Classification and Labelling – GHS and CLP

This page provides an overview of the CLP Regulation

CLP is the European implementation of the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) which has been introduced in over 70 countries around the World. CLP applies to all chemical products, both substances and mixtures. Since the UK left the EU, GB CLP now applies in Great Britain.

Further information is available on 

New CLP Hazard Classes For Endocrine Disruptors And Persistent Chemicals

Who has to submit and what can be submitted in a notification? – ECHA (europa.eu) (opens in new page)

Classification of mixtures and the use of expert judgement 

CLP and Candles

THE CLP REGULATION

The EU Classification, Labelling and Packaging Regulation (EC) No. 1272/2008, more commonly known as CLP, implements the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) in the European Union. This was initially mirrored in the UK following exit from the EU January 2021, but divergence is starting to show.

CLP replaced the previous system for classifying and labelling chemicals set out in the Dangerous Substances Directive (DSD) 67/548/EEC and the Dangerous Preparations Directive (DPD) 1999/45/EC (implemented through the CHIP Regulations 2009 in the UK).

CLP sets out a number of requirements for suppliers of chemical products

  • To classify (assess the hazards of) chemicals before placing them on the market
  • If classified as hazardous, to label and package them appropriately
  • For suppliers at the top of the EU supply chain, i.e. manufacturers and importers, to notify the classifications of hazardous chemicals to the Classification and Labelling Inventory
  • To document their classifications and keep them up to date as necessary

WHAT IS THE GHS?

The GHS aims to provide a consistent, harmonised system for the identification and communication of hazards about chemicals, so as to enable their safe use, transport and disposal. The GHS is regularly updated, on a 2 yearly basis. More information about GHS can be found on the GHS pages of the UNECE website.

The GHS is a framework for regulation and, as such, has no legal status of its own. It must be implemented in each country or region by appropriate legislation. Many countries have adopted, or are in the process of adopting the GHS into their regulatory systems. Further information on the progress of these countries, together with links to relevant national legislation is available here. International transport rules for dangerous goods are also aligned with GHS.

CLP IS NOT THE SAME AS GHS

The GHS is based upon a “building block” approach, allowing countries to select those elements they believe to be most relevant. In the EU, only those building blocks that most closely matched the DSD and DPD system have been incorporated into CLP. This may result in different classifications for some products in the EU compared to other parts of the world where different building blocks have been selected.

CLP also includes some additional classification elements from the DSD and DPD which are not yet included in the GHS, and some special phrases to be added to labels for certain types of mixtures. It includes requirements for the content, size and format of labels, and additional requirements such as child resistant packaging and tactile warnings.

The EU has also sought to retain some of the benefits from the 40 years of experience with the DSD and DPD, such as the list of harmonised classifications now included in Annex VI of CLP.

CLP CLASSIFICATION

CLP allows for two types of classification:

  • harmonised classification, in which the classification and labelling of a substance for some or all hazard endpoints is agreed at EU level; and
  • self classification where the substance or mixture is classified for some or all hazard endpoints by the supplier.

HARMONISED CLASSIFICATION

The system of harmonised classification introduced through the DSD has been transferred to CLP. Harmonised classifications are included in Annex VI of the CLP Regulation which is updated annually through amendments to CLP known as ATPs (Adaptations to Technical Progress). The process of agreeing a harmonised classification for a substance can be followed through the Registry of CLH intentions until outcome on the ECHA website.

Note that the EU and UK are starting to diverge on this with the EU publishing more additional harmonised classifications than the UK. In one case to date, the new UK harmonised classification (called ‘mandatory classification’) differs from the new EU harmonised classification (d-limonene).

Harmonised classifications do not normally cover all possible hazard end-points, and suppliers using these harmonised classifications will need to check and, if necessary, self-classify for all other hazard end-points. Current policy is to focus chiefly on CMR effects, and on respiratory sensitisation, and harmonised classifications will normally only be made for other hazard end-points on a case by case basis. New harmonised classifications for active biocides and plant protection substances, however, will normally cover all hazard end points.

SELF CLASSIFICATION

Where no harmonised classification exists for a chemical substance, or there are hazard end points not covered by the harmonised classification, suppliers will need to self-classify. Self-classification is also needed for mixtures. CLP allows for a number of different approaches to self-classification, depending on the data available for the substance or the mixture, and the components of mixtures.

PHYSICAL HAZARDS

The classification criteria for physical hazards within the GHS, and therefore CLP, were largely based upon those of the UN Recommendations on the Transport of Dangerous Goods (commonly known as the Orange Book) and are therefore harmonised with them.

Classification is usually based upon test data, although screening criteria are available for many end points that will often indicate that a particular hazard is unlikely and therefore testing is not required. However, if there is insufficient information to allow an assessment to be made for a particular end point, then CLP imposes an obligation on the supplier to carry out new testing for physical hazards. Since 1 January 2014 such tests need to be carried out to a recognised quality standard (GLP or ISO 17 025).

HEALTH AND ENVIRONMENTAL HAZARDS

The selection of building blocks by the European Commission was designed to avoid significant changes in scope between CLP and the DSD and the DPD, in order to avoid unwanted impacts on downstream legislation.

A key difference between the health and environmental hazards, and the physical hazards, is that where there is insufficient information to classify for a particular end point, CLP does not oblige suppliers to carry out new testing. CLP makes clear that new testing involving animals should only be carried out as a last resort. Any decisions on new testing should also take into account REACH and other obligations for the product.

LABELS

Labels under CLP must include the following elements:

  • name, address, telephone number of the supplier
  • nominal quantity for packages available to the general public, unless elsewhere on the package
  • product identifiers
  • hazard pictograms
  • signal words
  • hazard statements
  • appropriate precautionary statements
  • supplemental information

Following the GHS, and CLP, criteria, many substances and mixtures will be assigned a large number of Precautionary (P) statements –often 20-30 or even more if the product has several hazards. The CLP Regulation recommends that normally no more than six P statements should appear on the label. This may result in differences in labelling to other jurisdictions who require all relevant P statements to appear on labels.

CLP sets out some basic rules for the arrangement of labels, e.g. obligatory elements must be located together, and there are minimum sizes for labels and pictograms. Additional information required by, for example, the BPR or VOC legislation is considered to be ‘supplemental information’ for the purposes of labelling. There are also derogations for reduced information on labels of small packages.

CLP in the UK.

When the UK left the EU, all existing EU legislation was carried over into UK law. CLP therefore continues to apply, but with some modifications to give control over the legislation to UK rather than EU bodies. This modified regulation is known as GB CLP and applies only in Great Britain. Special arrangements apply in Northern Ireland, where EU CLP still applies. The modifications include:

  • Responsibility for the CLP regulation now resides with UK Government rather than the European Commission
  • HSE, acting as the GB CLP Agency take responsibility for the day-to-day activities instead of ECHA
  • A new GB Mandatory Classification List (MCL) has been created to replace the harmonised classifications in Annex VI of the CLP regulation.

GB CLP is already starting to diverge from EU CLP as the EU adopts new harmonised classifications, and the UK has either not yet adopted these classifications or may decide to adopt a different classification to the EU in future. The EU is also in the process of making major changes to the CLP regulation (eg with endocrine disruptors and environmentally persistent substances), which may or may not be followed by the UK.