- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (16/12/2008)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
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)
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Version Superseded: 19/04/2011
Point in time view as at 16/12/2008.
There are currently no known outstanding effects by UK legislation for Regulation (EC) No 1272/2008 of the European Parliament and of the Council, ANNEX II.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
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.
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.
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.
For substances and mixtures which are unstable at ambient temperatures, such as acetylene.
For substances and mixtures which react violently with water, such as acetyl chloride, alkali metals, titanium tetrachloride.
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.
For substances and mixtures which may form explosive peroxides during storage, such as diethyl ether, 1,4-dioxane.
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.
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.
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.
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.
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.
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.
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.
The statements set out in sections 2.1 to 2.10 shall be assigned to mixtures in accordance with Article 25(6).
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’
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.
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 %.
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.’
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.’
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)’
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’
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’
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’
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’.
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.
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 % |
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).
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).
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.
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.
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’
Ready mixed cement and concrete in the wet state.
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