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Commission Regulation (EC) No 466/2001 (repealed)Show full title

Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs (Text with EEA relevance) (repealed)

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Changes over time for: Commission Regulation (EC) No 466/2001 (repealed) (Annexes only)

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ANNEX IU.K.MAXIMUM LEVELS FOR CERTAIN CONTAMINANTS IN FOODSTUFFS

[F1Section 1: Nitrates
Product Maximum level (mg NO 3 /kg) Sampling method Reference analysis method

1.1. Fresh spinach b ( Spinacia oleracea )

Harvested 1 October to 31 March 3 000 Commission Directive 2002/63/EC
Harvested 1 April to 30 September 2 500

1.2. Preserved, deep-frozen or frozen spinach

2 000 Directive 2002/63/EC

1.3. Fresh lettuce ( Lactuca sativa L .) (protected and open-grown lettuce) excluding lettuce listed in point 1.4.

Harvested 1 October to 31 March: Directive 2002/63/EC. However, the minimum number of units per laboratory sample is 10
lettuce grown under cover 4 500 e
lettuce grown in the open air 4 000 e
Harvested 1 April to 30 September:
lettuce grown under cover 3 500 e
lettuce grown in the open air 2 500 e

1.4. Iceberg type lettuces

Lettuce grown under cover 2 500 e Directive 2002/63/EC. However, the minimum number of units per laboratory sample is 10
Lettuce grown in the open air 2 000 e

1.5. Baby foods and processed cereal-based foods for infants and young children

200 Directive 2002/63/EC (provisions as foreseen for processed foods of plant origin and for processed foods of animal origin) ]
Section 2: Mycotoxins
ProductMaximum level (µg / kg)Sampling methodPerformance criteria for methods of analysis
B1B1 + B2 + G1 + G2M1
2.1. AFLATOXINS
2.1.1. Groundnuts, nuts and dried fruit

2.1.1.1.Groundnuts, nuts and dried fruit and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs

2,0f4,0fCommission Directive 98/53/ECgDirective 98/53/EC

2.1.1.2.Groundnuts to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs

8,0f15,0fDirective 98/53/ECDirective 98/53/EC

2.1.1.3.Nuts and dried fruit to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs

5,0f10,0fDirective 98/53/ECDirective 98/53/EC
2.1.2. Cereals (including buckwheat,Fagopyrumsp)

2.1.2.1.Cereals (including buckwheat, Fagopyrum sp) and processed products thereof intended for direct human consumption or use as an ingredient in foodstuffs

2,04,0Directive 98/53/ECDirective 98/53/EC

2.1.2.2.Cereals (including buckwheat, Fagopyrum sp), with the exception of maize, to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs

2,04,0Directive 98/53/ECDirective 98/53/EC

2.1.2.3.Maize to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs

5,010,0Directive 98/53/ECDirective 98/53/EC

2.1.3.Milk (raw milk, milk for the manufacture of milk based products and heat-treated milk as defined by Council Directive 92/46/ECj as last amended by Regulation (EC) No 806/2003l

0,05Directive 98/53/ECDirective 98/53/EC

2.1.4.Following species of spices:

  • Capsicum spp. (dried fruits thereof, whole or ground, including chillies, chilli powder, cayenne and paprika)

  • Piper spp. (fruits thereof, including white and black pepper)

  • Myristica fragrans (nutmeg)

  • Zingiber officinale (ginger)

  • Curcuma longa (turmeric)

5,010,0Directive 98/53/ECDirective 98/53/EC

[F22.1.5. Baby foods and processed cereal-based foods for infants and young children

0,1 Directive 1998/53/EC Directive 1998/53/EC

2.1.6. Infant formulae and follow-on formulae, including infant milk and follow-on milk

0,025 Directive 1998/53/EC Directive 1998/53/EC

2.1.7. Dietary foods for special medical purposes intended specifically for infants

0,1 0,025 Directive 1998/53/EC Directive 1998/53/EC]
[F3Product Maximum levels (μg/kg or ppb) Sampling method Reference analysis method
[F42.2. OCHRATOXIN A
2.2.1. Cereals (including rice and buckwheat) and derived cereal products

2.2.1.1. Raw cereal grains (including raw rice and buckwheat)

5,0 Commission Directive 2002/26/EC z Directive 2002/26/EC

2.2.1.2. All products derived from cereals (including processed cereal products and cereal grains intended for direct human consumption)

3,0 Directive 2002/26/EC Directive 2002/26/EC

2.2.2. Dried vine fruit (currants, raisins and sultanas)

10,0 Directive 2002/26/EC Directive 2002/26/EC

2.2.3.

  • Roasted coffee beans and ground roasted coffee with the exception of soluble coffee

5,0 Directive 2002/26/EC Directive 2002/26/EC
  • Soluble coffee (instant coffee)

10,0

2.2.4.

  • Wine (red, white and rosé) and other wine and/or grape must based beverages

2,0 Directive 2002/26/EC Directive 2002/26/EC

2.2.5.

  • Grape juice, grape juice ingredients in other beverages, including grape nectar and concentrated grape juice as reconstituted

2,0 Directive 2002/26/EC Directive 2002/26/EC
  • Grape must and concentrated grape must as reconstituted, intended for direct human consumption

2,0 Directive 2002/26/EC Directive 2002/26/EC

2.2.6. Baby foods and processed cereal-based foods for infants and young children

0,5 Directive 2002/26/EC Directive 2002/26/EC

2.2.7. Dietary foods for special medical purposes intended specifically for infants

0,5 Directive 2002/26/EC Directive 2002/26/EC

2.2.8. Green coffee, dried fruit other than dried vine fruit, beer, cocoa and cocoa products, liqueur wines, meat products, spices and liquorice.

] ]
[F5Products Patulin: maximum levels (μg/kg or ppb) Sampling method Reference analysis method
2.3. PATULIN

2.3.1.

  • Fruit juices and fruit nectar, in particular apple juice, and fruit juice ingredients in other beverages

  • Concentrated fruit juice after reconstitution as instructed by the manufacturer

50,0 Directive 2003/78/EC Directive 2003/78/EC

2.3.2. Spirit drinks , cider and other fermented drinks derived from apples or containing apple juice

50,0 Directive 2003/78/EC Directive 2003/78/EC

2.3.3. Solid apple products, including apple compote, apple puree intended for direct consumption

25,0 Directive 2003/78/EC Directive 2003/78/EC

2.3.4.

  • Apple juice and solid apple products, including apple compote and apple puree, for infants and young children and labelled and sold as intended for infants and young children

  • [F6Other baby foods other than processed cereal-based foods]

10,0 Directive 2003/78/EC Directive 2003/78/EC]
[F7Product Maximum level (μg/kg) Sampling method Reference analysis method
2.4. DEOXYNIVALENOL (DON)

2.4.1. Unprocessed cereals other than durum wheat, oats and maize

1 250 Directive 2005/38/EC Directive 2005/38/EC

2.4.2. Unprocessed durum wheat and oats

1 750 Directive 2005/38/EC Directive 2005/38/EC

2.4.3. Unprocessed maize

Directive 2005/38/EC Directive 2005/38/EC

2.4.4. Cereal flour, including maize flour, maize grits ands maize meal

750 Directive 2005/38/EC Directive 2005/38/EC

2.4.5. Bread, pastries, biscuits, cereal snacks and breakfast cereals

500 Directive 2005/38/EC Directive 2005/38/EC

2.4.6. Pasta (dry)

750 Directive 2005/38/EC Directive 2005/38/EC

2.4.7. Processed cereal-based food for infants and young children and baby food

200 Directive 2005/38/EC Directive 2005/38/EC
Product Maximum level (μg/kg) Sampling method Reference analysis method
2.5. ZEARALENONE

2.5.1. Unprocessed cereals other than maize

100 Directive 2005/38/EC Directive 2005/38/EC

2.5.2. Unprocessed maize

Directive 2005/38/EC Directive 2005/38/EC

2.5.3. Cereal flour except maize flour

75 Directive 2005/38/EC Directive 2005/38/EC

2.5.4. Maize flour, maize meal, maize grits and refined maize oil

Directive 2005/38/EC Directive 2005/38/EC

2.5.5. — Bread, pastries, biscuits

50 Directive 2005/38/EC Directive 2005/38/EC
— maize snacks and maize-based breakfast cereals
— other cereal snacks and breakfast cereals 50

2.5.6. — processed maize-based foods for infants and young children

Directive 2005/38/EC Directive 2005/38/EC

other processed cereal-based foods for infants and young children and baby food

20
Product Maximum level FB 1  + FB 2 (μg/kg) Sampling method Reference analysis method
2.6. FUMONISINS

2.6.1. Unprocessed maize

Directive 2005/38/EC Directive 2005/38/EC

2.6.2. Maize grits, maize meal and maize flour

Directive 2005/38/EC Directive 2005/38/EC

2.6.3. Maize-based foods for direct consumption with the exception of 2.6.2 and 2.6.4

Directive 2005/38/EC Directive 2005/38/EC

2.6.4. Processed maize-based foods for infants and young children and baby food

Directive 2005/38/EC Directive 2005/38/EC
Product Maximum level (μg/kg) Sampling method Reference analysis method
2.7. T-2 AND HT-2 TOXIN

2.7.1. Unprocessed cereals and cereal products

Directive 2005/38/EC Directive 2005/38/EC]
Section 3: Heavy metals
ProductMaximum level (mg/kg wet weight)Performance criteria for samplingPerformance criteria for methods of analysis
3.1. LEAD (Pb)

3.1.1.Cows' milk (raw milk, milk for the manufacture of milk-based products and heat-treated milk as defined by Directive 92/46/EEC)

0,02Commission directive 2001/22/ECkDirective 2001/22/EC

3.1.2.Infant formulae and follow-on formulae as defined in Directive 91/321/EECm

0,02Directive 2001/22/ECDirective 2001/22/EC

3.1.3.Meat of bovine animals, sheep, pig and poultry as defined in Article 2(a) of Council Directive 64/433/EECn, as last amended by Directive 95/23/ECo, and Article 2(1) of Council Directive 71/118/EECp, as last amended by Directive 97/79/ECq, excluding offal as defined in Article 2(e) of Directive 64/433/EEC and Article 2(5) of Directive 71/118/EEC

0,1Directive 2001/22/ECDirective 2001/22/EC

3.1.3.1.Edible offal of cattle, sheep, pig and poultry as defined in Article 2(e) of Directive 64/433/EEC and Article 2(5) of Directive 71/118/EEC

0,5Directive 2001/22/ECDirective 2001/22/EC

[F83.1.4. Muscle meat of fish y , excluding species listed in 3.1.4.1.

0,2 Directive 2001/22/EC Directive 2001/22/EC

3.1.4.1. Muscle meat of the following fish y :

  • common two-banded seabream ( Diplodus vulgaris )

  • eel ( Anguilla anguilla )

  • grey mullet ( Mugil labrosus labrosus )

  • grunt ( Pomadasys benneti )

  • horse mackerel or scad ( Trachurus species )

  • sardine ( Sardina pilchardus )

  • sardinops ( Sardinops species )

  • spotted seabass ( Dicentrarchus punctatus )

  • wedge sole ( Dicologoglossa cuneata )

0,4 Directive 2001/22/EC Directive 2001/22/EC

3.1.5. Crustaceans, excluding brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans ( Nephropidae and Palinuridae )

0,5 Directive 2001/22/EC Directive 2001/22/EC]

[F93.1.6. Bivalve molluscs

1,5 Directive 2001/22/EC Directive 2001/22/EC]

3.1.7Cephalopods (without viscera)

1,0Directive 2001/22/ECDirective 2001/22/EC

3.1.8.Cereals (including buckwheat), legumes and pulses

0,2Directive 2001/22/ECDirective 2001/22/EC

3.1.9.Vegetables as defined in Article 1 of Council Directive 90/642/EECs, as last amended by Directive 2000/48/ECt, excluding brassica, leafy vegetables, fresh herbs and all fungi. For potatoes the maximum level applies to peeled potatoes

0,1Directive 2001/22/ECDirective 2001/22/EC

3.1.9.1.Brassica, leafy vegetables and all cultivated fungi

0,3Directive 2001/22/ECDirective 2001/22/EC

3.1.10.Fruit as defined in Article 1 of Directive 90/642/EEC, excluding berries and small fruits

0,1Directive 2001/22/ECDirective 2001/22/EC

3.1.10.1.Berries and small fruits as defined in Article 1 of Council Directive 90/642/EEC

0,2Directive 2001/22/ECDirective 2001/22/EC

3.1.11.Fats and oils, including milk fat

0,1Directive 2001/22/ECDirective 2001/22/EC

3.1.12.Fruit juices, concentrated fruit juices (for direct consumption) and fruit nectars as defined in Council Directive 93/77/EECu

0,05Directive 2001/22/ECDirective 2001/22/EC

3.1.13.Wines as defined in Council Regulation (EC) No 1493/1999v (including sparkling wines and excluding liqueur wines), aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails as defined in [X1Council Regulation (EEC) No 1601/91] w, and ciders, perry and fruit wines. Maximum level applies to products produced from the 2001 fruit harvest onwards

0,2Directive 2001/22/ECDirective 2001/22/EC
3.2. CADMIUM (Cd)

3.2.1.Meat of bovine animals, sheep, pig and poultry as defined in Article 2(a) of Directive 64/433/EEC and Article 2(1) of Directive 71/118/EEC excluding offal as defined in Article 2(e) of Directive 64/433/EEC and Article 2(5) of Directive 71/118/EEC

0,05Directive 2001/22/ECDirective 2001/22/EC

3.2.2.Horsemeat

0,2Directive 2001/22/ECDirective 2001/22/EC

3.2.3.Liver of cattle, sheep, pig and poultry

0,5Directive 2001/22/ECDirective 2001/22/EC

3.2.4.Kidney of cattle, sheep, pig and poultry

1,0Directive 2001/22/ECDirective 2001/22/EC

[F9 [F83.2.5. Muscle meat of fish y , excluding species listed in 3.2.5.1 and 3.2.5.2.

0,05 Directive 2001/22/EC Directive 2001/22/EC

3.2.5.1. Muscle meat of the following fish y :

  • anchovy ( Engraulis species )

  • bonito ( Sarda sarda )

  • common two-banded seabream ( Diplodus vulgaris )

  • eel ( Anguilla anguilla )

  • grey mullet ( Mugil labrosus labrosus )

  • horse mackerel or scad ( Trachurus species )

  • louvar or luvar ( Luvarus imperialis )

  • sardine ( Sardina pilchardus )

  • sardinops ( Sardinops species )

  • tuna ( Thunnus species, Euthynnus species, Katsuwonus pelamis )

  • wedge sole ( Dicologoglossa cuneata )

0,1 Directive 2001/22/EC Directive 2001/22/EC

3.2.5.2. Muscle meat of swordfish ( Xiphias gladius )

0,3 Directive 2001/22/EC Directive 2001/22/EC]

3.2.6. Crustaceans, excluding brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae)

0,5 Directive 2001/22/EC Directive 2001/22/EC]

3.2.7.Bivalve molluscs

1,0Directive 2001/22/ECDirective 2001/22/EC

3.2.8.Cephalopods (without viscera)

1,0Directive 2001/22/ECDirective 2001/22/EC

3.2.9.Cereals, excluding bran, germ, wheat grain and rice

0,1Directive 2001/22/ECDirective 2001/22/EC

3.2.9.1.Bran, germ, wheat grain and rice

0,2Directive 2001/22/ECDirective 2001/22/EC

3.2.10.Soybeans

0,2Directive 2001/22/ECDirective 2001/22/EC

3.2.11.Vegetables and fruits as defined in Article 1 of Directive 90/642/EEC, excluding leafy vegetables, fresh herbs, all fungi, stem vegetables, root vegetables and potatoes

0,05Directive 2001/22/ECDirective 2001/22/EC

3.2.11.1.Leafy vegetables, fresh herbs, celeriac and all cultivated fungi

0,2Directive 2001/22/ECDirective 2001/22/EC

3.2.11.2.Stem vegetables, root vegetables and potatoes, excluding celeriac. For potatoes the maximum level applies to peeled potatoes

0,1Directive 2001/22/ECDirective 2001/22/EC
3.3. MERCURY

[F83.3.1. Fishery products and muscle meat of fish y , excluding species listed in 3.3.1.1.

0,5 Directive 2001/22/EC Directive 2001/22/EC

3.3.1.1. Muscle meat of the following fish y :

  • anglerfish ( Lophius species )

  • atlantic catfish ( Anarhichas lupus )

  • bonito ( Sarda sarda )

  • eel ( Anguilla species )

  • emperor, orange roughy, rosy soldierfish ( Hoplostethus species )

  • grenadier ( Coryphaenoides rupestris )

  • halibut ( Hippoglossus hippoglossus )

  • marlin ( Makaira species )

  • megrim ( Lepidorhombus species )

  • mullet ( Mullus species )

  • pike ( Esox lucius )

  • plain bonito ( Orcynopsis unicolor )

  • poor cod ( Tricopterus minutes )

  • portuguese dogfish ( Centroscymnes coelolepis )

  • rays ( Raja species )

  • redfish ( Sebastes marinus, S. mentella, S. viviparus )

  • sail fish ( Istiophorus platypterus )

  • scabbard fish ( Lepidopus caudatus, Aphanopus carbo )

  • seabream, pandora ( Pagellus species )

  • shark (all species)

  • snake mackerel or butterfish ( Lepidocybium flavobrunneum, Ruvettus pretiosus, Gempylus serpens )

  • sturgeon ( Acipenser species )

  • swordfish ( Xiphias gladius )

  • tuna ( Thunnus species, Euthynnus species, Katsuwonus pelamis )

1,0 Directive 2001/22/EC Directive 2001/22/EC]
Section 4: 3-monochloropropane-1,2-diol (3-MCPD)
ProductMaximum level (mg/kg)Performance criteria for samplingPerformance criteria for methods of analysis

4.1.Hydrolysed vegetable proteinx

0,02Directive 2001/22/ECDirective 2001/22/EC

4.2.Soy saucex

0,02Directive 2001/22/ECDirective 2001/22/EC
[F10Section 5: Dioxin (sum of polychlorinated dibenzo- para -dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 1997)
Products Maximum levels (PCDD + PCDF) (pg WHO-PCDD/F-TEQ/g fat or product) Performance criteria for sampling Performance criteria for the methods of analysis
5.1.1. Meat and meat products originating from
— Ruminants (bovine animals, sheep) 3 pg WHO-PCDD/F-TEQ/g fat [F11Directive 2002/69/EC Directive 2002/69/EC
— Poultry and farmed game 2 pg WHO-PCDD/F-TEQ/g fat Directive 2002/69/EC Directive 2002/69/EC
— Pigs 1 pg WHO-PCDD/F-TEQ/g fat Directive 2002/69/EC Directive 2002/69/EC]
5.1.2. [F11Liver and derived products originating from terrestrial animals] 6 pg WHO-PCDD/F-TEQ/g fat [F11Directive 2002/69/EC Directive 2002/69/EC]
5.2. Muscle meat of fish and fishery products  and products thereof 4 pg WHO-PCDD/F-TEQ/g fresh weight [F11Directive 2002/69/EC Directive 2002/69/EC]
5.3. Milk  and milk products, including butter fat 3 pg WHO-PCDD/F-TEQ/g fat [F11Directive 2002/69/EC Directive 2002/69/EC]
5.4. Hen eggs and egg products 3 pg WHO-PCDD/F-TEQ/g fat [F11Directive 2002/69/EC Directive 2002/69/EC]
5.5. Oils and fats
Animal fat
— from ruminants 3 pg WHO-PCDD/F-TEQ/g fat [F11Directive 2002/69/EC Directive 2002/69/EC
— from poultry and farmed game 2 pg WHO-PCDD/F-TEQ/g fat Directive 2002/69/EC Directive 2002/69/EC
— from pigs 1 pg WHO-PCDD/F-TEQ/g fat Directive 2002/69/EC Directive 2002/69/EC
— mixed animal fat 2 pg WHO-PCDD/F-TEQ/g fat Directive 2002/69/EC Directive 2002/69/EC
[F11Vegetable oils and fats] 0,75 pg WHO-PCDD/F-TEQ/g fat Directive 2002/69/EC Directive 2002/69/EC
— fish oil intended for human consumption 2 pg WHO-PCDD/F-TEQ/g fat Directive 2002/69/EC Directive 2002/69/EC] ]
[F12Section 6: Tin (inorganic)
Product Maximum level (mg/kg wet weight) Performance criteria for sampling Performance criteria for methods of analysis

1. Canned foods other than beverages

200 Commission Directive 2004/16/EC Directive 2004/16/EC

2. Canned beverages, including fruit juices and vegetable juices

100 Directive 2004/16/EC Directive 2004/16/EC
3. Canned foods for infants and young children, excluding dried and powdered products:

3.1. Canned baby foods and processed cereal-based foods for infants and young children

50 Directive 2004/16/EC Directive 2004/16/EC

3.2. Canned infant formulae and follow-on formulae, including infant milk and follow-on milk

50 Directive 2004/16/EC Directive 2004/16/EC

3.3. Canned dietary foods for special medical purposes intended specifically for infants

50 Directive 2004/16/EC Directive 2004/16/EC]
[F13Section 7: Polycyclic aromatic hydrocarbons (PAH)
a

This section is already included in Regulation (EC) No 194/97 and is repeated here without changes.

b

The maximum levels for fresh spinach do not apply for fresh spinach to be subjected to processing and which is directly transported in bulk from field to processing plant.

c

[ F14 ]

e

In the absence of appropriate labelling, indicating the production method, the limit established for open-grown lettuce applies.

f

The maximum limits apply to the edible part of groundnuts, nuts and dried fruits. If nuts ‘in shell’ are analysed, it is assumed when calculating the aflatoxin content all the contamination is on the edible part.

h

[ F15 ]

i

[ F16 ]

k

See page 14 of this Official Journal.

m

Maximum level applies to the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer.

x

Maximum level is given for the liquid product containing 40 % dry matter, corresponding to a maximum level of 0,05 mg/kg in the dry matter. The level needs to be adjusted proportionally according to the dry matter content of the products.

y

[F18Where fish are intended to be eaten whole, the maximum level shall apply to the whole fish.]

z

[F4 OJ L 75, 16.3.2002, p. 38 . Directive as last amended by Directive 2004/43/EC ( OJ L 113, 20.4.2004, p. 14 ).]

[F19Described in Commission Regulation (EC) No 1543/2001 of 27 July 2001 , laying down the marketing standard for lettuces and curled-leaved and broad-leaved (Batavian) endives ( OJ L 203, 28.7.2001, p. 9 ).]

Upperbound concentrations; upperbound concentrations are calculated assuming that all values of the different congeners less than the limit of determination are equal to the limit of determination.

These maximum levels shall be reviewed for the first time by 31 December 2004 at the latest in the light of new data on the presence of dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs in the levels to be set and will be further reviewed by 31 December 2006 at the latest with the aim of significantly reducing the maximum levels.

The maximum levels are not applicable for food products containing < 1 % fat.

Meat of bovine animals, sheep, pig, poultry and farmed game as defined in Article 2(a) of Council Directive 64/433/EEC ( OJ L 121, 29.7.1964, p. 2012/64 ), as last amended by Directive 95/23/EC ( OJ L 243, 11.10.1995, p. 7 ) and Article 2(1) of Council Directive 71/118/EEC ( OJ L 55, 8.3.1971, p. 23 ), as last amended by Directive 97/64/EC ( OJ L 24, 30.1.1998, p.31 ), and Article 2(2) of Council Directive 91/495/EEC ( OJ L 268, 24.9.1991, p. 41 ) as last amended by Directive 94/65/EC ( OJ L 368, 31.12.1994, p. 10 ), excluding edible offal as defined in Article 2(e) of Directive 64/433/EEC and Article 2(5) of Directive 71/118/EEC.

Muscle meat of fish and fishery products as defined in categories (a), (b), (c), (e) and (f) of the list in Article 1 of Council Regulation (EC) No 104/2000 ( OJ L 17, 21.1.2000, p. 22 ). The maximum level applies to crustaceans excluding the brown meat of crab and to cephalopods without viscera. [F20Where fish are intended to be eaten whole, the maximum level shall apply to the whole fish.]

Milk (raw milk, milk for the manufacture of milk-based products and heat treated milk as defined in Council Directive 92/46/EEC ( OJ L 268, 14.9.1992, p. 1 ) as last amended by Council Directive 96/23/EC ( OJ L 125, 23.5.1996, p. 10 )).

Hen eggs and egg products as defined in Article 2 of Council Directive 89/437/EEC ( OJ L 212, 22.7.1989, p. 87 ), as last amended by Council Directive 96/23/EC ( OJ L 125, 23.5.1996, p. 10 ).

Free-range or semi-intensive eggs as defined in Article 18 of Commission Regulation (EEC) No 1274/91 ( OJ L 121, 16.5.1991, p. 11 ), as last amended by Commission Regulation (EC) No 1651/2001 ( OJ L 220, 15.8.2001, p. 5 ), must comply with the maximum level laid down as from [F111 January 2005] .]

[F5Fruit juices, including fruit juices from concentrates, concentrated fruit juice and fruit nectar as defined in Annex 1 and 2 to Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption ( OJ L 10, 12.1.2002, p. 58 ).

Spirit drinks as defined in Article 1 of CouncilRegulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on the definition, description and presentation of spirit drinks ( OJ L 160, 12.6.1989, p. 1 ), as last amended by Regulation (EC) No 3378/94 of the European Parliament and of the Council of 22 December 1994 ( OJ L 366, 31.12.1994, p. 1 ).

Infants and young children as defined in Article 1 of Commission Directive 91/321/EEC of 14 May 1991 , on infant formulae and follow-onformulae ( OJ L 175, 4.7.1991, p. 35 ), as last amended by Directive 2003/14/EC ( OJ L 41, 14.2.2003, p. 37 ) and Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed cereal based foods and baby foods for infants and young children ( OJ L 49, 28.2.1996, p. 17 ), as last amended by Directive 2003/13/EC ( OJ L 41, 14.2.2003, p. 33 ).

[ F21 ]

[F6Baby foods other than processed cereal-based foods as defined in Commission Directive 96/5/EC of 16 February 1996 on processed cereal based foods and baby foods for infants and young children ( OJ L 49, 28.2.1996, p. 17 ) as last amended by Directive 2003/13/EC ( OJ L 41, 14.02.2003, p. 33 ).] ]

[F12See page 16 of this Official Journal.

Baby foods and processed cereal-based foods for infants and young children as defined in Article 1 of Directive 96/5/EC. The maximum level refers to the product as sold.

Infant formulae and follow-on formulae as defined in Article 1 of Directive 91/321/EEC. The maximum level refers to the product as sold.

Dietary foods for special medical purposes as defined in Article 1(2) of Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes ( OJ L 91, 7.4.1999, p. 29 ). The maximum level refers to the product as sold.]

[F22 [F1Baby foods and processed cereal-based foods for infants and young children as defined in Article 1 of Commission Directive 96/5/EC, Euratom of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children ( OJ L 49, 28.2.1996, p. 17 ). The maximum levels shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers.]

The Commission shall review the maximum levels for nitrate in foods for infants and young children by 1 April 2006 taking into account the progress in scientific and technological knowledge.]

[F2Baby foods and processed cereal-based foods for infants and young children as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children ( OJ L 49, 28.2.1996, p. 17 ) as last amended by Directive 2003/13/EC ( OJ L 41, 14.2.2003, p. 33 ).

The maximum level for baby foods and processed cereal-based foods for infants and young children refer to the dry matter. The dry matter is determined in accordance with the provisions of Commission Directives 98/53/EC and 2002/26/EC.

Infant formulae and follow-on formulae as defined in Article 1 of Commission Directive 91/321/EEC of 14 May 1991 , on infant formulae and follow-on formulae ( OJ L 175, 4.7.1991, p.35 ) as last amended by Directive 2003/14/EC ( OJ L41, 14.2.2003, p. 37 ).

The maximum level for infant formulae and follow-on formulae refer to the product ready to use (marketed as such or after reconstitution as instructed by the manufacturer).

Dietary foods for special medical purposes as defined in Article 1(2) of Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes ( OJ L 91, 7.4.1999, p. 29 ).

The maximum level for dietary foods for special medical purposes intended specifically for infants refer

  • in the case of milk and milk products, to the products ready for use (marketed as such or reconstituted as instructed by the manufacturer),

  • in the case of products other than milk and milk products, to the dry matter. The dry matter is determined in accordance with the provisions of Commission Directives 98/53/EC and 2002/26/EC.]

[F23Fish as defined in the category (a) of the list of Article 1 of Council Regulation (EC) No 104/2000 ( OJ L 17, 21.1.2000, p. 22 ).]

[F23Fish and fishery products as defined in the category (a), (c) and (f) of the list of Article 1 of Council Regulation (EC) No 104/2000 ( OJ L 17, 21.1.2000, p. 22 ).]

[F24Wines, including sparkling wines but excluding liqueur wines and wines with an alcoholic strength of not less than 15 % vol., as defined in Council Regulation (EC) No 1493/1999 ( OJ L 179, 14.7.1999, p. 1 ) and fruit wines.

Aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails as defined in Council Regulation (EEC) No 1601/91 ( OJ L 149, 14.6.1991, p. 1 ). The maximum level for OTA applicable to these beverages is function of the proportion of wine and/or grape must present in the finished product.

Maximum level applies to products produced from the 2005 harvest onwards.

Fruit juices, including fruit juices from concentrates, concentrated fruit juice and fruit nectar as defined in Annex 1 and 2 of Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption ( OJ L 10, 12.1.2002, p. 58 ) and derived from grapes.

Baby foods and processed cereal-based foods for infants and young children as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children ( OJ L 49, 28.2.1996, p. 17 ) as last amended by Directive 2003/13/EC ( OJ L 41, 14.2.2003, p. 33 ).

The maximum level for baby foods and processed cereal-based foods for infants and young children refer to the dry matter. The dry matter is determined in accordance with the provisions of Commission Directive 2002/26/EC.

Dietary foods for special medical purposes as defined in Article 1(2) of Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes ( OJ L 91, 7.4.1999, p. 29 ).

The maximum level for dietary foods for special medical purposes intended specifically for infants refer

  • in the case of milk and milk products, to the products ready for use (marketed as such or reconstituted as instructed by the manufacturer),

  • in the case of products other than milk and milk products, to the dry matter. The dry matter is determined in accordance with the provisions of Commission Directive 2002/26/EC.]

[F13See page 15 of this Official Journal.

Benzo(a)pyrene, for which maximum levels are listed, is used as a marker for the occurrence and effect of carcinogenic PAH. These measures therefore provide full harmonisation on PAH in the listed foods across the Member States. The Commission shall review the maximum levels for PAH in the listed food categories by 1 April 2007 , taking into account the progress in scientific and technological knowledge on the occurrence of benzo(a)pyrene and other carcinogenic PAH in food.

Cocoa butter is excluded from this category whilst investigations into the presence of benzo(a)pyrene in cocoa butter are made. This derogation will be reviewed by 1 April 2007 .

Dietary foods for special medical purposes as defined in Article 1(2) of Directive 1999/21/EC. The maximum level refers to the product as sold.

Fish and fishery products as defined in the categories (b), (c), and (f) of the list in Article 1 of Regulation (EC) No 104/2000.

Fish as defined in the category (a) of the list in Article 1 of Regulation (EC) No 104/2000.]

[F7See page 18 of this Official Journal.

For the purpose of the application of maximum levels of deoxynivalenol, zearalenone, fumonisins B 1 and B 2 , T-2 and HT-2 toxin established in points 2.4, 2.5, 2.6 and 2.7 only, rice is not included in cereals and rice products not included in cereal products.

The maximum levels set for unprocessed cereals applies to cereals placed on the market for first-stage processing. However, the maximum levels do apply for the cereals harvested and taken over, as from the 2005/2006 marketing year, in accordance with Commission Regulation (EC) No 824/2000 of 19 April 2000 establishing procedures for the taking-over of cereals by intervention agencies and laying down methods of analysis for determining the quality of cereals ( OJ L 100, 20.4.2000, p. 31 ), as last amended by Regulation (EC) No 777/2004 ( OJ L 123, 27.4.2004, p. 50 ).

First-stage processing shall mean any physical or thermal treatment, other than drying, of or on the grain.

Cleaning, sorting and drying procedures are not considered to be first stage processing insofar as no physical action is exerted on the grain kernel itself and the whole grain remains intact after cleaning and sorting.

If no specific level is fixed before 1 July 2007 , the level of 1 750  μg/kg will apply thereafter to maize referred to in this point.

This category includes also similar products otherwise denominated such as semolina.

Processed cereal-based foods for infants and young children and baby food as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children ( OJ L 49, 28.2.1996, p. 17 ) as last amended by Directive 2003/13/EC ( OJ L 41, 14.2.2003, p. 33 ).

The maximum level for processed cereal-based foods for infants and young children and baby food refers to the dry matter.

If no specific level is fixed before 1 July 2007 , the level of

  • 200 μg/kg will apply thereafter to unprocessed maize

  • 200 μg/kg will apply thereafter to maize flour, maize meal, maize grits and refined maize oil

  • 50 μg/kg will apply thereafter to maize snacks and maize-based breakfast cereals

  • 20 μg/kg will apply thereafter to processed maize-based foods for infants and young children.

The maximum level applies to the sum of Fumonisin B 1 (FB 1 ) and Fumonisin B 2 (FB 2 ).

The maximum level set for unprocessed maize applies to maize placed on the market for first-stage processing. However, the maximum levels do apply for the maize harvested and taken over, as from the 2006/2007 marketing year, in accordance with Commission Regulation (EC) No 824/2000 establishing procedures for the taking over of cereals by intervention agencies and laying down methods of analysis for determining the quality of cereals ( OJ L 100, 20.4.2000, p. 31 ), as last amended by Regulation (EC) No 777/2004 ( OJ L 123, 27.4.2004, p. 50 ).

First-stage processing shall mean any physical or thermal treatment, other than drying, of or on the grain.

Cleaning, sorting and drying procedures are not considered to be first stage processing insofar as no physical action is exerted on the grain kernel itself and the whole grain remains intact after cleaning and sorting.

If no specific level is fixed before 1 October 2007 , the level of

  • 2 000  μg/kg will apply thereafter to unprocessed maize

  • 1 000  μg/kg will apply thereafter to maize flour, maize meal, maize grits and refined maize semolina

  • 400 μg/kg will apply thereafter to maize based foods for direct consumption

  • 200 μg/kg will apply thereafter to processed maize based foods for infants and young children and baby food.

The maximum level refers to the sum of T-2 and HT-2 toxin.

The maximum levels set for unprocessed cereals applies to cereals placed on the market for first-stage processing.

First-stage processing shall mean any physical or thermal treatment, other than drying, of or on the grain. Cleaning, sorting and drying procedures are not considered to be first stage processing insofar as no physical action is exerted on the grain kernel itself and the whole grain remains intact after cleaning and sorting.

A maximum level will be fixed, if appropriate, before 1 July 2007 .

Data on the presence of T-2 and HT-2 toxin are for the time being limited. However, intake estimates indicate clearly that the presence of T-2 and HT-2 can be of concern for public health. Therefore, the development of a sensitive method, collection of more occurrence data and more investigations/research in the factors involved in the presence of T-2 and HT-2 in cereal and cereal products particularly in oats and oat products is necessary and of high priority.]

Product Maximum level (μg/kg wet weight) Performance criteria for sampling Performance criteria for methods of analysis
7.1. Benzo(a)pyrene

7.1.1. Oils and fats intended for direct human consumption or use as an ingredient in foods

2,0 Directive 2005/10/EC Directive 2005/10/EC

7.1.2. Foods for infants and young children

1,0 Directive 2005/10/EC Directive 2005/10/EC

7.1.2.1. Baby foods and processed cereal-based foods for infants and young children

7.1.2.2. Infant formulae and follow-on formulae, including infant milk and follow-on milk

7.1.2.3. Dietary foods for special medical purposes intended specifically for infants

7.1.3. Smoked meats and smoked meat products

5,0 Directive 2005/10/EC Directive 2005/10/EC

7.1.4. Muscle meat of smoked fish and smoked fishery products , excluding bivalve molluscs

5,0 Directive 2005/10/EC Directive 2005/10/EC

7.1.5. Muscle meat of fish , other than smoked fish

2,0 Directive 2005/10/EC Directive 2005/10/EC

7.1.6. Crustaceans, cephalopods, other than smoked

5,0 Directive 2005/10/EC Directive 2005/10/EC

7.1.7. Bivalve molluscs

10,0 Directive 2005/10/EC Directive 2005/10/EC]

Editorial Information

Textual Amendments

ANNEX IIU.K.CORRELATION TABLE

This RegulationRegulation (EC) No 194/97
Article 1
Article 1 (1)Article 2 (1)(a)
Article 2 (1)Article 2 (1)(b)
Article 2 (1)Article 2 (1)(c)
Article 3 (1)Article 2 (2)
Article 3 (1)Article 2 (3)
Article 4 (2)Article 2 (4)
Article 4 (3)Article 2 (5)
Article 3 (2)Article 3, first paragraph
Article 3 (3)Article 3, second paragraph
Article 5 (1)Article 3, third paragraph
Article 1 (3)Article 4
Annex I, section 1 ‘Nitrates’Annex I, agricultural contaminants, point 1 ‘Nitrates’
Annex I, section 2 ‘Mycotoxins’Annex, I. agricultural contaminants, point 2 ‘Mycotoxins’
Annex, II. ‘Other contaminants’

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