Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32006R1881
Timestamp: 2019-07-20 17:05:42
Document Index: 488826357

Matched Legal Cases: ['art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 6']

In force: This act has been changed. Latest consolidated version: 19/03/2018
Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs (2) has been amended substantially many times. It is necessary to amend again maximum levels for certain contaminants to take into account new information and developments in Codex Alimentarius. At the same time, the text should, where appropriate, be clarified. Regulation (EC) No 466/2001 should therefore be replaced.
Regulation (EC) No 853/2004 of the European Parliament and Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (3) defines foodstuffs of animal origin, and consequently the entries as regards foodstuffs of animal origin should be amended in some cases according to the terminology used in that Regulation.
As regards nitrate, vegetables are the major source for the human intake of nitrate. The Scientific Committee on Food (SCF) stated in its opinion of 22 September 1995 (4) that the total intake of nitrate is normally well below the acceptable daily intake (ADI) of 3,65 mg/kg body weight (bw). It recommended, however, continuation of efforts to reduce exposure to nitrate via food and water.
As regards aflatoxins, the SCF expressed in its opinion of 23 September 1994 that aflatoxins are genotoxic carcinogens (5). Based on that opinion, it is appropriate to limit the total aflatoxin content of food (sum of aflatoxins B1, B2, G1 and G2) as well as the aflatoxin B1 content alone, aflatoxin B1 being by far the most toxic compound. For aflatoxin M1 in foods for infants and young children, a possible reduction of the current maximum level should be considered in the light of developments in analytical procedures.
As regards ochratoxin A (OTA), the SCF adopted a scientific opinion on 17 September 1998 (6). An assessment of the dietary intake of OTA by the population of the Community has been performed (7) in the framework of Council Directive 93/5/EEC of 25 February 1993 on assistance to the Commission and cooperation by the Member States in the scientific examination of questions relating to food (8) (SCOOP). The European Food Safety Authority (EFSA) has, on a request from the Commission, adopted an updated scientific opinion relating to ochratoxin A in food on 4 April 2006 (9), taking into account new scientific information and derived a tolerable weekly intake (TWI) of 120 ng/kg bw.
As regards patulin, the SCF endorsed in its meeting on 8 March 2000 the provisional maximum tolerable daily intake (PMTDI) of 0,4 μg/kg bw for patulin (10).
In 2001, a SCOOP-task ‘Assessment of the dietary intake of patulin by the population of EU Member States’ in the framework of Directive 93/5/EEC was performed (11).
Based on that assessment and taking into account the PMTDI, maximum levels should be set for patulin in certain foodstuffs to protect consumers from unacceptable contamination. These maximum levels should be reviewed and, if necessary, reduced taking into account the progress in scientific and technological knowledge and the implementation of Commission Recommendation 2003/598/EC of 11 August 2003 on the prevention and reduction of patulin contamination in apple juice and apple juice ingredients in other beverages (12).
As regards Fusarium toxins, the SCF has adopted several opinions evaluating deoxynivalenol in December 1999 (13) establishing a tolerable daily intake (TDI) of 1 μg/kg bw, zearalenone in June 2000 (14) establishing a temporary TDI of 0,2 μg/kg bw, fumonisins in October 2000 (15) (updated in April 2003) (16) establishing a TDI of 2 μg/kg bw, nivalenol in October 2000 (17) establishing a temporary TDI of 0,7 μg/kg bw, T-2 and HT-2 toxin in May 2001 (18) establishing a combined temporary TDI of 0,06 μg/kg bw and the trichothecenes as group in February 2002 (19).
In the framework of Directive 93/5/EEC the SCOOP-task ‘Collection of occurrence data on Fusarium toxins in food and assessment of dietary intake by the population of EU Member States’ was performed and finalised in September 2003 (20).
Climatic conditions during the growth, in particular at flowering, have a major influence on the Fusarium toxin content. However, good agricultural practices, whereby the risk factors are reduced to a minimum, can prevent to a certain degree the contamination by Fusarium fungi. Commission Recommendation 2006/583/EC of 17 August 2006 on the prevention and reduction of Fusarium toxins in cereals and cereal products (21) contains general principles for the prevention and reduction of Fusarium toxin contamination (zearalenone, fumonisins and trichothecenes) in cereals to be implemented by the development of national codes of practice based on these principles.
As regards lead, the SCF adopted an opinion on 19 June 1992 (22) endorsing the provisional tolerable weekly intake (PTWI) of 25 μg/kg bw proposed by the WHO in 1986. The SCF concluded in its opinion that the mean level in foodstuffs does not seem to be a cause of immediate concern.
In the framework of Directive 93/5/EEC 2004 the SCOOP-task 3.2.11 ‘Assessment of the dietary exposure to arsenic, cadmium, lead and mercury of the population of the EU Member States’ was performed in 2004 (23). In view of this assessment and the opinion delivered by the SCF, it is appropriate to take measures to reduce the presence of lead in food as much as possible
As regards cadmium, the SCF endorsed in its opinion of 2 June 1995 (24) the PTWI of 7 μg/kg bw and recommended greater efforts to reduce dietary exposure to cadmium since foodstuffs are the main source of human intake of cadmium. A dietary exposure assessment was performed in the SCOOP-task 3.2.11. In view of this assessment and the opinion delivered by the SCF, it is appropriate to take measures to reduce the presence of cadmium in food as much as possible.
As regards mercury EFSA adopted on 24 February 2004 an opinion related to mercury and methylmercury in food (25) and endorsed the provisional tolerable weekly intake of 1,6 μg/kg bw. Methylmercury is the chemical form of most concern and can make up more than 90 % of the total mercury in fish and seafood. Taking into account the outcome of the SCOOP-task 3.2.11, EFSA concluded that the levels of mercury found in foods, other than fish and seafood, were of lower concern. The forms of mercury present in these other foods are mainly not methylmercury and they are therefore considered to be of lower risk.
In addition to the setting of maximum levels, targeted consumer advice is an appropriate approach in the case of methylmercury for protecting vulnerable groups of the population. An information note on methylmercury in fish and fishery products responding to this need has therefore been made available on the website of the Health and Consumer Protection Directorate-General of the European Commission (26). Several Member States have also issued advice on this issue that is relevant to their population.
As regards inorganic tin, the SCF concluded in its opinion of 12 December 2001 (27) that levels of inorganic tin of 150 mg/kg in canned beverages and 250 mg/kg in other canned foods may cause gastric irritation in some individuals.
As regards 3-monochloropropane-1,2-diol (3-MCPD) the SCF adopted on 30 May 2001 a scientific opinion as regards 3-MCPD in food (28), updating its opinion of 16 December 1994 (29) on the basis of new scientific information and established a tolerable daily intake (TDI) of 2 μg/kg bw for 3-MCPD.
In the framework of Directive 93/5/EEC the SCOOP-task ‘Collection and collation of data on levels of 3-MCPD and related substances in foodstuffs’ was performed and finalised in June 2004 (30). The main contributors of 3-MCPD to dietary intake were soy sauce and soy-sauce based products. Some other foods eaten in large quantities, such as bread and noodles, also contributed significantly to intake in some countries because of high consumption rather than high levels of 3-MCPD present in these foods.
As regards dioxins and PCBs, the SCF adopted on 30 May 2001 an opinion on dioxins and dioxin-like PCBs in food (31), updating its opinion of 22 November 2000 (32) fixing a tolerable weekly intake (TWI) of 14 pg World Health Organisation toxic equivalent (WHO-TEQ)/kg bw for dioxins and dioxin-like PCBs.
Exposure estimates taking into account the SCOOP-task ‘Assessment of dietary intake of dioxins and related PCBs by the population of EU Member States’ finalised in June 2000 (33) indicate that a considerable proportion of the Community population has a dietary intake in excess of the TWI.
In order to encourage a proactive approach to reducing the dioxins and dioxin-like PCBs present in food and feed, action levels were set by Commission Recommendation 2006/88/EC of 6 February 2006 on the reduction of the presence of dioxins, furans and PCBs in feedingstuffs and foodstuffs (34). These action levels are a tool for competent authorities and operators to highlight those cases where it is appropriate to identify a source of contamination and to take measures to reduce or eliminate it. Since the sources of dioxins and dioxin-like PCBs are different, separate action levels are determined for dioxins on the one hand and for dioxin-like PCBs on the other hand. This proactive approach to actively reduce the dioxins and dioxin-like PCBs in feed and food and consequently, the maximum levels applicable should be reviewed within a defined period of time with the objective to set lower levels. Therefore, consideration will be given by 31 December 2008 to significantly reducing the maximum levels for the sum of dioxins and dioxin-like PCBs.
As regards polycyclic aromatic hydrocarbons, the SCF concluded in its opinion of 4 December 2002 (35) that a number of polycyclic aromatic hydrocarbons (PAH) are genotoxic carcinogens. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) performed in 2005 a risk assessment on PAHs and estimated margins of exposure (MOE) for PAH as a basis for advice on compounds that are both genotoxic and carcinogenic (36).
In the framework of Directive 93/5/EEC, a specific SCOOP-task ‘Collection of occurrence data on PAH in food’ has been performed in 2004 (37). High levels were found in dried fruits, olive pomace oil, smoked fish, grape seed oil, smoked meat products, fresh molluscs, spices/sauces and condiments.
changes of the concentration of the contaminant caused by drying or dilution processes;
changes of the concentration of the contaminant caused by processing;
the relative proportions of the ingredients in the product;
the analytical limit of quantification.
Specific provisions for groundnuts, nuts, dried fruit and maize
Groundnuts, nuts, dried fruit and maize not complying with the appropriate maximum levels of aflatoxins laid down in points 2.1.3, 2.1.5 and 2.1.6 of the Annex can be placed on the market provided that these foodstuffs:
comply with the appropriate maximum levels laid down in points 2.1.1, 2.1.2, 2.1.4 and 2.1.7 of the Annex;
are subjected to a treatment involving sorting or other physical treatment and that after this treatment the maximum levels laid down in points 2.1.3, 2.1.5 and 2.1.6 of the Annex are not exceeded, and this treatment does not result in other harmful residues;
are labelled clearly showing their use, and bearing the indication ‘product shall be subjected to sorting or other physical treatment to reduce aflatoxin contamination before human consumption or use as an ingredient in foodstuffs’. The indication shall be included on the label of each individual bag, box etc. or on the original accompanying document. The consignment/batch identification code shall be indelibly marked on each individual bag, box etc. of the consignment and on the original accompanying document.
Specific provisions for groundnuts, derived products thereof and cereals
A clear indication of the intended use must appear on the label of each individual bag, box, etc. or on the original accompanying document. This accompanying document must have a clear link with the consignment by means of mentioning the consignment identification code, which is on each individual bag, box, etc. of the consignment. In addition the business activity of the consignee of the consignment given on the accompanying document must be compatible with the intended use.
In the absence of a clear indication that their intended use is not for human consumption, the maximum levels laid down in points 2.1.3 and 2.1.6 of the Annex shall apply to all groundnuts, derived products thereof and cereals placed on the market.
The sampling and the analysis for the official control of the maximum levels specified in the Annex shall be performed in accordance with Commission Regulations (EC) No 1882/2006 (38), No 401/2006 (39), No 1883/2006 (40) and Commission Directives 2001/22/EC (41), 2004/16/EC (42) and 2005/10/EC (43).
3. Member States should report to the Commission findings on aflatoxins, dioxins, dioxin-like PCBs, non-dioxin-like PCBs and polycyclic aromatic hydrocarbons as specified in Commission Decision 2006/504/EC (44), Commission Recommendation 2006/794/EC (45) and Commission Recommendation 2005/108/EC (46).
1 July 2006 as regards the maximum levels for deoxynivalenol and zearalenone laid down in points 2.4.1, 2.4.2, 2.4.4, 2.4.5, 2.4.6, 2.4.7, 2.5.1, 2.5.3, 2.5.5 and 2.5.7 of the Annex;
1 July 2007 as regards the maximum levels for deoxynivalenol and zearalenone laid down in points 2.4.3, 2.5.2, 2.5.4, 2.5.6 and 2.5.8 of the Annex;
1 October 2007 as regards the maximum levels for fumonisins B1 and B2 laid down in point 2.6 of the Annex;
4 November 2006 as regards the maximum levels for the sum of dioxins and dioxin-like PCBs laid down in section 5 of the Annex.
(2) OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation (EC) No 199/2006 (OJ L 32, 4.2.2006, p. 32).
(3) OJ L 139, 30.4.2004, p. 55, as corrected by OJ L 226, 25.6.2004, p. 22. Regulation as last amended by Regulation (EC) No 1662/2006 (OJ L 320, 18.11.2006, p. 1).
(4) Reports of the Scientific Committee for Food, 38th series, Opinion of the Scientific Committee for Food on nitrates and nitrite, p. 1, http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_38.pdf
(5) Reports of the Scientific Committee for Food, 35th series, Opinion of the Scientific Committee for Food on aflatoxins, ochratoxin A and patulin, p. 45, http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_35.pdf
(6) Opinion of the Scientific Committee on Food on Ochratoxin A (expressed on 17 September 1998) http://ec.europa.eu/food/fs/sc/scf/out14_en.html
(7) Reports on tasks for scientific cooperation, Task 3.2.7 ‘Assessment of dietary intake of Ochratoxin A by the population of EU Member States’. http://ec.europa.eu/food/food/chemicalsafety/contaminants/task_3-2-7_en.pdf
(8) OJ L 52, 4.3.1993, p. 18.
(9) Opinion of the Scientific Panel on contaminants in the Food Chain of the EFSA on a request from the Commission related to ochratoxin A in food. http://www.efsa.europa.eu/etc/medialib/efsa/science/contam/contam_opinions/1521.Par.0001.File.dat/contam_op_ej365_ochratoxin_a_food_en1.pdf
(10) Minutes of the 120th Meeting of the Scientific Committee on Food held on 8 and 9 March 2000 in Brussels, Minute statement on patulin. http://ec.europa.eu/food/fs/sc/scf/out55_en.pdf
(11) Reports on tasks for scientific cooperation, Task 3.2.8, ‘Assessment of dietary intake of Patulin by the population of EU Member States’. http://ec.europa.eu/food/food/chemicalsafety/contaminants/3.2.8_en.pdf
(12) OJ L 203, 12.8.2003, p. 34.
(13) Opinion of the Scientific Committee on Food on Fusarium-toxins Part 1: Deoxynivalenol (DON), (expressed on 2 December 1999) http://ec.europa.eu/food/fs/sc/scf/out44_en.pdf
(14) Opinion of the Scientific Committee on Food on Fusarium-toxins Part 2: Zearalenone (ZEA), (expressed on 22 June 2000) http://ec.europa.eu/food/fs/sc/scf/out65_en.pdf
(15) Opinion of the Scientific Committee on Food on Fusarium-toxins Part 3: Fumonisin B1 (FB1) (expressed on 17 October 2000) http://ec.europa.eu/food/fs/sc/scf/out73_en.pdf
(16) Updated opinion of the Scientific Committee on Food on Fumonisin B1, B2 and B3 (expressed on 4 April 2003) http://ec.europa.eu/food/fs/sc/scf/out185_en.pdf
(17) Opinion of the Scientific Committee on Food on Fusarium-toxins Part 4: Nivalenol (expressed on 19 October 2000) http://ec.europa.eu/food/fs/sc/scf/out74_en.pdf
(18) Opinion of the Scientific Committee on Food on Fusarium-toxins Part 5: T-2 toxin and HT-2 toxin (adopted on 30 May 2001) http://ec.europa.eu/food/fs/sc/scf/out88_en.pdf
(19) Opinion of the Scientific Committee on Food on Fusarium-toxins Part 6: Group evaluation of T-2 toxin, HT-2toxin, nivalenol and deoxynivalenol. (adopted on 26 February 2002) http://ec.europa.eu/food/fs/sc/scf/out123_en.pdf
(20) Reports on tasks for scientific cooperation, Task 3.2.10 ‘Collection of occurrence data of Fusarium toxins in food and assessment of dietary intake by the population of EU Member States’. http://ec.europa.eu/food/fs/scoop/task3210.pdf
(21) OJ L 234, 29.8.2006, p. 35.
(22) Reports of the Scientific Committee for Food, 32nd series, Opinion of the Scientific Committee for Food on ‘The potential risk to health presented by lead in food and drink’, p. 7, http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_32.pdf
(23) Reports on tasks for scientific co-operation, Task 3.2.11 ‘Assessment of dietary exposure to arsenic, cadmium, lead and mercury of the population of the EU Member States’. http://ec.europa.eu/food/food/chemicalsafety/contaminants/scoop_3-2-11_heavy_metals_report_en.pdf
(24) Reports of the Scientific Committee for Food, 36th series, Opinion of the Scientific Committee for Food on cadmium, p. 67, http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_36.pdf
(25) Opinion of the Scientific Panel on contaminants in the Food Chain of the European Food Safety Authority (EFSA) on a request from the Commission related to mercury and methylmercury in food (adopted on 24 February 2004) http://www.efsa.eu.int/science/contam/contam_opinions/259/opinion_contam_01_en1.pdf
(27) Opinion of the Scientific Committee on Food on acute risks posed by tin in canned foods (adopted on 12 December 2001) http://ec.europa.eu/food/fs/sc/scf/out110_en.pdf
(28) Opinion of the Scientific Committee on Food on 3-monochloro-propane-1,2-diol (3-MCPD) updating the SCF opinion of 1994 (adopted on 30 May 2001) http://ec.europa.eu/food/fs/sc/scf/out91_en.pdf
(29) Reports of the Scientific Committee for Food, 36th series, Opinion of the Scientific Committee for Food on 3-monochloro-propane-1,2-diol 3-MCPD), p. 31, http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_36.pdf
(30) Reports on tasks for scientific cooperation, Task 3.2.9 ‘Collection and collation of data on levels of 3-monochloropropanediol (3-MCPD) and related substances in foodstuffs’. http://ec.europa.eu/food/food/chemicalsafety/contaminants/scoop_3-2-9_final_report_chloropropanols_en.pdf
(31) Opinion of the Scientific Committee on Food on the risk assessment of dioxins and dioxin-like PCBs in food. Update based on new scientific information available since the adoption of the SCF opinion of 22nd November 2000 (adopted on 30 May 2001) http://ec.europa.eu/food/fs/sc/scf/out90_en.pdf
(32) Opinion of the Scientific Committee on Food on the risk assessment of dioxins and dioxin-like PCBs in food. (adopted on 22 November 2000) http://ec.europa.eu/food/fs/sc/scf/out78_en.pdf
(33) Reports on tasks for scientific cooperation, Task 3.2.5 ‘Assessment of dietary intake of dioxins and related PCBs by the population of EU Member States’. http://ec.europa.eu/dgs/health_consumer/library/pub/pub08_en.pdf
(34) OJ L 42, 14.2.2006, p. 26.
(35) Opinion of the Scientific Committee on Food on the risks to human health of Polycyclic Aromatic Hydrocarbons in food (expressed on 4 December 2002) http://ec.europa.eu/food/fs/sc/scf/out153_en.pdf
(36) Evaluation of certain food contaminants — Report of the Joint FAO/WHO Expert Committee on Food Additives), 64th meeting, Rome, 8 to 17 February 2005, p. 1 and p. 61.
(37) Reports on tasks for scientific co-operation, Task 3.2.12 ‘Collection of occurrence data on polycyclic aromatic hydrocarbons in food’. http://ec.europa.eu/food/food/chemicalsafety/contaminants/scoop_3-2-12_final_report_pah_en.pdf
(38) See page 25 of this Official Journal.
(39) OJ L 70, 9.3.2006, p. 12.
(40) See page 32 of this Official Journal.
(41) OJ L 77, 16.3.2001, p. 14. Directive as amended by Directive 2005/4/EC (OJ L 19, 21.1.2005, p. 50).
(42) OJ L 42, 13.2.2004, p. 16.
(43) OJ L 34, 8.2.2005, p. 15.
(44) OJ L 199, 21.7.2006, p. 21.
(45) OJ L 322, 22.11.2006, p. 24.
(46) OJ L 34, 8.2.2005, p. 43.
Maximum levels for certain contaminants in foodstuffs (1)
Groundnuts to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs
Nuts to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs
Groundnuts and nuts and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs
All cereals and all products derived from cereals, including processed cereal products, with the exception of foodstuffs listed in 2.1.7, 2.1.10 and 2.1.12
Maize to be subjected to sorting or other physical treatment before human consumption or use as an ingredient in foodstuffs
Green coffee, dried fruit other than dried vine fruit, beer, cocoa and cocoa products, liqueur wines, meat products, spices and liquorice
Unprocessed maize (18)
Cereals intended for direct human consumption, cereal flour (including maize flour, maize meal and maize grits (21)), bran as end product marketed for direct human consumption and germ, with the exception of foodstuffs listed in 2.4.7
Cereals intended for direct human consumption, cereal flour, bran as end product marketed for direct human consumption and germ, with the exception of foodstuffs listed in 2.5.4, 2.5.7 and 2.5.8
Maize intended for direct human consumption, maize flour, maize meal, maize grits, maize germ and refined maize oil (21)
Bread (including small bakery wares), pastries, biscuits, cereal snacks and breakfast cereals, excluding maize snacks and maize based breakfast cereals
Maize snacks and maize based breakfast cereals
Maize flour, maize meal, maize grits, maize germ and refined maize oil (21)
Maize based foods for direct human consumption, excluding foods listed in 2.6.2 and 2.6.4
Infant formulae and follow-on formulae (4) (8)
Brassica vegetables, leaf vegetables and cultivated fungi (27)
Muscle meat of fish (24) (25), excluding species listed in 3.2.6 and 3.2.7
Muscle meat of swordfish (Xiphias gladius) (24) (25)
Vegetables and fruit, excluding leaf vegetables, fresh herbs, fungi, stem vegetables, pine nuts, root vegetables and potatoes (27)
Leaf vegetables, fresh herbs, cultivated fungi and celeriac (27)
Stem vegetables, root vegetables and potatoes, excluding celeriac (27). For potatoes the maximum level applies to peeled potatoes
Canned infant formulae and follow-on formulae (including infant milk and follow-on milk), excluding dried and powdered products (8) (29)
Muscle meat of fish and fishery products and products thereof, excluding eel (25) (34). The maximum level applies to crustaceans, excluding the brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae)
Infant formulae and follow-on formulae, including infant milk and follow-on milk (8) (29)
(1) As regards fruits, vegetables and cereals, reference is made to the foodstuffs listed in the relevant category as defined in Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1) as last amended by Regulation (EC) No 178/2006 (OJ L 29, 2.2.2006, p. 3). This means, inter alia, that buckwheat (Fagopyrum sp) is included in ‘cereals’ and buckwheat products are included in ‘cereal products’.
(5) The maximum levels refer to the edible part of groundnuts and nuts. If groundnuts and nuts ‘in shell’ are analysed, it is assumed when calculating the aflatoxin content all the contamination is on the edible part.
(8) Foodstuffs listed in this category as defined in 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 L 41, 14.2.2003, p. 37).
(20) Maximum level shall apply from 1 July 2007.
(34) Foodstuffs listed in this category as defined in categories (a), (b), (c), (e) and (f) of the list in Article 1 of Regulation (EC) No 104/2000 with the exclusion of fish liver falling under code CN 0302 70 00.