EFSA J. 2020 Dec 15;18(12):e06318. doi: 10.2903/j.efsa.2020.6318. eCollection 2020 Dec.
Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Article 12(2) of that Regulation stipulates that EFSA shall provide by 1 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC before 2 September 2008. Among the active substances that need to be reviewed under Article 12(1) or Article 12(2) of Regulation (EC) No 396/2005, EFSA identified 12 active substances for which a review of MRLs is no longer considered necessary, including five active substances that were already included temporarily in Annex IV of Regulation (EC) No 396/2005 by risk managers pending finalisation of their evaluation under Directive 91/414/EEC or Regulation (EC) No 1107/2009 and pending submission of EFSA's reasoned opinion in accordance with Article 12 of Regulation (EC) No 396/2005. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.
(欧盟)第396/2005号法规确立了欧洲层面农药最大残留限量(MRLs)的设定和审查规则。根据(欧盟)第396/2005号法规第12(1)条,欧洲食品安全局(EFSA)应在活性物质被纳入或未被纳入理事会指令91/414/EEC附件I之日起12个月内,就该活性物质现有最大残留限量的审查提供一份有理由的意见。该法规第12(2)条规定,欧洲食品安全局应在2009年9月1日前,就2008年9月2日前已纳入理事会指令91/414/EEC附件I的所有活性物质现有最大残留限量的审查提供一份有理由的意见。在根据(欧盟)第396/2005号法规第12(1)条或第12(2)条需要审查的活性物质中,欧洲食品安全局确定了12种不再认为有必要审查最大残留限量的活性物质,其中包括5种活性物质,风险管理者已根据理事会指令91/414/EEC或(欧盟)第1107/2009号法规对其进行最终评估,并根据(欧盟)第396/2005号法规第12条提交欧洲食品安全局有理由的意见之前,已将其临时列入(欧盟)第396/2005号法规附件IV。欧洲食品安全局编写了一份声明,解释了对这些物质最大残留限量审查过时的原因。本声明视为已解决相关问题编号。