EU rolls out new hazard classes in the CLP Regulation

The amendment adding hazard criteria to the CLP Regulation (1272/2008/EC) for endocrine disruptors (EDs) and substances with persistent, bioaccumulative, and toxic (PBT) and persistent, mobile, and toxic (PMT) properties has been published in the EU Official Journal. Coming into force on April 20, companies will now have until May 1, 2025 to prepare for the first round of changes when the requirements to classify and label substances in line with the new rules begin to apply.

Regulatory background

• The revision of the Classification, Labeling, and Packaging Regulation (EC) 1272/2008 (CLP) represents a key commitment of the Chemicals Strategy for Sustainability (CSS), which seeks to bolster the protection of European citizens and the environment from toxic substances while advancing the design of safer and more sustainable chemicals. The CSS is part of the EU’s zero pollution ambition which, in turn, is one of many initiatives under the bloc’s European Green Deal.
• The inclusion of six hazard classes and their formal classification criteria is one of two legislative initiatives being undertaken as part of the CLP revision (see the other one on this page of the European Commission’s ‘Have your say’ portal). The classes cover endocrine disruption for human health (ED HH) and for the environment (ED ENV); as well as persistent, bioaccumulative, and toxic (PBT); very persistent, and very bioaccumulative (vPvB); persistent, mobile, and toxic (PMT); and very persistent, and very mobile (vPvM) properties. On December 19, 2022, the Commission adopted a delegated regulation formally establishing these six hazard classes. (See AgencyIQ’s October 5, 2022 article for a detailed analysis of the delegated regulation and possible implications of the new rules.)

New hazard classes officially part of the CLP framework

• Published in the EU Official Journal on March 31, 2023, Delegated Regulation (EU) 2023/707 formally introduces theses six hazard classes by updating the corresponding sections of annexes I, II, III, and IV of the CLP. In annex I, each hazard class includes relevant definitions (e.g., “endocrine disruptor,” “adverse effect,” “PBT,” “log K_oc”), the harmonized classification criteria for substances and mixtures of the hazard class, including hazard categories for substances and generic concentration limits for classified mixtures, corresponding hazard communication elements (e.g., signal words, and hazard and precautionary statements for labeling), as well as the transition periods that stakeholders have to implement these new requirements. The sections stipulating the annex I provisions are listed below for each of the six hazard classes (note that the section numbers are linked directly to the relevant part of the regulation):

Transition periods

• Affected companies have until May 1, 2025, to implement the classification and labeling provisions for substances for all hazard classes. They are given an additional 18 months, or until November 1, 2026, to classify and label substances that were placed on the market before May 1, 2025.
• For mixtures, the deadline to implement the classification and labeling rules for the new hazard classes is May 1, 2026. Similar to substances, mixtures that were already on the market before May 1, 2026 do not need to be classified and labeled in accordance with the new rules until May 1, 2028.

Analysis

• The introduction of the new hazard classes was in principle welcomed by companies and the EU co-legislators, according to the Commission’s targeted Impact Assessment (IA). However, industry expressed a significant reservation, voicing preference for these changes to first be incorporated at the international level via the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) before implementation in the EU. The fear widely expressed has been that by leapfrogging the UN, the EU’s classification and hazard communication rules would be out of sync with the rest of the world, likely leading to barriers to international trade and overall general confusion about these unknown classifications as products thus classified and labeled begin to circulate across international borders.
• The authors of the IA, however, have rejected this contention, arguing that “acting at EU level first will strengthen the EU’s role as a global front-runner in health and environmental standards, driving the EU industry’s leadership in producing and using sustainable chemicals, levelling the playing field, and thereby giving the EU industry a competitive advantage allowing it to increase its global market share for chemicals and safer alternatives.”
• Another concern that has been raised is the fact that these amendments have been introduced by way of a delegated act. Some observers have been vocal about what they perceive as the Commission using this instrument, which is reserved for non-legislative changes driven by adaptations to scientific and technical progress, to implement essentially legislative decisions that lie beyond the EU executive’s authority and, thus, should be subject to the EU’s ordinary legislative procedure. Following this line of reasoning, it has been suggested that an action for annulment of this CLP amendment in the General Court of the EU could be justified.

This article contains previous analysis contributed by Scott Stephens
To contact the author of this analysis, please email Scott Stephens.
To contact the editor of this analysis, please email Patricia Iscaro.

Key Documents and Dates

• Classification, Labeling, and Packaging Regulation (EC) 1272/2008
• Chemicals Strategy for Sustainability
• Delegated Regulation (EU) 2023/707