On the 20th of November 2024, the Regulation (EU) 2024/2865 was published and is in force since the 10th of December. It amends the Regulation (EC) No 1272/2008 (CLP) and, among other changes, brings new requirements for notifications to the C&L Inventory, which are defined in Article 40. All new provisions derived from Article 40 revision shall apply from 1st of July 2026.
These changes aim to improve the C&L Inventory as a substance hazard communication tool and resolve hazard classification discrepancies, leading to a more robust and reliable regulatory framework.
In the following sections, we explain the most relevant aspects of the C&L Inventory changes and how they affect manufacturers and importers placing hazardous substances on the market.
Key Changes Related to the C&L Inventory
Acute Toxicity Estimation (ATE)
ATEs have always been an integral part of the CLP framework. These estimates are primarily used to determine acute toxicity classifications for human health when assessing mixtures containing substances classified for acute toxicity. Acute toxicity values are typically expressed as LD50 (oral, dermal) or LC50 (inhalation) values, or as acute toxicity estimates (ATEs).
This regulation amendment introduces a formal definition of ATE: numeric values used to classify substances and mixtures in one of four acute toxicity hazard categories based on the oral, dermal or inhalation exposure route.
Under the revised Article 40, manufacturers and importers must establish and notify the ATE values for all substances classified for acute toxicity, regardless of hazard category. In the same way as M-factors and concentration limits, acute toxicity estimates should be now part of the C&L notifications to ECHA.
This requirement ensures more precise hazard classifications based on specific data rather than generalized assessments, leading to a more accurate reflection of risk levels.
Hazard Classification Divergence
A key update introduced by the regulation under Article 40 is the requirement for companies to justify classification divergences.
When a company introduces a hazard classification that differs from the most severe classification already listed in the harmonized classification and labelling of substances in Part 3 of Annex VI, they must now explain their reasons for divergence.
This also applies to cases where a more severe classification per hazard class is proposed aiming to ensure scientific accuracy and consistency throughout the inventory.
New Responsibilities: Addressing Classification Inconsistencies
A significant challenge in the current C&L Inventory system is the frequent occurrence of divergent notifications for the same substance from different manufacturers and importers.
While some of these divergences are justified by legitimate factors such as varying impurities or physical states, others arise from less substantial reasons: differences in classification data interpretation, disagreements between notifiers or registrants, or simply outdated classification entries that have not been reviewed. This can ultimately lead to misleading hazard communications.
These inconsistencies have impacted the C&L Inventory's effectiveness as a hazard communication tool. The presence of divergent and imprecise classifications not only creates confusion but also increases the risk of misclassification throughout the supply chain.
To address these issues, notifiers should review and, if necessary, update their substance classifications, ensuring they are based on current data. When applicable, this includes providing specific ATE values. Exceptionally, ECHA may require the notifier to rectify an entry that is incomplete, incorrect or obsolete.
This shift towards an evidence-based approach aims to ensure that hazard labels reflect scientifically justified classifications.
Take Action and Prepare for Change
The new CLP requirements bring, among other things, important updates to how companies must manage their C&L notifications. While the changes strengthen transparency and safety in chemical hazard communication, they also introduce additional information demands.
Organizations are now required to maintain detailed records of classification decisions, ATEs, and justifications for any classification divergences.
In response to these evolving regulatory demands, companies are turning to automation to transform these challenges into an opportunity for process improvement: solutions for maintaining compliance while optimizing resources. This approach allows regulatory teams to focus on high-value processes rather than routine data management tasks.
Our opesus EPN solution for SAP enables automated notifications to the European Chemicals Agency (ECHA), ensuring your submissions are accurate, timely, and fully aligned with the new regulatory framework.
