This document provides an overview of 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, also known as the CLP Regulation.
The CLP Regulation (Classification, Labelling and Packaging) came into force on 20 January 2009 in all European Union Member States. It adopts the United Nations' Globally Harmonized System of the classification and labelling of chemicals (GHS) across all EU countries.[6]
The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles. It harmonizes the criteria for classification of substances and mixtures, and establishes rules on labelling and packaging for hazardous substances and mixtures.[5]
The EU CLP Regulation as amended, is retained in GB law. These arrangements mean that Great Britain continues to adopt GHS, independently of the European Union.[6]
The CLP Regulation applies to all chemical substances and mixtures supplied in the EU, with certain exceptions. The main areas not covered by this regulation are:[8][9]
The regulation has applied since 20 January 2009. It has applied compulsorily to substances from 1 December 2010 and mixtures from 1 June 2015.[9]
Substances and mixtures are classified in specific hazard classes (type of hazard) and categories (level of hazard) according to the criteria set out in Annex I of the regulation.[8]
The CLP classification system divides hazards into three main categories:[9]
| Hazard Type | Examples | Classification Criteria |
|---|---|---|
| Physicochemical | Explosive, Flammable, Oxidizing | Based on physical properties and chemical reactions |
| Health | Toxic, Carcinogenic, Mutagenic | Based on toxicological data and human experience |
| Environmental | Aquatic toxicity, Ozone depletion | Based on ecotoxicological data |
The CLP Regulation establishes specific requirements for the labelling of hazardous substances and mixtures. Labels must include the following information:[8][9]
Hazard pictograms are defined in Annex V of the regulation and are designed to convey specific information about the hazard(s) concerned. The pictograms have a black symbol on a white background with a red border.
The supplier information on the safety data sheet must be sufficient to enable quick and effective communication in case of emergency. It must include:[2]
Example of supplier information:
Company Name: Example Chemical Corporation
Full Address: 123 Industrial Street, Science Park
City, Region: Chemical City, Industrial Region
Postal Code: AB12 3CD
Country: United Kingdom
Telephone: +44 (0)123 456789
Email: sds.expert@example.com
The packaging of hazardous substances and mixtures must meet the following requirements:[8]
In some cases, child-resistant fastenings and tactile warnings are required, particularly for consumer products that present specific hazards.
While the industry should reach a consensus on the classification of all substances (self-classification), the CLP Regulation provides for harmonised classification for substances with particularly serious hazards.[8]
For substances that are carcinogenic, mutagenic, toxic to reproduction, or respiratory sensitizers, as well as for other substances on a case-by-case basis, EU Member States may propose harmonised classifications that the European Commission then makes compulsory by law.[8][9]
The harmonised classification and labelling for certain hazardous substances is set out in Annex VI of the regulation and is updated through an "Adaptation to Technical Progress (ATP)" adopted yearly by the European Commission, following the opinion of the Committee for Risk Assessment (RAC).[7]
The regulation consists of a main text and eight annexes:[9]
When classifying substances and mixtures, manufacturers, importers and downstream users must take into account all available information, including:[5]
The information shall relate to the forms or physical states in which the mixture is placed on the market and, when relevant, in which it can reasonably be expected to be used.
The CLP Regulation supplements the REACH system for the registration, evaluation, authorisation and restriction of chemicals. It replaced and repealed Directive 67/548/EEC on chemical substances and Directive 1999/45/EC on dangerous preparations.[9]
In Great Britain, the EU CLP Regulation has been amended to operate effectively after Brexit. This means there are changes to the requirements or allowances in existing processes and procedures.[6]
The consolidated version of the CLP Regulation incorporates all of the amendments and corrigenda up to the date marked in the first page of the regulation. For legal purposes, refer to the texts published in the Official Journal of the European Union.[7]
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).[9]
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.[9]
The most recent consolidated version includes the adaptations to technical progress up to the 16th ATP, but does not yet incorporate all the latest amendments as they apply from future dates.[7]