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ORIGINAL RESEARCH article

Front. Toxicol.
Sec. Regulatory Toxicology
Volume 6 - 2024 | doi: 10.3389/ftox.2024.1452065
This article is part of the Research Topic Emerging topics on chemical safety assessment View all articles

Fulfilling the criteria for CLP classification: the implications for substances under the EU chemicals legislation

Provisionally accepted
Diana Kättström Diana Kättström 1*Anna Beronius Anna Beronius 2Urban Boije Af Gennäs Urban Boije Af Gennäs 3Christina Rudén Christina Rudén 1Marlene Ågerstrand Marlene Ågerstrand 1
  • 1 Department of Environmental Science, Faculty of Science, Stockholm University, Stockholm, Stockholm, Sweden
  • 2 Institute of Environmental Medicine, Karolinska Institutet (KI), Stockholm, Stockholm, Sweden
  • 3 Swedish Chemicals Agency, Sundbyberg, Sweden

The final, formatted version of the article will be published soon.

    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. yes no no no Biocidal Products Regulation, (EU) 528/2012 02012R0528-20220415 yes yes yes yes Chemical Agents Directive, 98/24/EC 01998L0024-20190726 yes yes no no Carcinogens and Mutagens Directive, 2004/37/EC 02004L0037-20220405 no yes no no Cosmetic Products Regulation, (EC) 1223/2009 02009R1223-20230816 yes yes yes yes

    Keywords: clp, Hazard classification, Hazard criteria, EU legislation, Chemical Strategy for Sustainability

    Received: 20 Jun 2024; Accepted: 31 Jul 2024.

    Copyright: © 2024 Kättström, Beronius, Boije Af Gennäs, Rudén and Ågerstrand. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Diana Kättström, Department of Environmental Science, Faculty of Science, Stockholm University, Stockholm, SE-11418, Stockholm, Sweden

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.