I’ve recently been reminded that handling Harmonised Classifications can be quite tricky under CLP, so I thought I’d do a quick recap in case it’s something you’re interested in and I know that we have a few email subscribers outside the EU who may not be too sure about this concept.
You are probably aware that within CLP, that is GHS in the EU, there is a list of Harmonised Classifications, which are CLP classifications required to be used for certain chemical substances.
This is permissible under GHS, which anticipates that individual GHS jurisdictions will hold their own list of mandatory or recommended classifications, although, of course, this builds in differences between these jurisdictions, as many countries have subtle or not-so-subtle differences in what they think substance classifications should be. (This is a particular contrast with the Transport of Dangerous Goods, where the Dangerous Goods List is applicable globally).
So a few basics: what are Harmonised Classifications, where do you get them from, which products are they applicable to, how do you apply them, and when do you apply them?
Harmonised Classifications are:
- the EU’s list of mandatory classifications for certain substances which are so hazardous that the authorities wanted to make sure people were classifying them correctly; or they are classified differently to what may be expected, or which produce a different classification in mixtures than would be obtained if the normal mixture classification rules were applied, or both. (Harmonised Classifications may be either more or less hazardous than would normally be expected).
- published in Table III of Annex VI of the CLP Regulation (that’s why it’s such a large document!), online at ECHA as a downloadable Excel document, and also in the Classification and Labelling Inventory, where they are listed at the start of a substance, and shown in blue rather than orange/yellow.
- however, they are published with implementation dates, so the link to the consolidated version of the CLP regulation, above, does not include any Harmonised Classifications before they are implemented. These can be obtained from the relevant Adaptions to Technical Progress, ATPs to CLP, at the ECHA website legislation page for CLP. (Not every ATP contains updated Harmonised Classifications).
- they apply to the listed substances, and sometimes to mixtures containing those substances as well. The way in which they affect mixtures is through Specific Concentration Limits (used for most toxicity classifications); published Acute Toxicity Estimates (for Acute Toxicity classifications); and M-factors (for aquatic toxicity hazards which are more toxic than the normal classification rules would predict).
- you apply Harmonised Classifications when you classify a substance or a mixture containing Harmonised Classification substances for CLP
So far, so straightforward. But it’s not quite as simple as that, because
- some of the classifications are minimum classifications (identified with a single asterisk), whereas others are fixed
- notes can apply to the classification, which can change the meaning of the classification (e.g. if contains less than a certain impurity, this hazard does not apply)
- many of the Harmonised Classifications themselves are based on old data, and are being superseded or altered by new evidence coming out of REACH registration dossiers, and as a result some of the Harmonised Classifications are altering (and even if they aren’t, under Duty of Care in the UK, you may still want to use the most up to date information)
- and the elephant in the room – Harmonised Classifications do not always cover every possible hazard of a substance
What do I mean by Harmonised Classifications don’t always cover every possible hazard of a substance? Well, if the substance happens to be a biocide or a pesticide, all of the possible CLP-GHS hazards are covered by the Harmonised Classification entry. If a hazard isn’t mentioned, the substance is not classified for it.
For every non-pesticide and non-biocide substance, only health hazards tend to be classified, some hazards may be missing. And you don’t necessarily know why a hazard hasn’t been mentioned in a Harmonised Classification, without checking up on it.
You should be aware that this is only going to get worse with new Harmonised Classifications for non pesticides and biocides, which will legally under CLP only have to cover
- respiratory sensitisation, category 1, 1A or 1B, (H334)
- germ cell mutagenicity, category 1A, 1B (H340) or category 2 (H341)
- carcinogenicity, category 1A, 1B (H350) or category 2 (H351)
- reproductive toxicity, category 1A, 1B (H360) or category 2 (H361)
In fact, I tend to think of Harmonised Classifications as being “Partial”, unless they are pesticides or biocides, both because of the likelihood of missing hazard information, and also because there may be new data available from the REACH process.
The main way to check for extra hazards not included in a Harmonised Classification is to check the REACH registration CLP classification (if it has one, luckily most Harmonised Classifications have been registered for REACH. If a substance which holds a Harmonised Classification isn’t REACH-registered, your best bet is to find a Safety Data Sheet from a reputable supplier – the Classification and Labelling Inventory can be very misleading).
The reason you should check the REACH registration is because REACH requires the Lead Registrant, or their consultant, to classify all of the hazards of a registered substance, and to agree it within the SIEF (a group of people who are jointly registering the substance).
So unless your substance which holds a Harmonised Classification is a pesticide or biocide, you should always check for a REACH dossier (or if there isn’t one, a reputable company’s Safety Data Sheet) to see if you can fill in any of the “blanks” in the classification.
Of course, sometimes a substance hazard isn’t classified in the REACH dossier because there is “no data available”, but at least there’s more information than the Harmonised Classification, e.g. you may find out which hazards are genuinely “not classified”.
For mixtures, a complete CLP classification for component substances matters in two ways:
- you need to make sure you are publishing the full CLP classification of a hazardous substance in Section 3.2 of the Safety Data Sheet
- you also need to take into account all of the CLP classification hazards when you classify the mixture
From this, you can probably gather what happened to one of my contacts. They checked with me that yes, the substance which holds a Harmonised Classification does need to include the REACH dossier information, and updated their Safety Data Sheet…. but forgot to go back and reclassify the mixture on the basis of the new, fuller classification of one of the hazardous substances. Luckily, one of their customers queried this, and they checked back with me, so I was able to explain that yes, the new hazards also feed into the mixture classification.
This is something which can happen if any of us if we have a very large product range; or are overworked, as a lot of us are at the moment; if you’re rushing; or just have an off day.
It’s why I keep reminding everyone on our training course to keep records of all your classification information and decisions, so if, or when, something changes, you can go back and alter a classification later on.
Even if you are the most efficient classifier in the world, or use the best and most up to date classification software, sooner or later, something is going to catch you out.
I certainly have been caught out in the past, and expect I will be in the future. CLP is such a complicated system that it’s almost something to anticipate.
So please, if you are handling Harmonised Classifications:
- check whether the classification covers all of the hazard points (is it a pesticide or biocide?)
- if it doesn’t, check the REACH registration for all of the hazards, and fill in the gaps on the Harmonised Classification (or even use new information, if you think it should supersede the Harmonised Classification, but it may be sensible to check whether this is allowable in the countries you sell into, as only the UK has Duty of Care which suggest sthat this is the best approach)
- remember to include all of the hazards, if you are classifying a substance
- if you are classifying a mixture, classify the mixture for all of the hazards held by its component substances (as well as any new hazards which may be created in the mixture)
- if the classification of a component substance changes in any way, including new information coming to light or adding information to a Harmonised Classification, then the best thing to do is to reclassify your mixture from scratch, rather than just amending the existing classification. This will pick up any changes which may have occurred, and the new information can then be added to the label and SDS as required.
I hope this is useful as an introduction to, or reminder about, Harmonised Classifications within CLP, and if you have any queries about this, please email me, or if you think I’ve got something wrong, please let me know too :).
GHS Classification Courses from TT Environmental Ltd
4th November 2019
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