Annex II

Classification, Labelling and Packaging Regulation · 32008R1272 · every event for this act · on EUR-Lex

SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES

12 changes recorded across 12 events, newest first.

in force 2026-07-01 MODIFIED+3,561 −13§

Amended by Regulation (EU) 2024/2865 32024R2865

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

A new section 3.4 has been added covering supply via refill stations, setting out conditions suppliers must ensure are met, including labelling and packaging requirements, risk mitigation, staff training, restrictions based on hazard classification, and a derogation allowing a single label to cover multiple substances or mixtures with identical label elements.

Part 5 has been retitled by dropping the word "LIST OF" from its heading, and its content has been expanded from a single line naming ready mixed cement and concrete in the wet state to add requirements that such cement and concrete be accompanied by a copy of the label elements, and that label elements be provided at filling station pumps and, in certain cases, attached to portable receptacles.

Cited: Annex II, v2 · Annex II, v1

text before / after

02008R1272-20260501 → 02008R1272-20260701

ANNEX II SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES This Annex consists of 5 parts: Part 1 contains special rules for the labelling of certain classified substances and mixtures. Part 2 sets out rules for additional hazard statements to be … 2,422 unchanged words … seconds, in case of accidental oral exposure; (ii) retain its liquid content for at least 30 seconds when the soluble packaging is placed in water at 20 °C; (iii) resist mechanical compressive strength of at least 300 N under standard test conditions. 3.4. Supply via refill stations When hazardous substances or mixtures are supplied in accordance with Article 35(2a), the supplier shall ensure that the following conditions are met: (a) the refill station carries labels corresponding to the labels for each hazardous substance or mixture supplied at the station; (b) the labels on the refill station are firmly affixed horizontally on a visible place and fulfil the requirements in Article 31(2), (3) and (4) mutatis mutandis; (c) risk mitigation measures are applied to minimise the exposure of humans, especially of children, and of the environment; (d) measures are taken to prevent uncontrolled use of the refill station by children; (e) at the moment of refill, the supplier is available on site for maintenance and immediate assistance, including emergency assistance; (f) refill stations can be operated outdoors and outside business hours only if immediate assistance can be provided; (g) the substances or mixtures provided through a refill station do not react with each other in a way that could endanger clients or staff; (h) staff of the supplier are appropriately trained to minimise safety risks to consumers, professional users and themselves; (i) for every refilled package, the requirements on hazard communication in the form of labelling set out in Title III of this Regulation are fulfilled; (j) for every refilled package the requirements on packaging set out in Title IV of this Regulation are fulfilled; (k) hazardous substances or mixtures are not provided at a refill station if the criteria for classification in any of the following hazard classes or differentiations are met: (i) acute toxicity, any category; (ii) specific target organ toxicity – Single exposure, any category; (iii) specific target organ toxicity – repeated exposure, any category; (iv) skin corrosion, category 1, any sub-category; (v) serious eye damage category 1; (vi) respiratory sensitisation, any category; (vii) skin sensitisation, any category; (viii) aspiration hazard; (ix) germ cell mutagenicity, any category; (x) carcinogenicity, any category; (xi) reproductive toxicity, any category; (xii) flammable gases, any category; (xiii) flammable liquids, categories 1 and 2; (xiv) flammable solids, any category; (xv) endocrine disruption for human health, any category.; (xvi) endocrine disruption for the environment, any category; (xvii) persistent, bioaccumulative and toxic; (xviii) very persistent and very bioaccumulative; (xix) persistent, mobile and toxic; (xx) very persistent and very mobile. By way of derogation from point (a), a single label on the refill station may be used for several substances or mixtures for which the label elements referred to in Article 17(1) are identical, provided that the label clearly indicates the name of each substance or mixture that it applies to. 4. PART 4: SPECIAL RULE FOR LABELLING OF PLANT PROTECTION PRODUCTS Without prejudice to the information required in accordance with Article 16 of Directive 91/414/EEC and Annex V of that Directive, the labelling for plant protection products subject to Directive 91/414/EEC shall also include the following wording: EUH401 — To avoid risks to human health and the environment, comply with the instructions for use 5. PART 5: ~~LIST OF~~ HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES Ready mixed cement and concrete in the wet ~~state.~~ state shall be accompanied by a copy of the label elements in accordance with Article 17. For a substance or a mixture supplied at a filling station and directly pumped into a receptacle that forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the label elements referred to in Article 17 shall be provided on a visible place on the respective pump. When vehicle fuels are supplied at a filling station through pumping into portable receptacles designed to be used for fuels, a physical copy of the label elements referred to in Article 17 shall, in addition to the visible place on the pump, also be provided to be attached to the receptacle.

in force 2025-02-01 MODIFIED§

Amended by Regulation (EU) 2023/1435 32023R1435

applies from: unchanged

Sources disagree — the text comparison found this change; the EU's own amendment metadata does not list it and the amending act's instructions do not mention it. All are shown; none is overruled.

Section 3.4, which set out conditions for supplying hazardous substances or mixtures via refill stations, has been removed entirely from Annex II Part 3.

Part 5's heading changed from naming a list of hazardous substances and mixtures to describing itself as setting up such a list, and its content was shortened to a single line referring to ready mixed cement and concrete in the wet state, dropping the earlier text about the filling-station pump labelling requirements.

Cited: Annex II, v1 · Annex II, v2

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in force 2024-12-10 MODIFIED§

Amended by Regulation (EU) 2024/2865 32024R2865

applies from: unchanged

A new section 3.4 has been added setting out conditions that a supplier must ensure are met when hazardous substances or mixtures are supplied through refill stations, covering matters such as labelling of the refill station, risk mitigation, staff training, and exclusion of certain hazard classes from refill supply.

Part 5 has been changed from a bare list heading naming only ready mixed cement and concrete in the wet state to text stating that such cement and concrete shall be accompanied by a copy of the label elements under Article 17, and adding new text on providing label elements at filling stations for substances or mixtures pumped into vehicle receptacles or portable fuel receptacles.

Cited: Annex II, v2 · Annex II, v1

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in force 2023-04-20 MODIFIED§

Amended by Regulation (EU) 2023/707 32023R0707

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

Section 2.10 now adds two further concentration triggers requiring the EUH210 statement, covering mixtures containing 0.1% or more of a substance classified as an endocrine disruptor for human health category 2 or as an endocrine disruptor for the environment category 2.

Cited: Annex II, v2 · Annex II, v1

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in force 2021-10-01 MODIFIED§

Amended by Regulation (EU) 2021/797 32021R0797 · Regulation (EU) 2020/217 32020R0217 · Regulation (EU) 2021/1962 32021R1962

applies from: unchanged

The introductory sentence of Part 2 now includes section 2.12 among the statements assigned to mixtures under Article 25(6), where before it only referenced sections 2.1 to 2.10.

A new section 2.12 has been added covering mixtures containing titanium dioxide, setting out label statements EUH211 for liquid mixtures and EUH212 for solid mixtures containing 1% or more of titanium dioxide, and requiring statement EUH210 in addition for such mixtures not intended for the general public and not classified as hazardous.

Cited: Annex II, v1 · Annex II, v2

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in force 2020-10-17 MODIFIED§

Amended by Regulation (EU) 2019/521 32019R0521

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

The sub-point numbers for the EUH014, EUH018, EUH019 and EUH044 entries under section 1.1 were changed from 1.1.3, 1.1.4, 1.1.5 and 1.1.6 to 1.1.1, 1.1.2, 1.1.3 and 1.1.4 respectively, duplicating the numbering already used for EUH001 and EUH006.

In section 2.10, the qualifying phrase describing sensitisers with a specific concentration limit lower than 0,1 % was shortened to refer simply to a substance with a specific concentration limit, removing the numeric threshold wording.

Cited: Annex II, v1 · Annex II, v2

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detected 2026-08-13 MODIFIED§

no amending act named

applies from: unchanged

Section 2.8 now adds a sentence stating that where a mixture is labelled in accordance with Section 2.4 or 2.5, the EUH208 statement may be omitted from the label for the substance concerned.

The earlier version of section 2.8 contained no such allowance to omit EUH208 in those circumstances.

Cited: Annex II, v2 · Annex II, v1

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in force 2016-07-04 MODIFIED§

Amended by Regulation (EU) 2016/918 32016R0918 · Regulation (EU) 2016/1179 32016R1179

applies from: unknown

Sources disagree — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text. Both are shown; neither is overruled.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.

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in force 2015-06-01 MODIFIED§

Amended by Regulation (EU) No 1297/2014 32014R1297 · Regulation (EU) No 605/2014 32014R0605

applies from: unchanged

Section 3.2 on tactile warnings has been restructured: the list of hazard classes triggering a tactile warning is now numbered as section 3.2.1.1 and its wording on flammability categories has changed to refer separately to flammable gases, flammable liquids categories 1 or 2, and flammable solids, while the exclusion for aerosols and sealed spray containers relating to aspiration hazard is now set out as a new section 3.2.1.2 alongside the existing exclusion for transportable gas receptacles, and the reference to flammable aerosols exclusions has been removed.

The former section 3.2.2 provisions on tactile warning device specifications are retained but renumbered without its former sub-numbering, and a wholly new section 3.3 has been added setting out packaging requirements for liquid consumer laundry detergents in soluble packaging for single use, including outer packaging requirements at points (i) to (iv) and soluble packaging requirements at points (i) to (iii).

Cited: Annex II, v1 · Annex II, v2

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in force 2013-06-21 MODIFIED§

Amended by Regulation (EU) No 487/2013 32013R0487 · Regulation (EU) No 517/2013 32013R0517 · Regulation (EU) No 944/2013 32013R0944 · Regulation (EU) No 618/2012 32012R0618 · Regulation (EU) No 758/2013 32013R0758

applies from: unknown

Sources disagree — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text. Both are shown; neither is overruled.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.

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in force 2011-04-19 MODIFIED§

Amended by Regulation (EU) No 286/2011 32011R0286

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

Section 2.8 now sets the concentration threshold for the EUH208 statement by reference to Table 3.4.6 of Annex I instead of the fixed 0,1% figure or a specific note in part 3 of Annex VI, and it adds a new requirement that mixtures already classified as sensitising must name additional sensitising substances present above that threshold on the label.

Section 2.10 expands the listed triggers for the EUH210 statement by adding separate threshold conditions for substances classified as skin or respiratory sensitiser category 1B, category 1A at 0,01%, and substances with a specific concentration limit below 0,1%, alongside the pre-existing carcinogenic category 2 and other conditions.

Section 3.2.2.1 changes the aerosol exemption wording from referring to extremely flammable aerosols or flammable aerosols to referring to flammable aerosols Category 1 or Category 2, and adds that the provision also does not apply to transportable gas receptacles.

Cited: Annex II, v1 · Annex II, v2

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in force 2010-12-01 MODIFIED§

Amended by Regulation (EC) No 790/2009 32009R0790

applies from: unknown

Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.

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