Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)

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 Section 4.4.3.1 until 1 May 2028.

4.4.4.   Hazard communication

• 4.4.4.1.Label elements shall be used in accordance with Table 4.4.1 for substances or mixtures meeting the criteria for classification in this hazard class (PMT and vPvM properties).

Table 4.4.1.

Label elements for PMT and vPvM properties

	PMT	vPvM
Symbol/pictogram
Signal word	Danger	Danger
Hazard Statement	EUH450: Can cause long-lasting and diffuse contamination of water resources	EUH451: Can cause very long-lasting and diffuse contamination of water resources
Precautionary Statement Prevention	P201 P202 P273	P201 P202 P273
Precautionary Statement Response	P391	P391
Precautionary Statement Disposal	P501	P501

4.4.4.2.   Application in time for substances

From 1 May 2025 at the latest, substances shall be labelled in accordance with Section 4.4.4.1.

However, substances which were placed on the market before 1 May 2025 are not required to be labelled in accordance with Section 4.4.4.1 until 1 November 2026.

4.4.4.3.   Application in time for mixtures

From 1 May 2026 at the latest, mixtures shall be labelled in accordance with Section 4.4.4.1.

However, mixtures which were placed on the market before 1 May 2026 are not required to be labelled in accordance with Section 4.4.4.1 until 1 May 2028.

5. PART 5: ADDITIONAL HAZARDS

5.1.   Hazardous to the ozone layer

5.1.1.   Definitions and general considerations

• 5.1.1.1. Ozone depleting potential (ODP) is an integrative quantity, distinct for each halocarbon source species, that represents the extent of ozone depletion in the stratosphere expected from the halocarbon on a mass-for-mass basis relative to CFC-11. The formal definition of ODP is the ratio of integrated perturbations to total ozone, for a differential mass emission of a particular compound relative to an equal emission of CFC-11.

Substance hazardous to the ozone layer means a substance which, on the basis of the available evidence concerning its properties and its predicted or observed environmental fate and behaviour may present a danger to the structure and/or the functioning of the stratospheric ozone layer. This includes substances which are listed in Annex I to Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer ([^E0047]).

5.1.2.   Classification criteria for substances

• 5.1.2.1. A substance shall be classified as hazardous to the ozone layer (Category 1) if the available evidence concerning its properties and its predicted or observed environmental fate and behaviour indicate that it may present a danger to the structure and/or the functioning of the stratospheric ozone layer.

5.1.3.   Classification criteria for mixtures

• 5.1.3.1. Mixtures shall be classified as hazardous to the ozone layer (Category 1) on the basis of the individual concentration of the substance(s) contained therein that are also classified as hazardous to the ozone layer (Category 1), in accordance with Table 5.1.

Table 5.1

Generic concentration limits for substances (in a mixture), classified as hazardous to the ozone layer (Category 1), that trigger classification of the mixture as hazardous to the ozone layer (Category 1)

Classification of the substance	Classification of the mixture
Hazardous to the ozone layer (Category 1)	C ≥ 0,1 %

5.1.4.   Hazard communication

• 5.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 5.2.

Table 5.2

Label elements for hazardous to the ozone layer

Symbol/pictogram	Image omitted; see official source
Signal word	Warning
Hazard statement	H420: Harms public health and the environment by destroying ozone in the upper atmosphere
Precautionary statements	P502

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 included on the label of certain mixtures.

• — Part 3 sets out special rules for packaging.

• — Part 4 sets out a special rule for the labelling of plant protection products.

• — Part 5 sets up a list of hazardous substances and mixtures to which Article 29(3) applies.

1. PART 1: SUPPLEMENTAL HAZARD INFORMATION

The statements set out in sections 1.1 and 1.2 shall be assigned in accordance with Article 25(1) to substances and mixtures classified for physical, health or environmental hazards.

1.1.   Physical properties

1.1.1.   EUH014 — ‘Reacts violently with water’

For substances and mixtures which react violently with water, such as acetyl chloride, alkali metals, titanium tetrachloride.

1.1.2.   EUH018 — ‘In use, may form flammable/explosive vapour-air mixture’

For substances and mixtures not classified as flammable themselves, which may form flammable/explosive vapour-air mixtures. For substances this might be the case for halogenated hydrocarbons and for mixtures this might be the case due to a volatile flammable component or due to the loss of a volatile non-flammable component.

1.1.3.   EUH019 — ‘May form explosive peroxides’

For substances and mixtures which may form explosive peroxides during storage, such as diethyl ether, 1,4-dioxane.

1.1.4.   EUH044 — ‘Risk of explosion if heated under confinement’

For substances and mixtures not in themselves classified as explosive in accordance with section 2.1 of Annex I, but which may nevertheless display explosive properties in practice if heated under sufficient confinement. In particular, substances which decompose explosively if heated in a steel drum do not show this effect if heated in less-strong containers.

1.2.   Health properties

1.2.1.   EUH029 — ‘Contact with water liberates toxic gas’

For substances and mixtures which in contact with water or damp air, evolve gases classified for acute toxicity in category 1, 2 or 3 in potentially dangerous amounts, such as aluminium phosphide, phosphorus pentasulphide.

1.2.2.   EUH031 — ‘Contact with acids liberates toxic gas’

For substances and mixtures which react with acids to evolve gases classified for acute toxicity in category 3 in dangerous amounts, such as sodium hypochlorite, barium polysulphide.

1.2.3.   EUH032 — ‘Contact with acids liberates very toxic gas’

For substances and mixtures which react with acids to evolve gases classified for acute toxicity in category 1 or 2 in dangerous amounts, such as salts of hydrogen cyanide, sodium azide.

1.2.4.   EUH066 — ‘Repeated exposure may cause skin dryness or cracking’

For substances and mixtures which may cause concern as a result of skin dryness, flaking or cracking but which do not meet the criteria for skin irritancy in section 3.2 of Annex I, based on either:

• — practical observations; or

• — relevant evidence concerning their predicted effects on the skin.

1.2.5.   EUH070 — ‘Toxic by eye contact’

For substances or mixtures where an eye irritation test has resulted in overt signs of systemic toxicity or mortality among the animals tested, which is likely to be attributed to absorption of the substance or mixture through the mucous membranes of the eye. The statement shall also be applied if there is evidence in humans for systemic toxicity after eye contact.

The statement shall also be applied where a substance or a mixture contains another substance labelled for this effect, if the concentration of this substance is equal to, or greater than 0,1  %, unless otherwise specified in part 3 of Annex VI.

1.2.6.   EUH071 — ‘Corrosive to the respiratory tract’

For substances and mixtures in addition to classification for inhalation toxicity, if data are available that indicate that the mechanism of toxicity is corrosivity, in accordance with section 3.1.2.3.3 and Note 1 of Table 3.1.3 in Annex I.

For substances and mixtures in addition to classification for skin corrosivity, if no acute inhalation test data are available and which may be inhaled.

2. PART 2: SPECIAL RULES FOR SUPPLEMENTAL LABEL ELEMENTS FOR CERTAIN MIXTURES

The statements set out in sections 2.1 to 2.10 shall be assigned to mixtures in accordance with Article 25(6).

2.1.   Mixtures containing lead

The label on the packaging of paints and varnishes containing lead in quantities exceeding 0,15  % (expressed as weight of metal) of the total weight of the mixture, as determined in accordance with ISO standard 6503, shall bear the following statement:

EUH201 — ‘Contains lead. Should not be used on surfaces liable to be chewed or sucked by children’

In the case of packages the contents of which are less than 125 ml, the statement may be as follows:

EUH201A — ‘Warning! Contains lead’

2.2.   Mixtures containing cyanoacrylates

The label on the immediate packaging of adhesives based on cyanoacrylate shall bear the following statement:

EUH202 — ‘Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of the reach of children’

Appropriate advice on safety shall accompany the package.

2.3.   Cements and cement mixtures

Unless cements or cement mixtures are already classified and labelled as a sensitiser with the hazard statement H317, ‘May cause an allergic skin reaction’, the label on the packaging of cements and cement mixtures that contain, when they are hydrated, more than 0,0002  % soluble chromium (VI) of the total dry weight of the cement shall bear the statement:

EUH203 — ‘Contains chromium (VI). May produce an allergic reaction’

If reducing agents are used, then the packaging of cement or cement-containing mixtures shall include information on the packing date, the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below 0,0002  %.

2.4.   Mixtures containing isocyanates

Unless already identified on the label of the packaging, mixtures containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) shall bear the following statement:

EUH204 — ‘Contains isocyanates. May produce an allergic reaction.’

2.5.   Mixtures containing epoxy constituents with an average molecular weight ≤ 700

Unless already identified on the label of the packaging, mixtures containing epoxy constituents with an average molecular weight ≤ 700 shall bear the following statement:

EUH205 — ‘Contains epoxy constituents. May produce an allergic reaction.’

2.6.   Mixtures sold to the general public which contain active chlorine

The label on the packaging of mixtures containing more than 1 % of active chlorine shall bear the following statement:

EUH206 — ‘Warning! Do not use together with other products. May release dangerous gases (chlorine)’

2.7.   Mixtures containing cadmium (alloys) and intended to be used for brazing or soldering

The label on the packaging of the above mentioned mixtures shall bear the following statement:

EUH207 — ‘Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions’

2.8.   Mixtures containing at least one sensitising substance

The label on the packaging of mixtures not classified as sensitising but containing at least one substance classified as sensitising and present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I shall bear the statement:

EUH208 — ‘Contains (name of sensitising substance). May produce an allergic reaction’.

Mixtures classified as sensitising containing other substance(s) classified as sensitising (in addition to the one that leads to the classification of the mixture) and present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I shall bear the name(s) of that/those substance(s) on the label.

Where a mixture is labelled in accordance with Section 2.4 or 2.5, the statement EUH208 may be omitted from the label for the substance concerned.

2.9.   Liquid mixtures containing halogenated hydrocarbons

For liquid mixtures which show no flashpoint or a flashpoint higher than 60 ^oC but not more than 93 ^oC and contain a halogenated hydrocarbon and more than 5 % highly flammable or flammable substances, the label on the packaging shall bear one of the following statements, depending on whether the substances referred to above are highly flammable or flammable:

EUH209 — ‘Can become highly flammable in use’ or

EUH209A — ‘Can become flammable in use’

2.10.   Mixtures not intended for the general public

For mixtures not classified as hazardous but which contain:

• — ≥ 0,1 % of a substance classified as skin sensitiser category 1, 1B, respiratory sensitiser category 1, 1B, or carcinogenic category 2, or

• — ≥ 0,01 % of a substance classified as skin sensitiser category 1A, respiratory sensitiser category 1A, or

• — ≥ one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit, or

• — ≥ 0,1  % of a substance classified as toxic to reproduction categories 1A, 1B or 2, or with effects on or via lactation; or

• — at least one substance in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2  % by volume for gaseous mixtures either: — classified with other health or environmental hazards; or — for which there are Community workplace exposure limits

• — ≥ 0,1 % of a substance classified as endocrine disruptor for human health category 2; or

• — ≥ 0,1 % of a substance classified as endocrine disruptor for the environment category 2.

the label on the packaging shall bear the statement:

EUH210 — ‘Safety data sheet available on request’.

2.11   Aerosols

Note that aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 in the Annex to Directive 75/324/EEC.

3. PART 3: SPECIAL RULES ON PACKAGING

3.1.   Provisions relating to child-resistant fastenings

3.1.1.   Packaging to be fitted with child-resistant fastenings

• 3.1.1.1.Packaging of whatever capacity containing a substance or mixture supplied to the general public and classified for acute toxicity, categories 1 to 3, STOT — single exposure category 1, STOT — repeated exposure category 1, or skin corrosion category 1 shall be fitted with child-resistant fastenings.

• 3.1.1.2.Packaging of whatever capacity containing a substance or mixture supplied to the general public presenting an aspiration hazard and classified according to sections 3.10.2 and 3.10.3 of Annex I and labelled according to section 3.10.4.1 of Annex I, with the exception of substances and mixtures placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment, shall be fitted with child-resistant fastenings.

• 3.1.1.3Where a substances or mixture has at least one of the substances mentioned below present in a concentration equal to or greater than the maximum individual concentrations specified, which are supplied to the general public, the packaging of whatever capacity shall be fitted with child-resistant fastenings.

No	Identification of the substance	Identification of the substance	Identification of the substance	Concentration limit
No	CAS No	Name	EC No	Concentration limit
1	67-56-1	methanol	200-659-6	≥ 3 %
2	75-09-2	dichloromethane	200-838-9	≥ 1 %

3.1.2   Reclosable packages

Child-resistant fastenings used on reclosable packages shall comply with EN ISO standard 8317 as amended relating to ‘Child-resistant packages — Requirements and methods of testing for reclosable packages’ adopted by the European Committee for standardisation (CEN) and the International Standard Organisation (ISO).

3.1.3   Non-reclosable packages

Child-resistant fastenings used on non-reclosable packages shall comply with CEN standard EN 862 as amended relating to ‘Packaging — Child-resistant packaging — Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products’ adopted by the European Committee for Standardisation (CEN).

3.1.4   Notes

• 3.1.4.1.Evidence of conformity with the above standards may be certified only by laboratories which conform with Standard EN ISO/IEC 17025 as amended.

3.1.4.2.   Specific cases

If it seems obvious that packaging is sufficiently safe for children because they cannot get access to the contents without the help of a tool, the test referred to in section 3.1.2 or 3.1.3 does not need to be performed.

In all other cases and when there are sufficient grounds for doubting the security of the closure for a child, the national authority may ask the person responsible for putting the product on the market to give it a certificate from a certifying laboratory, referred to in section 3.1.4.1, stating that either:

• — the type of closure is such that it is not necessary to perform the test referred to in section 3.1.2. or 3.1.3; or

• — the closure has been tested and has been found to conform with the standards referred to above.

3.2   Tactile Warnings

3.2.1.   Packaging to be fitted with a tactile warning

• 3.2.1.1.Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, respiratory sensitisation, STOT categories 1 or 2, aspiration hazard, flammable gases, flammable liquids categories 1 or 2, or flammable solids, the packaging of whatever capacity, shall be fitted with a tactile warning of danger.

• 3.2.1.2.Section 3.2.1.1 does not apply to transportable gas receptacles. Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard need not be fitted with a tactile warning unless they are classified for one or more of the other hazards in section 3.2.1.1.

3.2.2.   Provisions relating to tactile warning

The technical specifications for tactile warning devices shall conform to EN ISO standard 11683 as amended ‘Packaging — Tactile warnings of danger — Requirements’.

3.3   Liquid consumer laundry detergents in soluble packaging for single use

Where a liquid consumer laundry detergent in dosages for single use is contained in a soluble packaging, the following additional provisions shall apply:

• 3.3.1. Liquid consumer laundry detergents contained in soluble packaging for single use shall be contained in an outer packaging. The outer packaging shall fulfil the requirements of section 3.3.2 and the soluble packaging shall fulfil the requirements of section 3.3.3.

• 3.3.2. The outer packaging shall:
• (i) be opaque or obscure so that it impedes the visibility of the product or individual doses;
• (ii) without prejudice to Article 32(3), bear the precautionary statement P102 ‘Keep out of reach of children’ at a visible place and in a format that attracts attention;
• (iii) be an easily reclosable, self-standing container;
• (iv) without prejudice to the requirements of section 3.1, be fitted with a closure that:
• (a) impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;
• (b) maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.

• 3.3.3. The soluble packaging shall:
• (i) contain an aversive agent in a concentration which is safe, and which elicits oral repulsive behaviour within a maximum time of 6 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.

ANNEX III

LIST OF HAZARD STATEMENTS, SUPPLEMENTAL HAZARD INFORMATION AND SUPPLEMENTAL LABEL ELEMENTS

1. Part 1: hazard statements

The hazard statements shall be applied in accordance with Parts 2, 3, 4 and 5 of Annex I.

In selecting the hazard statements in accordance with Articles 21 and 27, suppliers may use the combined hazard statements provided for in this Annex.

In accordance with Article 27 the following principles of precedence for hazard statements may apply to labelling:

• (a) if the hazard statement H410 ‘Very toxic to aquatic life with long lasting effects’ is assigned, the statement H400 ‘Very toxic to aquatic life’ may be omitted;

• (b) if the statement H314 ‘Causes severe skin burns and eye damage’ is assigned, the statement H318 ‘Causes serious eye damage’ may be omitted;

• (c) if the hazard statement EUH441 ‘Strongly accumulates in the environment and living organisms including in humans’ is assigned, the statement EUH440 ‘Accumulates in the environment and living organisms including in humans’ may be omitted;

• (d) if the hazard statement EUH451 ‘Can cause very long-lasting and diffuse contamination of water resources’ is assigned, the statement EUH450 ‘Can cause long-lasting and diffuse contamination of water resources’ may be omitted.

In order to indicate the route of administration or exposure the combined hazard statements in Table 1.2 may be used.

Table 1.1

Hazard statements for physical hazards