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. EUH001 — ‘Explosive when dry’
For explosive substances and mixtures as referred to in section 2.1 of Annex I, placed on the market wetted with water or alcohols or diluted with other substances to suppress their explosive properties.
1.1.2. EUH006 — ‘Explosive with or without contact with air’
For substances and mixtures which are unstable at ambient temperatures, such as acetylene.
1.1.3. EUH014 — ‘Reacts violently with water’
For substances and mixtures which react violently with water, such as acetyl chloride, alkali metals, titanium tetrachloride.
1.1.4. 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.
1.1.5. EUH019 — ‘May form explosive peroxides’
For substances and mixtures which may form explosive peroxides during storage, such as diethyl ether, 1,4-dioxane.
1.1.6. 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 not classified as sensitising but containing at least one sensitising substance
The label on the packaging of mixtures containing at least one substance classified as sensitising and present in a concentration equal to or greater than 0,1 % or in a concentration equal to or greater than that specified under a specific note for the substance in part 3 of Annex VI shall bear the statement:
EUH208 — ‘Contains (name of sensitising substance). May produce an allergic reaction’
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, respiratory sensitiser category 1, or carcinogenic category 2; 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
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.
3.1.1.3 Where 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 | Concentration limit | ||
CAS No | Name | EC No | ||
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
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, or Stot, categories 1 and 2, aspiration hazard, or flammable gases, liquids and solids in categories 1 and 2, the packaging of whatever capacity, shall be fitted with a tactile warning of danger.
3.2.2 Provisions relating to tactile warning
3.2.2.1 This provision does not apply to aerosols which are only classified and labelled as ‘extremely flammable aerosols’ or ‘flammable aerosols’.
3.2.2.2. The technical specifications for tactile warning devices shall conform to EN ISO standard 11683 as amended ‘Packaging — Tactile warnings of danger-Requirements’.
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.