Commission Regulation (EC) No 1881/2006

of 19 December 2006

setting maximum levels for certain contaminants in foodstuffs

(Text with EEA relevance)

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 food1, and in particular Article 2(3) thereof,

Whereas:

(1)
Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs2 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.
(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 risk 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 considered to be genotoxic carcinogens or in cases where current exposure of the population or of vulnerable groups in the population is close to or exceeds the tolerable intake, maximum levels should be set at a level which is as low as reasonably achievable (ALARA). Such approaches ensure that food business operators apply measures to prevent and reduce the contamination as far as possible in order to protect public health. It is furthermore 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 of the raw materials used for the manufacturing of foods for infants and young children. This strict selection of the raw materials is also appropriate for the production of some specific foodstuffs such as bran for direct human consumption.

(5)

To allow maximum levels to be applied to dried, diluted, processed and compound foodstuffs, where no specific Community maximum levels have been established, food business operators should provide the specific concentration and dilution factors accompanied by the appropriate experimental data justifying the factor proposed.

(6)

To ensure an efficient protection of public health, products containing contaminants exceeding the maximum levels should not be placed on the market either as such, after 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 reduce 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 ingredient 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 aflatoxin 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 contaminants in certain foodstuffs, it is appropriate to provide for suitable labelling provisions for these cases.

(9)

Because of the climatic conditions in some Member States, it is difficult to ensure 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 marketing of fresh lettuce and fresh spinach grown and intended for consumption in their territory with nitrate contents exceeding the maximum levels. Lettuce and spinach producers established in the Member States which have given the aforementioned authorisations should progressively modify their farming methods by applying the good agricultural practices recommended 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 negative 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 on consumption of fish from the Baltic region by identified vulnerable groups of the population in order to avoid potential health risks. Therefore, it is appropriate to grant a derogation to Finland and Sweden to place on the market for a temporary period certain fish species originating in the Baltic region and intended for consumption in their territory with levels of dioxins and dioxin-like PCBs higher than those set in this Regulation. The necessary measures must be implemented to ensure that fish and fish products not complying with the maximum levels are not marketed in other Member States. Finland and Sweden report 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 exposure 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 competent authorities throughout the Community. It is furthermore important that analytical results 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 interpretation.

(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 to 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 therefore 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 the Community accepted. It is therefore appropriate to modify the current provision for lead 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 origin3 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.
(18)

It is necessary to provide that the maximum levels for contaminants do not apply 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 nitrate. The Scientific Committee on Food (SCF) stated in its opinion of 22 September 19954 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.
(20)

Since climatic conditions have a major influence on the levels of nitrate in certain vegetables such as lettuce and spinach, different maximum nitrate levels should therefore be fixed depending on the season.

(21)
As regards aflatoxins, the SCF expressed in its opinion of 23 September 1994 that aflatoxins are genotoxic carcinogens5. 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.
(22)
As regards ochratoxin A (OTA), the SCF adopted a scientific opinion on 17 September 19986. An assessment of the dietary intake of OTA by the population of the Community has been performed7 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 food8 (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 20069, taking into account new scientific information and derived a tolerable weekly intake (TWI) of 120 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 and 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 as 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 the recent EFSA scientific opinion.

(25)
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 patulin10.
(26)
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 performed11.
(27)
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 beverages12.
(28)
As regards Fusarium toxins, the SCF has adopted several opinions evaluating deoxynivalenol in December 199913 establishing a tolerable daily intake (TDI) of 1 μg/kg bw, zearalenone in June 200014 establishing a temporary TDI of 0,2 μg/kg bw, fumonisins in October 200015 (updated in April 2003)16 establishing a TDI of 2 μg/kg bw, nivalenol in October 200017 establishing a temporary TDI of 0,7 μg/kg bw, T-2 and HT-2 toxin in May 200118 establishing a combined temporary TDI of 0,06 μg/kg bw and the trichothecenes as group in February 200219.
(29)
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 200320.
(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 regards 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 products can enter the food chain.

(31)

Intake estimates indicate that the presence of T-2 and HT-2 toxin can be of concern for public health. Therefore, the development of a reliable and sensitive method, collection 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-acetyl deoxynivalenol, 15-acetyl deoxynivalenol and fumonisin B3, as measures with regard to in particular deoxynivalenol and fumonisin B1 and B2 would also protect the human population from an unacceptable exposure from 3-acetyl deoxynivalenol, 15-acetyl deoxynivalenol and fumonisin B3. The same applies to nivalenol for which to a certain degree co-occurrence with deoxynivalenol can be observed. Furthermore, human exposure to nivalenol is estimated to be significantly below the t-TDI. As regards other trichothecenes considered in the abovementioned SCOOP-task, such as 3-acetyldeoxynivalenol, 15-acetyldeoxynivalenol, fusarenon-X, T2-triol, diacetoxyscirpenol, neosolaniol, monoacetoxyscirpenol and verrucol, 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 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 products21 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.
(34)

Maximum levels of Fusarium toxins should be set for unprocessed cereals placed on the market for first-stage processing. Cleaning, sorting and drying procedures are not 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 consumer cereal products as well as for major food ingredients derived from cereals to have enforceable legislation in the interest of ensuring public health protection.

(36)

For maize, not all factors involved in the formation of Fusarium toxins, in particular 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 investigations on the sources of the formation of these mycotoxins and on the identification of the management measures to be taken to prevent their presence as far as reasonably possible. Maximum levels based on currently available occurrence data are proposed to apply from 2007 in case no specific maximum levels based on new information on occurrence and formation are set before that time.

(37)

Given the low contamination levels of Fusarium toxins found in rice, no maximum levels are proposed for rice or rice products.

(38)

A review of the maximum levels for deoxynivalenol, zearalenone, fumonisin B1 and B2 as well as the appropriateness of setting a maximum level for T-2 and HT-2 toxin in cereals and cereal products should be considered by 1 July 2008, taking into account the progress in scientific and technological knowledge on these toxins in food.

(39)
As regards lead, the SCF adopted an opinion on 19 June 199222 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.
(40)
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 200423. 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 199524 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.
(42)
As regards mercury EFSA adopted on 24 February 2004 an opinion related to mercury and methylmercury in food25 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.
(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 responding to this need has therefore been made available on the website of the Health and Consumer Protection Directorate-General of the European Commission26. Several Member States 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 200127 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 available on the sensitivity of infants and young children to inorganic tin in foods, it is necessary 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 food28, updating its opinion of 16 December 199429 on the basis of new scientific information and established a tolerable daily intake (TDI) of 2 μg/kg bw for 3-MCPD.
(47)
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 200430. 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 vegetable 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 occurrence of 3-MCPD in order to consider the need to set maximum levels for additional foodstuffs.

(49)
As regards dioxins and PCBs, the SCF adopted on 30 May 2001 an opinion on dioxins and dioxin-like PCBs in food31, updating its opinion of 22 November 200032 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) congeners, 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 their 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-like toxicity but have a different toxicological profile.

(51)

Each congener of dioxins or dioxin-like PCBs exhibits a different level of toxicity. 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 dioxin and dioxin-like PCB congeners of toxicological concern are expressed in terms of a quantifiable unit, namely the TCDD toxic equivalent (TEQ).

(52)
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 200033 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 for 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 dioxins 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 period with the maximum levels for dioxins and with the maximum levels for the sum of dioxins and dioxin-like PCBs. Consideration will be given by 31 December 2008 to dispensing 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 Recommendation 2006/88/EC of 6 February 2006 on the reduction of the presence of dioxins, furans and PCBs in feedingstuffs and foodstuffs34. 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.
(55)

Operators need to make efforts to step up their capacity to remove dioxins, furans and dioxin-like PCBs from marine oil. The significant lower level, to which consideration shall be given by 31 December 2008, shall be based on the technical possibilities of the most effective decontamination procedure.

(56)

As regards the establishment of maximum levels for other foodstuffs by 31 December 2008, particular attention shall be paid to the need to set specific lower maximum 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 monitoring 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 200235 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 carcinogenic36.
(58)

According to the SCF, benzo(a)pyrene can be used as a marker for the occurrence and effect of carcinogenic PAH in food, including also benz(a)anthracene, benzo(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 recommendation 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 addition, environmental pollution may cause contamination with PAH, in particular in fish and fishery products.

(60)
In the framework of Directive 93/5/EEC, a specific SCOOP-task ‘Collection of occurrence data on PAH in food’ has been performed in 200437. High levels were found 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 processes might cause high levels of contamination. Maximum levels are also necessary in foods where environmental pollution may cause high levels of contamination, in particular in 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 has been found, but available data are inconclusive on what levels are reasonably achievable. Further investigation is needed to clarify the levels that are reasonably achievable in these 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 the progress in scientific and technological knowledge on the occurrence of benzo(a)pyrene and other carcinogenic PAH in food.

(64)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1General rules

1.

The foodstuffs listed in the Annex shall not be placed on the market where they contain 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 foodstuffs concerned, unless otherwise specified in the Annex.

Article 2Dried, 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 processes;

(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 and/or mixing operations concerned or for the dried, diluted, processed and/or compound foodstuffs 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 justification 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 levels 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 3Prohibitions 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 contamination 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.

F1Article 4Specific provisions for groundnut, other oilseeds, tree nuts, dried fruit, rice and maize

Groundnuts (peanuts), other oilseeds, tree nuts, dried fruit, rice and maize not complying with the appropriate maximum levels of aflatoxins laid down in points 2.1.5, 2.1.6, 2.1.7, 2.1.8, 2.1.10 and 2.1.11 of the Annex can be placed on the market provided that these foodstuffs:

  1. (a)

    are not intended for direct human consumption or use as an ingredient in foodstuffs;

  2. (b)

    comply with the appropriate maximum levels laid down in points 2.1.1, 2.1.2, 2.1.3, 2.1.4, 2.1.9 and 2.1.12 of the Annex;

  3. (c)

    are subjected to a treatment involving sorting or other physical treatment and that after this treatment the maximum levels laid down in points 2.1.5, 2.1.6, 2.1.7, 2.1.8, 2.1.10 and 2.1.11 of the Annex are not exceeded, and this treatment does not result in other harmful residues;

  4. (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 included on the label of each individual bag, box etc. and 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.

F1Article 5Specific provisions for groundnuts (peanuts), other oilseeds, derived products thereof and cereals

A clear indication of the intended use must appear on the label of each individual bag, box, etc. and 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 2.1.5 and 2.1.11 of the Annex shall apply to all groundnuts (peanuts), other oilseeds and derived products thereof and cereals placed on the market.

As regards the exception of groundnuts (peanuts) and other oilseeds for crushing and the application of the maximum levels laid down in point 2.1.1 of the Annex, the exception only applies to consignments which are clearly labelled showing their use and bearing the indication ‘ product to be subject to crushing for the production of refined vegetable oil ’ . The indication shall be included on the label of each individual bag, box etc. and on the accompanying document(s). The final destination must be a crushing plant.

Article 6Specific 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 apply.

Article 7F2Derogations

F31.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F32.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F33.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F24.

By way of derogation from Article 1, Finland, Sweden and Latvia may authorise the placing on their market of wild caught salmon ( Salmo salar ) and products thereof originating in the Baltic region and intended for consumption in their territory with levels of dioxins and/or dioxin-like PCBs and/or non-dioxin-like PCBs higher than those set out in point 5.3 of the Annex, provided that a system is in place to ensure that consumers are fully informed of the dietary recommendations with regard to the restrictions on the consumption of wild caught salmon from the Baltic region and products thereof by identified vulnerable sections of the population in order to avoid potential health risks.

Finland, Sweden and Latvia shall continue to apply the necessary measures to ensure that wild caught salmon and products thereof not complying with point 5.3 of the Annex are not marketed in other Member States.

Finland, Sweden and Latvia will report yearly to the Commission the measures they have taken to effectively inform the identified vulnerable sections of the population of the dietary recommendations and to ensure that wild caught salmon and products thereof not compliant with the maximum levels is not marketed in other Member States. They shall furthermore provide evidence of the effectiveness of these measures.

F45.

By way of derogation from Article 1, Finland and Sweden may authorise the placing on their market of wild caught herring larger than 17 cm ( Clupea harengus ), wild caught char ( Salvelinus spp.), wild caught river lamprey ( Lampetra fluviatilis ) and wild caught trout ( Salmo trutta ) and products thereof originating in the Baltic region and intended for consumption in their territory with levels of dioxins and/or dioxin-like PCBs and/or non dioxin-like PCBs higher than those set out in point 5.3 of the Annex, provided that a system is in place to ensure that consumers are fully informed of the dietary recommendations with regard to the restrictions on the consumption of wild caught herring larger than 17 cm, wild caught char, wild caught river lamprey and wild caught trout from the Baltic region and products thereof by identified vulnerable sections of the population in order to avoid potential health risks.

Finland and Sweden shall continue to apply the necessary measures to ensure that wild caught herring larger than 17 cm, wild caught char, wild caught river lamprey and wild caught trout and products thereof not complying with point 5.3 of the Annex are not marketed in other Member States.

Finland and Sweden will report yearly to the Commission the measures they have taken to effectively inform the identified vulnerable sections of the population of the dietary recommendations and to ensure that fish and products thereof not compliant with the maximum levels is not marketed in other Member States. They shall furthermore provide evidence of the effectiveness of these measures.

F56.

By way of derogation from Article 1, Ireland, Spain, Croatia, Cyprus, Latvia, Poland, Portugal, Romania, Slovak Republic, Finland, Sweden and the United Kingdom may authorise the placing on their market of traditionally smoked meat and smoked meat products, smoked in their territory and intended for consumption in their territory with levels of PAHs higher than those set out in point 6.1.4. of the Annex, provided that those products comply with the maximum levels applicable before 1 September 2014 , i.e. 5,0 μg/kg for benzo(a)pyrene and 30,0 μg/kg for the sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene.

Those Member States shall continue to monitor the presence of PAHs in traditionally smoked meat and smoked meat products and shall establish programmes to implement good smoking practices where possible, within the limits of what is economically feasible and what is possible without losing typical organoleptic characteristics of those products.

Within 3 years from the application of the Regulation, the situation shall be re-assessed, on the basis of all available information, in view of determining a list of smoked meat and smoked meat products for which the derogation for local production and consumption shall be continued without a time limit.

7.

By way of derogation from Article 1, Ireland, Latvia, Romania, Finland, Sweden and the United Kingdom may authorise the placing on their market of traditionally smoked fish and smoked fishery products, smoked in their territory and intended for consumption in their territory with levels of PAHs higher than those set out in point 6.1.5. of the Annex, provided that those smoked products comply with the maximum levels applicable before 1 September 2014 , i.e. 5,0 μg/kg for benzo(a)pyrene and 30,0 μg/kg for the sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene.

These Member States shall continue to monitor the presence of PAHs in traditionally smoked fish and smoked fishery products and shall establish programmes to implement good smoking practices where possible, within the limits of what is economically feasible and what is possible without losing typical organoleptic characteristics of those products.

Within 3 years from the application of this Regulation, the situation shall be re-assessed, on the basis of all available information, in view of determining a list of smoked fish and smoked fishery products for which the derogation for local production and consumption shall be continued without a time limit.

Article 8Sampling and analysis

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 1882/200638, No 401/200639, No 1883/200640 and Commission Directives 2001/22/EC41, 2004/16/EC42 and 2005/10/EC43.

F6Article 9Monitoring and reporting

1.

Member States shall monitor nitrate levels in vegetables which may contain significant levels, in particular green leafy vegetables, and communicate the results to EFSA on a regular basis.

2.

Member States shall communicate to the Commission a summary of the findings on aflatoxins obtained in accordance with Commission Implementing Regulation (EU) No 884/2014 44 and the individual occurrence data shall be reported to EFSA by the Member States.

3.

Member States and professional stakeholder organisations shall communicate each year to the Commission the results of investigations undertaken and the progress with regard to the application of prevention measures to avoid contamination by deoxynivalenol, zearalenone, fumonisin B 1 and B 2, T-2 and HT-2 toxin. The Commission shall make the results available to the Member States. The related occurrence data shall be reported to EFSA.

4.

Member States and professional stakeholder organisations are strongly recommended to monitor the presence of ergot alkaloids in cereals and cereal products.

Member States and professional stakeholder organisations are strongly recommended to report to EFSA their findings on ergot alkaloids by 30 September 2016 . Those findings shall include occurrence data and specific information on the relationship between the presence of ergot sclerotia and the level of individual ergot alkaloids.

The Commission shall make those findings available to the Member States.

5.

Occurrence data on other contaminants than those referred to in paragraphs 1 to 4 collected by Member States and professional stakeholder organisations may be reported to EFSA.

6.

Occurrence data shall be provided to EFSA in the EFSA data submission format in accordance with the requirements of EFSA's Guidance on Standard Sample Description (SSD) for Food and Feed 45 and the additional EFSA's specific reporting requirements for specific contaminants. The occurrence data from professional stakeholder organisations may be provided to EFSA, if appropriate, in a simplified data submission format, defined by EFSA.

Article 10Repeal

Regulation (EC) No 466/2001 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation.

Article 11Transitional measures

F7This Regulation shall not apply to products that were placed on the market before the dates referred to in points (a) to (f) in conformity with the provisions applicable at the respective date:

  1. (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 the Annex;

  2. (b)

    F81 October 2007 as regards the maximum levels for deoxynivalenol and zearalenone laid down in points 2.4.3, 2.4.8, 2.4.9, 2.5.2, 2.5.4, 2.5.6, 2.5.8, 2.5.9 and 2.5.10 of the Annex;

  3. (c)

    1 October 2007 as regards the maximum levels for fumonisins B1 and B2 laid down in point 2.6 of the Annex;

  4. (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 AnnexF7;

  5. (e)

    F901 January 2012 as regards the maximum levels for non dioxin-like PCBs laid down in section 5 of the Annex;

  6. (f)

    01 January 2015 as regards the maximum level for Ochratoxin A in Capsicum spp. laid down in point 2.2.11. of the Annex.

The burden of proving when the products were placed on the market shall be borne by the food business operator.

Article 12Entry 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.

ANNEX

Maximum levels for certain contaminants in foodstuffs54

F10Section 1: Nitrate

Foodstuffs54

Maximum levels (mg NO 3 /kg)

1.1

Fresh spinach ( Spinacia oleracea )55

3 500

1.2

Preserved, deep-frozen or frozen spinach

2 000

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:

lettuce grown under cover

5 000

lettuce grown in the open air

4 000

Harvested 1 April to 30 September:

lettuce grown under cover

4 000

lettuce grown in the open air

3 000

1.4

‘Iceberg’ type lettuce

Lettuce grown under cover

2 500

Lettuce grown in the open air

2 000

F101.5

Rucola ( Eruca sativa , Diplotaxis sp., Brassica tenuifolia , Sisymbrium tenuifolium )

Harvested 1 October to 31 March:

7 000

Harvested 1 April to 30 September:

6 000

F101.6

Processed cereal-based foods and baby foods for infants and young children5657

200

55

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.

56

F17Foodstuffs listed in this category as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 ( OJ L 181, 29.6.2013, p. 35 ).

57

The maximum level refers to the products ready to use (marketed as such or after reconstitution as instructed by the manufacturer).

Section 2:Mycotoxins

Foodstuffs54

Maximum levels (μg/kg)

F12.1.

Aflatoxins

B 1

Sum of B 1 , B 2 , G 1 and G 2

M 1

2.1.1.

Groundnuts (peanuts) and other oilseeds 93 , to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs,

with the exception of:

  • groundnuts (peanuts) and other oilseeds for crushing for refined vegetable oil production

8,058

15,058

—

2.1.2.

Almonds, pistachios and apricot kernels to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs

12,058

15,058

—

2.1.3.

Hazelnuts and Brazil nuts, to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs

8,058

15,058

2.1.4.

Tree nuts, other than the tree nuts listed in 2.1.2 and 2.1.3, to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs

5,058

10,058

—

2.1.5.

Groundnuts (peanuts) and other oilseeds 93 and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs,

with the exception of:

  • crude vegetable oils destined for refining

  • refined vegetable oils

2,058

4,058

—

2.1.6.

Almonds, pistachios and apricot kernels, intended for direct human consumption or use as an ingredient in foodstuffs94

8,058

10,058

—

2.1.7.

Hazelnuts and Brazil nuts, intended for direct human consumption or use as an ingredient in foodstuffs94

5,058

10,058

2.1.8.

Tree nuts, other than the tree nuts listed in 2.1.6 and 2.1.7, and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs

2,058

4,058

—

F112.1.9.

Dried fruit, other than dried figs, to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs

5,0

10,0

—

2.1.10.

Dried fruit, other than dried figs, and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs

2,0

4,0

—

2.1.11.

All cereals and all products derived from cereals, including processed cereal products, with the exception of foodstuffs listed in 2.1.12, 2.1.15 and 2.1.17

2,0

4,0

—

2.1.12.

Maize and rice to be subjected to sorting or other physical treatment before human consumption or use as an ingredient in foodstuffs

5,0

10,0

—

2.1.13.

Raw milk59, heat-treated milk and milk for the manufacture of milk-based products

—

—

0,05

2.1.14.

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)

Mixtures of spices containing one or more of the abovementioned spices

5,0

10,0

—

2.1.15.

Processed cereal-based foods and baby foods for infants and young children5660

0,1

—

—

2.1.16.

Infant formulae and follow-on formulae, including infant milk and follow-on milk5756

—

—

0,025

2.1.17.

Dietary foods for special medical purposes5663 intended specifically for infants

0,1

—

0,025

F122.1.18.

Dried figs

6,0

10,0

—

2.2

Ochratoxin A

2.2.1

Unprocessed cereals

5,0

F72.2.2.

All products derived from unprocessed cereals, including processed cereal products and cereals intended for direct human consumption with the exception of foodstuffs listed in 2.2.9, 2.2.10 and 2.2.13

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 alcoholic strength of not less than 15 % vol) and fruit wine64
2,065

2.2.7

Aromatised wine, aromatised wine-based drinks and aromatised wine-product cocktails66

2,065

2.2.8

Grape juice, concentrated grape juice as reconstituted, grape nectar, grape must and concentrated grape must as reconstituted, intended for direct human consumption67

2,065

2.2.9

Processed cereal-based foods and baby foods for infants and young children5660

0,5

2.2.10

Dietary foods for special medical purposes5663 intended specifically for infants

0,5

F132.2.11.

Spices, including dried spices

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

Myristica fragrans (nutmeg)

Zingiber officinale (ginger)

Curcuma longa (turmeric)

15 μg/kg

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

20 μg/kg

Mixtures of spices containing one of the abovementioned spices

15 μg/kg

F142.2.12.

Liquorice ( Glycyrrhiza glabra, Glycyrrhiza inflate and other species)

2.2.12.1.

Liquorice root, ingredient for herbal infusion

20 μg/kg

2.2.12.2.

Liquorice extract95, for use in food in particular beverages and confectionary

80 μg/kg

F92.2.13.

Wheat gluten not sold directly to the consumer

8,0

2.3

Patulin

2.3.1

Fruit juices, concentrated fruit juices as reconstituted and fruit nectars67

50

2.3.2

Spirit drinks68, cider and other fermented drinks derived from apples or containing 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 children69 and labelled and sold as such57

10,0

2.3.5

Baby foods other than processed cereal-based foods for infants and young children5657

10,0

F82.4

Deoxynivalenol 70

2.4.1

Unprocessed cereals7172 other than durum wheat, oats and maize

1 250

2.4.2

Unprocessed durum wheat and oats7172

1 750

2.4.3

Unprocessed maize71, with the exception of unprocessed maize intended to be processed by wet milling90
1 75073

2.4.4

Cereals intended for direct human consumption, cereal flour, bran and germ as end product marketed for direct human consumption, with the exception of foodstuffs listed in 2.4.7, 2.4.8 and 2.4.9

750

2.4.5

Pasta (dry)75

750

2.4.6

Bread (including small bakery wares), pastries, biscuits, cereal snacks and breakfast cereals

500

2.4.7

Processed cereal-based foods and baby foods for infants and young children5660

200

2.4.8

Milling fractions of maize with particle size > 500 micron falling within CN code 1103 13 or 1103 20 40 and other maize milling products with particle size > 500 micron not used for direct human consumption falling within CN code 1904 10 10

75073

2.4.9

Milling fractions of maize with particle size ≤ 500 micron falling within CN code 1102 20 and other maize milling products with particle size ≤ 500 micron not used for direct human consumption falling within CN code 1904 10 10

1 25073

2.5

Zearalenone 70

2.5.1

Unprocessed cereals7172 other than maize

100

2.5.2

Unprocessed maize71 with the exception of unprocessed maize intended to be processed by wet milling90

35073

2.5.3

Cereals intended for direct human consumption, cereal flour, bran and germ as end product marketed for direct human consumption, with the exception of foodstuffs listed in 2.5.6, 2.5.7, 2.5.8, 2.5.9 and 2.5.10

75

2.5.4

Refined maize oil

40073

2.5.5

Bread (including small bakery wares), pastries, biscuits, cereal snacks and breakfast cereals, excluding maize-snacks and maize-based breakfast cereals

50

2.5.6

Maize intended for direct human consumption, maize-based snacks and maize-based breakfast cereals

10073

2.5.7

Processed cereal-based foods (excluding processed maize-based foods) and baby foods for infants and young children5660

20

2.5.8

Processed maize-based foods for infants and young children5660

2073

2.5.9

Milling fractions of maize with particle size > 500 micron falling within CN code 1103 13 or 1103 20 40 and other maize milling products with particle size > 500 micron not used for direct human consumption falling within CN code 1904 10 10

20073

2.5.10

Milling fractions of maize with particle size ≤ 500 micron falling within CN code 1102 20 and other maize milling products with particle size ≤ 500 micron not used for direct human consumption falling within CN code 1904 10 10

30073

2.6

Fumonisins

Sum of B 1 and B 2

2.6.1

Unprocessed maize71, with the exception of unprocessed maize intended to be processed by wet milling90

4 00076

2.6.2

Maize intended for direct human consumption, maize-based foods for direct human consumption, with the exception of foodstuffs listed in 2.6.3 and 2.6.4

1 00076

2.6.3

Maize-based breakfast cereals and maize-based snacks

80076

2.6.4

Processed maize-based foods and baby foods for infants and young children5660

20076

2.6.5

Milling fractions of maize with particle size > 500 micron falling within CN code 1103 13 or 1103 20 40 and other maize milling products with particle size > 500 micron not used for direct human consumption falling within CN code 1904 10 10

1 40076

2.6.6

Milling fractions of maize with particle size ≤ 500 micron falling within CN code 1102 20 and other maize milling products with particle size ≤ 500 micron not used for direct human consumption falling within CN code 1904 10 10

2 00076

2.7

T-2 and HT-2 toxin70

Sum of T-2 and HT-2 toxin

2.7.1

Unprocessed cereals71 and cereal products

F152.8

Citrinin

2.8.1

Food supplements based on rice fermented with red yeast Monascus purpureus

2 00046

F162.9

Ergot sclerotia and ergot alkaloids

2.9.1.

Ergot sclerotia

2.9.1.1.

Unprocessed cereals71 with the exception of corn and rice

0,5 g/kg48

2.9.2.

Ergot alkaloids49

2.9.2.1.

Unprocessed cereals71 with the exception of corn and rice

—50

2.9.2.2.

Cereal milling products excluding corn and rice milling products

—50

2.9.2.3.

Bread (including small bakery wares), pastries, biscuits, cereal snacks, breakfast cereals and pasta

—50

2.9.2.4.

Cereal-based food for infants and young children

—50

93

F38Oilseeds falling under codes CN 1201 , 1202 , 1203 , 1204 , 1205 , 1206 , 1207 and derived products CN 1208 ; melon seeds fall under code ex 1207 99 .

58

F1The maximum levels refer to the edible part of groundnuts (peanuts) and tree nuts. If groundnuts (peanuts) and tree nuts ‘in shell’ are analysed, it is assumed when calculating the aflatoxin content all the contamination is on the edible part, except in the case of Brazil nuts.

94

In case derived/processed products thereof are derived/processed solely or almost solely from the tree nuts concerned, the maximum levels as established for the corresponding tree nuts apply also to the derived/processed products. In other cases, Article 2(1) and 2(2) apply for the derived/processed products.

59

Foodstuffs listed in this category as defined in Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 226, 25.6.2004, p. 22).

60

The maximum level refers to the dry matter. The dry matter is determined in accordance with Regulation (EC) No 401/2006.

63

The maximum level refers in the case of milk and milk products, to the products ready for use (marketed as such or reconstituted as instructed by the manufacturer) and 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.

64

F17Wine and sparkling wines as defined in Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( OJ L 347, 20.12.2013, p. 671 ).

65

The maximum level applies to products produced from the 2005 harvest onwards.

66

F17Foodstuffs listed in this category as defined in Regulation (EU) No 251/2014 of the European Parliament and of the Council of 26 February 2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products and repealing Council Regulation (EEC) No 1601/91 ( OJ L 84, 20.3.2014, p. 14 ).

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.

67

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 human consumption (OJ L 10, 12.1.2002, p. 58).

95

F39The maximum level applies to the pure and undiluted extract, obtained whereby 1 kg of extract is obtained from 3 to 4 kg liquorice root.

68

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 presentation of spirit drinks (OJ L 160, 12.6.1989, p. 1), as last amended by the Protocol concerning the conditions and arrangements for admission of the Republic of Bulgaria and Romania to the European Union.

69

F17Infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 ( OJ L 181, 29.6.2013, p. 35 ).

70

For the purpose of the application of maximum levels for deoxynivalenol, zearalenone, 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’.

71

F6The maximum level applies to unprocessed cereals placed on the market for first-stage processing.

‘ First-stage processing ’ means any physical or thermal treatment, other than drying, of or on the grain. Cleaning, including scouring, sorting and drying procedures are not considered to be ‘ first-stage processing ’ in so far as the whole grain remains intact after cleaning and sorting.

Scouring is cleaning cereals by brushing and/or scrubbing it vigorously.

In case scouring is applied in the presence of ergot sclerotia, the cereals need to undergo a first cleaning step before scouring. The scouring, performed in combination with a dust aspirator, is followed by a colour sorting before milling.

Integrated production and processing systems means systems whereby all incoming lots of cereals are cleaned, sorted and processed in the same establishment. In such integrated production and processing systems, the maximum level applies to the unprocessed cereals after cleaning and sorting but before first-stage processing.

Food business operators shall ensure compliance through their HACCP procedure whereby an effective monitoring procedure is established and implemented at this critical control point.

72

The maximum level applies to cereals harvested and taken over, as from the 2005/06 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 agencies and laying down methods of analysis for determining the quality of cereals (OJ L 100, 20.4.2000, p. 31), as last amended by Regulation (EC) No 1068/2005 (OJ L 174, 7.7.2005, p. 65).

90

F36The exemption applies only for maize for which it is evident e.g. through labelling, destination, that it is intended for use in a wet milling process only (starch production).

73

F8Maximum level shall apply from 1 October 2007 .

75

Pasta (dry) means pasta with a water content of approximately 12 %.

76

Maximum level shall apply from 1 October 2007.

46

F15The maximum level is to be reviewed before 1 January 2016 in the light of information on exposure to citrinin from other foodstuffs and updated information on the toxicity of citrinin in particular as regards carcinogenicity and genotoxicity.

48

F16The sampling shall be performed in accordance with point B of Annex I to Commission Regulation (EC) No 401/2006 ( OJ L 70, 9.3.2006, p. 12 ).

The analysis shall be performed by microscopic examination.

49

Sum of 12 ergot alkaloids: ergocristine/ergocristinine; ergotamine/ergotaminine; ergocryptine/ergocryptinine; ergometrine/ergometrinine; ergosine/ergosinine; ergocornine/ergocorninine.

50

Appropriate and achievable maximum levels, providing a high level of human health protection, shall be considered for these relevant food categories before 1 July 2017 .

Section 3:Metals

Foodstuffs54

Maximum levels(mg/kg wet weight)

F173.1

Lead

3.1.1

Raw milk59, heat-treated milk and milk for the manufacture of milk-based products

0,020

3.1.2

Infant formulae and follow-on formulae

marketed as powder5682

0,050

marketed as liquid5682

0,010

3.1.3

Processed cereal-based foods and baby foods for infants and young children5682 other than 3.1.5

0,050

3.1.4

Foods for special medical purposes56 intended specifically for infants and young children

marketed as powder82

0,050

marketed as liquid82

0,010

3.1.5

Drinks for infants and young children labelled and sold as such, other than those mentioned in 3.1.2 and 3.1.4

marketed as liquids or to be reconstituted following instructions of the manufacturer including fruit juices57

0,030

to be prepared by infusion or decoction82

1,50

3.1.6

Meat (excluding offal) of bovine animals, sheep, pig and poultry59

0,10

3.1.7

Offal of bovine animals, sheep, pig and poultry59

0,50

3.1.8

Muscle meat of fish7778

0,30

3.1.9

Cephalopods105

0,30

3.1.10

Crustaceans7997

0,50

3.1.11

Bivalve molluscs79

1,50

3.1.12

Cereals and pulses

0,20

3.1.13

Vegetables excluding leafy brassica, salsify, leaf vegetables & fresh herbs, fungi, seaweed and fruiting vegetables80106

0,10

3.1.14

Leafy brassica, salsify, leaf vegetables excluding fresh herbs and the following fungi Agaricus bisporus (common mushroom), Pleurotus ostreatus (Oyster mushroom), Lentinula edodes (Shiitake mushroom)80

0,30

3.1.15

Fruiting vegetables

sweetcorn80

0,10

other than sweetcorn80

0,05

3.1.16

Fruit, excluding cranberries, currants, elderberries and strawberry tree fruit80

0,10

3.1.17

Cranberries, currants, elderberries and strawberry tree fruit80

0,20

3.1.18

Fats and oils, including milk fat

0,10

3.1.19

Fruit juices, concentrated fruit juices as reconstituted and fruit nectars

exclusively from berries and other small fruits67

0,05

from fruits other than berries and other small fruits67

0,03

3.1.20

Wine (including sparkling wine, excluding liqueur wine), cider, perry and fruit wine64

products produced from the 2001 fruit harvest to 2015 fruit harvest

0,20

products produced from the 2016 fruit harvest onwards

0,15

3.1.21

Aromatised wine, aromatised wine-based drinks and aromatised wine-product cocktails66

products produced from the 2001 fruit harvest to 2015 fruit harvest

0,20

products produced from the 2016 fruit harvest onwards

0,15

3.1.22

Food supplements92

3,0

3.1.23

Honey

0,10

F183.2

Cadmium

3.2.1

Vegetables and fruit, excluding root and tuber vegetables, leaf vegetables, fresh herbs, leafy brassica, stem vegetables, fungi and seaweed80

0,050

3.2.2

Root and tuber vegetables (excluding celeriac, parsnips, salsify and horseradish), stem vegetables (excluding celery)80. For potatoes the maximum level applies to peeled potatoes

0,10

3.2.3

Leaf vegetables, fresh herbs, leafy brassica, celery, celeriac, parsnips, salsify, horseradish and the following fungi80: Agaricus bisporus (common mushroom), Pleurotus ostreatus (Oyster mushroom), Lentinula edodes (Shiitake mushroom)

0,20

3.2.4

Fungi, excluding those listed in point 3.2.380

1,0

3.2.5

Cereal grains excluding wheat and rice

0,10

3.2.6

  • Wheat grains, rice grains

  • Wheat bran and wheat germ for direct consumption

  • Soy beans

0,20

3.2.7

Specific cocoa and chocolate products as listed below102

—

Milk chocolate with < 30 % total dry cocoa solids

0,10 as from 1 January 2019

—

Chocolate with < 50 % total dry cocoa solids; milk chocolate with ≥ 30 % total dry cocoa solids

0,30 as from 1 January 2019

—

Chocolate with ≥ 50 % total dry cocoa solids

0,80 as from 1 January 2019

—

Cocoa powder sold to the final consumer or as an ingredient in sweetened cocoa powder sold to the final consumer (drinking chocolate)

0,60 as from 1 January 2019

3.2.8

Meat (excluding offal) of bovine animals, sheep, pig and poultry59

0,050

3.2.9

Horsemeat, excluding offal59

0,20

3.2.10

Liver of bovine animals, sheep, pig, poultry and horse59

0,50

3.2.11

Kidney of bovine animals, sheep, pig, poultry and horse59

1,0

3.2.12

Muscle meat of fish7778, excluding species listed in points 3.2.13, 3.2.14 and 3.2.15

0,050

3.2.13

Muscle meat of the following fish 77 78 :

  • mackerel ( Scomber species ), tuna ( Thunnus species, Katsuwonus pelamis , Euthynnus species) , bichique ( Sicyopterus lagocephalus )

0,10

3.2.14

Muscle meat of the following fish 77 78 :

  • bullet tuna (Auxis species)

0,15

3.2.15

Muscle meat of the following fish 77 78 :

  • anchovy ( Engraulis species )

  • swordfish ( Xiphias gladius )

  • sardine ( Sardina pilchardus )

0,25

3.2.16

Crustaceans79: muscle meat from appendages and abdomen97. In case of crabs and crab-like crustaceans ( Brachyura and Anomura ) muscle meat from appendages

0,50

3.2.17

Bivalve molluscs79

1,0

3.2.18

Cephalopods (without viscera)79

1,0

3.2.19

Infant formulae and follow on-formulae5682

—

powdered formulae manufac- tured from cows' milk proteins or protein hydrolysates

0,010 as from 1 January 2015

—

liquid formulae manufactured from cows' milk proteins or protein hydrolysates

0,005 as from 1 January 2015

—

powdered formulae manufac-tured from soya protein isolates, alone or in a mixture with cows' milk proteins

0,020 as from 1 January 2015

—

liquid formulae manufactured from soya protein isolates, alone or in a mixture with cows' milk proteins

0,010 as from 1 January 2015

3.2.20

Processed cereal-based foods and baby foods for infants and young children5682

0,040 as from 1 January 2015

3.2.21

Food supplements92 excl. food supplements listed in point 3.2.22

1,0

3.2.22

Food supplements92 consisting exclusively or mainly of dried seaweed, products derived from seaweed, or of dried bivalve molluscs

3,0

3.3

Mercury

F193.3.1

Fishery products79 and muscle meat of fish7778, excluding species listed in 3.3.2. The maximum level for crustaceans applies to muscle meat from appendages and abdomen97. In case of crabs and crab-like crustaceans ( Brachyura and Anomura ) it applies to muscle meat from appendages.

0,5

F203.3.2

Muscle meat of the following fish 77 78 :

  • 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 )

  • kingklip ( Genypterus capensis )

  • marlin ( Makaira species )

  • megrim ( Lepidorhombus species )

  • mullet ( Mullus species )

  • pink cusk eel ( Genypterus blacodes )

  • pike ( Esox lucius )

  • plain bonito ( Orcynopsis unicolor )

  • poor cod ( Tricopterus minutes )

  • Portuguese dogfish ( Centroscymnus 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

F213.3.3

Food supplements92

0,1

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 children, excluding dried and powdered products5682

50

3.4.4

Canned infant formulae and follow-on formulae (including infant milk and follow-on milk), excluding dried and powdered products5682

50

3.4.5

Canned dietary foods for special medical purposes5682 intended specifically for infants, excluding dried and powdered products

50

F223.5

Arsenic (inorganic) 103104

3.5.1

Non-parboiled milled rice (polished or white rice)

0,20

3.5.2

Parboiled rice and husked rice

0,25

3.5.3

Rice waffles, rice wafers, rice crackers and rice cakes

0,30

3.5.4

Rice destined for the production of food for infants and young children56

0,10

82

The maximum level refers to the product as sold.

77

Fish listed in this category as defined in category (a), with the exclusion of fish liver falling under code CN 0302 70 00, 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 concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic 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 (OJ L 236, 23.9.2003, p. 33). In case of dried, diluted, processed and/or compound foodstuffs Article 2(1) and 2(2) apply.

78

Where fish are intended to be eaten whole, the maximum level shall apply to the whole fish.

105

F43The maximum level applies to the animal as sold without viscera.

79

F27Foodstuffs falling within categories (c) and (i) of the list in Annex I of Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulation (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 ( OJ L 354, 28.12.2013, p. 1 ), as appropriate (species as listed in the relevant entry). In case of dried, diluted, processed and/or compound foodstuffs Article 2(1) and 2(2) apply. In case of Pecten maximus, the maximum level applies to the adductor muscle and gonad only.

97

F17Muscle meat from appendages and abdomen. This definition excludes the cephalothorax of crustaceans. In case of crabs and crab-like crustaceans ( Brachyura and Anomura ): muscle meat from appendages.

80

The maximum level applies after washing of the fruit or vegetables and separating the edible part.

106

For potatoes, the maximum level applies to peeled potatoes.

92

F21The maximum level applies to the food supplements as sold.

102

F42For the specific cocoa and chocolate products the defxinitions set out in points A. 2, 3 and 4 of Annex I to Directive 2000/36/EC of the European Parliament and of the Council of 23 June 2000 relating to cocoa and chocolate products intended for human consumption ( OJ L 197, 3.8.2000, p. 19 ) apply.

103

F22Sum of As(III) and As(V).

104

Rice, husked rice, milled rice and parboiled rice as defined in Codex Standard 198-1995.

F23Section 4: 3-monochloropropanediol (3-MCPD) and glycidyl fatty acid esters

Foodstuffs54

Maximum level(μg/kg)

4.1

3-monochloropropanediol (3-MCPD)

4.1.1

Hydrolysed vegetable protein83

20

4.1.2

Soy sauce83

20

4.2

Glycidyl fatty acid esters expressed as glycidol

4.2.1.

Vegetable oils and fats placed on the market for the final consumer or for use as an ingredient in food with the exception of the foods referred to in 4.2.2

1 000

4.2.2.

Vegetable oils and fats destined for the production of baby food and processed cereal-based food for infants and young children56

500

4.2.3

Infant formula, follow-on formula and foods for special medical purposes intended for infants and young children (powder)5682

75 until 30.6.2019

50 as from 1.7.2019

4.2.4

Infant formula, follow-on formula and foods for special medical purposes intended for infants and young children (liquid)5682

10,0 until 30.6.2019

6,0 as from 1.7.2019

83

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.

F2Section 5: Dioxins and PCBs 84

Foodstuffs

Maximum levels

Sum of dioxins (WHO-PCDD/F-TEQ)85

Sum of dioxins and dioxin-like PCBS (WHO-PCDD/F-PCB-TEQ)85

Sum of PCB28, PCB52, PCB101, PCB138, PCB153 and PCB180 (ICES – 6)85

5.1

Meat and meat products (excluding edible offal) of the following animals59:

—

bovine animals and sheep

2,5 pg/g fat86

4,0 pg/g fat86

40 ng/g fat86

—

poultry

1,75 pg/g fat86

3,0 pg/g fat86

40 ng/g fat86

—

pigs

1,0 pg/g fat86

1,25 pg/g fat86

40 ng/g fat86

F245.2

Liver of terrestrial animals referred to in 5.1 with the exception of sheep and derived products thereof

0,30 pg/g wet weight

0,50 pg/g wet weight

3,0 ng/g wet weight

Liver of sheep and derived products thereof

1,25 pg/g wet weight

2,00 pg/g wet weight

3,0 ng/g wet weight

F255.3

Muscle meat of fish and fishery products and products thereof 78   87 , with the exemption of:

  • wild caught eel

  • wild caught spiny dogfish ( Squalus acanthias )

  • wild caught fresh water fish, with the exception of diadromous fish species caught in fresh water

  • fish liver and derived products

  • marine oils

The maximum level for crustaceans applies to muscle meat from appendages and abdomen 97 . In case of crabs and crab-like crustaceans ( Brachyura and Anomura ) it applies to muscle meat from appendages.

3,5 pg/g wet weight

6,5 pg/g wet weight

75 ng/g wet weight

5.4

Muscle meat of wild caught fresh water fish, with the exception of diadromous fish species caught in fresh water, and products thereof78

3,5 pg/g wet weight

6,5 pg/g wet weight

125 ng/g wet weight

F265.4a

Muscle meat of wild caught spiny dogfish ( Squalus acanthias ) and products thereof 87

3,5 pg/g wet weight

6,5 pg/g wet weight

200 ng/g wet weight

5.5

Muscle meat of wild caught eel ( Anguilla anguilla) and products thereof

3,5 pg/g wet weight

10,0 pg/g wet weight

300 ng/g wet weight

5.6

Fish liver and derived products thereof with the exception of marine oils referred to in point 5.7

—

20,0 pg/g wet weight91

200 ng/g wet weight91

5.7

Marine oils (fish body oil, fish liver oil and oils of other marine organisms intended for human consumption)

1,75 pg/g fat

6,0 pg/g fat

200 ng/g fat

5.8

Raw milk59 and dairy products59, including butter fat

2,5 pg/g fat86

5,5 pg/g fat86

40 ng/g fat86

5.9

Hen eggs and egg products59

2,5 pg/g fat86

5,0 pg/g fat86

40 ng/g fat86

5.10

Fat of the following animals:

—

bovine animals and sheep

2,5 pg/g fat

4,0 pg/g fat

40 ng/g fat

—

poultry

1,75 pg/g fat

3,0 pg/g fat

40 ng/g fat

—

pigs

1,0 pg/g fat

1,25 pg/g fat

40 ng/g fat

5.11

Mixed animal fats

1,5 pg/g fat

2,50 pg/g fat

40 ng/g fat

5.12

Vegetable oils and fats

0,75 pg/g fat

1,25 pg/g fat

40 ng/g fat

5.13

Foods for infants and young children57

0,1 pg/g wet weight

0,2 pg/g wet weight

1,0 ng/g wet weight

84

F2Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated 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 assessment based on the conclusions of the World Health Organization (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006))

Congener

TEF value

Dibenzo-p-dioxins ( ‘ PCDDs ’ )

2,3,7,8-TCDD

1

1,2,3,7,8-PeCDD

1

1,2,3,4,7,8-HxCDD

0,1

1,2,3,6,7,8-HxCDD

0,1

1,2,3,7,8,9-HxCDD

0,1

1,2,3,4,6,7,8-HpCDD

0,01

OCDD

0,0003

Dibenzofurans ( ‘ PCDFs ’ )

2,3,7,8-TCDF

0,1

1,2,3,7,8-PeCDF

0,03

2,3,4,7,8-PeCDF

0,3

1,2,3,4,7,8-HxCDF

0,1

1,2,3,6,7,8-HxCDF

0,1

1,2,3,7,8,9-HxCDF

0,1

2,3,4,6,7,8-HxCDF

0,1

1,2,3,4,6,7,8-HpCDF

0,01

1,2,3,4,7,8,9-HpCDF

0,01

OCDF

0,0003

‘ Dioxin-like ’ PCBs Non-ortho PCBs + Mono-ortho PCBs

Non-ortho PCBs

PCB 77

0,0001

PCB 81

0,0003

PCB 126

0,1

PCB 169

0,03

Mono-ortho PCBs

PCB 105

0,00003

PCB 114

0,00003

PCB 118

0,00003

PCB 123

0,00003

PCB 156

0,00003

PCB 157

0,00003

PCB 167

0,00003

PCB 189

0,00003

Abbreviations used: ‘ T ’ = tetra; ‘ Pe ’ = penta; ‘ Hx ’ = hexa; ‘ Hp ’ = hepta; ‘ O ’ = octa; ‘ CDD ’ = chlorodibenzodioxin; ‘ CDF ’ = chlorodibenzofuran; ‘ CB ’ = chlorobiphenyl.

85

Upperbound concentrations: Upperbound concentrations are calculated on the assumption that all the values of the different congeners below the limit of quantification are equal to the limit of quantification.

86

F2The maximum level expressed on fat is not applicable for foods containing < 2 % fat. For foods containing less than 2 % fat, the maximum level applicable is the level on product basis corresponding to the level on product basis for the food containing 2 % fat, calculated from the maximum level established on fat basis, making use of following formula:

Maximum level expressed on product basis for foods containing less than 2 % fat = maximum level expressed on fat for that food x 0,02.

87

F34Foodstuffs 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 referred to in point 5.11.

91

F37In the case of canned fish liver, the maximum level applies to the whole edible content of the can.

F27Section 6: Polycyclic aromatic hydrocarbons

Foodstuffs

Maximum levels (μg/kg)

6.1

Benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene

Benzo(a)pyrene

Sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene98

6.1.1

Oils and fats (excluding cocoa butter and coconut oil) intended for direct human consumption or use as an ingredient in food

2,0

10,0

F286.1.2

Cocoa beans and derived products with the exception of the products referred to in point 6.1.11

5,0 μg/kg fat as from 1.4.2013

35,0 μg/kg fat as from 1.4.2013 until 31.3.2015

30,0 μg/kg fat as from 1.4.2015

6.1.3

Coconut oil intended for direct human consumption or use as an ingredient in food

2,0

20,0

6.1.4

Smoked meat and smoked meat products

5,0 until 31.8.2014

2,0 as from 1.9.2014

30,0 as from 1.9.2012 until 31.8.2014

12,0 as from 1.9.2014

6.1.5

Muscle meat of smoked fish and smoked fishery products 7889, excluding fishery products listed in points 6.1.6 and 6.1.7. The maximum level for smoked crustaceans applies to muscle meat from appendages and abdomen 97. In case of smoked crabs and crab-like crustaceans ( Brachyura and Anomura ) it applies to muscle meat from appendages.

5,0 until 31.8.2014

2,0 as from 1.9.2014

30,0 as from 1.9.2012 until 31.8.2014

12,0 as from 1.9.2014

6.1.6

Smoked sprats and canned smoked sprats 78100 ( Sprattus sprattus ); Smoked Baltic herring ≤ 14 cm length and canned smoked Baltic herring ≤ 14 cm length 78100 ( Clupea harengus membras ); Katsuobushi (dried bonito, Katsuwonus pelamis ); bivalve molluscs (fresh, chilled or frozen)79; heat treated meat and heat treated meat products99 sold to the final consumer

5,0

30,0

6.1.7

Bivalve molluscs 89 (smoked)

6,0

35,0

6.1.8

Processed cereal-based foods and baby foods for infants and young children 5682

1,0

1,0

6.1.9

Infant formulae and follow-on formulae, including infant milk and follow-on milk5682

1,0

1,0

6.1.10

Dietary foods for special medical purposes5682 intended specifically for infants

1,0

1,0

F296.1.11

Cocoa fibre and products derived from cocoa fibre, intended for use as an ingredient in food

3,0

15,0

F296.1.12

Banana chips

2,0

20,0

6.1.13

Food supplements containing botanicals and their preparations 92 52 53

Food supplements containing propolis, royal jelly, spirulina or their preparations 92

10,0

50,0

6.1.14

Dried herbs

10,0

50,0

6.1.15

Dried spices with the exception of cardamon and smoked Capsicum spp.

10,0

50,0

98

F41Lower bound concentrations are calculated on the assumption that all the values of the four substances below the limit of quantification are zero.

89

F27Foodstuffs listed in this category as defined in categories (b), (c) and (i) of the list in Annex 1 of Regulation (EU) No 1379/2013.

100

For the canned product the analysis shall be carried out on the whole content of the can. As regards the maximum level for the whole composite product Art. 2(1)(c) and 2(2) shall apply.

99

Meat and meat products that have undergone a heat treatment potentially resulting in formation of PAH, i.e. only grilling and barbecuing.

52

F29Botanical preparations are preparations obtained from botanicals (e.g. whole, plant parts, fragmented or cut plants) by various processes (e.g. pressing, squeezing, extraction, fractionation, distillation, concentration, drying up and fermentation). This definition includes comminuted or powdered plants, plant parts, algae, fungi, lichen, tinctures, extracts, essential oils (other than the vegetable oils referred to in point 6.1.1), expressed juices and processed exudates.

53

The maximum level does not apply to food supplements containing vegetable oils. Vegetable oils used as an ingredient in food supplements should comply with the maximum level established in point 6.1.1.

F9Section 7: Melamine and its structural analogues

Foodstuffs

Maximum levels(mg/kg)

7.1.

Melamine

7.1.1.

Food with the exception of infant formulae and follow-on formulae101

2,5

7.1.2.

Powdered infant formulae and follow-on formulae

1

101

F9The maximum level does not apply to food for which it can be proven that the level of melamine higher than 2,5 mg/kg is the consequence of authorized use of cyromazine as insecticide. The melamine level shall not exceed the level of cyromazine.

F30Section 8: Inherent plant toxins

Foodstuffs54

Maximum levels (g/kg)

8.1

Erucic acid

8.1.1

Vegetable oils and fats

5047

8.1.2

Foods containing added vegetable oils and fats with the exception of the foods referred to in 8.1.3

5047

8.1.3

Infant formulae and follow-on formulae56

1047

47

F30The maximum level refers to the level of erucic acid, calculated on the total level of fatty acids in the fat component in food.

F31Foodstuffs54

Maximum level (μg/kg)

8.2

Tropane alkaloids 51

Atropine

Scopolamine

8.2.1

Processed cereal-based foods and baby foods for infants and young children, containing millet, sorghum, buckwheat or their derived products82

1,0 μg/kg

1,0 μg/kg

F448.3

Hydrocyanic acid, including hydrocyanic acid bound in cyanogenic glycosides

8.3.1

Unprocessed whole, ground, milled, cracked, chopped apricot kernels placed on the market for the final consumer107108

20,0

F32

F32

F33

F32

F35

F40The maximum level for leaf vegetables does not apply to fresh herbs (falling under Code number 0256000 in Annex I to Regulation (EC) No 396/2005).

51

F31The tropane alkaloids referred to are atropine and scopolamine. Atropine is the racemic mixture of (-)-hyoscyamine and (+)-hyoscyamine of which only the (-)-hyoscyamine enantiomer exhibits anticholinergic activity. As for analytical reasons it is not always possible to distinguish between the enantiomers of hyoscyamine, the maximum levels are established for atropine and scopolamine.

107

F44‘ Unprocessed products ’ as defined in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( OJ L 139, 30.4.2004, p. 1 ).

108

‘ Placing on the market ’ and ‘ final consumer ’ as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( OJ L 31, 1.2.2002, p. 1 ).