(EC) No 1881 2006 设定食品中某些污染物的最高含量

(EC) No 1881/2006 设定食品中某些污染物的最高含量 【发布单位】欧盟委员会 【发布文号】(EC) No 1881/2006 【发布日期】2006-12-19 【生效日期】2007-01-08 【废止日期】 【替代法规】 【效力】有效 【食品伙伴网解读】该委员会条例规定了食品中硝酸盐类、毒枝菌素、重金属、3-氯-1,2-丙二醇、二噁英类及多氯联苯、多环芳香族碳氢化合物污染物的最大限量(mg/Kg)。 Amended by: (EC)No 1126/2007 就玉米和玉米产品中的镰刀霉毒菌,修订关于设定食品内某些污染物的最高含量的条例(EC)No 1881/2006(Amending Regulation (EC)No 1881/2 006 setting maximum levels for certain contaminants in foodstuffs as regards Fusarium tox ins in maize and maize products) (EC)No 565/2008 就鱼肝脏二氧(杂)芑和PCBs的最高含量,修订有关设定食品中某些污染物最高含量的条例(EC)No 1881/2006 (EC)No 629/2008 对条例(EC)No 1881/2006 关于食品中特定污染物最高含量的修订(Amending Regulation (EC)No 1881/2006 setting maximum levels for certain c ontaminants in foodstuffs) (EU)No 105/2010 就赭曲霉毒素A,修订有关设定食品中某些污染物的最高含量的条例(EC)No 1881/2006 (EU)No 165/2010 针对黄曲霉毒素,修订有关设定食品中某些污染物的最高含量的条例(EC)No 1881/2006(Amending Regulation (EC)No 1881/2006 setting maximu m levels for certain contaminants in foodstuffs as regards aflatoxins) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Regulation (EEC)No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food [1], and in particular Article 2(3) thereof, Whereas: (1)Commission Regulation (EC)No 466/2001 of 8 March 2001 setting maximu m levels for certain contaminants in foodstuffs [2] has been amended substantially many ti mes. 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 there fore be replaced. (2)It is essential, in order to protect public health, to keep contaminants at levels which are toxicologically acceptable. (3)In view of disparities between the laws of Member States and the consequent r isk of distortion of competition, for some contaminants Community measures are necessary in order to ensure market unity while abiding by the principle of proportionality. (4)Maximum levels should be set at a strict level which is reasonably achievable by following good agricultural, fishery and manufacturing practices and taking into account the risk related to the consumption of the food. In the case of contaminants which are c onsidered to be genotoxic carcinogens or in cases where current exposure of the populatio n or of vulnerable groups in the population is close to or exceeds the tolerable intake, ma ximum levels should be set at a level which is as low as reasonably achievable (ALAR A). Such approaches ensure that food business operators apply measures to prevent and r educe the contamination as far as possible in order to protect public health. It is furtherm ore appropriate for the health protection of infants and young children, a vulnerable group, to establish the lowest maximum levels, which are achievable through a strict selection o f the raw materials used for the manufacturing of foods for infants and young children. T his strict selection of the raw materials is also appropriate for the production of some spe cific foodstuffs such as bran for direct human consumption. (5)To allow maximum levels to be applied to dried, diluted, processed and compo und foodstuffs, where no specific Community maximum levels have been established, food business operators should provide the specific concentration and dilution factors accompan ied by the appropriate experimental data justifying the factor proposed. (6)To ensure an efficient protection of public health, products containing contamin ants exceeding the maximum levels should not be placed on the market either as such, aft er mixture with other foodstuffs or used as an ingredient in other foods. (7)It is recognised that sorting or other physical treatments make it possible to re duce the aflatoxin content of consignments of groundnuts, nuts, dried fruit and maize. In order to minimise the effects on trade, it is appropriate to allow higher aflatoxin contents for those products which are not intended for direct human consumption or as an ingredie nt in foodstuffs. In these cases, the maximum levels for aflatoxins should be fixed taking into consideration the effectiveness of the above-mentioned treatments to reduce the aflatox in content in groundnuts, nuts, dried fruit and maize to levels below the maximum limits fixed for those products intended for direct human consumption or use as an ingredient in foodstuffs. (8)To enable effective enforcement of the maximum levels for certain contaminant s in certain foodstuffs, it is appropriate to provide for suitable labelling provisions for thes e cases. (9)Because of the climatic conditions in some Member States, it is difficult to ens ure that the maximum levels are not exceeded for fresh lettuce and fresh spinach. These Member States should be allowed for a temporary period to continue to authorise the mar keting of fresh lettuce and fresh spinach grown and intended for consumption in their terri tory with nitrate contents exceeding the maximum levels. Lettuce and spinach producers es tablished in the Member States which have given the aforementioned authorisations should progressively modify their farming methods by applying the good agricultural practices re commended at national level. (10)Certain fish species originating from the Baltic region may contain high levels of dioxins and dioxin-like PCBs. A significant proportion of these fish species from the Baltic region will not comply with the maximum levels and would therefore be excluded from the diet. There are indications that the exclusion of fish from the diet may have a n egative health impact in the Baltic region. (11)Sweden and Finland have a system in place which has the capacity to ensure that consumers are fully informed of the dietary recommendations concerning restrictions o n consumption of fish from the Baltic region by identified vulnerable groups of the popul ation in order to avoid potential health risks. Therefore, it is appropriate to grant a deroga tion to Finland and Sweden to place on the market for a temporary period certain fish sp ecies originating in the Baltic region and intended for consumption in their territory with l evels of dioxins and dioxin-like PCBs higher than those set in this Regulation. The necess ary measures must be implemented to ensure that fish and fish products not complying wi th the maximum levels are not marketed in other Member States. Finland and Sweden rep ort every year to the Commission the results of their monitoring of the levels of dioxins and dioxin-like PCBs in fish from the Baltic region and the measures to reduce human ex posure to dioxins and dioxin-like PCBs from the Baltic region. (12)To ensure that the maximum levels are enforced in a uniform way, the same sampling criteria and the same analysis performance criteria should be applied by the com petent authorities throughout the Community. It is furthermore important that analytical res ults are reported and interpreted in a uniform way. The measures as regards sampling and analysis specified in this Regulation provide for uniform rules on reporting and interpretat ion. (13)For certain contaminants, Member States and interested parties should monitor and report levels, as well report on the progress with regard to application of preventative measures, to allow the Commission to assess the need to modify existing measures or to adopt additional measures. (14)Any maximum level adopted at Community level can be subject to a review t o take account of the advance of scientific and technical knowledge and improvements in good agricultural, fishery and manufacturing practices. (15)Bran and germ can be marketed for direct human consumption and it is there fore appropriate to establish a maximum level for deoxynivalenol and zearalenone in these commodities. (16)Codex Alimentarius has recently set a maximum level for lead in fish which t he Community accepted. It is therefore appropriate to modify the current provision for lea d in fish accordingly. (17)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 fo odstuffs of animal origin, and consequently the entries as regards foodstuffs of animal orig in should be amended in some cases according to the terminology used in that Regulatio n. (18)It is necessary to provide that the maximum levels for contaminants do not a pply to the foodstuffs which have been lawfully placed on the Community market before the date of application of these maximum levels. (19)As regards nitrate, vegetables are the major source for the human intake of ni trate. The Scientific Committee on Food (SCF)stated in its opinion of 22 September 1 995 [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 e fforts to reduce exposure to nitrate via food and water. (20)Since climatic conditions have a major influence on the levels of nitrate in ce rtain vegetables such as lettuce and spinach, different maximum nitrate levels should theref ore be fixed depending on the season. (21)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 l imit 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. Fo r 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 procedure s. (22)As regards ochratoxin A (OTA), the SCF adopted a scientific opinion on 1 7 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 Sta tes in the scientific examination of questions relating to food [8] (SCOOP). The Europe an 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 int o account new scientific information and derived a tolerable weekly intake (TWI)of 12 0 ng/kg bw. (23)Based on these opinions, it is appropriate to set maximum levels for cereals, cereal products, dried vine fruit, roasted coffee, wine, grape juice and foods for infants an d young children, all of which contribute significantly to general human exposure to OTA or to the exposure of vulnerable groups of consumers such as children. (24)The appropriateness of setting a maximum level for OTA in foodstuffs such a s dried fruit other than dried vine fruit, cocoa and cocoa products, spices, meat products, green coffee, beer and liquorice, as well as a review of the existing maximum levels, in particular for OTA in dried vine fruit and grape juice, will be considered in the light of t he recent EFSA scientific opinion. (25)As regards patulin, the SCF endorsed in its meeting on 8 March 2000 the pr ovisional maximum tolerable daily intake (PMTDI)of 0,4 ??g/kg bw for patulin [10]. (26)In 2001, a SCOOP-task "Assessment of the dietary intake of patulin by the p opulation of EU Member States" in the framework of Directive 93/5/EEC was performed [11]. (27)Based on that assessment and taking into account the PMTDI, maximum level s should be set for patulin in certain foodstuffs to protect consumers from unacceptable co ntamination. These maximum levels should be reviewed and, if necessary, reduced taking i nto 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 bever ages [12]. (28)As regards Fusarium toxins, the SCF has adopted several opinions evaluating deoxynivalenol in December 1999 [13] establishing a tolerable daily intake (TDI)of 1 ?? g/kg bw, zearalenone in June 2000 [14] establishing a temporary TDI of 0,2 ??g/kg bw, f umonisins in October 2000 [15] (updated in April 2003)[16] establishing a TDI of 2 ?? g/kg bw, nivalenol in October 2000 [17] establishing a temporary TDI of 0,7 ??g/kg bw, T-2 and HT-2 toxin in May 2001 [18] establishing a combined temporary TDI of 0,06 ?? g/kg bw and the trichothecenes as group in February 2002 [19]. (29)In the framework of Directive 93/5/EEC the SCOOP-task "Collection of occur rence 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]. (30)Based on the scientific opinions and the assessment of the dietary intake, it is appropriate to set maximum levels for deoxynivalenol, zearalenone and fumonisins. As re gards fumonisins, monitoring control results of the recent harvests indicate that maize and maize products can be very highly contaminated by fumonisins and it is appropriate that measures are taken to avoid such unacceptably highly contaminated maize and maize prod ucts can enter the food chain. (31)Intake estimates indicate that the presence of T-2 and HT-2 toxin can be of c oncern for public health. Therefore, the development of a reliable and sensitive method, c ollection of more occurrence data and more investigations/research in the factors involved in the presence of T-2 and HT-2 toxin in cereals and cereal products, in particular in oats and oat products, is necessary and of high priority. (32)It is not necessary due to co-occurrence to consider specific measures for 3-ac etyl deoxynivalenol, 15-acetyl deoxynivalenol and fumonisin B3, as measures with regard t o in particular deoxynivalenol and fumonisin B1 and B2 would also protect the human po pulation from an unacceptable exposure from 3-acetyl deoxynivalenol, 15-acetyl deoxynival enol and fumonisin B3. The same applies to nivalenol for which to a certain degree co-oc currence with deoxynivalenol can be observed. Furthermore, human exposure to nivalenol i s estimated to be significantly below the t-TDI. As regards other trichothecenes considered in the abovementioned SCOOP-task, such as 3-acetyldeoxynivalenol, 15-acetyldeoxynivalen ol, fusarenon-X, T2-triol, diacetoxyscirpenol, neosolaniol, monoacetoxyscirpenol and verruco l, the limited information available indicates that they do not occur widely and the levels found are generally low. (33)Climatic conditions during the growth, in particular at flowering, have a major influence on the Fusarium toxin content. However, good agricultural practices, whereby th e risk factors are reduced to a minimum, can prevent to a certain degree the contaminatio n by Fusarium fungi. Commission Recommendation 2006/583/EC of 17 August 2006 on t he prevention and reduction of Fusarium toxins in cereals and cereal products [21] contain s general principles for the prevention and reduction of Fusarium toxin contamination (ze aralenone, fumonisins and trichothecenes)in cereals to be implemented by the developme nt of national codes of practice based on these principles. (34)Maximum levels of Fusarium toxins should be set for unprocessed cereals pla ced on the market for first-stage processing. Cleaning, sorting and drying procedures are n ot considered as first-stage processing insofar as no physical action is exerted on the grain kernel itself. Scouring is to be considered as first-stage processing. (35)Since the degree to which Fusarium toxins in unprocessed cereals are removed by cleaning and processing may vary, it is appropriate to set maximum levels for final c onsumer cereal products as well as for major food ingredients derived from cereals to hav e enforceable legislation in the interest of ensuring public health protection. (36)For maize, not all factors involved in the formation of Fusarium toxins, in pa rticular zearalenone and fumonisins B1 and B2, are yet precisely known. Therefore, a time period is granted to enable food business operators in the cereal chain to perform investi gations on the sources of the formation of these mycotoxins and on the identification of t he management measures to be taken to prevent their presence as far as reasonably possib le. Maximum levels based on currently available occurrence data are proposed to apply fr om 2007 in case no specific maximum levels based on new information on occurrence an d formation are set before that time. (37)Given the low contamination levels of Fusarium toxins found in rice, no maxi mum levels are proposed for rice or rice products. (38)A review of the maximum levels for deoxynivalenol, zearalenone, fumonisin B 1 and B2 as well as the appropriateness of setting a maximum level for T-2 and HT-2 to xin in cereals and cereal products should be considered by 1 July 2008, taking into accou nt the progress in scientific and technological knowledge on these toxins in food. (39)As regards lead, the SCF adopted an opinion on 19 June 1992 [22] endorsing the provisional tolerable weekly intake (PTWI)of 25 ??g/kg bw proposed by the WH O in 1986. The SCF concluded in its opinion that the mean level in foodstuffs does not seem to be a cause of immediate concern. (40)In the framework of Directive 93/5/EEC 2004 the SCOOP-task 3.2.11 "Assess ment 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 (41)As regards cadmium, the SCF endorsed in its opinion of 2 June 1995 [24] th e PTWI o f 7 ??g/k g bw and recommended greater efforts to reduce dietary exposure to c admium since foodstuffs are the main source of human intake of cadmium. A dietary exp osure assessment was performed in the SCOOP-task 3.2.11. In view of this assessment an d the opinion delivered by the SCF, it is appropriate to take measures to reduce the prese nce of cadmium in food as muc h as possible. (42)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 i ntake of 1,6 ??g/kg bw. Methylmercury is the chemical form of most concern and can ma ke 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. (43)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 respondin g to this need has therefore been made available on the website of the Health and Consu mer Protection Directorate-General of the European Commission [26]. Several Member Stat es have also issued advice on this issue that is relevant to their population. (44)As regards inorganic tin, the SCF concluded in its opinion of 12 December 2 001 [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. (45)To protect public health from this health risk it is necessary to set maximum levels for inorganic tin in canned foods and canned beverages. Until data becomes availab le on the sensitivity of infants and young children to inorganic tin in foods, it is necessar y on a precautionary basis to protect the health of this vulnerable population group and to establish lower maximum levels. (46)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 tolera ble daily intake (TDI)of 2 ??g/kg bw for 3-MCPD. (47)In the framework of Directive 93/5/EEC the SCOOP-task "Collection and coll ation of data on levels of 3-MCPD and related substances in foodstuffs" was performed a nd 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. (48)Accordingly maximum levels should be set for 3-MCPD in hydrolysed vegetab le protein (HVP)and soy sauce taking into account the risk related to the consumption of these foods. Member States are requested to examine other foodstuffs for the occurrenc e of 3-MCPD in order to consider the need to set maximum levels for additional foodstuf fs. (49)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. (50)Dioxins as referred to in this Regulation cover a group of 75 polychlorinated dibenzo-p-dioxin (PCDD)congeners and 135 polychlorinated dibenzofuran (PCDF)co ngeners, of which 17 are of toxicological concern. Polychlorinated biphenyls (PCBs)are a group of 209 different congeners which can be divided into two groups according to th eir toxicological properties: 12 congeners exhibit toxicological properties similar to dioxins and are therefore often termed dioxin-like PCBs. The other PCBs do not exhibit dioxin-li ke toxicity but have a different toxicological profile. (51)Each congener of dioxins or dioxin-like PCBs exhibits a different level of tox icity. In order to be able to sum up the toxicity of these different congeners, the concept of toxic equivalency factors (TEFs)has been introduced to facilitate risk assessment and regulatory control. This means that the analytical results relating to all the individual dio xin and dioxin-like PCB congeners of toxicological concern are expressed in terms of a q uantifiable unit, namely the TCDD toxic equivalent (TEQ). (52)Exposure estimates taking into account the SCOOP-task "Assessment of dietar y intake of dioxins and related PCBs by the population of EU Member States" finalised i n June 2000 [33] indicate that a considerable proportion of the Community population has a dietary intake in excess of the TWI. (53)From a toxicological point of view, any level set should apply to both dioxins and dioxin-like PCBs, but in 2001 maximum levels were set on Community level only f or dioxins and not for dioxin-like PCBs, given the very limited data available at that time on the prevalence of dioxin-like PCBs. Since 2001, however, more data on the presence of dioxin-like PCBs have become available, therefore, maximum levels for the sum of dio xins and dioxin-like PCBs have been set in 2006 as this is the most appropriate approach from a toxicological point of view. In order to ensure a smooth transition, the levels for dioxins should continue to apply for a transitional period in addition to the levels for the sum of dioxins and dioxin-like PCBs. Foodstuffs must comply during that transitional per iod with the maximum levels for dioxins and with the maximum levels for the sum of di oxins and dioxin-like PCBs. Consideration will be given by 31 December 2008 to dispensi ng with the separate maximum levels for dioxins. (54)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 Recommendati on 2006/88/EC of 6 February 2006 on the reduction of the presence of dioxins, furans an d 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 sour ce 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 dioxin s on the one hand and for dioxin-like PCBs on the other hand. This proactive approach t o actively reduce the dioxins and dioxin-like PCBs in feed and food and consequently, th e 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 200 8 to significantly reducing the maximum levels for the sum of dioxins and dioxin-like PC Bs. (55)Operators need to make efforts to step up their capacity to remove dioxins, f urans and dioxin-like PCBs from marine oil. The significant lower level, to which conside ration shall be given by 31 December 2008, shall be based on the technical possibilities o f the most effective decontamination procedure. (56)As regards the establishment of maximum levels for other foodstuffs by 31 D ecember 2008, particular attention shall be paid to the need to set specific lower maximu m levels for dioxins and dioxin-like PCBs in foods for infants and young children in the light of the monitoring data obtained through the 2005, 2006 and 2007 programmes for m onitoring dioxins and dioxin-like PCBs in foods for infants and young children. (57)As regards polycyclic aromatic hydrocarbons, the SCF concluded in its opinion of 4 December 2002 [35] that a number of polycyclic aromatic hydrocarbons (PAH)a re genotoxic carcinogens. The Joint FAO/WHO Expert Committee on Food Additives (JE CFA)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 carci nogenic [36]. (58)According to the SCF, benzo(a)pyrene can be used as a marker for the oc currence and effect of carcinogenic PAH in food, including also benz(a)anthracene, benz o(b)fluoranthene, benzo(j)fluoranthene, benzo(k)fluoranthene, benzo(g,h,i)perylene, chrysene, cyclopenta(c,d)pyrene, dibenz(a,h)anthracene, dibenzo(a,e)pyrene, dibenzo (a,h)pyrene, dibenzo(a,i)pyrene, dibenzo(a,l)pyrene, indeno(1,2,3-cd)pyrene and 5 -methylchrysene. Further analyses of the relative proportions of these PAH in foods would be necessary to inform a future review of the suitability of maintaining benzo(a)pyrene as a marker. In addition benzo(c)fluorene should be analysed, following a recommendat ion of JECFA. (59)PAH can contaminate foods during smoking processes and heating and drying processes that allow combustion products to come into direct contact with food. In additio n, environmental pollution may cause contamination with PAH, in particular in fish and fi shery products. (60)In the framework of Directive 93/5/EEC, a specific SCOOP-task "Collection o f occurrence data on PAH in food" has been performed in 2004 [37]. High levels were f ound in dried fruits, olive pomace oil, smoked fish, grape seed oil, smoked meat products, fresh molluscs, spices/sauces and condiments. (61)In order to protect public health, maximum levels are necessary for benzo(a) pyrene in certain foods containing fats and oils and in foods where smoking or drying pr ocesses might cause high levels of contamination. Maximum levels are also necessary in f oods where environmental pollution may cause high levels of contamination, in particular i n fish and fishery products, for example resulting from oil spills caused by shipping. (62)In some foods, such as dried fruit and food supplements, benzo(a)pyrene h as been found, but available data are inconclusive on what levels are reasonably achievabl e. Further investigation is needed to clarify the levels that are reasonably achievable in th ese foods. In the meantime, maximum levels for benzo(a)pyrene in relevant ingredients should apply, such as in oils and fats used in food supplements. (63)The maximum levels for PAH and the appropriateness of setting a maximum level for PAH in cocoa butter should be reviewed by 1 April 2007, taking into account t he progress in scientific and technological knowledge on the occurrence of benzo(a)pyre ne and other carcinogenic PAH in food. (64)The measures provided for in this Regulation are in accordance with the opini on of the Standing Committee on the Food Chain and Animal Health, HAS ADOPTED THIS REGULATION: Article 1 General rules 1. The foodstuffs listed in the Annex shall not be placed on the market where they c ontain a contaminant listed in the Annex at a level exceeding the maximum level set out in the Annex. 2. The maximum levels specified in the Annex shall apply to the edible part of the f oodstuffs concerned, unless otherwise specified in the Annex. Article 2 Dried, diluted, processed and compound foodstuffs 1. When applying the maximum levels set out in the Annex to foodstuffs which are dried, diluted, processed or composed of more than one ingredient, the following shall be taken into account: (a)changes of the concentration of the contaminant caused by drying or dilution pr ocesses; (b)changes of the concentration of the contaminant caused by processing; (c)the relative proportions of the ingredients in the product; (d)the analytical limit of quantification. 2. The specific concentration or dilution factors for the drying, dilution, processing an d/or mixing operations concerned or for the dried, diluted, processed and/or compound foo dstuffs concerned shall be provided and justified by the food business operator, when the competent authority carries out an official control. If the food business operator does not provide the necessary concentration or dilution factor or if the competent authority deems that factor inappropriate in view of the justific ation given, the authority shall itself define that factor, based on the available information and with the objective of maximum protection of human health. 3. Paragraphs 1 and 2 shall apply in so far as no specific Community maximum leve ls are fixed for these dried, diluted, processed or compound foodstuffs. 4. As far as Community legislation does not provide for specific maximum levels for foods for infants and young children, Member States may provide for stricter levels. Article 3 Prohibitions on use, mixing and detoxification 1. Foodstuffs not complying with the maximum levels set out in the Annex shall not be used as food ingredients. 2. Foodstuffs complying with the maximum levels set out in the Annex shall not be mixed with foodstuffs which exceed these maximum levels. 3. Foodstuffs to be subjected to sorting or other physical treatment to reduce contami nation levels shall not be mixed with foodstuffs intended for direct human consumption or with foodstuffs intended for use as a food ingredient. 4. Foodstuffs containing contaminants listed in section 2 of the Annex (Mycotoxins) shall not be deliberately detoxified by chemical treatments. Article 4 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 place d on the market provided that these foodstuffs: (a)are not intended for direct human consumption or use as an ingredient in foods tuffs; (b)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; (c)are subjected to a treatment involving sorting or other physical treatment and t hat 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; (d)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 includ ed on the label of each individual bag, box etc. or on the original accompanying docume nt. The consignment/batch identification code shall be indelibly marked on each individual bag, box etc. of the consignment and on the original accompanying document. Article 5 Specific provisions for groundnuts, derived products thereof and cereals A clear indication of the intended use must appear on the label of each individual ba g, box, etc. or on the original accompanying document. This accompanying document mus t have a clear link with the consignment by means of mentioning the consignment identifi cation code, which is on each individual bag, box, etc. of the consignment. In addition th e business activity of the consignee of the consignment given on the accompanying docum ent must be compatible with the intended use. In the absence of a clear indication that their intended use is not for human consump tion, 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. Article 6 Specific provisions for lettuce Unless lettuce grown under cover (protected lettuce)is labelled as such, maximum levels set in the Annex for lettuce grown in the open air (open-grown lettuce)shall ap ply. Article 7 Temporary derogations 1. By way of derogation from Article 1, Belgium, Ireland, the Netherlands and the U nited Kingdom may authorise until 31 December 2008 the placing on the market of fresh spinach grown and intended for consumption in their territory with nitrate levels higher t han the maximum levels set out in point 1.1 of the Annex. 2. By way of derogation from Article 1, Ireland and the United Kingdom may author ise until 31 December 2008 the placing on the market of fresh lettuce grown and intende d for consumption in their territory and harvested throughout the year with nitrate levels h igher than the maximum levels set out in point 1.3 of the Annex. 3. By way of derogation from Article 1, France may authorise until 31 December 20 08 the placing on the market of fresh lettuce grown and intended for consumption in its t erritory and harvested from 1 October to 31 March with nitrate levels higher than the ma ximum levels set out in point 1.3 of the Annex. 4. By way of derogation from Article 1, Finland and Sweden may authorise until 31 December 2011 the placing on their market of salmon (Salmo salar), herring (Clupea harengus), river lamprey (Lampetra fluviatilis), trout (Salmo trutta), char (Salvelinu s spp.)and roe of vendace (Coregonus albula)originating in the Baltic region and int ended for consumption in their territory with levels of dioxins and/or levels of the sum of dioxins and dioxin-like PCBs higher than those set out in point 5.3 of the Annex, provid ed that a system is in place to ensure that consumers are fully informed of the dietary re commendations with regard to the restrictions on the consumption of these fish species fro m the Baltic region by identified vulnerable sections of the population in order to avoid p otential health risks. By 31 March each year, Finland and Sweden shall communicate to t he Commission the results of their monitoring of the levels of dioxins and dioxin-like PC Bs in fish from the Baltic region obtained in the preceding year and shall report on the measures taken to reduce human exposure to dioxins and dioxin-like PCBs from fish from the Baltic region. Finland and Sweden shall continue to apply the necessary measures to ensure that fis h and fish products not complying with point 5.3 of the Annex are not marketed in other Member States. Article 8 Sampling and analysis The sampling and the analysis for the official control of the maximum levels specifie d in the Annex shall be performed in accordance with Commission Regulations (EC)N o 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]. Article 9 Monitoring and reporting 1. Member States shall monitor nitrate levels in vegetables which may contain signifi cant levels, in particular green leaf vegetables, and communicate the results to the Commi ssion by 30 June each year. The Commission will make these results available to the Me mber States. 2. Member States and interested parties shall communicate each year to the Commissi on the results of investigations undertaken including occurrence data and the progress with regard to the application of prevention measures to avoid contamination by ochratoxin A, deoxynivalenol, zearalenone, fumonisin B1 and B2, T-2 and HT-2 toxin. The Commission will make these results available to the Member States. 3. Member States should report to the Commission findings on aflatoxins, dioxins, di oxin-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]. Article 10 Repeal Regulation (EC)No 466/2001 is repealed. References to the repealed Regulation shall be construed as references to this Regulati on. Article 11 Transitional measures This Regulation shall not apply to products that were placed on the market before th e dates referred to in points (a)to (d)in conformity with the provisions applicable at the respective date: (a)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 t he Annex; (b)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; (c)1 October 2007 as regards the maximum levels for fumonisins B1 and B2 laid down in point 2.6 of the Annex; (d)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. The burden of proving when the products were placed on the market shall be borne by the food business operator. Article 12 Entry into force and application This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 March 2007. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 19 December 2006. For the Commission Markos Kyprianou Member of the Commission ANNEX Maximum levels for certain contaminants in foodstuffs [1] +++++ TIFF +++++ Section 1: Nitrate Foodstuffs [1] | Maximum levels (mg NO3/kg)| 1.1 | Fresh spinach (Spinacia oleracea)[2] | Harvested 1 October to 31 March | 30 00 | Harvested 1 April to 30 September | 2500 | 1.2 | Preserved, deep-frozen or frozen spinach | | 2000 | 1.3 | Fresh Lettuce (Lactuca sativa L.)(protected and open-grown lettuce)exclu ding lettuce listed in point 1.4 | Harvested 1 October to 31 March: | | lettuce grown under cover | 4500 | lettuce 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 lettuce | Lettuce grown under cover | 2500 | Lettuce grown in the open air | 2000 | 1.5 | Processed cereal-based foods and baby foods for infants and young children [3] [4] | | 200 | Section 2: Mycotoxins Foodstuffs [1] | Maximum levels (μg/kg)| 2.1 | Aflatoxins | B1 | Sum of B1, B2, G1 and G2 | M1 | 2.1.1 | Groundnuts to be subjected to sorting, or other physical treatment, before hum an consumption or use as an ingredient in foodstuffs | 8,0 [5] | 15,0 [5] | —| 2.1.2 | Nuts to be subjected to sorting, or other physical treatment, before human con sumption or use as an ingredient in foodstuffs | 5,0 [5] | 10,0 [5] | —| 2.1.3 | Groundnuts and nuts and processed products thereof, intended for direct huma n consumption or use as an ingredient in foodstuffs | 2,0 [5] | 4,0 [5] | —| 2.1.4 | Dried fruit to be subjected to sorting, or other physical treatment, before huma n consumption or use as an ingredient in foodstuffs | 5,0 | 10,0 | —| 2.1.5 | Dried fruit and processed products thereof, intended for direct human consump tion or use as an ingredient in foodstuffs | 2,0 | 4,0 | —| 2.1.6 | All cereals and all products derived from cereals, including processed cereal pr oducts, with the exception of foodstuffs listed in 2.1.7, 2.1.10 and 2.1.12 | 2,0 | 4,0 | —| 2.1.7 | Maize to be subjected to sorting or other physical treatment before human con sumption or use as an ingredient in foodstuffs | 5,0 | 10,0 | —| 2.1.8 | Raw milk [6], heat-treated milk and milk for the manufacture of milk-based p roducts | —| —| 0,050 | 2.1.9 | Following species of spices: Capsicum spp. (dried fruits thereof, whole or gr ound, including chillies, chilli powder, cayenne and paprika)Piper spp. (fruits thereof, in cluding white and black pepper)Myristica fragrans (nutmeg)Zingiber officinale (ginger) Curcuma longa (turmeric)| 5,0 | 10,0 | —| 2.1.10 | Processed cereal-based foods and baby foods for infants and young children [3] [7] | 0,10 | —| —| 2.1.11 | Infant formulae and follow-on formulae, including infant milk and follow-on milk [4] [8] | —| —| 0,025 | 2.1.12 | Dietary foods for special medical purposes [9] [10] intended specifically for i nfants | 0,10 | —| 0,025 | 2.2 | Ochratoxin A | | 2.2.1 | Unprocessed cereals | 5,0 | 2.2.2 | All products derived from unprocessed cereals, including processed cereal prod ucts and cereals intended for direct human consumption with the exception of foodstuffs li sted in 2.2.9 and 2.2.10 | 3,0 | 2.2.3 | Dried vine fruit (currants, raisins and sultanas)| 10,0 | 2.2.4 | Roasted coffee beans and ground roasted coffee, excluding soluble coffee | 5,0 | 2.2.5 | Soluble coffee (instant coffee)| 10,0 | 2.2.6 | Wine (including sparkling wine, excluding liqueur wine and wine with an alc oholic strength of not less than 15 % vol)and fruit wine [11] | 2,0 [12] | 2.2.7 | Aromatised wine, aromatised wine-based drinks and aromatised wine-product c ocktails [13] | 2,0 [12] | 2.2.8 | Grape juice, concentrated grape juice as reconstituted, grape nectar, grape must and concentrated grape must as reconstituted, intended for direct human consumption [14] | 2,0 [12] | 2.2.9 | Processed cereal-based foods and baby foods for infants and young children [3] [7] | 0,50 | 2.2.10 | Dietary foods for special medical purposes [9] [10] intended specifically for i nfants | 0,50 | 2.2.11 | Green coffee, dried fruit other than dried vine fruit, beer, cocoa and cocoa p roducts, liqueur wines, meat products, spices and liquorice | —| 2.3 | Patulin | | 2.3.1 | Fruit juices, concentrated fruit juices as reconstituted and fruit nectars [14] | 5 0 | 2.3.2 | Spirit drinks [15], cider and other fermented drinks derived from apples or co ntaining apple juice | 50 | 2.3.3 | Solid apple products, including apple compote, apple puree intended for direct consumption with the exception of foodstuffs listed in 2.3.4 and 2.3.5 | 25 | 2.3.4 | Apple juice and solid apple products, including apple compote and apple puree, for infants and young children [16] and labelled and sold as such [4] | 10,0 | 2.3.5 | Baby foods other than processed cereal-based foods for infants and young chil dren [3] [4] | 10,0 | 2.4 | Deoxynivalenol [17] | | 2.4.1 | Unprocessed cereals [18] [19] other than durum wheat, oats and maize | 1250 | 2.4.2 | Unprocessed durum wheat and oats [18] [19] | 1750 | 2.4.3 | Unprocessed maize [18] | 1750 [20] | 2.4.4 | 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 | 750 | 2.4.5 | Pasta (dry)[22] | 750 | 2.4.6 | Bread (including small bakery wares), pastries, biscuits, cereal snacks and br eakfast cereals | 500 | 2.4.7 | Processed cereal-based foods and baby foods for infants and young children [3] [7] | 200 | 2.5 | Zearalenone [17] | | 2.5.1 | Unprocessed cereals [18] [19] other than maize | 100 | 2.5.2 | Unprocessed maize [18] | 200 [20] | 2.5.3 | Cereals intended for direct human consumption, cereal flour, bran as end prod uct marketed for direct human consumption and germ, with the exception of foodstuffs list ed in 2.5.4, 2.5.7 and 2.5.8 | 75 | 2.5.4 | Maize intended for direct human consumption, maize flour, maize meal, maize grits, maize germ and refined maize oil [21] | 200 [20] | 2.5.5 | Bread (including small bakery wares), pastries, biscuits, cereal snacks and br eakfast cereals, excluding maize snacks and maize based breakfast cereals | 50 | 2.5.6 | Maize snacks and maize based breakfast cereals | 50 [20] | 2.5.7 | Processed cereal-based foods (excluding processed maize-based foods)and b aby foods for infants and young children [3] [7] | 20 | 2.5.8 | Processed maize-based foods for infants and young children [3] [7] | 20 [20] | 2.6 | Fumonisins | Sum of B1 and B2 | 2.6.1 | Unprocessed maize [18] | 2000 [23] | 2.6.2 | Maize flour, maize meal, maize grits, maize germ and refined maize oil [21] | 1000 [23] | 2.6.3 | Maize based foods for direct human consumption, excluding foods listed in 2. 6.2 and 2.6.4 | 400 [23] | 2.6.4 | Processed maize-based foods and baby foods for infants and young children [3] [7] | 200 [23] | 2.7 | T-2 and HT-2 toxin [17] | Sum of T-2 and HT-2 toxin | 2.7.1 | Unprocessed cereals [18] and cereal products | | Section 3: Metals Foodstuffs [1] | Maximum levels (mg/kg wet weight)| 3.1 | Lead | | 3.1.1 | Raw milk [6], heat-treated milk and milk for the manufacture of milk-based p roducts | 0,020 | 3.1.2 | Infant formulae and follow-on formulae [4] [8] | 0,020 | 3.1.3 | Meat (excluding offal)of bovine animals, sheep, pig and poultry [6] | 0,10 | 3.1.4 | Offal of bovine animals, sheep, pig and poultry [6] | 0,50 | 3.1.5 | Muscle meat of fish [24] [25] | 0,30 | 3.1.6 | Crustaceans, excluding brown meat of crab and excluding head and thorax me at of lobster and similar large crustaceans (Nephropidae and Palinuridae)[26] | 0,50 | 3.1.7 | Bivalve molluscs [26] | 1,5 | 3.1.8 | Cephalopods (without viscera)[26] | 1,0 | 3.1.9 | Cereals, legumes and pulses | 0,20 | 3.1.10 | Vegetables, excluding brassica vegetables, leaf vegetables, fresh herbs and fun gi [27]. For potatoes the maximum level applies to peeled potatoes | 0,10 | 3.1.11 | Brassica vegetables, leaf vegetables and cultivated fungi [27] | 0,30 | 3.1.12 | Fruit, excluding berries and small fruit [27] | 0,10 | 3.1.13 | Berries and small fruit [27] | 0,20 | 3.1.14 | Fats and oils, including milk fat | 0,10 | 3.1.15 | Fruit juices, concentrated fruit juices as reconstituted and fruit nectars [14] | 0,050 | 3.1.16 | Wine (including sparkling wine, excluding liqueur wine), cider, perry and f ruit wine [11] | 0,20 [28] | 3.1.17 | Aromatized wine, aromatized wine-based drinks and aromatized wine-product cocktails [13] | 0,20 [28] | 3.2 | Cadmium | | 3.2.1 | Meat (excluding offal)of bovine animals, sheep, pig and poultry [6] | 0,050 | 3.2.2 | Horsemeat, excluding offal [6] | 0,20 | 3.2.3 | Liver of bovine animals, sheep, pig, poultry and horse [6] | 0,50 | 3.2.4 | Kidney of bovine animals, sheep, pig, poultry and horse [6] | 1,0 | 3.2.5 | Muscle meat of fish [24] [25], excluding species listed in 3.2.6 and 3.2.7 | 0, 050 | 3.2.6 | Muscle meat of the following fish [24] [25]: anchovy (Engraulis species)bon ito (Sarda sarda)common two-banded seabream (Diplodus vulgaris)eel (Anguilla ang uilla)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 (D icologoglossa cuneata)| 0,10 | 3.2.7 | Muscle meat of swordfish (Xiphias gladius)[24] [25] | 0,30 | 3.2.8 | Crustaceans, excluding brown meat of crab and excluding head and thorax me at of lobster and similar large crustaceans (Nephropidae and Palinuridae)[26] | 0,50 | 3.2.9 | Bivalve molluscs [26] | 1,0 | 3.2.10 | Cephalopods (without viscera)[26] | 1,0 | 3.2.11 | Cereals excluding bran, germ, wheat and rice | 0,10 | 3.2.12 | Bran, germ, wheat and rice | 0,20 | 3.2.13 | Soybeans | 0,20 | 3.2.14 | Vegetables and fruit, excluding leaf vegetables, fresh herbs, fungi, stem veget ables, pine nuts, root vegetables and potatoes [27] | 0,050 | 3.2.15 | Leaf vegetables, fresh herbs, cultivated fungi and celeriac [27] | 0,20 | 3.2.16 | Stem vegetables, root vegetables and potatoes, excluding celeriac [27]. For po tatoes the maximum level applies to peeled potatoes | 0,10 | 3.3 | Mercury | | 3.3.1 | Fishery products [26] and muscle meat of fish [24] [25], excluding species list ed in 3.3.2. The maximum level applies to crustaceans, excluding the brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans (Nephropid ae and Palinuridae)| 0,50 | 3.3.2 | Muscle meat of the following fish [24] [25]: anglerfish (Lophius species)atl antic catfish (Anarhichas lupus)bonito (Sarda sarda)eel (Anguilla species)emperor, orange roughy, rosy soldierfish (Hoplostethus species)grenadier (Coryphaenoides rupestr is)halibut (Hippoglossus hippoglossus)marlin (Makaira species)megrim (Lepidorhom bus species)mullet (Mullus species)pike (Esox lucius)plain bonito (Orcynopsis unic olor)poor cod (Tricopterus minutes)portuguese dogfish (Centroscymnus coelolepis)ray s (Raja species)redfish (Sebastes marinus, S. mentella, S. viviparus)sail fish (Istioph orus platypterus)scabbard fish (Lepidopus caudatus, Aphanopus carbo)seabream, pandora (Pagellus species)shark (all species)snake mackerel or butterfish (Lepidocybium fla vobrunneum, Ruvettus pretiosus, Gempylus serpens)sturgeon (Acipenser species)swordfis h (Xiphias gladius)tuna (Thunnus species, Euthynnus species, Katsuwonus pelamis)| 1,0 | 3.4 | Tin (inorganic)| | 3.4.1 | Canned foods other than beverages | 200 | 3.4.2 | Canned beverages, including fruit juices and vegetable juices | 100 | 3.4.3 | Canned baby foods and processed cereal-based foods for infants and young ch ildren, excluding dried and powdered products [3] [29] | 50 | 3.4.4 | Canned infant formulae and follow-on formulae (including infant milk and fol low-on milk), excluding dried and powdered products [8] [29] | 50 | 3.4.5 | Canned dietary foods for special medical purposes [9] [29] intended specificall y for infants, excluding dried and powdered products | 50 | Section 4: 3-monochloropropane-1,2-diol (3-MCPD) Foodstuffs [1] | Maximum levels (μg/kg)| 4.1 | Hydrolysed vegetable protein [30] | 20 | 4.2 | Soy sauce [30] | 20 | Section 5: Dioxins and PCBs [31] Foodstuffs | Maximum levels | Sum of dioxins (WHO-PCDD/F-TEQ)[32] | Sum of dioxins and dioxin-like PCBs (WHO-PCDD/F-PCB-TEQ)[32] | 5.1 | Meat and meat products (excluding edible offal)of the following animals [6] | | | —bovine animals and sheep | 3,0 pg/g fat [33] | 4,5 pg/g fat [33] | —poultry | 2,0 pg/g fat [33] | 4,0 pg/g fat [33] | —pigs | 1,0 pg/g fat [33] | 1,5 pg/g fat [33] | 5.2 | Liver of terrestrial animals referred to in 5.1 [6], and derived products thereof | 6,0 pg/g fat [33] | 12,0 pg/g fat [33] | 5.3 | Muscle meat of fish and fishery products and products thereof, excluding eel [2 5] [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 an d Palinuridae)| 4,0 pg/g wet weight | 8,0 pg/g wet weight | 5.4 | Muscle meat of eel (Anguilla anguilla)and products thereof | 4,0 pg/g wet w eight | 12,0 pg/g wet weight | 5.5 | Raw milk [6] and dairy products [6], including butterfat | 3,0 pg/g fat [33] | 6, 0 pg/g fat [33] | 5.6 | Hen eggs and egg products [6] | 3,0 pg/g fat [33] | 6,0 pg/g fat [33] | 5.7 | Fat of the following animals: | | | —bovine animals and sheep | 3,0 pg/g fat | 4,5 pg/g fat | —poultry | 2,0 pg/g fat | 4,0 pg/g fat | —pigs | 1,0 pg/g fat | 1,5 pg/g fat | 5.8 | Mixed animal fats | 2,0 pg/g fat | 3,0 pg/g fat | 5.9 | Vegetable oils and fats | 0,75 pg/g fat | 1,5 pg/g fat | 5.10 | Marine oils (fish body oil, fish liver oil and oils of other marine organisms i ntended for human consumption)| 2,0 pg/g fat | 10,0 pg/g fat | Section 6: Polycyclic aromatic hydrocarbons Foodstuffs | Maximum levels (μg/kg wet weight)| 6.1 | Benzo(a)pyrene [35] | | 6.1.1 | Oils and fats (excluding cocoa butter)intended for direct human consumptio n or use as an ingredient in foods | 2,0 | 6.1.2 | Smoked meats and smoked meat products | 5,0 | 6.1.3 | Muscle meat of smoked fish and smoked fishery products [25] [36], excluding bivalve molluscs. The maximum level applies to smoked crustaceans, excluding the brow n meat of crab and excluding head and thorax meat of lobster and similar large crustacea ns (Nephropidae and Palinuridae)| 5,0 | 6.1.4 | Muscle meat of fish [24] [25], other than smoked fish | 2,0 | 6.1.5 | Crustaceans, cephalopods, other than smoked [26]. 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)| 5,0 | 6.1.6 | Bivalve molluscs [26] | 10,0 | 6.1.7 | Processed cereal-based foods and baby foods for infants and young children [3] [29] | 1,0 | 6.1.8 | Infant formulae and follow-on formulae, including infant milk and follow-on milk [8] [29] | 1,0 | 6.1.9 | Dietary foods for special medical purposes [9] [29] intended specifically for in fants | 1,0 | [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 Europ ean Parliament and of the Council of 23 February 2005 on maximum residue levels of pe sticides in or on food and feed of plant and animal origin and amending Council Directiv e 91/414/EEC (OJ L 70, 16.3.2005, p. 1)as last amended by Regulation (EC)No 1 78/2006 (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". [2] The maximum levels do not apply for fresh spinach to be subjected to processing and which is directly transported in bulk from field to processing plant. [3] Foodstuffs listed in this category 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, 14.2.2003, p. 33). [4] The maximum level refers to the products ready to use (marketed as such or aft er reconstitution as instructed by the manufacturer). [5] The maximum levels refer to the edible part of groundnuts and nuts. If groundnut s and nuts "in shell" are analysed, it is assumed when calculating the aflatoxin content all the contamination is on the edible part. [6] Foodstuffs listed in this category as defined in Regulation (EC)No 853/2004 o f the European Parliament and of the Council of 29 April 2004 layin g down specific hygi ene rules for food of animal origin (OJ L 226, 25.6.2004, p. 22). [7] The maximum level refers to the dry matter. The dry matter is determined in acc ordance with Regulation (EC)No 401/2006. [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). [9] Foodstuffs listed in this category as defined in Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29). [10] The maximum level refers in the case of milk and milk products, to the product s ready for use (marketed as such or reconstituted as instructed by the manufacturer)an d in the case of products other than milk and milk products, to the dry matter. The dry matter is determined in accordance with Regulation (EC)No 401/2006. [11] Foodstuffs listed in this category as defined in Council Regulation (EC)No 1 493/1999 of 17 May 1999 on the common organisation of the market in wine (OJ L 17 9, 14.7.1999, p. 1)as last amended by the Protocol concerning the conditions and arrang ements for admission of the Republic of Bulgaria and Romania to the European Union (OJ L 157, 21.6.2005, p. 29). [12] The maximum level applies to products produced from the 2005 harvest onward s. [13] Foodstuffs listed in this category as defined in Council Regulation (EEC)No 1601/91 of 10 June 1991 laying down general rules on the definition, description and pres entation of aromatised wines, aromatised wine-based drinks and aromatised wine-product c ocktails (OJ L 149, 14.6.1991, p. 1)as last amended by the Protocol concerning the co nditions and arrangements for admission of the Republic of Bulgaria and Romania to the European Union. The maximum level for OTA applicable to these beverages is function o f the proportion of wine and/or grape must present in the finished product. [14] Foodstuffs listed in this category as defined in Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for huma n consumption (OJ L 10, 12.1.2002, p. 58). [15] Foodstuffs listed in this category as defined in Council Regulation (EEC)No 1576/89 of 29 May 1989 laying down general rules on the definition, description and pres entation of spirit drinks (OJ L 160, 12.6.1989, p. 1), as last amended by the Protocol c oncerning the conditions and arrangements for admission of the Republic of Bulgaria and Romania to the European Union. [16] Infants and young children as defined in Directive 91/321/EEC and Directive 96/ 5/EC. [17] For the purpose of the application of maximum levels for deoxynivalenol, zearal enone, T-2 and HT-2 toxin established in points 2.4, 2.5 and 2.7 rice is not included in " cereals" and rice products are not included in "cereal products". [18] The maximum level applies to unprocessed cereals placed on the market for first -stage processing. "First-stage processing" shall mean any physical or thermal treatment, ot her than drying, of or on the grain. Cleaning, sorting and drying procedures are not consi dered to be "first-stage processing" insofar no physical action is exerted on the grain kern el itself and the whole grain remains intact after cleaning and sorting. In integrated produ ction and processing systems, the maximum level applies to the unprocessed cereals in cas e they are intended for first-stage processing. [19] The maximum level applies to cereals harvested and taken over, as from the 20 05/06 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 agenci es 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 1068/2005 (OJ L 174, 7. 7.2005, p. 65). [20] Maximum level shall apply from 1 July 2007. [21] This category includes also similar products otherwise denominated such as semo lina. [22] Pasta (dry)means pasta with a water content of approximately 12 %. [23] Maximum level shall apply from 1 October 2007. [24] Fish listed in this category as defined in category (a), with the exclusion of f ish liver falling under code CN 03027000, of the list in Article 1 of Council Regulation (EC)No 104/2000 (OJ L 17, 21.1.2000, p. 22)as last amended by the Act concerni ng the conditions of accession of the Czech Republic, the Republic of Estonia, the Republ ic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (O J L 236, 23.9.2003, p. 33). In case of dried, diluted, processed and/or compound foodstuf fs Article 2(1)and 2(2)apply. [25] Where fish are intended to be eaten whole, the maximum level shall apply to th e whole fish. [26] Foodstuffs falling within category (c)and (f)of the list in Article 1 of Re gulation (EC)No 104/2000, as appropriate (species as listed in the relevant entry). I n case of dried, diluted, processed and/or compound foodstuffs Article 2(1)and 2(2) apply. [27] The maximum level applies after washing of the fruit or vegetables and separati ng the edible part. [28] The maximum level applies to products produced from the 2001 fruit harvest on wards. [29] The maximum level refers to the product as sold. [30] The maximum level is given for the liquid product containing 40 % dry matter, corresponding to a maximum level of 50 μg/kg in the dry matter. The level needs to be adjusted proportionally according to the dry matter content of the products. [31] Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs)and polychlori nated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO)toxic equivalent using the WHO-toxic equivalency factors (WHO-TEFs))and sum of dioxins and dioxin-like PCBs (sum of PCDDs, PCDFs and polychlorinated biphenyls (PCBs), expressed as WHO toxic equivalent using the WHO-TEFs). WHO-TEFs for human risk a ssessment based on the conclusions of the WHO meeting in Stockholm, Sweden, 15 to 18 June 1997 (Van den Berg et al., (1998)Toxic Equivalency Factors (TEFs)for PC Bs, PCDDs, PCDFs for Humans and for Wildlife. Environmental Health Perspectives, 106 (12), 775).Abbreviations used: ‘T’ = tetra; ‘Pe’ = penta; ‘Hx’ = hexa; ‘Hp’ = hepta; ‘O’= octa; ‘CDD’ = chlorodibenzodioxin;‘CDF’ = chlorodibenzofuran; ‘CB’ = chlorobipheny l. [32] Upperbound concentrations: Upperbound concentrations are calculated on the assu mption that all the values of the different congeners below the limit of quantification are equal to the limit of quantification. [33] The maximum level is not applicable for foods containing < 1 % fat. [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 excl usion of fish liver falling under code CN 03027000. [35] Benzo(a)pyrene, for which maximum levels are listed, is used as a marker for the occurrence and effect of carcinogenic polycyclic aromatic hydrocarbons. These measure s therefore provide full harmonisation on polycyclic aromatic hydrocarbons in the listed fo ods across the Member States. [36] Foodstuffs listed in this category as defined in categories (b), (c), and (f) of the list in Article 1 of Regulation (EC)No 104/2000.