Council of the European Union Approves Amendments to CLP Regulation Annex VI

On 9th June 2023, the Council of the European Union expressed its non-objection to the "Commission Delegated Regulation (EU) /... aimed at amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council". The proposed amendments are intended to align the regulation with the latest technical and scientific progress in the field of classification, labeling, and packaging of substances and mixtures.

The CLP regulation (Regulation (EC) No 1272/2008) plays a crucial role in ensuring the safe handling and communication of hazardous substances and mixtures within the European Union. It sets standards for their classification, labeling, and packaging to safeguard human health and the environment.

In this regard, Annex VI of the CLP regulation contains a comprehensive list of notes that can be attributed to substances with harmonized classification. These notes provide specific instructions on how to classify and label substances or mixtures containing them, enhancing the accuracy and consistency of hazard communication.

The delegated act amends Part 1 of Annex VI of the CLP regulation by introducing new notes in sections 1.1.3.1 and 1.1.3.2. Here is a summary of the changes:

1. In section 1.1.3.1, a new note X is added. This note clarifies that the classification for the hazard class(es) mentioned in the entry is based solely on the hazardous properties of the part of the substance that is common to all substances within the entry. It emphasizes that the hazardous properties of any substances within the entry also depend on the properties of the part of the substance that is not common to all substances in the group. To ensure accurate classification, the non-common part of the substance must be evaluated to assess whether a higher category or a broader scope of the same classification (additional differentiation, target organs, and/or hazard statements) might apply for the hazard class(es) in the entry.

2. In section 1.1.3.2, two new notes, 11 and 12, are introduced. Note 11 states that if a mixture contains individual boron compounds classified as reproductive toxicants, the classification of the mixture as a reproductive toxicant is necessary when the sum of the concentrations of these compounds in the mixture, as placed on the market, is equal to or exceeds 0.3%. Note 12 states that if a mixture contains individual substances covered by the entry, the classification of the mixture as a reproductive toxicant is necessary when the sum of the concentrations of these substances in the mixture, as placed on the market, is equal to or above the applicable generic concentration limit for the assigned category or a specific concentration limit mentioned in the entry.

These amendments provide additional guidance for the classification and labeling of substances and mixtures. They address the considerations related to the common and non-common parts of substances within an entry, as well as specific criteria for the classification of mixtures as reproductive toxicants based on the concentrations of certain substances. These updates aim to enhance the accuracy and consistency of hazard communication within the CLP regulation framework.

Link to Delegated act and related annex