European Union Proposes to Add New Hazard Classes to its CLP Regulations for Endocrine Disrupting Chemicals

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December 6, 2022

European Union Proposes to Add New Hazard Classes to its CLP Regulations for Endocrine Disrupting Chemicals

On September 20, the European Commission (EC) published a proposal to amend the European Union’s Classification, Labelling and Packaging (CLP) Regulation of substances and mixtures (EC No. 1272/2008), and sought stakeholder feedback on this proposed amendment by October 18.  The proposal identified four new hazard categories for endocrine disrupting chemicals, including “known or presumed” (Category 1) and “suspected” (Category 2) endocrine disruptors for human health or the environment.  The proposal also describes a range of criteria to be used for classification, and advocates for the use of a weight-of-evidence approach informed by expert judgment.

Given that the proposed new hazard categories have not been adopted under the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS), it is yet unclear how the EC proposal will impact GHS and other chemical regulations. Further, given a lack of technical guidance for the proposed CLP classifications, the type of endocrine-related data that should be used and how it will support classification decisions is currently uncertain.

Regardless of these uncertainties, it is clear that enactment of the EC’s proposal would result in significant impacts to businesses, such as reclassification and labeling of substances and mixtures containing endocrine disruptors, updates to safety data sheets, revised registrations, etc.  Even if the CLP proposal is not enacted in its current form, it is critical for industry stakeholders to evaluate the impact of this proposal, or similar future regulatory proposals, on their products.

For more than two decades, Gradient scientists have been at the forefront of the topic of endocrine disrupting chemicals, including drafting technical documents to support the United States Environmental Protection Agency’s Endocrine Disruptor Screening Program, conducting weight-of-evidence reviews, overseeing product portfolio vulnerability assessments, and incorporating endocrine disruption into product stewardship programs. To discuss this issue further, please contact us (see the list below).

Gradient will be hosting a webinar in the near future to discuss the potential impact of the EC’s recent CLP proposal. This webinar will discuss recommended actions businesses can take, with examples from past and ongoing projects. Watch for more information on this webinar, which will be coming soon.

Topics:  Endocrine Disruption, Hazard Categories, Safety Data Sheets, Chemical Registration


Ari S. Lewis, M.S.

Tim Verslycke, Ph.D.