According to Article 6 of the Regulation (EC) No 396/2005, the United Kingdom received an application from Syngenta to modify the existing MRLs for chlorothalonil in barley and in several food commodities of animal origin. In order to accommodate the intended use of chlorothalonil on barley in the United Kingdom, it is proposed to raise the existing MRL in barley from 0.1 mg/kg to 0.3 mg/kg. It is also proposed to raise the existing MRLs for chlorothalonil in bovine, sheep and goat milk, fat, meat, kidney and liver. The United Kingdom drafted an evaluation report according to Article 8 of Regulation ( EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 30 January 2009. On 30 April some data requirements were identified which prevented EFSA to conclude on the consumer risk assessment. An updated evaluation report, addressing those data requirements, was submitted by the EMS on 10 December 2009 and taken into consideration by EFSA for finalization of this reasoned opinion. EFSA derived the following conclusions based on the above mentioned evaluation report and the Draft Assessment Report (DAR) prepared under Directive 91/414/EEC. The toxicological studies submitted on chlorothalonil under the peer review were sufficient to conclude on an ADI value of 0.015 mg/kg bw/d and an ARfD value of 0.015 mg/ kg bw. For the metabolite 2,5,6-trichloro-4-hydroxyphtalonitrile (SDS-3701), which was identified in plants and in significant concentrations in animals, an ADI of 0.01 mg/kg bw/d and an ARfD of 0.01 mg/kg bw was derived. The metabolism of chlorothalonil in primary plants was investigated under the peer review of Directive 91/414 in four crop categories. Studies were sufficient to conclude on the risk assessment and enforcement residue definition in all plant commodities as parent chlorothalonil. It has to be noted that available metabolism studies do not provide sufficient information on the nature of chlorothalonil residues in crops with PHI intervals exceeding 21/28 days. It is assumed that chlorothalonil is metabolised to a greater extent after longer intervals. Adequate analytical methods are available to control the compliance of the proposed MRL in barley. It has to be noted that laboratories performing residue analysis have to pay particular attention to the storage of the analytical samples prior analyses since losses of chlorothalonil have been observed during the laboratory processing of various fruit and vegetable samples. The submitted supervised residue field trials indicate that an MRL of 0.3 mg/kg would be required to accommodate the intended GAP of chlorothalonil on barley in the United Kingdom. Chlorothalonil was stable under conditions simulating pasteurisation, but showed increased degradation in baking/brewing/boiling and sterilisation. Relevant degradation products were SDS-3701 and 3-cyano-2,4,5,6-tetrachlorobenzamide (SDS-19221). A processing study investigating the magnitude of chlorothalonil and metabolite SDS-3701 in beer and pot barley is available. No concentration of residues was observed. It is concluded that for the intended GAP, no significant concentrations of chlorothalonil or SDS-3701 are expected in beer or in pot barley. EFSA, however, recommends investigating the need for the inclusion of metabolite SDS-3701 and possibly SDS-19221 in the residue definition for processed commodities. The occurrence of chlorothalonil residues in rotational crops was also investigated. Studies indicate that metabolite 3-carboxy-2,5,6-trichloro benzamide (SDS-46851) is the main residue in rotational crops. The peer review decided that, based on the data on metabolites in plant products and in view of the information from toxicological studies, the residue in plant products has to be defined as the parent compound chlorothalonil only, although parent compound was found in significantly lower concentrations than SDS-46851. Considering the available data, EFSA concludes that the intended use of chlorothalonil on barley will not result in significant residues of chlorothalonil and its metabolites in rotational crops provided that the active substance is applied according to the intended GAP. The occurrence of chlorothalonil residues in commodities of animal origin was also investigated. The dietary burden for different types of livestock was calculated considering the residues in barley grain and straw as well as in other feed crops. The livestock dietary burden significantly exceeds the trigger value of 0.1 mg/kg DM for all livestock species. Based on the metabolism studies with lactating goats and laying hens the peer review concluded that the residue for enforcement and risk assessment in livestock should be provisionally defined as metabolite SDS-3701. From the toxicological studies, differences between metabolic patterns in ruminants and non-ruminants were observed indicating that mono-, di-, triglutathione conjugates of chlorothalonil are the main metabolites in monogastric animals. The available data give some evidence that the main residues in non-ruminants would be chlorothalonil conjugates, but there is no information on the quantity and distribution of these compounds in non-ruminant tissues. EFSA is of the opinion that the need of a pig metabolism study should be discussed with experts in the framework of Article 12(2) of Regulation (EC) No 396/2005 to elucidate the metabolism in non- ruminants. EFSA concludes that the current residue definition for animal products as established in the Regulation ( EC) No 396/2005 does not comprise the compounds that were identified as major residues in ruminants. EFSA agrees with the residue definition derived in the peer review (SDS-3701) and recommends to amend the current residue definition for ruminants in Regulation (EC) No 396/2005 accordingly. Also for non- ruminants the residue definition may need to be changed but further information would be required for poultry and pigs. The magnitude of chlorothalonil and its metabolite SDS-3701 in livestock was studied in a feeding study where both substances were administered orally to lactating cows as a blend. For estimating the MRLs in the food commodities of bovine, sheep and goat, EFSA took into account the calculated dietary burdens for ruminants following their exposure to chlorothalonil and the results from the livestock feeding study. The derived MRL proposals for food commodities of animal origin are higher as proposed by the EMS because EFSA considered the livestock exposure to chlorothalonil residues not only from the intake of treated cereals but also from other feed crops. The derived MRL proposals are compiled in the table below. Metabolism studies with poultry indicate that no chlorothalonil or SDS-3701 residues will occur in poultry products above the LOQ at the calculated dietary burden. The MRL proposals for swine products were not derived since there are no sufficient data available on the nature and magnitude of chlorothalonil in pigs. The consumer risk assessment for chlorothalonil is hampered by the lack of information on the full data set of all authorized uses of chlorothalonil and therefore this consumer risk assessment has to be considered as provisional giving the best estimate which is possible at the moment. The consumer intake assessment was performed with revision 2 of the EFSA PRIMo. For the chronic exposure assessment EFSA used the existing MRLs as established in Annex II and Annex IIIB of Regulation (EC) No 396/2005 as well as the derived STMR values for barley and relevant commodities of food origin. EFSA was able to derive STMR values for several other crops. The acute exposure assessment was performed only with regard to commodities for which the MRL proposals are made using the HR values as derived from the supervised residue trials (for barley) and the livestock feeding studies ( for commodities of animal origin). The calculated exposure to residues from plant products was compared with the toxicological reference values of chlorothalonil. The calculated exposure to residues from the products of animal origin was compared with the toxicological reference values of SDS-3701. Regarding food commodities of plant origin, no long-term intake concerns were identified for any of the European diets. The total calculated exposure values ranged from 16.4 - 96.9% of the ADI. The highest individual contribution of barley to the total exposure was identified for the Irish adult diet (0.41% of the ADI). No short-term intake concerns were identified with regard to the intake of barley (2.7% of the ARfD). Regarding food commodities of animal origin, no long-term concerns were observed with regard to the consumer exposure to SDS-3701 residues. The total calculated intake values accounted for a maximum of 24 % of the ADI. The highest contributing commodity was milk and cream (15.8% of the ADI) for FR toddler diet. No acute intake concerns were identified. The contribution of food commodities of animal origin to the total acute exposure to SDS-3701 accounted for 87% of the ARfD for milk and milk products, 11.3% of the ARfD for bovine kidney, 4.8 % of the ARfD for bovine liver and 3.8% of the ARfD for bovine meat. Consequently EFSA concludes that the proposed MRL of 0.3 mg/kg in barley and the derived MRL proposals for food commodities of animal origin are acceptable with regard to long-term and shortterm consumer exposure. In addition, the following recommendations were derived during the risk assessment and are proposed to be addressed the framework of the Article 12 (2) of Regulation (EC) No 396/2005: the need for studies investigating the nature of chlorothalonil in pigs has to be further discussed and, depending on the outcome, a need for a pig feeding study has to be considered; the residue definition for processed commodities has to be reconsidered in accordance with the results from the study on the effects of processing on the nature of chlorothalonil; a possible formation of SDS-3701 in crops for which the GAP envisages long PHI intervals; if a decision is taken to consider SDS-3701 residues in plant commodities, a sufficiently validated analytical method and a storage stability studies have to be provided; [GRAPHICS]
