CLP Regulation

The Classification, Labelling and Packaging or CLP Regulation (EC 1272/2008) is an EU regulation that has been in force since 2009. Its purpose is to protect human health and the environment, as well as support the free movement of substances, mixtures and finished products. 

A couple of updates have happened along the way. Since 2015, the CLP Regulation has overridden older laws and has been the only EU legislation in force for the classification and labelling of substances and mixtures. Annex VIII was added in 2017, requiring information to be submitted to national Poison Centres. The new annex requires a unique formula identifier (UFI) to be included on labels for mixtures, as a direct link to information for emergency health response teams.

The CLP Regulation is based on the United Nations’ Globally Harmonised System (GHS) and is applicable to all industry sectors.  If you’re a manufacturer, importer or user of substances or mixtures in the EU, they must be appropriately classified, labelled and packaged before they’re placed on the market.

  • Classification criteria must be used to describe any hazards to humans or the environment
  • Labelling must comply with strict criteria, using approved pictograms, wording and safety data sheets (SDS) to communicate information about hazards, prevention, response, storage and safe disposal measures for all in the supply chain, including consumers
  • Packaging standards support safe supply, storage and transport


The ECHA guidance states “One of the main aims of CLP is to determine whether a substance or mixture displays properties that lead to a hazardous classification. In this context, classification is the starting point for hazard communication.

Often, existing safety information is available and may be enough to classify your substance or mixture for CLP purposes. The regulation supports the use of a variety of animal-free approaches including computer modelling, in vitro testing and read-across of historical data (in vivo or in vitro) from similar substances. If there are data gaps, new testing might be needed – these tests should comply with REACH and be performed in a GLP accredited lab.

XCellR8 provides CLP compliant, regulatory in vitro tests to support a variety of human health endpoints. In some cases, our non-regulatory screens can also be used as part of a Weight of Evidence (WoE) approach.

If you’re uncertain about the best approach to ensure CLP compliance for your products, we partner with professional regulatory advisors who can help you to formulate the best strategy to fit with your needs. As a starting point, we also recommend reading the guidance from ECHA and HSE on this topic.


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