Article 11.The foodstuffs indicated in Annex I must not, when placed on the market, contain higher contaminant levels than those specified in that Annex.1a.By way of derogation from paragraph 1, Sweden and Finland are authorised for a transitional period, up to 31 December 2006, to place on the market fish, originating from the Baltic region, which is intended for consumption in their territory with dioxin levels higher than those set in point 5.2. of section 5 of Annex I, provided that a system is in place to ensure that consumers are fully informed of the dietary recommendations with regard to the restrictions on consumption of fish from the Baltic region by identified vulnerable groups of the population in order to avoid potential health risks.Any future application of this derogation will be considered in the framework of the review of section 5 of Annex I, provided for in Article 5(3).Finland and Sweden shall communicate to the Commission by 31 December each year, the results of their monitoring of the levels of dioxins in fish from the Baltic region and report on the measures taken to reduce human exposure to dioxins from fish from the Baltic region.1b.By way of derogation from paragraph 1, the Commission may authorise Estonia for a transitional period, up to 31 December 2006, to place on its market fish, originating from the Baltic region, which is intended for consumption in its territory with dioxin levels higher than those set in point 5.2. of Section 5 of Annex I. This derogation will be granted in accordance with the procedure laid down in Article 8 of Council Regulation (EEC) No 315/93 laying down Community procedures for contaminants in foodOJ L 37, 13.2.1993, p. 1.. To this end, Estonia shall demonstrate that the conditions applicable to Finland and Sweden laid down in paragraph 1a are fulfilled and that human exposure to dioxins in Estonia is not higher than the highest average level in any of the Member States of the Community as constituted on 30 April 2004.If such a derogation is granted to Estonia, any future application of it will be considered in the framework of the review of Section 5 of Annex I, provided for in Article 5(3).Notwithstanding the above, Estonia shall implement the necessary measures to ensure that fish or fish products not complying with point 5.2 of Section 5 of Annex I are not marketed in other Member States.2.The maximum levels specified in Annex I shall apply to the edible part of the foodstuffs mentioned.3.The sampling and analysis methods applied shall be those specified in Annex I.

Article 21.In the case of products, other than those mentioned under Article 4(1), which are dried, diluted, processed or composed of more than one ingredient, the maximum level applicable shall be that laid down in Annex I, taking into account respectively:(a)changes of the concentration of the contaminant caused by drying or dilution processes,(b)changes of the concentration of the contaminant caused by processing,(c)the relative proportions of the ingredients in the product and(d)the analytical limit of quantification.The first subparagraph shall apply in so far as no specific maximum levels are fixed for these dried, diluted, processed or compound products.2.The maximum levels specified in Annex I shall apply also to food intended for infants and young children covered by Directive 91/321/EEC and Directive 96/5/EC, taking into account respectively, the changes of the concentration of the contaminant caused by drying, dilution or processing and the relative concentrations of the ingredients in the product. This does not apply to the contaminants for which specific Community maximum levels have been set for the specified foods or to the cases where in the absence of Community maximum levels, stricter levels have been set by national legislation for the specified foods.3.Without prejudice to Articles 3(1) and 4(3), it is prohibited to use products as food ingredients for the production of compound foodstuffs which do not comply with the maximum levels set in Annex I.

Article 31.Member States may, where justified, authorise for a transitional period the placing on the market of fresh lettuces and fresh spinach, grown and intended for consumption in their territory, with nitrate levels higher than those set as maximum levels in points 1.1, 1.3 and 1.4 of the Annex provided that codes of good agricultural practice are applied to achieve gradual progress towards the levels laid down in this Regulation.The transitional period:(a)with regard to lettuces, shall cease on 1 January 2005;(b)with regard to spinach, shall be reviewed not later than 1 January 2005.Member States shall inform the other Member States and the Commission each year of steps taken to implement the first sub-paragraph.2.Member States shall communicate to the Commission by 30 June of each year, the results of their monitoring and report on the measures taken and the progress made with regard to the application and improvement of codes of good agricultural practice to reduce nitrate levels in lettuce and spinach. This information shall also contain the data on which their codes of good agricultural practice are based.3.The Member States, who do not apply paragraph 1, shall carry out the monitoring of nitrate levels in lettuce and spinach and apply good agricultural practices using means proportionate to the desired objective, the monitoring results obtained, particularly in the light of the risks and of experience gained.

Article 41.The maximum limits of aflatoxins applicable to the products, as laid down in points 2.1.1.1 and 2.1.2.1 of Annex I shall also be applicable to processed products thereof in so far as no specific maximum limits are fixed for such processed products.2.With regard to aflatoxins and ochratoxin A in products mentioned in points 2.1 and 2.2 of Annex I, it is prohibited:(a)to mix products complying with the maximum levels laid down in Annex I with products exceeding these maximum levels or to mix products to be subjected to a sorting technique or physical treatment with products intended for direct human consumption or as an ingredient in foodstuffs,(b)to use products which do not comply with the maximum levels laid down in points 2.1.1.1, 2.1.2.1, 2.1.3, 2.1.4, 2.2.1 , 2.2.2, 2.2.3, 2.2.4 and 2.2.5 of Annex I as an ingredient for the manufacture of other foodstuffs,(c)to detoxify products by chemical treatments.3.Groundnuts, nuts and dried fruit not complying with the maximum levels of aflatoxins laid down in point 2.1.1.1 of Annex I and maize not complying with the maximum levels laid down in point 2.1.2.1 of that Annex can be placed on the market provided that these products:(a)are not intended for direct human consumption or used as an ingredient in foodstuffs;(b)comply with the maximum levels laid down in point 2.1.1.2 of Annex I for groundnuts, in point 2.1.1.3 of Annex I for nuts and dried fruit and in point 2.1.2.3 of Annex I for maize;(c)are subjected to a secondary treatment involving sorting or other physical treatment and that after this treatment the maximum limits laid down in points 2.1.1.1 and 2.1.2.1 of Annex I are not exceeded, and this treatment does not result in other harmful residues;(d)are labelled clearly showing their destination, and bearing the indication "product must be subjected to sorting or other physical treatment to reduce aflatoxin contamination before human consumption or use as an ingredient in foodstuffs".

Article 4aWith regard to dioxins in products referred to in section 5 of Annex I, it shall be prohibited:(a)to mix products complying with the maximum levels with products exceeding these maximum levels;(b)to use products, which do not comply with the maximum levels as an ingredient for the manufacture of other foodstuffs.

Article 51.On the basis of the results of controls carried out by the Member States to check compliance with the maximum levels of nitrates laid down in section 1 of Annex I, the reports with regard to the application and improvement of codes of good agricultural practice to reduce nitrate levels and the evaluation of the data on which the Member States have based their good agricultural practice, the Commission shall proceed, every five years, and before 1 January 2002 for the first time, to a review of the maximum levels with the overall objective of reducing the said levels.2.On the basis of new scientific data and the results of controls carried out by the Member States to check compliance with the maximum levels of heavy metals and 3-MCPD in sections 3 and 4 of Annex I, the Commission shall proceed, every five years, and before 5 April 2003 for the first time, to a review of the maximum levels with the overall objective of ensuring a high level of consumer health protection.2a.The Commission shall, based on an up-to-date risk assessment on ochratoxin A (OTA) performed by the EFSA and taking into account the prevention measures applied to reduce the OTA content, review the provisions under the heading 2.2 of section 2 of Annex I by 30 June 2006 at the latest. This review will concern in particular the maximum level for OTA in dried vine fruit and grape juice and the consideration of setting a maximum level for OTA in green coffee, dried fruit other than dried vine fruit, beer, cocoa and cocoa products, liqueur wines, meat and meat products, spices and liquorice.For this purpose, Member States and interested parties shall communicate each year to the Commission the results of the investigations undertaken and the progress with regard to the application of prevention measures to avoid contamination by OTA. The Commission will make these results available to the Member States.3.The Commission shall review section 5 of Annex I 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.Section 5 of Annex I shall be further reviewed by 31 December 2006 at the latest with the aim of significantly reducing the maximum levels and possibly laying down maximum levels for other foodstuffs.4.The Commission shall review the maximum levels for patulin laid down in points 2.3.1 and 2.3.2 of section 2 of Annex I by 30 June 2005 at the latest with a view to reducing them to take account of the progress in scientific and technological knowledge and the implementation of the "Code of practice for the prevention and reduction of patulin contamination in apple juice and apple juice ingredients in other beverages".

Article 6Regulation (EC) No 194/97 shall be repealed with effect from 5 April 2002.References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.

Article 7This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.It shall apply from 5 April 2002. Sections 3 (heavy metals) and 4 (3-MCPD) of Annex I shall not apply to products which have been lawfully placed on the Community market before this date.Τhe maximum levels established in point 2.3. Patulin of section 2 (Mycotoxins) of Annex I shall not apply to products which have been lawfully placed on the Community market before 1 November 2003. The burden of proving when the products were placed on the market shall be borne by the food business operator.

This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX IMAXIMUM LEVELS FOR CERTAIN CONTAMINANTS IN FOODSTUFFSThis section is already included in Regulation (EC) No 194/97 and is repeated here without changes.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.Subject to review before 1 January 2002 pursuant to the provisions of Article 5(1).OJ L 207, 15.8.1979, p. 26.In the absence of appropriate labelling, indicating the production method, the limit established for open-grown lettuce applies.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.OJ L 201, 17.7.1998, p. 93.The maximum limits shall be reconsidered before 1 July 2001 according to the progress of scientific and technological knowledge.If no specific level is fixed before 1 July 2003, the levels laid down in point 2.1.2.1 of the table will apply thereafter to maize referred to in this point.OJ L 268, 14.9.1992, p. 1.OJ L 122, 16.5.2003, p. 1.See page 14 of this Official Journal.Maximum level applies to the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer.OJ 121, 29.7.1964, p. 2012.OJ L 243, 11.10.1995, p. 7.OJ L 55, 8.3.1971, p. 23.OJ L 24, 30.1.1998, p. 31.OJ L 17, 21.1.2000, p. 22.OJ L 350, 14.12.1990, p. 71.OJ L 197, 3.8.2000, p. 26.OJ L 244, 30.9.1993, p. 23.OJ L 179, 14.7.1999, p. 1.OJ L 149, 14.6.1991, p. 1.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.Where fish are intended to be eaten whole, the maximum level shall apply to the whole fish.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).Described 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).OJ L 209, 6.8.2002, p. 5Upperbound 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.Where 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 1 January 2005.Fruit 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).A method of analysis will be validated by an international collaborativering trial which will be performed before 1 November 2003 in order to demonstrate that the level of 10 μg/kg patulin can be reliably determined. In case there is no evidence by 1 November 2003 that the level of 10 μg/kg patulin can be reliably determined, the level of 25 μg/kg will apply.Baby 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).See 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.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. 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.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 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 referin 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.Fish 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).Fish 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).Wines, 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 referin 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.See 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.

Section 1:Nitrates

Product	Maximum level (mg NO3 / kg)		Sampling method
1.1. Fresh spinach (Spinacia oleracea)	Harvested 1 November to 31 March	3000	Commission Directive 79/700/EEC
1.1. Fresh spinach (Spinacia oleracea)	Harvested 1 April to 31 October	2500	Commission Directive 79/700/EEC
1.2. Preserved, deep-frozen or frozen spinach		2000	Directive 79/700/EEC
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 79/700/EEC. However, the minimum number of units per laboratory sample is 10
	— lettuce grown under cover	4500
	— grown in the open air	4000
	Harvested 1 April to 30 September:
	— lettuce grown under cover	3500
	— lettuce grown in the open air	2500
1.4. "Iceberg" type lettuces	Lettuce grown under cover	2500	Directive 79/700/EEC. However, the minimum number of units per laboratory sample is 10
1.4. "Iceberg" type lettuces	Lettuce grown in the open air	2000
1.5.Baby foods and processed cereal-based foods for infants and young children		200	Commission Directive 2002/63/EC (provisions as foreseen for processed foods of plant origin and for processed foods of animal origin)

Section 2:Mycotoxins2.1.AFLATOXINS2.1.1.Groundnuts, nuts and dried fruit2.1.2.Cereals (including buckwheat,Fagopyrumsp)

Product	Maximum level (µg / kg)			Sampling method	Performance criteria for methods of analysis
Product	B1	B1 + B2 + G1 + G2	M1	Sampling method	Performance criteria for methods of analysis
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	2,0	4,0	—	Commission Directive 98/53/EC	Directive 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	8,0	15,0	—	Directive 98/53/EC	Directive 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	5,0	10,0	—	Directive 98/53/EC	Directive 98/53/EC
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	2,0	4,0	—	Directive 98/53/EC	Directive 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	2,0	4,0	—	Directive 98/53/EC	Directive 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	5,0	10,0	—	Directive 98/53/EC	Directive 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/EC as last amended by Regulation (EC) No 806/2003	—	—	0,05	Directive 98/53/EC	Directive 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)	5,0	10,0	—	Directive 98/53/EC	Directive 98/53/EC
2.1.5.Baby foods and processed cereal-based foods for infants and young children	0,10	—	—	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	0,10	—	0,025	Directive 1998/53/EC	Directive 1998/53/EC

2.2.OCHRATOXIN A2.2.1.Cereals (including rice and buckwheat) and derived cereal products

Product	Maximum levels(μg/kg or ppb)	Sampling method	Reference analysis method
2.2.1.1.Raw cereal grains (including raw rice and buckwheat)	5,0	Commission Directive 2002/26/EC	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	Directive 2002/26/EC	Directive 2002/26/EC
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	0,50	Directive 2002/26/EC	Directive 2002/26/EC
2.2.7.Dietary foods for special medical purposes intended specifically for infants	0,50	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.	—

2.3.PATULIN

Products	Patulin: maximum levels(μg/kg or ppb)	Sampling method	Reference analysis method
2.3.1.Fruit juices and fruit nectar, in particular apple juice, and fruit juice ingredients in other beveragesConcentrated 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 childrenOther baby foods other than processed cereal-based foods	10,0	Directive 2003/78/EC	Directive 2003/78/EC

Section 3:Heavy metals3.1.LEAD (Pb)3.2.CADMIUM (Cd)3.3.MERCURY

Product	Maximum level (mg/kg wet weight)	Performance criteria for sampling	Performance criteria for methods of analysis
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)	0,02	Commission directive 2001/22/EC	Directive 2001/22/EC
3.1.2.Infant formulae and follow-on formulae as defined in Directive 91/321/EEC	0,02	Directive 2001/22/EC	Directive 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/EEC, as last amended by Directive 95/23/EC, and Article 2(1) of Council Directive 71/118/EEC, as last amended by Directive 97/79/EC, excluding offal as defined in Article 2(e) of Directive 64/433/EEC and Article 2(5) of Directive 71/118/EEC	0,1	Directive 2001/22/EC	Directive 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	0,5	Directive 2001/22/EC	Directive 2001/22/EC
3.1.4.Muscle meat of fish, excluding species listed in 3.1.4.1.	0,20	Directive 2001/22/EC	Directive 2001/22/EC
3.1.4.1.Muscle meat of the following fish: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)	0,40	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)	0,50	Directive 2001/22/EC	Directive 2001/22/EC
3.1.6.Bivalve molluscs	1,5	Directive 2001/22/EC	Directive 2001/22/EC
3.1.7Cephalopods (without viscera)	1,0	Directive 2001/22/EC	Directive 2001/22/EC
3.1.8.Cereals (including buckwheat), legumes and pulses	0,2	Directive 2001/22/EC	Directive 2001/22/EC
3.1.9.Vegetables as defined in Article 1 of Council Directive 90/642/EEC, as last amended by Directive 2000/48/EC, excluding brassica, leafy vegetables, fresh herbs and all fungi. For potatoes the maximum level applies to peeled potatoes	0,1	Directive 2001/22/EC	Directive 2001/22/EC
3.1.9.1.Brassica, leafy vegetables and all cultivated fungi	0,3	Directive 2001/22/EC	Directive 2001/22/EC
3.1.10.Fruit as defined in Article 1 of Directive 90/642/EEC, excluding berries and small fruits	0,1	Directive 2001/22/EC	Directive 2001/22/EC
3.1.10.1.Berries and small fruits as defined in Article 1 of Council Directive 90/642/EEC	0,2	Directive 2001/22/EC	Directive 2001/22/EC
3.1.11.Fats and oils, including milk fat	0,1	Directive 2001/22/EC	Directive 2001/22/EC
3.1.12.Fruit juices, concentrated fruit juices (for direct consumption) and fruit nectars as defined in Council Directive 93/77/EEC	0,05	Directive 2001/22/EC	Directive 2001/22/EC
3.1.13.Wines as defined in Council Regulation (EC) No 1493/1999 (including sparkling wines and excluding liqueur wines), aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails as defined in Council Regulation (EEC) No 1601/91, and ciders, perry and fruit wines. Maximum level applies to products produced from the 2001 fruit harvest onwards	0,2	Directive 2001/22/EC	Directive 2001/22/EC
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	0,05	Directive 2001/22/EC	Directive 2001/22/EC
3.2.2.Horsemeat	0,2	Directive 2001/22/EC	Directive 2001/22/EC
3.2.3.Liver of cattle, sheep, pig and poultry	0,5	Directive 2001/22/EC	Directive 2001/22/EC
3.2.4.Kidney of cattle, sheep, pig and poultry	1,0	Directive 2001/22/EC	Directive 2001/22/EC
3.2.5.Muscle meat of fish, 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: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)	0,10	Directive 2001/22/EC	Directive 2001/22/EC
3.2.5.2.Muscle meat of swordfish (Xiphias gladius)	0,30	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	1,0	Directive 2001/22/EC	Directive 2001/22/EC
3.2.8.Cephalopods (without viscera)	1,0	Directive 2001/22/EC	Directive 2001/22/EC
3.2.9.Cereals, excluding bran, germ, wheat grain and rice	0,1	Directive 2001/22/EC	Directive 2001/22/EC
3.2.9.1.Bran, germ, wheat grain and rice	0,2	Directive 2001/22/EC	Directive 2001/22/EC
3.2.10.Soybeans	0,2	Directive 2001/22/EC	Directive 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	0,05	Directive 2001/22/EC	Directive 2001/22/EC
3.2.11.1.Leafy vegetables, fresh herbs, celeriac and all cultivated fungi	0,2	Directive 2001/22/EC	Directive 2001/22/EC
3.2.11.2.Stem vegetables, root vegetables and potatoes, excluding celeriac. For potatoes the maximum level applies to peeled potatoes	0,1	Directive 2001/22/EC	Directive 2001/22/EC
3.3.1.Fishery products and muscle meat of fish, excluding species listed in 3.3.1.1.	0,50	Directive 2001/22/EC	Directive 2001/22/EC
3.3.1.1.Muscle meat of the following fish: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)

Product	Maximum level (mg/kg)	Performance criteria for sampling	Performance criteria for methods of analysis
4.1.Hydrolysed vegetable protein	0,02	Directive 2001/22/EC	Directive 2001/22/EC
4.2.Soy sauce	0,02	Directive 2001/22/EC	Directive 2001/22/EC

Section 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)5.1.1.Meat and meat productsoriginating from5.5.Oils and fats—Animal fat

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
— Ruminants (bovine animals, sheep)	3 pg WHO-PCDD/F-TEQ/g fat	Directive 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. Liver and derived products originating from terrestrial animals	6 pg WHO-PCDD/F-TEQ/g fat	Directive 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	Directive 2002/69/EC	Directive 2002/69/EC
5.3. Milk and milk products, including butter fat	3 pg WHO-PCDD/F-TEQ/g fat	Directive 2002/69/EC	Directive 2002/69/EC
5.4. Hen eggs and egg products	3 pg WHO-PCDD/F-TEQ/g fat	Directive 2002/69/EC	Directive 2002/69/EC
— from ruminants	3 pg WHO-PCDD/F-TEQ/g fat	Directive 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
— Vegetable 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

Section 6:Tin (inorganic)3.Canned foods for infants and young children, excluding dried and powdered products:

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
3.1.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

Section 7:Polycyclic aromatic hydrocarbons (PAH)7.1.Benzo(a)pyrene

Product	Maximum level(μg/kg wet weight)	Performance criteria for sampling	Performance criteria for methods of analysis
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

ANNEX IICORRELATION TABLE

This Regulation	Regulation (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"

July 1, 2006	article 2.3	Replacement
July 1, 2006	annex 1	Amendment
July 1, 2006	article 5.5	Completion

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

Modified by

Commission Regulation (EC) No 856/2005 of 6 June 2005 amending Regulation (EC) No 466/2001 as regards Fusarium toxins (Text with EEA relevance)