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Compliance: European Commission Spurs Confusion

Nov. 22, 2022
European Commission proposes adding new hazard classes and criteria to its CLP labeling regulations to address endocrine disruptors and substances that are persistent, bioaccumulative, toxic and mobile.

On September 20, 2022, the European Commission (EC) began a public consultation on an initiative that would introduce new hazard classes to Regulation (EC) No 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures (CLP). It would add hazard classes and criteria for endocrine disruptors and substances that are persistent, bioaccumulative, and toxic (PBT); very persistent and very bioaccumulative (vPvB); persistent, mobile, and toxic (PMT); or very persistent and very mobile (vPvM). This column explains why this could be a very big deal in the United States.

Why Is the EC Proposing This?

The inclusion of the new hazard classes addresses commitments under the Chemicals Strategy for Sustainability (CSS). This is a key building block for the European Green Deal and is intended to protect human health and the environment. Public consultations on the revisions to the CLP regulation were held in 2021, eliciting a variety of responses. Some supported the introduction of new hazard classes, while others pointed out that the introduction of new hazard classes, which are not currently part of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS), would “lead to potential information overload in hazard communication, distort the level playing field of international trade, and lead to cost increases for various activities.”

The proposed changes include amendments to Part 3 of Annex I of CLP to incorporate new hazard classes for endocrine-disrupting properties for human health with definitions, classification criteria for both substances and mixtures, and new label elements. The definitions proposed do not align with World Health Organization (WHO) definitions and criteria for endocrine disruptors. A separate inclusion in Part 4 of Annex I of CLP would include endocrine-disrupting properties for the environment. This would add definitions, classification criteria for both substances and mixtures, and new label elements.

Part 4 will also include the introduction of PBT or vPvB properties, the criteria of which align with the concepts introduced in Annex XIII to Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), except it includes, as part of toxicity criteria, consideration for endocrine disruption for humans and the environment. Classification as a PBT or vPvB will include new criteria for classification of substances and mixtures, and new label elements.

Further proposed amendments to Part 4 include the additions of PMT or vPvM properties, and will contain definitions, classification criteria for substances and mixtures, and new label elements. Note that “persistent” and “very persistent” here are defined identically to P and vP from PBT and vPvB. “Toxicity” definitions also are identical to T from the amended PBT. The introduction of “mobility, (M)” and “very mobile, (vM)” centers around organic carbon partition coefficients (Koc) and Koc with pH values for ionizable substances. A log Koc of less than 3 meets the criteria for M, and a log Koc of less than 2 is considered vM.

Discussion

The UN GHS adaptation into its CLP regulation is one of the most complex aspects of GHS implementation. CLP contains many variations to UN GHS that result in a hazard communication process consistently misaligned with other countries’ approaches. The proposed revisions lack clarity and add layers of confusion to an already complex approach to hazard classification. Previous responses to comments agreed the criteria are important, but introducing PBT, vPvB, PMT, and vPvM was not necessary.

Adding endocrine disruption to the toxicity category also invites confusion with respect to alignment with REACH Annex XIII. Changes to the safety data sheet (SDS) format as part of the amendments to Annex II to REACH, which take effect later this year, also incorporate endocrine disruption. By including these endpoints as required elements for classification, the EC appears to be pushing its agenda in advance of any consideration of the UN GHS subcommittee and the process of harmonization. Comments from responders noted these measures should only be introduced in response to implementation at the UN GHS level.

Stakeholders should consider the implications of these criteria and the impact of the hazard communication tools utilized within the European Union. These endpoints are not part of the United Kingdom approach, and the addition of new hazard classes will create further separation from the post-Brexit operations for companies within the region.

About the Author

Lynn L. Bergeson, Compliance Advisor columnist

LYNN L. BERGESON is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.

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