《欧洲透明度法规:风险评估和食品安全的新框架》

  • 来源专题:食物与营养
  • 编译者: 李晓妍
  • 发布时间:2021-04-27
  • 欧洲议会和理事会于2019年6月20日颁布的法规(EU) 2019/1381,即“透明度法规”,自2021年3月27日起生效,旨在提高欧盟食物链风险评估的透明度和可持续性。以下概述了该条例的主要变化及其对企业、民间社会代表和国家卫生机构的影响。法规(EU) 2019/1381正在提高欧盟食物链风险评估的透明度,以及欧洲食品安全局(EFSA)使用的研究的可靠性、客观性和独立性。它还加强了欧洲食品安全局的管理,每个成员国都在其管理委员会中有代表。
    新规定使公民能够查阅由行业提交给欧洲食品安全管理局的科学研究和信息。它规定,这些研究和这些信息应在风险评估过程开始时就以易于获取的电子格式发布,研究应可供搜索、下载和打印。《透明度法规》还包括在评估受监管产品授权申请的过程中进行公众咨询,目的是让欧洲食品安全局在进行风险评估时能够充分查阅现有证据。该法规确保欧洲食品安全管理局获悉所有由工业界委托和实验室进行的研究,以确保申请授权的企业提交所有相关信息。法规还修改了欧洲食品安全局的治理模式,将所有成员国的代表加入其管理委员会。目前正在努力增加会员国参与起草欧洲食品安全署的意见,并使每个人更容易获得关于评估和管理与食品有关的风险的信息。

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    • 来源专题:食物与营养
    • 编译者:潘淑春
    • 发布时间:2016-03-24
    • Commission Implementing Regulation (EU) No 844/2012 (hereinafter referred to as ‘the Regulation’) lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012. Mesotrione is one of the active substances listed in Regulation (EU) No 686/2012. In accordance with Article 1 of the Regulation, the rapporteur Member State (RMS), the United Kingdom, and co-rapporteur Member State (co-RMS), Belgium, received an application from Syngenta Crop Protection AG for the renewal of approval of the active substance mesotrione. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co-RMS (Belgium), the European Commission and the European Food Safety Authority (EFSA) about the admissibility. The RMS provided its initial evaluation of the dossier on mesotrione in the renewal assessment report (RAR), which was received by EFSA on 23 February 2015. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Syngenta Crop Protection AG, for comments on 17 April 2015. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 18 June 2015. Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicant, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour and ecotoxicology. In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether mesotrione can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of mesotrione as a herbicide on maize, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report. The use of mesotrione according to the representative use proposed at EU level results in a sufficient herbicidal efficacy against the target weeds. In the area of identity, physical/chemical/technical properties and methods of analysis, a data gap was identified for specifying two of the significant impurities on dry weight basis. Data gaps were identified for validation data of methods used in data generation. Regarding the mammalian toxicology area, a number of data gaps were identified. The toxicological relevance of individual impurities present in the technical specification in comparison with the toxicity profile of mesotrione needs to be addressed. Interspecies comparative in vitro metabolism should be conducted to identify at least potentially unique human metabolites to mesotrione. As the genotoxic potential of metabolite AMBA could not be ruled out due to positive results obtained in an in vitro cytogenetic assay, and no in vivo genotoxicity testing was performed, a critical area of concern has been identified regarding consumer risk assessment; repeated dose toxicity would also have to be addressed for this metabolite. Mesotrione is proposed to be classified as Repr. 2 for development by the peer review (in contrast with the harmonised classification according to CLP Regulation) and adverse effects were observed on endocrine organs. 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Enough information was available to finalise the exposure assessment in the environment. Nevertheless, a data gap has been identified for the applicant to address the substances of potential toxicological concern that could be derived from mesotrione and its metabolites under drinking water treatment procedure conditions to assess if the approval criteria in Article 4 of Regulation (EC) No 1107/2009 are satisfied. In the area of ecotoxicology, a data gap and a critical area of concern were identified to further address the long-term risk for wild mammals. A data gap was identified to further refine the risk to aquatic organisms in the scenarios R2, R3, and R4. Data gaps were also identified for bees to provide information to further assess the risk to adult honeybees and honeybee larvae from exposure via guttation and via consumption of contaminated water. Effects on HPG development should be considered. Furthermore additional data would be needed to assess the risk to honeybees for relevant metabolites in pollen and nectar. The risk to non-target terrestrial plants was low with mitigation measures. A data gap was also identified to further address the sensitivity to mesotrione of dicotyledonous and monocotyledonous plant species.
  • 《欧洲食品安全署(EFSA)发布关于转基因大豆新的测序信息的风险评估》

    • 来源专题:转基因生物新品种培育
    • 编译者:Zhao
    • 发布时间:2017-09-02
    • 日前,欧洲食品安全署(EFSA)发布了关于转基因大豆305423和40-3-2两种品系新的测序研究结果。 转基因生物研究小组目前就转基因大豆305423单一品系及双品系305423×40-3-2杂交组成部分来进行检测评估。这些品系的大豆经科学检测,其安全性与普通种类或其他类似植株一样,不会对人类和其他动物个体健康和生存环境造成威胁。2017年2月,欧盟委员会(EC)要求欧洲食品安全署(EFSA)对转基因大豆305423品系进行核酸序列测定,更新相关的生物信息学数据,以验证转基因生物研究小组之前对其作出的评估结果是否仍然有效。 研究表明,单品系305423转基因大豆与双品系杂交系305423×40-3-2之前的评估测定结果仍旧有效。而且,新的测序数据及其相应生物学分析研究,包括RNA脱靶搜索干扰,并没有引起安全问题。由此,欧洲食品安全署(EFSA)得出结论:之前做的关于品系305423转基因大豆与双品系杂交系305423×40-3-2的评估报告截至目前仍然有效。 同样地,转基因生物研究小组针对转基因大豆40-3-2单一品系及双品系305423×40-3-2杂交组成部分来进行检测评估。并且这些大豆品系的检测评估结果与305423品系相同,其安全性与普通种类或其他类似植株一样,不会对人类和其他动物个体健康和生存环境造成威胁。2017年4月,欧洲食品安全署(EFSA)对转基因大豆40-3-2品系进行新的核酸序列测定,更新了相关的生物信息学数据,验证了转基因生物研究小组之前对其作出的评估结果是否仍然有效。研究表明,单品系40-3-2转基因大豆与双品系杂交系305423×40-3-2之前的评估测定结果仍旧有效。而且,对新的测序数据的生物学分析也并没有显示出安全性问题有任何提升。因此,欧洲食品安全署(EFSA)得出结论:基于目前掌握的数据,转基因大豆40-3-2单一品系及双品系305423×40-3-2的原始风险评估仍旧有效。 需要了解更多信息,请查阅相关欧洲食品安全署期刊,以了解转基因大豆305423和40-3-2两个品类的更多资料。