Modification of the existing MRLs for difenoconazole in various leafy vegetables
Modification of the existing MRLs for difenoconazole in various leafy vegetables
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DOI：
10.2903/j.efsa.2009.337r
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发表时间：
2009-07-01
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影响因子：
3.3
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中科院分区：
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根据第396/2005号法规（EC）第6条，比利时（以下简称为评估成员国）编制了两份申请，以修改欧芹、芹菜叶、雪维尔和茴香中苯醚甲环唑的现有最大残留限量。为了适应苯醚甲环唑在比利时的新用途，建议将茴香的现有最高残留限量从0.3毫克/公斤提高到5毫克/公斤，欧芹、芹菜叶的最高残留限量从3毫克/公斤提高到10毫克/公斤，雪芹的最高残留限量从2毫克/公斤提高到10毫克/公斤。比利时根据第396/2005号法规（EC）第8条起草了评估报告，并于2009年5月29日提交给欧盟委员会和欧洲食品安全局。欧洲食品安全局在一个合理的意见中考虑了这两项申请。欧洲食品安全局得出以下关于申请的结论，在DAR中报告了苯醚甲环唑的毒理学参考值，目前ADI设定为0.01 mg/kg bw/d，ARfD设定为0.2 mg/kg bw/d。根据DAR，阐明了苯醚甲环唑在4种主要作物中的代谢，并提出了苯醚甲环唑母体残留定义，以供风险评估和执法使用。然而，除了苯醚甲环唑，在作物的几个部分三唑衍生物代谢物（TDM），这是已知的几种物质属于三唑类化学物质的共同代谢物，被确定为TRR的主要部分。尽管在拟议用途后，TDM不会以令人担忧的数量出现，但应考虑到TDM可能出现在来自苯醚甲环唑以外其他来源的植物商品中，因此可能需要对消费者接触水平进行评估。为解决这一问题，欧盟正在制定一项关于贸易发展机制风险评估的共同办法。这将涉及设定TDM的毒理学参考值，并对母体化合物和TDM进行单独的风险评估。由于根据代谢研究，在植物的多叶部分（叶子，叶子），母体苯醚甲环唑是主要的关注残留物，EFSA得出结论，考虑中的作物（叶菜）的代谢途径已得到充分解决，目前不需要进行额外的代谢研究。然而，这一结论可根据同行审评的结果并按照欧盟关于贸易发展机制风险评估的办法重新审议。提交的关于茴香、欧芹、芹菜叶和细芹的监督残留试验数据表明，为了适应苯醚甲环唑在比利时的预期用途，将需要比环境管理系统建议的更高的最高残留限量。尚未提交关于所考虑作物的加工研究，也没有必要提交，因为这些作物对总膳食摄入量的贡献很小。所有所考虑作物都可以作为轮作作物种植，因此还调查了轮作作物中苯醚甲环唑残留的情况。在DAR中得出的结论是，轮作作物中鉴定的代谢物与在主要作物中观察到的代谢途径一致。然而，一旦有了这类评估的方法，就应重新考虑轮作作物中有关TDM的情况，同时考虑到产生这些共同代谢物的所有活性物质。关于目前的申请，欧洲食品安全局的结论是，如果苯醚甲环唑按照拟议的GAP施用，预计轮作作物中苯醚甲环唑的残留水平不会很高。由于考虑中的作物不用作牲畜饲料，因此未在提交的申请框架内评估动物源性商品中的残留。消费者风险评估是根据欧洲食品安全局PRIMo第2版进行的。对于慢性摄入评估，EFSA使用了法规（EC）No 396/ 2005附件III中规定的苯醚甲环唑的现有MRL以及苯醚甲环唑在考虑作物上预期用途的STMR值。对于各种植物商品，STMR值可用于改进摄入量计算。急性摄入量评估仅针对所考虑的作物进行，使用根据苯醚甲环唑在这些作物上的预期用途得出的HR值。总计算摄入量值范围为ADI的16.6 - 98.7%。芹菜叶、欧芹和山芹对膳食摄入量的贡献微不足道。茴香对总膳食摄入量的贡献最大为ADI（IT成人膳食）的1.62%。未发现所考虑作物的急性摄入问题。对急性参考剂量的贡献最大，茴香为33.7%，芹菜叶为16.3%，雪芹为3.7%，欧芹为2.2%。数据充分支持了TDM残留对消费者的风险，应该注意的是，TDM残留在主要作物和轮作作物中的贡献由于目前欧盟对三唑代谢物的风险评估方法仍在制定中，因此在消费者风险评估中未考虑使用苯醚甲环唑产生的毒性。由于欧洲食品安全局尚未对DAR进行同行评审，因此必须将本合理意见中得出的结论视为临时结论，并可能根据苯醚甲环唑同行评审过程中得出的结论重新考虑。（图形）
According to Article 6 of the Regulation (EC) No 396/2005, Belgium hereafter referred to as the Evaluating Member State (EMS), compiled two applications to modify the existing MRLs for difenoconazole in parsley, celery leaves, chervil and fennel. In order to accommodate for a new uses of difenoconazole in Belgium, it is proposed to raise the existing MRLs for fennel from 0.3 mg/kg to 5 mg/kg, for parsley, celery leaves from 3 mg/kg to 10 mg/kg and for chervil from 2 mg/kg to 10 mg/kg. Belgium drafted evaluation reports according to Article 8 of Regulation (EC) No 396/2005 which were submitted to the European Commission and forwarded to EFSA on 29 may 2009. EFSA considered both applications in one reasoned opinion.EFSA derives the following conclusions regarding the applications, based on the above mentioned evaluation reports as well as the Draft Assessment Report prepared by Sweden.The toxicological reference values for difenoconazole are reported in the DAR and currently the ADI is set at 0.01 mg/kg bw/d and the ARfD is set at 0.2 mg/kg bw.According to the DAR metabolism of difenoconazole in primary crops is elucidated in four crop categories and residue definition for risk assessment and enforcement is proposed as parent difenoconazole. Nevertheless, apart from difenoconazole, in several parts of crops triazole derivative metabolites (TDMs), which are known as common metabolites of several substances belonging to the triazole chemical class, were identified as a major part of the TRR. Even though TDMs would not occur in amounts of concern following the proposed use, consideration should be given to the fact that TDMs can occur in plant commodities from other sources than difenoconazole therefore resulting in levels that might require consumer exposure assessment. For addressing this issue, a common EU approach on risk assessment of TDMs is under development. It would involve setting of toxicological reference values for TDMs and performing separate risk assessments for the parent compounds and TDMs. Since in leafy parts of the plants (foliage, leaves) parent difenoconazole was the major residue of concern according to metabolism studies, EFSA concludes that metabolic pathway in crops under consideration (leafy vegetables) is sufficiently addressed and no additional metabolism studies are currently required. This conclusion, however, might be reconsidered in a light of the outcome of the peer review and in accordance with the EU approach regarding risk assessment of TDMs. Adequate analytical methods are available to enforce the proposed MRLs.Submitted supervised residue trials data on fennel, parsley, celery leaves and chervil indicate that higher MRLs than proposed by the EMS would be required in order to accommodate for the intended use of difenoconazole in Belgium. Processing studies have not been submitted with regard to the crops under consideration and are not necessary, since the contribution of them to the total dietary intake is very low.All crops under consideration can be grown as rotational crops therefore occurrence of difenoconazole residues in rotational crops was also investigated. In the DAR it was concluded that the identified metabolites in rotational crops are in accordance with the metabolic pathway observed in primary crops. However, the situation in rotational crops regarding TDMs should be reconsidered taking into account all active substances which produce these common metabolites as soon as the methodology for this type of assessment is available. With regard to the current application, EFSA concludes that significant residue levels of difenoconazole are not expected in rotational crops provided that difenoconazole is applied according to the proposed GAP.Residues in commodities of animal origin were not assessed in the framework of submitted applications since crops under consideration are not used as a livestock feed.The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the chronic intake assessment EFSA used the existing MRLs for difenoconazole as established in Annex III of Regulation (EC) No 396/ 2005 as well as the STMR values derived for the intended use of difenoconazole on crops under consideration. For various plant commodities STMR values were available to refine intake calculations. Acute intake assessment was performed only with regard to crops under consideration, using HR values as derived for the intended use of difenoconazole on these crops.No consumer intake concerns were identified for any of the European diets. Total calculated intake values ranged from 16.6 -98.7 % of the ADI. Contribution of celery leaves, parsley and chervil to the dietary intake is insignificant. The contribution of fennel to the total dietary intake amounts for a maximum of 1.62% of the ADI (IT Adult diet). No acute intake concerns were identified for the crops under consideration. Contribution to the ARfD amounts for a maximum of 33.7% for fennel, 16.3% for celery leaves, 3.7% for chervil and 2.2% for parsley.Consequently, EFSA concludes that the intended use on fennel, parsley, celery leaves and chervil is sufficiently supported by data and no risk for consumers was identified.It should be noted that the contribution of TDM residues in primary crops and rotational crops resulting from the use of difenoconazole has not been taken into account in the consumer risk assessment since at the moment the EU approach for the risk assessment of triazole metabolites is still under development. As the DAR has not yet been peer reviewed by EFSA, the conclusions reached in this reasoned opinion have to be taken as provisional and might be reconsidered in the light of the conclusions reached in the peer review process for difenoconazole.(GRAPHICS)