One of the trickiest things I’ve found with classifying chemicals in the EU and UK is understanding the relationship between CLP and REACH.
The pre-GHS EU regime for hazards of chemicals for supply, that is classification, labelling, packaging and safety data sheets were all gathered together into two directives, the Dangerous Substances Directive and Dangerous Preparations Directive. In the UK, these were further combined in a single piece of legislation in the UK called CHIP, the Chemicals (Hazard Information and Packaging for Supply) Regulations.
This is entirely logical, because classifying, labelling and writing safety data sheets comprises the full range of communication methods applied to chemicals for supply, that is providing information on the hazards for the end user. Packaging is also placed in this sequence because (a) packages need to be labelled; and (b) it’s the most appropriate place in the legislation ecosystem to have this information.
The same sequence of classifying, labelling and writing safety data sheets is also used within GHS, the Global Harmonised System, which covers classification, labelling and safety data sheets.
As you’re probably aware, GHS in the UK and EU is covered by the CLP regulation (classification and labelling) and Annex II of the REACH regulation, which covers safety data sheets.
So why did the EU decide to separate safety data sheets from the rest of supply chain communication, and place it inside the REACH regulation? This goes against the spirit of GHS, which keeps all three pieces of supply chain communication in one place, and it also goes against the historical way they were handled inside the EU and UK.
Well, I don’t know how the EU’s minds work, so the best I can do is try to work out why this happened on the basis of the evidence.
It looks to me like Safety Data Sheets were placed inside REACH because of the requirement under REACH to communicate certain hazards down the supply chain. As the SDS is a legal document, and compliance can be enforced, and it was already an accepted part of hazard communication, presumably the EU thought that this was a quick way to make sure that REACH hazards were going to be communicated, without having to ask people to have a second piece of paper to be sent out with their chemicals.
However, this has made the relationship between CLP and REACH complicated, to say the least:
- CLP affects REACH because:
- it provides the language of hazard communication which REACH uses to assess the risks of the registered substances (prior to CLP-GHS, REACH used CHIP)
- it includes the methods of classification, including thresholds which must be used in the REACH dossier, so a change in a GHS and then CLP classification method can mean that a REACH dossier needs to be updated
- the Harmonised Classifications provide the basis for classification for a number of substances, which must be included in the REACH dossier, even if new evidence contradicts this classification and the Lead Registrant has to provide one or more alternative classifications
- The CLP classification and CLP labelling information for the product must be placed in the SDS (section 2), and also for hazardous mixture components (section 3.2)
- REACH affects CLP in a number of ways:
- if a substance in your supply chain has been registered for REACH, by you or your suppliers, you are obliged to use (one of) the published REACH classifications, (and you also must include the supporting data in the relevant parts of the SDS, that is sections 9, 11 and 12)
- if you are making or importing a substance which is registered for REACH but at sub-REACH levels, you are encouraged (by ECHA) to use one of the REACH registered classifications, (although you cannot use the supporting data on the SDS if this breaches copyright, e.g. on new data not otherwise in the public domain)
- The REACH dossiers do provide a lot of information which may be useful if you have to classify substances in mixtures when they are imported
As you would expect, the relationship between CLP and REACH which means that a change in one can affect the other. For example, an updated CLP classification will need to be communicated on an updated SDS, as well as on a new label.
On the other hand, if new information comes out of the REACH registration process and gives rise to a new CLP classification, this information needs to be communicated down the supply chain, and classification and labelling for the substance and any mixtures it contains must be updated, as well as the SDS. (Note that labels do not necessarily need to be updated when a classification changes if they are out in the supply chain, depending on the importance of the classification change).
In the EU, we are still working through the classification changes which have come to light from the 2018 registration deadline, and it would be nice to think that everything will be stable after a couple of years.
Unfortunately, depending on the information already available for REACH purposes, the registration process often includes a requirement to have extra tests carried out, and these can take years to be approved, carried out and then the information published in the dossier. For example, we are only now starting to have some new tests carried out on substances which went into REACH on the original 2010 registration deadline.
So it is possible that REACH registration changes will continue for quite some time, and that is before any changes to GHS classifications, or new test methods, or improved methods of detection are taken into account.
All this means that if you’re classifying e.g. substances in an imported mixture, you can’t just assume that checking a REACH CLP-GHS classification is a one-off action, you may need to check regularly to make sure your information is up to date.
It’s not quite as important to check if you have a substance which holds a REACH registration, because you should be informed of any classification changes via updates to the SDS, and eventually via a new label.
Of course, you may still want to do this in the UK under Duty of Care, rather than waiting for information to percolate down to you, as this can be delayed significantly (e.g. it took much longer than anticipated for the change from CHIP to CLP classifications to happen), and you may want to make sure your downstream users have access to the most up to date information.
There is also the overall impact of REACH on GHS in the EU to consider. REACH adds in a great many legal obligations, and one way this is visible is in the extra information on the SDS, which simply do not exist in other GHS jurisdictions.
- SVHCs, substances of very high concern, either in their own right, and as components in mixtures at or above 0.1%
- Substances holding an Authorisation under REACH
- Substances holding a Restriction under REACH
- PBT and vPvB classifications, which are not part of GHS, but are required as part of the REACH registration process for substances made or imported into the EU at 10 tonnes per annum or more (this concept was being developed in the EU prior to REACH)
- REACH registration numbers, to demonstrate that a substance, or a mixture within a substance, holds a valid REACH registration
- Safety information in an Annex containing information from the Chemical Safety Report which is required for some substances regardless of tonnages made or imported per year, and for all hazardous substances made or imported at 10 tonnes per annum or more
CLP also has extra obligations compared to GHS. The most obvious of these is the Harmonised Classifications in Annex VI, but these are actually permissible under GHS, which expects that individual jurisdictions will have their own list of approved or mandatory classifications in their own versions of GHS. EUH statements, which are EU-only labelling hazards, are also permissible under GHS. However, the requirement to notify to the Classification and Labelling Inventory is an EU-only obligation.
Overall, when you look at GHS as published by the UN, and GHS as it is delivered in the EU, I get the impression that GHS in the EU is a bit like Frankenstein’s monster, with extra bits bolted on here and there. It is something which is so complicated that it hardly seems to function efficiently, and places an enormous burden on Regulatory Affairs people in the EU (and those outside the EU who sell into the EU) which simply didn’t exist 10 years ago.
Of course, the GHS aspects of REACH are a small part of the overall REACH process, and I will go over this (in outline) in my next post, as we have overseas subscribers who are interested in this.
GHS Classification Courses from TT Environmental Ltd
2nd December 2019
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