Classification, packaging and labelling of chemical substances and mixtures

 

SUMMARY OF:

Regulation (EC) No 1272/2008 – classification, labelling and packaging of substances and mixtures

WHAT IS THE AIM OF THE REGULATION?

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.

KEY POINTS

Classification

Substances and mixtures are classified in specific hazard classes (type of hazard) and categories (level of hazard):

• physicochemical hazard (e.g. flammable liquid)
• health hazard (e.g. acute toxicity, carcinogenicity)
• environmental hazard (e.g. for the ozone layer, aquatic environment).

Annex I lays down the criteria for the classification and labelling of hazardous substances and mixtures.

Labelling

Substances and mixtures must be labelled with the following information:

• supplier identity
• name of the substance or mixture and/or identification number
• nominal quantity of the product in the package
• hazard pictograms (graphic designs combining symbols and other visual elements)
• signal words for the level of hazard (‘Warning’ or ‘Danger’)
• risk phrases (‘Fire or projection hazard’, ‘Fatal if swallowed’, etc.)
• safety advice (‘Keep only in original container’, ‘Protect from moisture’, ‘Keep out of reach of children’, etc.).

Packaging

The packaging of hazardous substances and mixtures must:

• prevent the contents from escaping;
• be made of materials that are resistant when in contact with the contents;
• be strong and solid; and
• have sealable fastenings.

In some cases, child-resistant fastenings and tactile warnings are required.

Harmonisation

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.

Notification

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.

Annexes

The regulation has eight annexes:

• Annex I – classification and labelling requirements for hazardous substances and mixtures;
• Annex II – special rules for labelling and packaging of certain substances and mixtures;
• Annex III – list of hazard statements, supplemental hazard information and supplemental label elements;
• Annex IV – list of precautionary statements;
• Annex V – hazard pictograms;
• Annex VI – harmonised classification and labelling for certain hazardous substances;
• Annex VII – translation table from classification under Directive 67/548/EEC to classification under this regulation;
• Annex VIII – harmonised information relating to emergency health response and preventative measures.

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.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 20 January 2009. It has applied compulsorily to substances from 1 December 2010 and mixtures from 1 June 2015.

BACKGROUND

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:

• Classification and labelling (CLP/GHS) (European Commission)
• Understanding CLP (European Chemicals Agency).

MAIN DOCUMENT

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.

RELATED DOCUMENTS

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 31.07.2023