GHS Revision 8: What’s Included

 

GHS Revision 8 has finally been made available as a free-to-download pdf in English and French. It’s also available to purchase for $67.50 USD from the UN shop, which you should only consider if you’re going to be cutting and pasting out of the pdf (as I do, for review purposes, but then I’m a complete nerd).

If you’re a full-time regulatory affairs person, it can be really useful to know what’s in GHS Rev. 8, because it gives a “heads up” on what may be adopted into CLP; and it’s essential reading if you’re dealing with other GHS jurisdictions which may adopt it. But if you’ve got a lot of other things to think about, just leave this email on one side, and don’t feel that you have to go into these details, as there’s no immediate rush to consider this.

The best way to tell what GHS version is being used in a particular country is to check first on the UN website at https://www.unece.org/trans/danger/publi/ghs/implementation_e.html (this also gives implementation status for Transport of Dangerous Goods), and then if you’re still not sure, to check with the GHS regulations and/or Competent Authority of the country in question.

You’re probably already aware that it’s not enough to know that a country is using GHS, it’s important to know which revision has been adopted, so you are giving them information in the format they are familiar with and not using classification methods which are outdated or beyond what they expect.

For example, the USA are still on GHS Rev 3 (as far as I’m aware), and presumably they will update e.g. every 5 years or so.which seems quite a sensible approach to me when we’re struggling in the EU to keep up with yet another CLP update! Of course, CLP is much more than GHS, so we have the Harmonised Classification updates and non-GHS information updates to deal with as well.

The summary of changes made in GHS Rev 8 is:

1. new classification criteria, hazard communication elements, decision logics and guidance for chemicals under pressure;
2. new provisions for the use of in vitro/ex vivo data and non-test methods to assess skin corrosion and skin irritation;
3. miscellaneous amendments to clarify the classification criteria for Specific Target Organ Toxicity;
4. revised and further rationalized precautionary statements and an editorial revision of Sections 2 and 3 of Annex 3;
5. new examples of precautionary pictograms to convey the precautionary statement “Keep out reach of children”;
6. a new example in Annex 7 addressing labelling of sets or kits; and
7. guidance on the identification of dust explosion hazards and the need for risk assessment, prevention, mitigation, and hazard communication.

This list from the UN doesn’t really give you the full flavour of what’s going on, so I’ll go through these items in order.

1. New hazard category, Chemicals under Pressure

The biggest change is that Chapter 2.3, which previously covered aerosols, has been extended to include aerosols and chemicals under pressure, that is chemicals under pressure which aren’t in aerosol format.

Aerosols become Hazard Class 2.3.1, and Chemicals Under Pressure are Hazard Class 2.3.2 .

Chemicals under Pressure are defined as “liquids or solids (e.g., pastes or powders), pressurized with a gas at a pressure of 200 kPa (gauge) or more at 20 °C in pressure receptacles other than aerosol dispensers and which are not classified as gases under pressure. NOTE:Chemicals under pressure typically contain 50% or more by mass of liquids or solids whereas mixtures containing more than 50% gases are typically considered as gases under pressure.”

The classification protocol is based on the percentage of flammable components, and the overall heat of combustion (similar to the calculations required for aerosols, but without the specific aerosol foam or spray tests).

The chemicals under pressure hazard class comprises 3 categories, and 3 new hazard statements:

• Chem. press. 1, H282, Extremely flammable chemical under pressure: may explode if heated
• Chem. press. 2, H283, Flammable chemical may explode if heated
• Chem. press. 3, H284, Chemical under pressure, may explode if heated

The labelling elements are:

As you can see, the top two categories attract two pictograms. There are no new P statements associated with the new H statements.

2. New provisions on in vitro/ ex vivo data and non test methods for skin corrosion and skin irritation

The following OECD in vitro/ex vivo test methods are included, along with provisions where they do not fully describe skin corrosion sub-effects (eg 1A/1B/1C):

Test No. 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER) (2015) Test No. 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method (2019) Test No. 435: In Vitro Membrane Barrier Test Method for Skin Corrosion (2015) Test No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (2019)

There is also more detail on the non test methods and tiered method for classification of skin corrosion and skin irritation.

3. Specific Target Organ Toxicity clarification – this simply emphasises that you have to classify for STOT single exposure and STOT repeated exposure hazards separately (which we already know about under CLP).

4. New and altered P Statements

This is actually quite a big set of changes, luckily they should make label information much clearer when they are adopted. The changes are:

• P201, Obtain special instructions before use, and P202, Do not handle until all safety precautions have been read and are understood, are deleted, and replaced like for like by a single new P statement, P203, Obtain, read and follow all safety instructions before use.
• P310, Immediately call a POISON CENTRE/doctor/…, P311, Call a POISON CENTRE/doctor/…, P312, Call a POISON CENTRE/doctor/… if you feel unwell, P313 Get medical advice/attention, P314, Get medical advice/attention if you feel unwell , and P315, Get immediate medical advice/attention, have all been deleted. These are replaced by P316, Get emergency medical help immediately, P317, Get medical help, P318, IF exposed or concerned, get medical advice, and P319,Get medical help if you feel unwell. It looks like these replacements are simply to make the P Statements more understandable
• P353 has been adapted to include “affected areas”, and now reads “Rinse affected areas with water [or shower]”.
• There is a new P statement, P354, Immediately rinse with water for several minutes, which will apply to Skin Corrosion category 1, and Serious Eye Damage category 1.
• Several compound statements have been altered to take into account the new or amended P statements

5. New precautionary pictograms adopted.

This is a minor change for those of us under CLP, as the EU (and UK, if we do Brexit) does not use mandatory precautionary pictograms as part of the CLP regulations. The two new pictograms are the AISE one for keep out of reach of children (currently voluntary, I understand), and an equivalent one from the Japan Soap and Detergents Association.

Ironically, the only reason we have precautionary pictograms in GHS is because the EU insisted on it, and there is a reference to Council Directive 92/58/EEC of 24 June 1992 within GHS. In the EU, these are safety signs, and have never been adopted into CLP. You couldn’t make it up, could you?

6. A new labelling example in Annex 7 for kits containing chemicals.

This is a minor change which will only affect manufacturers who makes kits containing chemicals, this gives ways in which labelling can be made so the kits are compliant with GHS.

7. Guidance on identification of dust explosion hazards.

This is included in a completely new Annex 11, Guidance on Other Hazards Not Resulting in Classification. This is 14 pages long, and refers to ISO/IEC 80079-20-2, ASTM E1226 and VDI 2263-1. It includes guidance on classification and handling of substances which may cause a dust explosion, which in the UK are handled under the DSEAR regulations http://www.hse.gov.uk/fireandexplosion/dsear-regulations.htm

Annex 11 also provides guidance on information for the SDS, some of which is already in use under CLP (e.g. the suggestion to use the phrase “May form explosible dust-air mixture if dispersed“) and brings in a new phrase, “May form explosible dust-air mixture if small particles are generated during further processing, handling, or by other means.“, for products which may generate dust due to handling or use. It also allows for the use of the word Warning: in front of either of these phrases on the SDS.

At the moment, Annex 11 only includes dust explosion hazards, but presumably may be extended to cover other non-GHS hazards in future editions.

So these are the main changes within GHS Revision 8. If you are interested, you should download the free pdf and read through it yourself, as I can only give an overview of the changes which are included.

I hope this is useful, and please remember that GHS Rev. 8 has not been brought into CLP yet, and its provisions may not be allowed in the EU or UK for some time.  Of course, I will do my best let you know when GHS Rev. 8 is brought into effect.

GHS Classification Courses from TT Environmental Ltd

28th October 2019

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