The CLP Regulation
The 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. CLP has 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
The transitional period for the introduction of CLP finished on the 1st June 2015 and all chemical products must now be classified, labelled and packaged according to CLP. However, for mixtures that were already placed on the market before 1 June 2015 and were classified, packaged and labelled according to the Dangerous Preparations Directive (DPD), a further 2 years transition period, until 1 June 2017, is still available to allow them to work their way through the supply chain.
WHAT IS THE GHS?
Development of the GHS began following the 1992 Rio de Janeiro UN Conference on Environment and Development with the aim of providing 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. The 6th Edition of the GHS will be published in July 2015. 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. 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 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.
The system of harmonised classification introduced through the DSD has been transferred to CLP, and the existing classifications from Annex 1 of the DSD have been transferred to Annex VI of CLP, together with their new CLP equivalents. Annex VI is regularly updated through amendments to CLP known as ATPs (Adaptations to Technical Progress). 6 ATPs have so far been published, and more are in progress. It is expected that Annex VI will be updated at least annually. The process of agreeing a harmonised classification for a substance can be followed here on the ECHA website.
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.
Where no harmonised classification exists for a chemical substance, or there are 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.
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 that 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.
HEALTH AND ENVIRONMENTAL HAZARDS
The selection of building blocks by the Commission was designed to avoid significant changes in scope between CLP and the DSD and the DPD. However, there have been some significant changes in the way that classifications for mixtures are calculated, particularly for corrosives and irritants that mean that many more mixtures will be classified as hazardous under CLP than were classified under the DPD.
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 obligations for the product.
A number of labelling elements have changed under CLP. There are new pictograms; the descriptive Indications of Danger, such as “Flammable” and “Harmful” are replaced by the simpler Signal Words “Danger” and “Warning”; and Risk and Safety Phrases are replaced by Hazard Statements and Precautionary Statements. In many cases these new phrases are very similar to the old phrases, but there are also many new phrases, particularly for the Precautionary Statements.
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, following on from the normal practice under the DSD and DPD, recommends that normally no more than six P statements should appear on the label. Selection of these P Statements may be a complex process for some products, and further guidance is available in the Guidance on Labelling and Packaging in Accordance with the CLP Regulation.
Labels under CLP must include the following elements:
- name, address, telephone number
- nominal quantity for packages available to the general public, unless elsewhere on the package
- product identifiers
- signal words
- hazard statements
- appropriate precautionary statements
- supplemental information
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 BPD or VOC legislation is considered to be ‘supplemental information’ for the purposes of labelling. For multilingual labels, the hazard and precautionary statements need to be kept together for each language.
This page was last updated on 4th June 2015.