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 [Official Journal L 353 of 31.12.2008].
This Regulation harmonises requirements concerning the classification, labelling and packaging of chemical substances and mixtures in line with the international system approved by the United Nations. This harmonisation enhances protection of health and the environment, and improves the free circulation of chemical substances and mixtures.
Enterprises must classify, label and pack their substances and mixtures in line with the provisions of this Regulation before putting them on the market.
The Regulation covers chemical substances and mixtures which are composed of two chemical substances or more.
The Regulation does not apply to:
- radioactive substances and mixtures covered by Directive 96/29/Euratom;
- substances subject to customs supervision which are in temporary storage, in a free zone or free warehouse with a view to re-exportation or still in transit;
- non-isolated intermediates (substances which are manufactured in order to be chemically transformed into another substance);
- substances and mixtures for scientific research and development which are not placed on the market;
- medicinal products;
- cosmetic products;
- some medical devices;
- the transport of dangerous goods.
The classification of chemical substances and mixtures is based on categories which take into account the degree of hazard and the specific nature of the hazardous properties. These include inflammable substances or mixtures, those which are highly toxic, those which are dangerous for the aquatic environment, etc. Annex I establishes the criteria for the classification and labelling of hazardous substances and mixtures.
The Annexes of the Regulation also include the list of hazard statements, the list of precautionary statements, pictograms for each hazard class and the lists of classifications and labelling harmonised at Community level.
Labelling must mention:
- the name of the substance or mixture and/or an identification number;
- the name, address and telephone number of the supplier;
- the nominal quantity of the substance or mixture.
If applicable, labelling must include:
- hazard pictograms (see Annex V of the Regulation);
- the signal words “Danger” or “Warning”;
- hazard statements such as “Fire or projection hazard”, “Fatal if swallowed”, etc. (see Annex III of the Regulation);
- precautionary statements such as “Keep only in original container”, “Protect from moisture”, “Keep out of reach of children”, etc. (see Annex IV of the Regulation);
- supplemental information, for example on physical properties or health hazards (see Annex II of the Regulation).
Hazard pictograms shall be in the shape of a square set at a point. They shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible. Each hazard pictogram shall cover at least one fifteenth of the surface area of the harmonised label and the minimum area shall not be less than 1 cm2.
The dimensions of the label shall be as follows:
|Capacity of the package||Dimensions (in millimetres)|
|Not exceeding 3 litres||If possible, at least 52 × 74|
|Greater than 3 litres but not exceeding 50 litres||At least 74 × 105|
|Greater than 50 litres but not exceeding 500 litres||At least 105 × 148|
|Greater than 500 litres||At least 148 × 210|
The label for the hazardous substance or mixture shall be written in the official language(s) of the Member State where it is placed on the market, unless the Member State concerned provides otherwise.
Hazard pictograms, signal words, hazard statements and precautionary statements shall be located together on the label in an order established by the supplier, provided that the statements are grouped by language.
Packaging containing hazardous substances or mixtures shall comply with the following requirements:
- packaging must prevent any of the contents escaping;
- packaging must be made of materials which are resistant if they come into contact with the contents;
- packaging must be strong and solid;
- packaging must have sealable fastenings.
In some cases, child-resistant fastenings and tactile warnings are required.
In order to trigger the harmonisation procedure for the classification and labelling of substances, Member States, or even manufacturers, importers or downstream users, can submit a proposal for the harmonised classification and labelling of substances, containing the information set out in Annex VI, Part 1 of this Regulation to the European Chemicals Agency. Generally, only substances satisfying the classification criteria for Category 1 respiratory sensitisation, mutagenicity, carcinogenicity or reproductive toxicity, or active ingredients in pesticides or biocides will be subject to such harmonisation, but other substances may be subject thereto if a necessity for harmonisation is demonstrated.
Within eighteen months from receipt of the proposal, the risk assessment committee of the Agency shall give an opinion on the proposal.
The Agency shall send this opinion to the Commission which, if it considers that harmonisation is appropriate, will include the substance and its classification and labelling elements in Annex VI, Part 3 of this Regulation.
The classification and labelling inventory
At the latest one month after having placed a substance on the market, the manufacturer or importer shall notify the Agency of information concerning its identity, the identity of the substance, hazard classes, concentration limits, etc. All this information shall be included in an inventory of classification and labelling that the Agency shall update on a regular basis.
This Regulation supplements the REACH system for registration, assessment, authorisation and restrictions concerning chemical substances.
This Regulation amends Directive 67/548/EEC on chemical substances and Directive 1999/45/EC on mixtures and repeals them with effect from 1June 2015.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 1272/2008||20.1.2009
1.12.2010 (Titles II, III and IV for substances)
1.6.2015 (Titles II, III and IV for mixtures)
|–||OJ L 353 of 31.12.2008|