CLP is the Classification, Labelling and Packaging Regulation, EC No 1272/2008. It’s the EU’s way of implementing GHS, the Globally Harmonised System for hazardous substance classification.
This will run alongside, and eventually replace, the current system for classifying substances for supply, which is the CHIP regulations in the UK.
Main changes from current CHIP3
There are two new hazard symbols for human health, and the St Andrews Cross (Harmful) is being removed
There are more classes within human health and environmental hazard categories, and some thresholds have been changed. There are new hazard concepts, such as target organ, single or repeat dose, for human health hazard classes; and self-reactive substances and self-heating substances of physicochemical hazards
There are new abbreviations for the new concepts, such as STOT – Specific Target Organ Toxicity
The language used is different – instead of “preparations”, there are “mixtures”. Mixtures can contain substances, and they can also contain other mixtures.
Although most of the hazard symbols remain the same, the descriptive words are being replaced by a “Signal Word” – eg Danger or Warning will replace Toxic or Harmful. The familiar Risk Phrases are being replaced by Hazard Phrases, which may or may not be directly equivalent Safety Phrases are replaced with Precautionary Phrases, which may or may not be directly equivalent There will also be a requirement to notify ECHA about hazardous substances and mixtures brought into the EU CLP is a very large change to the way that substances and mixtures are classified for supply.
How is CLP being implemented?
CLP is being implemented across Europe as an EU-wide regulation, like REACH.
CLP, Regulation no. 1272/2008 came into force on 20th January 2009, see www.eur-lex.europa.eu (1355 pages, mostly annexes).
Like REACH, the CLP Regulation is managed by the European Chemicals Agency, ECHA.
Note – although classification of hazardous substances will be regulated under CLP, Safety Data Sheets (SDSs) will continue to be regulated through the REACH regulations.
There will be a phase in period where UK CHIP regulations run alongside the EU CLP Regulation, and both classifications must be used on SDSs. This will inevitably create a great deal of work for the chemical industry, particularly for Product Safety specialists.
What’s happening to UK regulation during the phase-in period?
There needed to be some changes to CHIP3 to prepare for CLP, so CHIP4 was brought in on 6th April 2009, see www.hse.gov.uk .
One major change is that the Approved Supply List has been superseded by Table 3-2 of Part 3 of Annex VI of the CLP regulations, see this link to the documentation.
This is planned to be the last set of CHIP regulations, and will apply until 1st June 2015, when the CLP regulations will take over completely.
The HSE will continue to be the Competent Authority for Classification, Labelling and Packaging after CLP has been fully implemented.
Details of the CLP phase in period
Both the CLP and CHIP4 classification systems will run side-by-side:
You may start to reclassify your substances and mixtures under CLP now, but the SDS must contain both classifications, and the CLP label can be used.
Substances must all be reclassified by 1st December 2010, and the Safety Data Sheet must contain CHIP and CLP classifications until 1st June 2015
Mixtures must all be reclassified by 1st June 2015
After 1st June 2015, CLP is fully implemented, all labels must be CLP compliant, and SDSs will only contain the CLP classification
The CLP phase-in period is similar to the REACH phase-in period, but doesn’t coincide completely:
Timeline Now to 1st December 2010 1st Dec 2010 to 1st June 2013 1st June 2013 to 1st June 2015 1st June 2013 to 1st June 2015 1st June 2018 onwards
REACH timeline High volume/ CMR registration Medium volume registration Low volume registration REACH fully implemented
Substances CHIP4 mandatory, CLP optional; CLP label if CLP classified, but SDS must still have CHIP classification CLP label compulsory; SDS must contain both CHIP4 and CLP classification CLP fully implemented – label and SDS should be CLP only
Mixtures CHIP4 mandatory, CLP optional; CLP label if CLP classified, but SDS must have CHIP classification CLP fully implemented – label and SDS should be CLP only
n.b. In the table above, ”CLP label if CLP classified” means that you can use the existing label only where you use the CHIP method of classification on your SDS. If you start using the CLP classification on your SDS alongside the CHIP system, then the label must be the CLP label.
Requirement to notify ECHA under CLP
This is a really important part of CLP.
Notification is mandatory under CLP from 1st December 2010, within 1 month of being placed on the EU market for:
Substances subject to registration under REACH
Hazardous substances placed on the market individually or in mixtures classified as hazardous
Hazardous substances which are not REACH-liable
Note – there is no threshold tonnage, ie R & D samples are affected too, unless the supplies are made within the same legal entity.
You do not need to notify under CLP if
The substance has been registered under REACH by 1st December 2010, and classification and labelling has already been submitted as part of the registration dossier
Note – this means that you will have to notify under CLP if you have not registered for REACH by 1st December 2010, ie you are registering later.
Information to be provided to ECHA for notification under CLP regulations
Identity of notifiers
Identity of the substance
Hazard classification of substance,
Explanation of classification (if required)
Specific concentration limits and M factor, where applicable, with justification
Pictograms, signal words and hazard statement, where applicable.
At the moment, the method of notification has not been set up. Hopefully it may turn out to be a fairly easy process along the lines of REACH-IT for REACH pre-registration – although this had its pitfalls and problems along the way.
CLP and in-house COSHH Assessments
It is anticipated that re-classification is likely to mean that substances move into more hazardous categories.
This can have a knock-on effect on in-house COSHH assessments and risk assessments, particularly where substances are re-classified as carcinogenic or toxic to reproduction. There may also be a knock-on effect for environmental risk assessments.
CLP and REACH
There are likely to be many inter-reactions between CLP and REACH.
REACH will generate new data, so classification and labelling may change; and CLP changes the hazard criteria, so classification and labelling may change.
Changes in classification may lead to possible changes in REACH status, especially where a substance is classified as more hazardous, which may bring the registration deadline forward.
Important practical tip – if you have 2010 or earlier registrations, make sure you use CLP classifications in your ECHA submission, this will prevent having to update them later. This issue should be discussed at an early stage with your SIEF and Consortium (if you join one).
CLP and COMAH
Many substances are classified for COMAH purposes by their Supply classification. This means that the COMAH regulations will need to be updated to include the new CLP classifications as well as the existing CHIP classifications.
Reclassifying substances under CLP may mean that they go into a more hazardous classification, which in turn may increase COMAH liability.
The EU are apparently working on changing the Seveso II/ COMAH boundaries, with the intention that businesses are not brought into COMAH because of CLP.
However, TT Environmental Ltd’s experience of other regulatory changes suggests that it is possible that the CLP changes may bring some companies into COMAH, or move them from Lower Tier to Top Tier, and we suggest that managers should keep a close watch on their COMAH-liable substances and inventory as CLP is implemented.
CLP and other regulations
There will be other knock-on effects in other chemical regulations caused by the CLP regulations, but these may take some time to work through the regulatory system, and there will probably be some unintended consequences.
Example – the Solvents Emissions Directive, SED, (covered by the Environmental Permitting Regulations in the UK) defines some solvents by their hazard classification eg R40 substances have more stringent air emissions limits than other substances. Obviously “R40” will eventually be replaced with the CLP equivalent, which may bring more substances into a different SED category.
It will be important to keep up to date with changes in all chemical regulations so that your business is prepared for any consequences from CLP.
If diluted substances are covered, won’t that include some consumer goods?
Consumer goods such as pharmaceuticals and cosmetics have been exempted from CLP, so you won’t see hazard warning labels on them in the supermarket. Other products will carry the new labels, for example cleaning products.
What are the new pictograms?
Low-level health hazard
May be equivalent to some types of Harmful, St Andrews Cross
Chronic health hazard
May be equivalent to some types of Harmful, St Andrews Cross, or some types of Skull & Crossbones, Toxic
Note – the St Andrews Cross, currently used for Harmful, will not be used under CLP, but the Skull and Crossbones will still be used for toxic and carcinogenic substances.
There is a full set of GHS pictograms for both Supply and Transport, which will be used by the CLP regulations, at http://www.unece.org.
Practical ways to prepare for CLP
Get CLP training for your Product Safety Specialist(s) as soon as possible.
CIA (Chemical Industries Association) are running a two day training course on 7th and 8th July 2009, see www. cia.org.uk events
Yorkshire Chemical Focus is planning to run a training course in early summer, see www.ycf.org.uk events.
Start to familiarise staff with the new pictograms and hazard thresholds – Merck have produced a free poster which can be downloaded from: http://www.merck-chemicals.com/ghs-labeling (the poster link is at the bottom of the page)
Liaise with your SDS and label software suppliers to ensure that they are aware of CLP and can provide CLP and CHIP4 classifications simultaneously.
Consider carrying out a private first-run translation of your main products into the CLP classification
For harmonized substances, use the classifications in Table 3-1 of Part 3 of Annex VI of CLP Regulations, which is the CLP equivalent of the old Approved Supply List (now superseded by Table 3-2 of Part 3 of Annex VI of CLP).
For other substances, use the translation tables in Annex VII of CLP to make an initial classification
Make a list of the substances which change classification/ become more hazardous because of CLP – these may need to be reclassified using the detailed method of classification
This will give you an idea of whether you need to reclassify substances in detail, and how much work CLP is likely to be for your organization.
Keep up to date with any changes of regulations and advice coming out of Europe and the HSE
These notes are based on a Chemical Industries Association (CIA) meeting held in Bradford on 3rd March 2009, and we would like to thank them for allowing us to publish this document.
TT Environmental Ltd would also like to thank Bob Warner of Chemwise, for his advice.
J Murfin, TT Environmental Ltd, April 2009
This document is intended as general advice on the potential implications of the CLP, and it is up to the reader to verify the suitability of the advice for their own business before taking any of the actions suggested.