Anastassiadou Maria, Bernasconi Giovanni, Brancato Alba, Carrasco Cabrera Luis, Greco Luna, Jarrah Samira, Kazocina Aija, Leuschner Renata, Magrans Jose Oriol, Miron Ileana, Nave Stefanie, Pedersen Ragnor, Reich Hermine, Rojas Alejandro, Sacchi Angela, Santos Miguel, Theobald Anne, Vagenende Benedicte, Verani Alessia
EFSA J. 2020 Aug 25;18(8):e06234. doi: 10.2903/j.efsa.2020.6234. eCollection 2020 Aug.
According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sp. strain DSMZ 13134. To assess the occurrence of sp. strain DSMZ 13134 residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals cannot be derived and are deemed not to be necessary. A consumer risk assessment cannot be performed quantitatively. Although no apparent risk to consumers was identified, some information required by the regulatory framework would still be desirable. The outcome of the assessment was compared to the criteria defined by the European Commission for inclusion of pesticide active substances in Annex IV of the Regulation. A proposal for inclusion of sp. strain DSMZ 13134 into Annex IV of Regulation (EC) No 396/2005 is derived by EFSA based on the authorised uses of this Art. 12 review.
根据欧盟第396/2005号法规第12条,欧洲食品安全局(EFSA)审查了目前在欧洲层面为农药活性物质sp. strain DSMZ 13134设定的最大残留限量(MRLs)。为评估sp. strain DSMZ 13134在植物、加工产品、轮作作物和牲畜中的残留情况,EFSA考虑了欧盟委员会第188/2011号法规框架下得出的结论,以及成员国报告的欧洲授权情况(包括支持性残留数据)。基于对现有数据的评估,无法得出最大残留限量提案,且认为没有必要。无法进行定量的消费者风险评估。虽然未发现对消费者有明显风险,但监管框架仍需要一些信息。将评估结果与欧盟委员会在法规附件IV中纳入农药活性物质所定义的标准进行了比较。基于第12条审查的授权用途,EFSA提出了将sp. strain DSMZ 13134纳入欧盟第396/2005号法规附件IV的提案。