)GooseberriesOthers
(e) Wild berries and wild fruit 0,01 (*) (
p)
(vi) MISCELLANEOUS 0,05 (*) (p) 0,01 (*) (p)
AvocadosBananasDates▼C22003L0113 — EN — 31.12.2003 — 000.001 — 10
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
Figs
Kiwi
Kumquats
LitchisMangoes
Olives
Passion fruit
Pineapples
Papaya
Others
2. Vegetables, fresh or uncooked, frozen or dry 0,05 (*) (
p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,01 (*) (p) 0,01 (*) (p)
(i) ROOT AND TUBER VEGETABLES 0,01 (*) (p)
BeetrootCarrots 0,2 (
p) 0,2 (p)
Celeriac 0,5 (p)
Horseradish 0,2 (p)
Jerusalem artichokes
Parsnips 0,2 (p) 0,2 (p)
Parsley root 0,2 (p) 0,2 (p)▼C22003L0113 — EN — 31.12.2003 — 000.001 — 11
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
Radishes
Salsify
Sweet potatoes
SwedesTurnips
Yam
Others 0,05 (*) (
p) 0,05 (*) (p)
(ii) BULB VEGETABLES 0,05 (*) (p) 0,05 (*) (p) 0,01 (*) (p)
Garlic
Onions
Shallots
Spring onions
Others
(iii) FRUITING VEGETABLES 0,05 (*) (p) 0,05 (*) (p)
(a) Solanacea
Tomatoes 0,2 (p)
Peppers
Aubergines
Others 0,01 (*) (p)▼C22003L0113 — EN — 31.12.2003 — 000.001 — 12
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
(b) Cucurbits — edible peel
Cucumbers 0,1 (p)
Gherkins
CourgettesOthers 0,01 (*) (
p)
(c) Cucurbits — inedible peel 0,1 (p)
Melons
Squashes
Watermelons
Others
(d) Sweet corn 0,01 (*) (p)
(iv) BRASSICA VEGETABLES 0,05 (*) (p) 0,05 (*) (p) 0,01 (*) (p)
(a) Flowering brassica
Broccoli
Cauliflower
Others
(b) Head brassica
Brussels sprouts
Head cabbage▼C22003L0113 — EN — 31.12.2003 — 000.001 — 13
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
Others
(c) Leafy brassica
Chinese cabbage
Kale
Others
(d) Kohlrabi
(v) LEAF VEGETABLES AND FRESH
HERBS0,05 (*) (p) 0,01 (*) (p)
(a) Lettuce and similar 0,05 (*) (p)
CressLamb's lettuceLettuceScaroleOthers
(b) Spinach and similar 0,05 (*) (
p)
Spinach
Beet leaves (chard)Others
(c) Water cress 0,05 (*) (
p)
(d) Witloof 0,05 (*) (p)▼C22003L0113 — EN — 31.12.2003 — 000.001 — 14
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
(e) Herbs
Chervil
Chives
Parsley 1 (p)
Celery leaves 1 (p)
Others 0,05 (*) (p)
(vi) LEGUME VEGETABLES (fresh) 0,2 (p) 0,01 (*) (p)
Beans (with pods)
Beans (without pods) 0,1 (p)
Peas (with pods)
Peas (without pods) 0,1 (p)
Others 0,05 (*) (p)
(vii) STEM VEGETABLES (fresh) 0,05 (*) (p) 0,01 (*) (p)
Asparagus
Cardoons
Celery 0,1 (p)
Fennel
Globe artichokes
Leek▼C22003L0113 — EN — 31.12.2003 — 000.001 — 15
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
Rhubarb
Others 0,05 (*) (p)
(viii) FUNGI 0,05 (*) (p) 0,05 (*) (p) 0,01 (*) (p)
(a) Cultivated mushrooms(b) Wild mushrooms
3. PULSES 0,05 (*) (
p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,01 (*) (p) 0,01 (*) (p) 0,01 (*) (p)
Beans
Lentils
Peas
Others
4. OIL SEED 0,05 (*) (p) 0,1 (*) (p) 0,1 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,01 (*) (p) 0,01 (*) (p) 0,02 (*) (p)
Linseed
PeanutsPoppy seeds
Sesame seeds
Sunflower seed
Rape seed
Soya bean
Mustard seed▼C22003L0113 — EN — 31.12.2003 — 000.001 — 16
Groups and examples of individual products to which the
MRLs apply2,4-DB Linuron Pendimethalin Imazamox Oxasulfuron Ethoxysulfuron Foramsulfuron Oxadiargyl Cyazofamid
Cotton seed
Others
5. POTATOES 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,05 (*) (p) 0,01 (*) (p) 0,01 (*) (p) 0,01 (*) (p)
Early potatoesWare potatoes
6. TEA (leaves and stems, dried, fermented or
otherwise, from the leaves of Camellia
sinensis)0,1 (
p) (*) 0,1 (p) (*) 0,1 (p) (*) 0,1 (p) (*) 0,1 (p) (*) 0,1 (p) (*) 0,05 (*) (p) 0,05 (*) (p) 0,02 (*) (p)
7. HOPS (dried), including hop pellets and
unconcentrated powder0,1 (p) (*) 0,1 (p) (*) 0,1 (p) (*) 0,1 (p) (*) 0,1 (p) (*) 0,1 (p) (*) 0,05 (*) (p) 0,05 (*) (p) 0,02 (*) (p)
(*) Indicates lower limit of analytical determination
(p) Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become de finitive with effect from [4 years from date of coming into force of the
Directive introducing this amendment].▼C22003L0113 — EN — 31.12.2003 — 000.001 — 17