Hunt Neil, Kestens Vikram, Rasmussen Kirsten, Badetti Elena, Soeteman-Hernández Lya G, Oomen Agnes G, Peijnenburg Willie, Hristozov Danail, Rauscher Hubert
YORDAS Group, Lancaster Environment Centre, Lancaster University, Lancaster, UK.
European Commission, Joint Research Centre (JRC), Geel, Belgium.
NanoImpact. 2025 Jan;37:100538. doi: 10.1016/j.impact.2024.100538. Epub 2024 Dec 19.
In 2018 the European Commission adopted revisions to the Annexes of Regulation (EC) No 1907/2006 concerning registration, evaluation, authorisation and restriction of chemicals (REACH) to introduce nanomaterial-specific clarifications and provisions. Multicomponent nanomaterial (MCNM) is a non-regulatory term that has been used in recent EU-funded projects to describe nanomaterials with a complex structure and/or composition and which are expected to be increasingly used in products in the near future. This paper examines the regulatory preparedness of REACH, and its revised Annexes, for MCNMs. Several situations have been identified where there is potential confusion and uncertainty around how regulatory definitions used in REACH should be applied to MCNMs. If a MCNM cannot be identified as falling within a specific definition, understanding the regulatory obligations that apply to it is very difficult. Examples of these grey areas include how the term "surface functionalisation or modification" applies when a chemical is physisorbed to the surface of a nanoform, and the identity of the substance that should be registered when the modification takes it outside the definition of a nanoform. We conclude that the regulatory preparedness can be improved by amending the REACH guidance on information requirements for nanoforms and revising the definition of "nanoform" in line with the updated EC Recommendation on the definition of nanomaterial.
2018年，欧盟委员会对关于化学品注册、评估、授权和限制的第（EC）No 1907/2006号法规的附件进行了修订，以引入针对纳米材料的具体说明和规定。多组分纳米材料（MCNM）是一个非监管术语，在最近由欧盟资助的项目中被用来描述具有复杂结构和/或组成的纳米材料，预计在不久的将来这类材料在产品中的使用会越来越多。本文研究了REACH法规及其修订后的附件对多组分纳米材料的监管准备情况。已确定了几种情况，即围绕REACH法规中使用的监管定义应如何应用于多组分纳米材料存在潜在的混淆和不确定性。如果无法确定一种多组分纳米材料属于某个特定定义范围，那么理解适用于它的监管义务就非常困难。这些灰色地带的例子包括，当一种化学品物理吸附在纳米形式的表面时，“表面官能化或改性”这一术语如何适用，以及当改性使其超出纳米形式的定义时应注册的物质的身份。我们得出结论，通过修订REACH法规中关于纳米形式信息要求的指南，并根据欧盟委员会关于纳米材料定义的最新建议修订“纳米形式”的定义，可以提高监管准备情况。
