EU Proposes CLP Annex VI Updates for Endocrine Disruptors and PBT Substances

What would change in CLP Annex VI

The two proposals address different parts of Annex VI. The draft on new notes would amend Part 1, Section 1.1.3, while the draft on harmonised classification and labelling would add or replace entries in Part 3, Table 3.

The classification proposal implements Article 37(7)(b) of CLP, drawing on assessments under REACH (Regulation (EC) No 1907/2006), the Plant Protection Products Regulation (Regulation (EC) No 1107/2009), and the Biocidal Products Regulation (Regulation (EU) No 528/2012). The notes proposal relies on Article 53(1). Together, they support the EU's "one substance, one assessment" approach by reflecting existing hazard assessments in CLP and avoiding duplicate work.

New notes would clarify substance and mixture classification

Note Y and PBT assessment for substances containing D4

For entries assigned Note Y, including decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6), the harmonised PBT classification would apply unless it can be shown that the substance contains less than 0.1% w/w octamethylcyclotetrasiloxane (D4; EC No 209-136-7). Below that level, manufacturers, importers and downstream users would still need to assess PBT classification under Title II of CLP. Demonstrating a D4 content below 0.1% would therefore require a self-classification assessment; it would not establish that the substance is non-PBT.

Note Z and identification of substances within group entries

Where an entry bearing Note Z names a group of substances and the supplier can provide the name of a specific substance in accordance with Note A, Article 18(2) would apply to that more precise identification. The supplier would have to select the corresponding identification number, where available.

Notes 14 to 17 and concentration addition within one entry

For mixtures placed on the market, these notes would require the concentrations of individual substances covered by the same entry to be added together for the specified hazard assessment.

Notes 18 to 21 and addition across selected entries

Some substances fall within a common group for these hazards but appear in separate Annex VI entries because of other harmonised classifications. Notes 18 to 21 would define addition rules for selected sets of entries:

These would be rules attached to specified entries and hazard classes, rather than a general requirement to add all endocrine-disrupting or PBT/vPvB substances together.

Which substances are covered by the classification proposal

The transfer mechanism covers substances included in the REACH Candidate List before 11 June 2026 for the relevant properties, where the Annex XV dossier was under assessment by 11 June 2025. It also covers active substances for which decisions on applications for approval or renewal had been adopted by 11 June 2025 under the plant protection products framework, or before 11 June 2025 under the biocidal products framework.

The draft would add or replace numerous entries with classifications including ED HH 1, ED ENV 1, PBT and vPvB, and the corresponding hazard statement codes EUH380, EUH430, EUH440 and EUH441. ED HH 1 and ED ENV 1 refer to Category 1 endocrine disruption for human health and the environment, respectively. Each substance's proposed classifications and assigned notes must be checked individually.

Representative substances in the proposed entries

Industrial and specialty chemicals from the REACH Candidate List include the following groups. The proposed hazards across these groups include ED HH 1, ED ENV 1, PBT and vPvB; individual entries do not necessarily carry all four.

Plant protection active substances include quinoxyfen, thiophanate-methyl, mancozeb, benthiavalicarb-isopropyl, clofentezine, triflusulfuron-methyl, asulam-sodium, mepanipyrim, dimethomorph, metribuzin and flufenacet.

Biocidal active substances include hexaflumuron, brodifacoum, bromadiolone, difenacoum, difethialone, flocoumafen, cholecalciferol (vitamin D3), creosote, 2,2-dibromo-2-cyanoacetamide (DBNPA), cyanamide and propiconazole.

For both active-substance groups, the proposed classifications may include ED HH 1, ED ENV 1, PBT or vPvB, depending on the substance-specific assessment. The proposed Annex VI entries provide the exact scope, identifiers, classifications and notes.

What suppliers should assess now

The Commission expects the additional costs of transferring these substances into Annex VI to be limited because their relevant hazardous properties have already been assessed under other EU legislation. The classification draft nevertheless proposes an adaptation period to mitigate additional labelling costs.

Regulatory affairs and product stewardship teams should prioritise the following preparatory reviews while the texts remain under consultation:

• Screen substances and formulations. Compare the proposed new and revised entries with products supplied to the EU, particularly siloxanes, UV absorbers, phthalates, flame retardants, fluorinated substances, and plant protection or biocidal active substances.

• Assess mixture classifications. Identify ingredients within the same group entry or assigned Notes 18 to 21, and calculate whether the relevant concentration sums would trigger an ED, PBT or vPvB classification if the proposals are adopted.

• Plan SDS and label revisions. Identify affected safety data sheets (SDSs), labels and packaging inventories. Review the substance identity and concentration information needed from suppliers, including the more precise names and identifiers addressed by Note Z.

Consultation deadline and proposed application dates

Public feedback on both drafts is open until 24 November 2026. The Commission's consultation pages indicate planned adoption in the second quarter of 2027; this is an indicative timetable, not a confirmed adoption or application date.

If adopted and published in the Official Journal of the European Union, each regulation would enter into force on the twentieth day after publication. The classification and labelling draft envisages an 18-month adaptation period and would apply from the first day of the month of entry into force plus 19 months. Suppliers could apply the new or revised classifications, labelling and packaging voluntarily from entry into force.

The notes draft contains no separate 18-month deferral. Suppliers should track both final texts and their respective dates when planning implementation.

How REACH24H Can Help

REACH24H supports chemical suppliers with EU CLP compliance, including:

• Substance and mixture classification reviews

• SDS updates

• Label revisions

Recommended Reading

• ECHA REACH and CLP Report 2026 — CLP New Hazard Classes, C&L Inventory and PCN UFI

Official References

• European Commission — proposed addition of Notes Y and Z and Notes 14 to 21 (initiative 17632; draft and annex, Ares(2026)10072732).

• European Commission — proposed harmonised classification and labelling entries (initiative 15632; draft and annex, Ares(2026)10072784).