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Editor-in-chief: Maurizio Roncaccia
Editors: Paul Trouth and Päivi Jokiniemi
Article related to: CLP
Want to know about… harmonised classification and labelling?
You know the symbols printed on a white background framed within a red border on product labels? These pictograms tell the user that the product may cause harm if it is not handled correctly. ECHA Newsletter explains what is behind the labels and why the hazard classification is sometimes harmonised.
What is the CLP Regulation?
All substances and mixtures have to be classified and any hazardous ones have to be labelled and packaged according to the Regulation on classification, labelling and packaging of substances and mixtures (CLP Regulation) before they can be placed on the market. This is important for workers and consumers who are using mixtures such as cleaning products or paints daily. Some of these contain hazardous substances that need to be handled with care and kept away from children.
The CLP Regulation entered into force on 20 January 2009. It aligns the EU legislation with the United Nations' Globally Harmonised System (GHS). The internationally agreed classification criteria and labelling helps to protect human health and the environment. The standardised statements and pictograms are useful, for example, when the hazards of chemicals are communicated to workers and consumers using them.
When is a classification harmonised?
The most hazardous substances, in particular those that cause respiratory sensitisation, cancer, mutations, or are toxic for reproduction, have a harmonised classification. This is agreed at EU level and is legally binding for all suppliers of that substance.
EU member states, manufacturers, importers and downstream users of substances can propose that a substance has a harmonised classification if they believe it to be hazardous. EU Member States can also propose to revise an existing classification.
A public consultation is organised every time there is a proposal to harmonise the classification of a substance. The consultation lasts for 45 days and anyone, from the EU or other parts of the world, can comment. Comments are received from EU Member States, individual experts, companies and organisations representing industry or civil society.
After the consultation period, ECHA’s Committee for Risk Assessment (RAC) prepares a scientific opinion on the proposal, taking into account the received comments. The opinion has to be adopted within 18 months from the receipt of the proposal. RAC examines the evidence for all hazard classes proposed, and those that were open for commenting during the public consultation. They may also consider another category more appropriate for the classification of the substance after examining the evidence.
ECHA sends RAC’s opinions and any comments received during the public consultation to the European Commission, which decides on the proposal and updates the list of the harmonised classification in Annex VI to the CLP Regulation.
For most substances, the classification is not harmonised. Even when a substance has a harmonised classification, it may not be for all the hazard classes. In these cases, companies need to self-classify their substances and mixtures. It is important to collect all available information, evaluate its reliability and review it against the classification criteria before concluding on the self-classification.
Important sources of information are industry associations and the existing classifications in the C&L Inventory.
CLP - the bigger picture
CLP deals with the majority of the chemicals placed on the industrial, professional and consumer markets in the EU.
More than 20 EU laws refer to classifying and labelling chemicals, meaning that once a substance is classified, other legal requirements kick-in to control their use. These range from the requirement on employers to undertake workplace risk assessment to the possibilities to get an eco-label on a product.
When substances cannot be placed on the market for certain uses because of their classification, companies need to find safer alternatives. For example, substances which are classified as carcinogenic, mutagenic or toxic for reproduction cannot be used in mixtures supplied to consumers above certain concentration levels. A further example is that chemicals with this classification can be added to the Candidate List of substances of very high concern, which means that in the future, an authorisation may be needed for continued use of the substance. A recent example is bisphenol A, which was classified as toxic for reproduction category 1B in July 2016 and which is now proposed for the Candidate List.
Did you know?
Over 4 200 substances have a harmonised classification.
The C&L Inventory includes over 130 000 substances.
There are over 6.5 million notifications for substances in C&L Inventory.
Notifying your classification
Manufacturers and importers of substances and mixtures must notify ECHA of each substance that meets the criteria to be classified as hazardous and is placed on the market on its own or in a mixture.
They also have to notify ECHA about each substance that has to be registered under REACH. If the substance has already been registered, then there is no need to notify ECHA about the classification separately.
Companies have to make every effort to agree on the self-classifications and labelling of the same substance. There should not be different classifications for the same substance without a justified reason.
CLP notifications are submitted free-of-charge and there is an online tool designed to guide companies through the process. Mixtures themselves do not have to be notified, but they cannot be placed on the market unless all the hazardous substances they contain have been notified by their manufacturers or importers.