Regulatory Developments: UN Publishes GHS Rev 10


On July 27, 2023, the United Nations (UN) published an electronic version of the tenth revision (Rev 10) of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) available for free for consultation purposes. The amendments to the ninth revision of the GHS (Rev 9) include the classification procedure for desensitized explosives (Chapter 2.17); the use of non-animal testing methods for classification of health hazards, in particular: skin corrosion/irritation (Chapter 3.2), serious eye damage/eye irritation (Chapter 3.3), and respiratory or skin sensitization (Chapter 3.4); further rationalization of precautionary statements to improve users’ comprehensibility while taking into account usability for labeling practitioners; and the review of Annexes 9 and 10 to ensure alignment of the classification strategy, guidance, and tools on metals and metal compounds with the provisions for long-term aquatic classification toxicity in Chapter 4.1.

The most significant changes are in Chapters 3.3 and 3.4. The changes focus heavily on guidance for the use of non-animal test methods and how to apply a weight of evidence assessment. These additions/revisions allow the user additional insight on how to utilize multiple data endpoints to determine if the criteria are met. The revisions include the following new subchapters:

Chapter 3.3

Chapter 3.4

Commentary

The most relevant revisions and additions to Rev 10 relate to the non-animal method approaches for serious eye damage/irritation and skin sensitization endpoints. The inclusion of several new/revised figures and tables will allow users to navigate this space more efficiently. The continued use and development of these non-animal methods in the registration and evaluation of chemicals created a gap in criteria-based approaches to classification and labeling. The revisions and additions in Rev 10 and previous revised editions are now addressing these developments. The use of non-animal methods is a useful tool for any stakeholder in this space, even if the jurisdiction you are operating within is not yet aligned with these revisions.

The UN GHS sub-committee continues to clarify physical hazard classes with revisions to Chapter 2.17, Desensitized Explosives. Rev 9 included revisions to Chapter 2.1, Explosives, and Rev 10 further clarifies the exclusion of desensitized explosives from Chapter 2.1. These hazard classes appear to be a priority within the sub-committee, which aims to establish consistent approaches and address transport configurations.


©2024 Bergeson & Campbell, P.C.
National Law Review, Volumess XIII, Number 236