关于在 REACH 中实施混合物分配系数的法规和实际考虑因素

IF 6 3区 环境科学与生态学 Q1 ENVIRONMENTAL SCIENCES Environmental Sciences Europe Pub Date : 2024-05-19 DOI:10.1186/s12302-024-00910-z
Gabriele Treu, Jona Schulze, Wiebke Galert, Enken Hassold
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引用次数: 0

摘要

有无可争辩的证据表明,环境、人类和野生动物持续接触的不是单一的化学品,而是来自不同来源的多种化学品。接触这些混合物可能会导致综合风险,但任何欧洲化学品立法都没有充分解决这一问题。根据针对工业化学品的 REACH 法规,由于缺乏有关毒性、使用和接触的数据以及供应链上的数据交流,具体的环境混合物评估面临挑战。在化学品可持续发展战略中,欧盟委员会建议引入混合物分配系数(MAF)作为法规管理工具,以减少无意混合物的暴露、影响和潜在风险。根据 REACH 法规,建议将 MAF 作为默认值应用于公司进行的化学品安全评估。在此,我们对相关文献进行了批判性回顾,讨论了 MAF 的概念背景和得出其大小的方法。分析的重点是在监管实践中实施的环境和关键问题,以及剩余的不确定性和可能的前进方向需求。现阶段,在 REACH 法规附件 I 中引入 MAF 似乎是解决环境中无意混合物风险的最务实和可立即实施的措施。所谓的 MAF 上限似乎是决策者的首选方案,因为它只会影响接近各自风险阈值的相关物质。虽然 MAF 的大小将在政治上决定,但得出其大小的方法和假设的选择应清晰透明,以现有的科学证据为基础,并考虑到不确定性。如果风险减缓措施得到切实执行,那么最大允许减排量就能最有效地减少环境排放和暴露水平。其社会经济影响和成本需要与对环境、社会和公司的益处进行平衡评估,同时也要与特定混合物风险评估所需的努力进行比较。未来,根据在实践中积累的经验,需要讨论如何在不同的化学品立法中对无意混合物进行评估和监管,以考虑真实的暴露情况并确保协调性。
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Regulatory and practical considerations on the implementation of a mixture allocation factor in REACH

There is indisputable evidence that the environment, humans and wildlife are continuously exposed not to single but to multiple chemicals from different sources. Exposure to these mixtures can lead to combined risks not yet sufficiently addressed in any of the European chemical legislations. Under the REACH regulation for industrial chemicals, specific environmental mixture assessments are challenged by a lack of data on toxicity, use and exposures and the communication of data along the supply chain. Within the Chemicals Strategy for Sustainability the European Commission proposed to introduce (a) mixture allocation factor(s) (MAF) as regulatory management tool to reduce exposures, effects and potential risks of unintentional mixtures. The MAF is proposed to be applied as default value within the chemical safety assessments undertaken by companies under REACH. Here, we critically review the relevant literature discussing the conceptual background of the MAF and approaches to derive its magnitude. The analysis focuses on the environment and key issues for an implementation in regulatory practise together with remaining uncertainties and needs for possible ways forward. At this stage introducing a MAF in REACH Annex I appears the most pragmatic and immediately implementable measure to address risks from unintentional mixtures in the environment. A so-called MAFceiling appears as the preferred option of policy makers, since it would only affect relevant substances close to their respective risk threshold. While the magnitude of a MAF will be decided politically, the choice of methods and assumptions to derive its size should be clear and transparent, build on the available scientific evidence and take account for uncertainties. A MAF will be most effective reducing environmental releases and exposure levels if risk mitigation measures are implemented in practise. Its socioeconomic impacts and costs need to be assessed in a balanced way together with the benefits for the environment, society, and for companies—also in comparison to the efforts needed for specific mixture risk assessments. In the future and with the experiences gathered in practise, a discussion is needed on how to assess and regulate unintentional mixtures across different pieces of chemicals legislation to consider the true exposure situation and ensure harmonisation.

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来源期刊
Environmental Sciences Europe
Environmental Sciences Europe Environmental Science-Pollution
CiteScore
11.20
自引率
1.70%
发文量
110
审稿时长
13 weeks
期刊介绍: ESEU is an international journal, focusing primarily on Europe, with a broad scope covering all aspects of environmental sciences, including the main topic regulation. ESEU will discuss the entanglement between environmental sciences and regulation because, in recent years, there have been misunderstandings and even disagreement between stakeholders in these two areas. ESEU will help to improve the comprehension of issues between environmental sciences and regulation. ESEU will be an outlet from the German-speaking (DACH) countries to Europe and an inlet from Europe to the DACH countries regarding environmental sciences and regulation. Moreover, ESEU will facilitate the exchange of ideas and interaction between Europe and the DACH countries regarding environmental regulatory issues. Although Europe is at the center of ESEU, the journal will not exclude the rest of the world, because regulatory issues pertaining to environmental sciences can be fully seen only from a global perspective.
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