Decoquinate sodium is a quinoline coccidiostat agent that is authorised as a feed additive under Regulations (EC) No 1289/2004 for use in chickens for fattening at a minimummaximum concentration of 20-40 mg/kg complete feed withdrawal period of 3 days for all target animals. Despite the requirements set for feed business operators in Regulation (EC) No 183/2005, it is generally acknowledged that under practical conditions during the production of mixed feeds, a certain percentage of a feed batch remains in the production circuit and these residual amounts can contaminate the subsequent feed batches. This cross contamination may result in the exposure of non-target animal species, and hence the potential health risks for non-target animal species as well as the potential residue deposition in foods derived from these non-target species have been evaluated.Toxicological studies in laboratory animals have identified the dog as the most sensitive species with a NOAEL of 15 mg/kg b. w. per day for subdued behaviour, reduced activity and emesis in a 12-week oral toxicity study. Based on limited tolerance studies on pigs, ruminants, horses and rabbits, it is considered that accidental ingestion of feed intended for chickens containing decoquinate at the maximum authorised level of 40 mg/kg feed does not present a health risk for these non-target animal species. At a level of cross-contamination of 10% of the maximum authorised level, the intake of decoquinate would be well below the overall NOAEL value. Hence, the CONTAM Panel concluded that adverse effects are unlikely to occur in non-target animals as a result of cross-contamination of feed at a level up to 10% of the maximum authorised level of decoquinate sodium in feed for target animals.Consumer exposure was estimated from the results of kinetic studies in chickens and laying hens. Linear extrapolation from the results of the kinetic studies gave an estimate of the residue concentrations in chickens that had been fed diet that was cross-contaminated at levels of 10% (4 mg/kg feed) at a withdrawal time of essentially zero. By linear extrapolation of the data at 24 hours withdrawal, chickens fed a diet cross-contaminated with 10% decoquinate would be expected to have concentrations of 12, 51, 63, 30 and 75 mu g decoquinate equivalents/kg in eggs, liver, kidney, muscle and skin/fat, respectively. Overall, the estimated human exposure would correspond to a total of 33.4 mu g/person per day (0.56 mu g/kg b. w. per day for a 60 kg person). This exposure is well below (0.75%) the ADI of 75 mu g/kg b. w as established by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP). Therefore, the CONTAM Panel concluded that there is no indication of appreciable risk to consumers' health from ingestion of decoquinate residues in tissues of animals exposed to feed cross-contaminated up to a hypothetical level of 10% of the maximum level authorised for target animal species.

Monensin sodium is a polyether carboxylic ionophore coccidiostat agent that is authorised as a feed additive under Commission Regulations No 2430/1999 and 1455/2004 for use in chickens for fattening (100-125 mg/kg feed, withdrawal period 3 days), chickens reared for laying (up to 16 weeks of age; 100-120 mg/kg feed; no withdrawal period) and turkeys for fattening (up to 16 weeks of age, concentration range 60-100 mg/kg feed; withdrawal period 3 days). Despite the requirements set for feed business operators in Regulation (EC) No 183/2005, it is generally acknowledged that under practical conditions during the production of mixed feeds, a certain percentage of a feed batch remains in the production circuit and these residual amounts can contaminate the subsequent feed batches. This crosscontamination may result in the exposure of non-target animal species, and hence the potential health risks for non-target animal species as well as the potential residue deposition in foods derived from these non-target species have been evaluated.

Chlordane was commercially introduced as a non-systemic (not taken up in the plant), contact and ingested insecticide in 1947. Technical chlordane is a mixture, which consists of at least 147 compounds and the composition varies with the manufacturing process. It contained 43 – 75 % cisand trans-chlordane and lesser amounts of heptachlor, cisand trans-nonachlor and chlordenes. After 1970, a more refined formulation containing >95 % of cisand transchlordane was also produced. Chlordane was used for agricultural purposes, mainly for soil and seed treatment and wood protection, the latter being applied mostly in the USA. It has been banned for use in the European Union since 1981 and currently in most other countries worldwide. In the environment chlordane is relatively stable and can be transported over long ranges. Chlordane is included in the Stockholm convention on persistent organic pollutants (POPs) and the United Nations Economic Commission for Europe (UNECE) Convention on long-range transboundary air pollution protocol on POPs (CLRTAP-POP). Because of their lipophilic properties and persistence in the environment, chlordane and related compounds are bioaccumulated and biomagnified along the food chain. Chlordane compounds show

Mercury exists in the environment as elemental mercury (metallic), inorganic mercury and organic mercury (primarily methylmercury). Elemental and inorganic mercury released into the air from mining, smelting, industrial activities, combustion of fossil fuels, is deposited to soil, water and thereby to sediments where the mercury is transformed into methylmercury. Methylmercury bioaccumulates and biomagnifies along the food chain, particularly in the aquatic food chain; longlived carnivorous fish and marine mammals exhibiting the highest contents. The toxicity and toxicokinetics of mercury in animals and humans depends on its chemical form. Elemental mercury is volatile and mainly absorbed through the respiratory tract, whereas its absorption through the gastrointestinal tract is negligible. Gastrointestinal absorption of inorganic mercury is in the 10-30% range. Following absorption, inorganic mercury distributes mainly to the kidneys and, to a lesser extent, to the liver. The critical effect of inorganic mercury is renal damage. In animals, as in humans, methylmercury and its salts are readily absorbed in the gastrointestinal tract (> 80%). Absorbed methylmercury is widely distributed to all tissues, although the largest deposition occurs in the kidney. Excretion of unchanged methylmercury occurs predominantly in the faeces through biliary excretion. The enterohepatic cycle results in a long half-life for this compound compared to inorganic mercury. Methylmercury is able to cross the blood-brain and the placental barriers. As a consequence, the nervous system is the primary site of toxicity in animals and humans. In humans, effects on neurological development have been observed in children of mothers orally exposed to methylmercury. Animal studies confirmed these neurodevelopmental effects in foetus of dams exposed to methylmercury in the diet.A substantial number of feed materials have been analysed for total mercury in recent years within the EU Member States, and for the large majority, the concentrations were below the maximum level specified in the feedingstuffs legislation. The most common source of mercury in feed materials is fishmeal, however, in this category, no sample exceeded the maximum level of 0.5 mg/kg. In contrast, approximately 8% of the complete feedingstuffs for fish exceeded the maximum level of 0.1 mg/kg. The relatively few data available on the speciation of mercury in fishmeals indicate that it is mainly present as methylmercury. The most sensitive domestic animal species to methylmercury toxicity are cats and mink. Based on the available data on the occurrence of total mercury in feed materials and complete feedingstuffs, it is unlikely that these species will be exposed to toxic levels.The maximum concentration reported in farmed salmonids is approximately five times lower than the EU maximum level for mercury in fish for human consumption (500 mu g/kg for salmonids). This mercury concentration in salmonids would allow weekly consumption of two fish meals, as recommended by nutritionists, without appreciable health risk. The maximum level for fish feed is sufficient to ensure that contamination levels in farmed salmonids pose no appreciable risk to consumers, but the validity of the maximum level need to be ascertained for other farmed fish.

Glucosinolates (alkyl aldoxime-O-sulphate esters with a β-D-thioglucopyranoside group) occur in important oiland protein-rich agricultural crops, including among others Brassica napus (rapeseed of Canola), B. campestris (turnip rape) and Sinapis alba (white mustard), all belonging to the plant family of Brassicaceae. They are present in all parts of these plants, with the highest concentrations often found in seeds. Several of these Brassica species are important feed ingredients and some species are also commonly used in human nutrition such as cauliflower, cabbages, broccoli and Brussels sprouts. Glucosinolates and their breakdown products determine the typical flavour and (bitter) taste of these vegetables.

Salinomycin sodium is a polyether carboxylic ionophore agent that is authorised according to Regulation No (EC) 1831/2003 as a coccidiostat for use in chickens for fattening with a maximum content of the active ingredient in feed of 70 mg/kg and a withdrawal period of one day, for chickens reared for laying (up to 12 weeks of age) with a maximum content of 50 mg/kg and no withdrawal period, and for rabbits for fattening with a maximum concentration in feed of 25 mg/kg and a withdrawal period of five days. Despite the requirements set for feed business operators in Regulation No (EC) 183/2005, it is generally acknowledged that under practical conditions during the production of mixed feeds, a certain percentage of a feed batch remains in the production circuit and these residual amounts can contaminate subsequent feed batches. This cross-contamination may result in the exposure of non-target animal species, and hence the potential health risks for non-target animal species as well as the potential residue deposition in foods derived from these non-target animal species have been evaluated.

Following a request from the European Commission, the Panel on Contaminants in the Food Chain was asked to deliver a scientific opinion on cross-contamination of non-target feedingstuffs by lasalocid authorised for use as a feed additive.Lasalocid sodium is a polyether carboxylic ionophore agent that is authorised according to Regulations No (EC) 2430/1999 and 1455/2004 as a coccidiostat for use in chickens for fattening, chickens reared for laying (up to 16 weeks of age) and turkeys (up to 12 weeks of age) with a maximum content of the active ingredient in feed of 125 mg/kg and a withdrawal period of 5 days. Despite the requirements set for feed business operators in Regulation No (EC) 183/2005, it is generally acknowledged that under practical conditions during the production of mixed feeds, a certain percentage of a feed batch remains in the production circuit and these residual amounts can contaminate subsequent feed batches. This cross-contamination may result in the exposure of nontarget animal species, and hence the potential health risks for non-target animal species as well as the potential residue deposition in foods derived from these non-target animal species have been evaluated.Signs of intoxication in animals comprising neurological signs (depression, ataxia, paresis, paralysis, muscle tremor) and cardiac effects (inotropy and tachycardia) have been reported in various non-target animal species following accidental exposure, and neurotoxic symptoms without histopathological changes have been described in experimental studies with dogs. These signs of toxicity are consistent with the mode of action of ionophoric polyether coccidiostats, and are comparable to the symptoms observed in the target animal species at doses exceeding the authorised dose. Particularly sensitive are dogs, calves, rabbits, and horses. The Panel on Contaminants in the Food Chain (CONTAM Panel) concluded that accidental ingestion of poultry feed containing the highest authorised level of lasalocid (125 mg/kg feed) may cause intoxications in non-target animal species.Cross-contamination of feed for non-target animal species at a hypothetical level equal to 10 % (12.5 mg/kg feed) of the maximum authorised concentration of lasalocid in feed for target animal species could result in an intake of 0.6 mg/kg b. w. per day of lasalocid. This level slightly exceeds the overall no observed effect level (NOEL) of 0.5 mg/kg b. w. derived from controlled studies in experimental animals, conducted as a prerequisite for the authorisation of lasalocid as coccidiostat in poultry. The CONTAM Panel concluded that adverse health effects in non-target animals in the event of cross-contamination are unlikely to occur.Kinetic studies and residue analyses showed that high concentrations of lasalocid can occur in eggs of laying hens and quails. The deposition of residues in eggs corresponds almost linearly to the concentrations in feeds, and model experiments demonstrated that it is likely that the levels in eggs slightly exceed the provisional maximum residue limit (MRL) of 150 mu g/kg following exposure of laying hens to feed cross-contaminated at a level of 2 % with feed containing lasalocid at the maximum authorised concentration for the target animal species (2.5 mg/kg feed)Cross-contamination of feed material for non-target animal species can also result in undesirable residues in livers of ruminants. Model calculations revealed that cross-contamination at a level of 10 % could result in lasalocid residues in liver of 1400 and 2500 mu g/kg in sheep and cattle, respectively.In consideration of these findings, frequent monitoring of feed materials for non-target animal species, especially feeds intended for laying hens, is recommended. Moreover, feedingstuffs for cattle and sheep as well as the livers of these animals should be monitored for the presence of lasalocid residues.Human exposure estimates based on worst case scenarios indicate that consumption of products from animals exposed to feed cross-contaminated at levels up to 10 % could lead to lasalocid exposure slightly above the ADI of 5 mu g/kg b.w. as established by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). Given the fact that exposure to lasalocid residues resulting from cross-contamination of feed is likely to be rare, the CONTAM Panel concluded that adverse health effects in consumers resulting from exposure to lasalocid residues in products from animals exposed to feed cross-contaminated even up to a level of 10 %, is unlikely.

Nicarbazin is a non-ionophoric synthetic complex composed of an equimolar amount of 4,4’dinitrocarbanilide (DNC) and 2-hydroxy-4,6-dimethylpyrimidine (HDP) that is authorised as a coccidiostat feed additive for use in chickens for fattening at a maximum concentration of 50 mg/kg in complete feed as a combination product with narasin (List of authorised additives in feedingstuffs (2004/C 50/01)). Despite the requirements set for feed business operators in Regulation (EC) No 183/2005, it is generally acknowledged that under practical conditions during the production of mixed feeds, a certain percentage of a feed batch remains in the

Ethyl carbamate occurs naturally in fermented foods and alcoholic beverages such as bread, soy sauce, yoghurt, wine, beer, and spirits, particularly in stone-fruit brandies. A number of precursors present in food and beverages such as hydrocyanic acid, urea and ethanol can lead to the formation of ethyl carbamate during food processing and storage.Ethyl carbamate is genotoxic and a multisite carcinogen in animals and probably carcinogenic in man. The European Commission asked the CONTAM Panel for a scientific opinion on the risks to human health related to the presence of ethyl carbamate and hydrocyanic acid in food and alcoholic beverages, in particular stone-fruit brandies.In response, EFSA in late September 2006 issued a call for submission of data on levels of ethyl carbamate and hydrocyanic acid in food and beverages. Seven EU Member States, the Liquor Control Board of Ontario and the Wine Institute of California responded to EFSA's call for data on ethyl carbamate and submitted results covering analyses from 1998 to 2006. Three Member States submitted data on hydrocyanic acid in alcoholic beverages.Only very few food (excluding alcoholic beverages) results for ethyl carbamate were reported to EFSA and of the results 41% were below the limit of detection. In the 2005 the Joint FAO/WHO Expert Committee on Food Additives (JECFA) review it was concluded that food products in general would contribute less than 1 mu g/person per day and this figure was used in exposure assessment calculations.In contrast to the few food results, EFSA received over 33,000 testing results of alcoholic beverages. For almost 93% of the beer samples, 42% of the wine samples, but fewer than 15% of the spirit samples, the results were below the limit of detection. Median levels of ethyl carbamate in alcoholic beverages of up to 5 mu g/L for beer and wine, 21 mu g/L for spirits other than fruit brandy and 260 mu g/L for fruit brandy were calculated. From these data, a dietary exposure of 17 ng/kg b.w. per day3 was estimated from food for an average 60 kg person who does not consume alcohol, whereas this would increase up to 65 ng/kg b.w. for consumers of a variety of different alcoholic beverages. The highest exposure to ethyl carbamate can be expected for persons exclusively consuming fruit brandy with exposure at a 95th percentile consumption level of 558 ng/kg b.w. per day.The estimated dietary exposure to hydrocyanic acid was about 1.6 mu g/kg b.w. per day for a 60 kg person. The main contributor to hydrocyanic acid exposure in average consumers was food products, with alcoholic beverages contributing only minor amounts. At the 95th percentile consumption level of fruit brandy and the 95th percentile concentration level for hydrocyanic acid a peak dietary exposure of 24 mu g/kg b.w. per day would be possible, which is undesirable.A risk characterisation was performed using the Margin of Exposure (MOE) approach comparing a BMDL104 derived from animal cancer data with scenarios for exposure to ethyl carbamate. A value of 10,000 and above was considered to be of low concern for public health. The MOEs were calculated using the estimated intake of ethyl carbamate at the median levels in alcoholic beverages and the BMDL10 value of 0.3 mg/kg b.w per day (10% incidence of alveolar and bronchiolar neoplasms in male and female mice).The Panel concluded that the MOE of almost 18,000 calculated for exposure to ethyl carbamate in food excluding alcoholic beverages indicates a low concern for human health. However, the MOE was in the region of 5,000 for food consumed together with a variety of alcoholic beverages, and for high consumers of fruit brandy the MOE was less than 600. Based on these MOEs the Panel concluded that ethyl carbamate in alcoholic beverages indicates a health concern, particularly with respect to stone fruit brandies. The Panel noted that for consumers of particular brands of stone fruit brandy, with higher than average levels of ethyl carbamate, the MOEs could be even lower.Mitigation measures should be taken to reduce the levels of ethyl carbamate in certain alcoholic beverages such as fruit brandies. Such measures should include focus on hydrocyanic acid and other precursors of ethyl carbamate to prevent the formation of ethyl carbamate during shelf-life of these products.

Hydrogen cyanide (HCN) is formed following the enzymatic hydrolysis of cyanogenic glycosides, which are produced as secondary metabolites by various plant species. In the intact plant these cyanogenic compounds are stored separated from hydrolytic enzymes. Crushing of plant materials either by technical processes or by chewing by animals obliterates this separation and initiates the enzymatic hydrolysis of cyanogenic compounds, resulting ultimately in the formation of HCN. Hydrolysis to release HCN can also be accomplished by microorganisms in the digestive tract.Cyanogenic glycosides are widely distributed in the plant kingdom. Typical feed materials that contain cyanogenic glycosides are linseed (flax), cassava root and the green parts of sorghum species. Linseed is presented as animal feed mainly as pressor extraction cake, both being by-products in the production of linseed oil. The same applies to the seeds of various Prunus species, of which the press-or extraction cake is used as feed material. Cassava roots are commonly processed into chips, which are exported to Europe as feed material for pigs.Depending on the pH HCN may also occur as the cyanide anion. Both HCN and cyanide are toxic to all animal species. Exposure to HCN may lead to acute, fatal intoxications. More frequently, however, chronic intoxications are observed, characterized by growth depression and neurological symptoms resulting from tissue damage in the central nervous system. Ruminants, in which the forestomach flora contributes to the hydrolysis of cyanogenic glycosides, are considered to be more vulnerable to such compounds than monogastric animals and humans. This results in a higher prevalence of clinical cases of intoxication in ruminant species following exposure to cyanogenic glycosides.No systematic experimental studies exist on the carry over of cyanide or its precursors into edible products such as meat, offals and eggs. Cyanogenic residues have been found in the liver of a fatally intoxicated goat. However, provided the animal is not intoxicated with hydrogen cyanide, based on kinetic considerations and a common metabolic pathway of degradation of cyanide, the levels in meat, or eggs intended for human consumption can be expected to be very low in all food producing animals. Carry over of cyanogenic residues into milk has been demonstrated in intoxicated animals. Based on similar considerations as above, levels are expected to be very low.Good Agricultural and Manufacturing Practice in the preparation of feeds can prevent clinical and subclinical intoxications in animals. The Panel noted the need for more data on the toxicology and the presence of cyanogenic glycosides in feeding stuffs. The Panel also identified the need for up-to-date analytical methods that allow the determination of the total cyanogenic potential.

In line with the obligations as defined in Article 11a of Directive 96/22/EC as amended by Directive 2003/74/EC the Commission asked EFSA to examine new data on substances and products thereof with hormonal activity which may be used legally in Third Countries for growth promoting purposes in bovine meat production. The substances under consideration are the naturally occurring steroids, testosterone and progesterone, as well as the synthetic compounds trenbolone acetate, which has demonstrated affinity to androgen receptors, zeranol, which has a high affinity for oestrogen receptors, and melengestrol acetate, which resembles progestins. In accordance with the mandate, the Panel on Contaminants in the Food Chain reviewed the scientific literature that became available in the period between 2002 and the first few months of 2007, until drafting of the present Opinion. The Panel noted that the understanding of the complex mechanisms of action of steroid hormones is still a matter of scientific research and new insights into the complex genomic and non-genomic regulatory mechanisms controlling hormonal homeostasis in different phases of life are still emerging.The Panel noted the availability of advanced methods of analysis with high sensitivity and reproducibility, allowing the measurement of residues of natural and synthetic hormones in animal tissues. However, no surveillance studies quantifying the amount and nature of residues in edible tissues of cattle treated with growth promoting hormones under practical conditions have been conducted in countries that have licensed the use of growth promoting hormones.At present, epidemiological data provide convincing evidence for an association between the amount of red meat consumed and certain forms of hormone-dependent cancers. Whether or not hormone residues in meat contribute to this risk is currently unknown.The CONTAM Panel concluded that the new data that are publicly available do not provide quantitative information that would be informative for risk characterisation and therefore do not call for a revision of the previous assessments of the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) (EC, 1999, 2000, 2002).