Kättström Diana, Beronius Anna, Boije Af Gennäs Urban, Rudén Christina, Ågerstrand Marlene
Department of Environmental Science, Stockholm University, Stockholm, Sweden.
Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
Front Toxicol. 2024 Oct 3;6:1452065. doi: 10.3389/ftox.2024.1452065. eCollection 2024.
The CLP mandates manufacturers and importers to classify substances and mixtures according to hazard criteria, with notifications submitted to the European Chemicals Agency (ECHA). Substances meeting hazard criteria must be appropriately labelled and packaged to communicate hazards effectively. The CLP establishes hazard classification criteria but does not independently prohibit or restrict the use of hazardous chemicals. Instead, it serves as a basis for regulatory obligations in other specific regulations. This study investigates the regulatory implications of meeting hazard criteria under the CLP across EU regulations and directives listed in EU Chemicals Legislation Finder (EUCLEF). The results show that fulfilling criteria for human health hazard classes trigger regulatory obligations in the highest number of regulations/directives, with carcinogenicity, mutagenicity, and reproductive toxicity (CMR) leading to obligations in 19 of 20 pieces of legislation linked to the CLP. Conversely, physical, environmental, and ozone layer hazards are associated with fewer regulations and directives, and lead to fewer prohibitions. The study underscores the pivotal role of the CLP in EU chemical legislation and the need for coherence and consistency across regulations. While regulatory obligations are primarily aimed at substances meeting hazard criteria, the variability in self-classification notifications and limitations in harmonized classification processes were observed. Moreover, the complexity of the regulatory structure poses challenges for stakeholders and policymakers, including inconsistencies, compliance difficulties, and the need for frequent revisions. Addressing these challenges is critical for enhancing regulatory effectiveness and ensuring a more coherent and harmonized approach to chemical management in the EU.
《分类、标签和包装法规》规定制造商和进口商应根据危险标准对物质和混合物进行分类,并向欧洲化学品管理局(ECHA)提交通知。符合危险标准的物质必须进行适当的标签和包装,以有效传达危险信息。《分类、标签和包装法规》确立了危险分类标准,但并不独立禁止或限制危险化学品的使用。相反,它作为其他具体法规中监管义务的基础。本研究调查了在《分类、标签和包装法规》下符合危险标准对欧盟法规和指令(列于欧盟化学品立法查找器(EUCLEF)中)的监管影响。结果表明,满足人类健康危险类别的标准会触发最多数量法规/指令中的监管义务,其中致癌性、致突变性和生殖毒性(CMR)导致与《分类、标签和包装法规》相关的20项立法中的19项产生义务。相反,物理、环境和臭氧层危害涉及的法规和指令较少,导致的禁令也较少。该研究强调了《分类、标签和包装法规》在欧盟化学品立法中的关键作用,以及法规间保持连贯和一致的必要性。虽然监管义务主要针对符合危险标准的物质,但观察到自我分类通知存在差异以及统一分类过程存在局限性。此外,监管结构的复杂性给利益相关者和政策制定者带来了挑战,包括不一致性、合规困难以及频繁修订的必要性。应对这些挑战对于提高监管有效性以及确保欧盟在化学品管理方面采取更连贯和统一的方法至关重要。