It is essential, in order to protect public health, to keep contaminants at levels which are toxicologically acceptable.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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