EU Commission expert group set to discuss 19th and 20th ATPs to the CLP Regulation

The European Commission’s CARACAL expert group will consider proposed amendments to the CLP Regulation’s Annex VI harmonized substances list at its upcoming meeting in November. The draft ATPs propose adding notes clarifying classification requirements for certain substance group entries, as well as amending the entries to which these new notes apply.

BY SCOTT STEPHENS, MPA | NOV 7, 2022 9:56 AM EST

Harmonized classification and labeling (CLH) under the CLP Regulation

Substances that are identified as hazards of highest concern must be classified and labeled uniformly across all 27 European Union member states in accordance with the Classification, Labeling and Packaging Regulation (CLP – 1272/2008/EC). Such substances include carcinogens, mutagens, reproductive toxins (CMRs), and respiratory sensitizers, as well as other substances on a case-by-case basis.
Referred to as harmonized classification and labeling (CLH), the EU-wide approach is established in Title V of the CLP to ensure a high level of protection of human health and the environment while maintaining regulatory certainty and consistency throughout the EU market.
Table 3 of Part 3 of Annex VI to the CLP contains the harmonized list of substances that have been assigned classifications and corresponding labeling elements that are required for products (i.e., substances on their own and articles containing them) intended for the EU market. In other words, the substances listed in Table 3 are subject to the same classification and labeling requirements under the CLP regardless of where they are sold in the EU.

A short description of how the Annex VI harmonized list is amended

Member-state competent authorities or industry stakeholders signal their plans to initiate a CLH procedure by submitting a CLH intention. They then submit the proposal, called a CLH dossier. Note that the period between registering an intention and submission of the CLH dossier varies according to substance or substance group.
After dossier submission, a 60-day consultation is held, followed by the ECHA Committee for Risk Assessment’s (RAC) preparation of an opinion on the proposed harmonized classification of the substance or substance group in question.
Subsequently, the Commission, assisted by its CARACAL expert group, reviews the dossier, RAC’s opinion and stakeholder feedback, before making the final decision on updating Annex VI of the CLP.
Barring objections by the Council and the Parliament, the list is updated through delegated acts published in the EU Official Journal, so-called adaptations to scientific and technical progress (ATPs), which may also include changes to align the CLP with revisions of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). (See the European Chemicals Agency (ECHA) website for a detailed description of the entire CLH procedure.)

CARACAL’s November 2022 meeting agenda includes a discussion of the 19th and 20th ATP draft versions

At its upcoming November 17-18, 2022 meeting, the Competent Authorities for REACH and CLP expert group (CARACAL) is scheduled to discuss the proposed versions of the 19th and 20th ATPs to the CLP, among other matters. (Note that CARACAL will also discuss ATP 21; for an in-depth analysis of this ATP, please see AgencyIQ’s June 2022 article.)

Amendments proposed by ATP 19

The 19th ATP adds three separate notes to section 1.1.3 of Part 1 of Annex VI to the CLP. This section sets down the complete list of notes that may be assigned to entries in Table 3, i.e., the list of substances with harmonized classifications and labeling elements. The notes provide further instructions to industry on how to classify and label these substances, or mixtures containing them.
Note X is proposed to be included in subsection 1.1.3.1, which relates to the identification, classification and labeling of substances. While notes 11 and 12 are proposed to be added to subsection 1.1.3.2, which relates to the classification and labeling of mixtures.
The explanatory note prefacing the proposed 19th ATP explains that RAC and CARACAL have agreed to include these three notes to address “the appropriate classification of certain substances belonging to a group entry, and of certain mixtures that contain several substances belonging to a group of related substances.”

Note	Section (Part 1 of Annex VI to CLP)	Proposed wording of note
X	1.1.3.1	The classification for the hazard class(es) in this entry is based only on the hazardous properties of the part of the substance which is common to all substances in the entry. The hazardous properties of any substances in the entry also depend on the properties of the part of the substance which is not common to all substances in the group. The latter must be evaluated to assess whether more severe classification(s) (i.e. 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.
11	1.1.3.2	The classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual boron compounds that are classified as reproductive toxicant in the mixture as placed on the market is ≥ 0.3 %.
12	1.1.3.2	The classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual substances covered by this entry 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 given in this entry.

Note X has been added “to clarify that the classification covering a group of substances in the same entry is only based on the hazardous properties of that part of the substance which is common to all substances in that entry.” RAC found this to hold true for the substance 2-ethylhexanoic acid (2-EHA) and its salts. This note is necessary because, as is explained in Recital 2 of the proposed 19th ATP, the non-common parts of a substance must also be assessed to determine “if their hazardous properties may warrant a more severe classification (higher category) or a broader classification (including additional differentiation, target organs and/or hazard statements) for the same hazard class.” This note has been worded in such a way that it can be assigned to other entries sharing the same properties in the future and is not limited to the entry for 2-EHA and its salts.
Notes 11 and 12 are being added to clarify group entries as they relate to mixtures after RAC provided scientific evidence that the reproductive toxicity of a group of borates and of 2-EHA and its salts “is due to a molecular entity common to all members of the respective group.”
In Recital 3, CARACAL has concluded that the two notes are required “to allow a more accurate identification of the hazard of mixtures contain[ing] several substances belonging to the same ‘group entry’.” The expert group determined that for a group of “substances whose hazard is due to the presence or formation of a common molecular entity,” the principle of additivity applies for purposes of classification. This means that it is necessary “to take account of the contribution of these substances to the overall hazardous property of the mixture in proportion to their concentration, by comparing the applicable generic or specific concentration limit with the sum of the concentrations of the substances present.”
Note 11 applies specifically to the borates group, while note 12 is written in a generic way so that it may apply to 2-EHA and its salts, as well as to other group entries with the same properties in the future.

Amendments proposed by ATP 20

The draft of the 20th ATP updates five entries for the borates group (i.e., with index nos. 005-007-00-2, 005-008-00-8, 005-011-00-4, 005-011-01-1, and 005-011-02-9) and the entry for 2-EHA and its salts by adding the notes that are being included via ATP 19.
Note 11 is added to the five borate entries, while notes X and 12 are assigned to 2-EHA and its salts. Also, note A is added to the entry for 2-EHA and its salts, which provides a labeling requirement for “substances covered by an entry with a general description, such as ‘…compounds’ or ‘…salts’,” directing suppliers to state on the label the correct name.

What’s Next?

The proposed 19th and 20th ATPs are expected to be adopted by the Commission by the end of 2022. A transition period of 18 months will apply to all entries updated in the harmonized list (i.e., Table 3 of Part 3 of Annex VI to the CLP). This means that, if adopted as expected, suppliers will be required to take these changes into account in mid-2024 at the latest.
Changes made to the CLP’s Annex VI harmonized list are significant given the sheer number of products on the EU market potentially impacted by them. In this case, the proposed amendments would affect the specified borates group and 2-EHA and its salts, as well as any other future entries assigned the new notes. It is noteworthy that several constituents of the borates group, including boric acid and disodium tetraborate, anhydrous, and 2-EHA have been registered under REACH at annual tonnage thresholds ranging between 10,000 metric tons and 1 million metric tons.

To contact the author of this item, please email Scott Stephens ( [email protected])