CLP hazard classes

Delegated Regulation (EU) 2023/707 added endocrine, PBT/vPvB, and PMT/vPvM hazard classes to CLP

Direct answer. CLP, Regulation (EC) No 1272/2008, classifies substances and mixtures into hazard classes. Commission Delegated Regulation (EU) 2023/707 amended Annex I to add new hazard classes for endocrine disruption for human health and for the environment, and for PBT/vPvB and PMT/vPvM substances and mixtures. The quotes below are from the original English Official Journal of that delegated regulation, OJ L 93, 31 March 2023, CELEX 32023R0707, read as the Publications Office HTML of that issue. The ELI page is the public citation. This page is limited to those 2023 additions. It is not legal advice.

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What the act adds

Article 1: “Regulation (EC) No 1272/2008 is amended as follows.” Point (1): “Annex I is amended as set out in Annex I to this Regulation.”

Annex I then says: “in Part 3, the following Section 3.11 is added:” and the inserted heading is “3.11. Endocrine disruption for human health.” Later: “in Part 4, the following Sections 4.2, 4.3 and 4.4 are added,” headed “4.2. Endocrine disruption for the environment,” “4.3. Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties,” and “4.4. Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties.”

The Commission’s Environment news item of 20 April 2023 says: “The Delegated Regulation introduces new hazard classes for endocrine disruptors, as well as for chemicals that do not break down in the environment and can accumulate in living organisms, or risk entering and spreading across the water cycle, including drinking water.”

Definitions in Section 3.11

Section 3.11.1.1, as written:

Section 4.2.1.1 repeats those three definitions for endocrine disruption for the environment. The environment definition of “endocrine disruptor” uses the same words as the human-health definition quoted above.

Category 1 and category 2

Recital (10): “The level of evidence as regards endocrine disrupting properties may be of different scientific strength. It is therefore appropriate to create two categories of endocrine disruptors: known or presumed endocrine disruptors (category 1) and suspected endocrine disruptors (category 2), both for human health and for the environment.”

Table 3.11.1 is headed “Hazard categories for endocrine disruptors for human health.” Its category headings are “CATEGORY 1 / Known or presumed endocrine disruptors for human health” and “CATEGORY 2 / Suspected endocrine disruptors for human health.”

Table 4.2.1 is headed “Hazard categories for endocrine disruptors for the environment.” Its category headings are “CATEGORY 1 / Known or presumed endocrine disruptors for the environment” and “CATEGORY 2 / Suspected endocrine disruptors for the environment.”

Hazard statements

Table 3.11.3, “Label elements of endocrine disruption for human health,” prints these hazard-statement cells:

Hazard-statement cells from Tables 3.11.3 and 4.2.3 of the original OJ
Table Category 1 Category 2
3.11.3, human health EUH380: May cause endocrine disruption in humans EUH381: Suspected of causing endocrine disruption in humans
4.2.3, environment EUH430: May cause endocrine disruption in the environment EUH431: Suspected of causing endocrine disruption in the environment

Table 3.11.3 includes a Symbol/pictogram row. In the Official Journal HTML, that row does not print a pictogram name or an image. This page does not invent one. Pictograms already assigned GHS01 to GHS09 are CLP hazard pictograms. The signal-word cells in Table 3.11.3 are Danger for Category 1 and Warning for Category 2. Signal words generally are CLP signal words.

Section 4.3 defines “PBT” as “a persistent, bioaccumulative and toxic substance or mixture that meets the classification criteria set out in Section 4.3.2.1” and “vPvB” as “a very persistent and very bioaccumulative substance or mixture that meets the classification criteria set out in Section 4.3.2.2.” Section 4.4 defines “PMT” and “vPvM” in the same pattern, pointing at Sections 4.4.2.1 and 4.4.2.2. Their label tables print EUH440, EUH441, EUH450, and EUH451. The EUH list that already covers other supplemental statements is CLP EUH statements.

Dates, quoted from the application-in-time paragraphs

Section 3.11.2.4, substances: “From 1 May 2025 at the latest, substances shall be classified in accordance with the criteria laid down in Sections 3.11.2.1 to 3.11.2.3.” “However, substances which were placed on the market before 1 May 2025 are not required to be classified in accordance with the criteria laid down in Sections 3.11.2.1 to 3.11.2.3 until 1 November 2026.”

Section 3.11.3.4, mixtures: “From 1 May 2026 at the latest, mixtures shall be classified in accordance with the criteria laid down in Sections 3.11.3.1, 3.11.3.2 and 3.11.3.3.” “However, mixtures which were placed on the market before 1 May 2026 are not required to be classified in accordance with the criteria laid down in Sections 3.11.3.1, 3.11.3.2 and 3.11.3.3 until 1 May 2028.”

Sections 3.11.4.2 and 3.11.4.3 repeat those dates for labelling. Sections 4.2, 4.3, and 4.4 each have their own application-in-time paragraphs with the same two pairs of dates, pointed at their own section numbers. This page quotes the Section 3.11 pair in full and does not retype every parallel sentence.

Classes that pre-date 2023

This guide is limited to the classes 2023/707 added. It does not restate the physical, health, and environmental classes that were already in Annex I. Those surfaces are the guides below, including CLP vs GHS and hazard statements.

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What this page is not

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Not legal advice. Confirm the live text of Delegated Regulation (EU) 2023/707 and of CLP as amended before you classify or label. The quotes above are the original Official Journal of 31 March 2023, not a later consolidation of Regulation (EC) No 1272/2008. The app records CLP hazard display data you enter. It does not classify substances or replace an SDS.