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Regulation (EC) No 1272/2008 – classification, labelling and packaging of substances and mixtures
It lays down uniform requirements for the classification, labelling and packaging (CLP) of chemical substances and mixtures according to the United Nations’ globally harmonised system (GHS). It requires companies to classify, label and package hazardous chemicals appropriately before placing them on the market.
The main areas not covered by this regulation are: radioactive substances and mixtures, cosmetics, medicines and certain medical devices, food and the transport of dangerous goods.
Substances and mixtures are classified in specific hazard classes (type of hazard) and categories (level of hazard):
Annex I lays down the criteria for the classification and labelling of hazardous substances and mixtures.
Substances and mixtures must be labelled with the following information:
The packaging of hazardous substances and mixtures must:
In some cases, child-resistant fastenings and tactile warnings are required.
The industry should reach a consensus on the classification of all substances (self-classification). However, for particularly serious hazards (e.g. for substances that are carcinogenic, mutagenic or toxic to reproduction), European Union (EU) Member States may propose harmonised classifications that the European Commission then makes compulsory by law.
The classification and labelling of any REACH registered or hazardous substance for sale must be notified to the European Chemicals Agency (ECHA) for inclusion in its classification and labelling inventory, which the agency regularly updates.
Information submissions for poison centres
Member States are required to set up appointed bodies (often known as poison centres) for receiving information on the composition of hazardous mixtures (detergents, paints, adhesives, etc.). Suppliers of hazardous chemical products must provide information to the national poison centres for emergency health responses.
The regulation has eight annexes:
Revisions to the regulation
Since its adoption in 2008, the regulation has been amended approximately on a yearly basis, whereby harmonised classification and labelling of hazardous substances is updated through an adaptation to technical progress (ATP). The Commission adopts an ATP following the scientific opinion of the ECHA’s Committee for Risk Assessment. Other changes to the legal text may also be implemented through an ATP, such as those that implement amendments of the GHS and the addition of Annex VIII to the regulation (see also consolidated version of Regulation (EC) No 1272/2008). Most of the amendments that have been made relate to the regulation’s annexes.
It has applied since 20 January 2009. It has applied compulsorily to substances from 1 December 2010 and mixtures from 1 June 2015.
The regulation supplements the REACH system for the registration, evaluation, authorisation and restriction of chemicals. It replaces and repeals Directive 67/548/EEC on chemical substances and Directive 1999/45/EC on dangerous preparations.
For further information, see:
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 (OJ L 353, 31.12.2008, pp. 1–1355).
Successive amendments to Regulation (EC) No 1272/2008 have been incorporated into the original text. This consolidated version is of documentary value only.
Directive 2014/27/EU of the European Parliament and of the Council of 26 February 2014 amending Council Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council, in order to align them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L 65, 5.3.2014, pp. 1–7).
Commission Regulation (EU) No 440/2010 of 21 May 2010 on the fees payable to the European Chemicals Agency pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 126, 22.5.2010, pp. 1–5).
last update 17.12.2022