Four new substances on the Candidate List, July 2019

You may have seen that ECHA has recently identified four new SVHCs (Substances of Very High Concern), https://echa.europa.eu/-/four-new-substances-added-to-the-candidate-list .

We can look at this in two ways: from the technical point of view of the duties it places on companies making or importing these substances; and from the political point of view, to consider why we have the SVHC process, and what it means for the chemical industry in the medium to long term.

In this first post, I’ll go through the technical side of compliance.

SVHC, as I mentioned above, stands for Substances of Very High Concern.  These are substances which have gone through an evaluation process before being placed on the Candidate List for substances which may eventually be Authorised.  (This is all brought in by the REACH regulation).

Confusingly, the SVHC list also includes substances which have been Authorised!

I think this is a bit of laziness on the part of the people drafting the CLP Regulation, as it means they only needed to refer to “substances on the Candidate List” rather than “substances on the Candidate List and Authorisation List” at various points in the Regulation.  I dare say someone more knowledgeable may correct me, but that’s what it looks like to the average end user.

Anyway, when ECHA publish new SVHCs, they mean that these have been newly placed on the Candidate List, and that they will, in due course, go through the evaluation process to decide whether they should be Authorised or not.

Authorisation involves substances that are deemed to be so nasty that their use has to be under an Authorisation, that is an extra layer of (expensive) permissions, with a view to banning their use over the course of several years.

Not every substance on the SVHC list does become Authorised, but as far as I know, no SVHC chemical has been taken off the list, which would seem to be a sensible thing to do to avoid having people worrying un-necessarily about a substance that is not as hazardous as originally feared.

Similarly, some Authorised substances are so vital to specific products or industries that they do not have a “sunset date”, that is the end date when a substance will be banned.

The main criteria for a substance being identified as an SVHC are one or more of the following:

• Category 1A or 1B Carcinogen classification
• Category 1A or 1B Mutagen classification
• Category 1A or 1B Reproductive toxin classification
• Persistent Bioaccumulative and Toxic (PBT) and/or very Persistent and very Bioaccumulative (vPvB)
• An endocrine disrupting substance

Note that not all of these SVHC criteria would necessarily mean that a substance is classified as hazardous under CLP.

Carcinogens, Mutagens and Reprotoxins are CLP hazards, but PBT and vPvB are designations under the REACH regulation, and are not GHS classifications.  Endocrine disrupters are a broad church, and almost “in the eye of the beholder (or regulator)”.

ECHA administer the SVHC process on behalf of the European Commission and also participate in it.

The entire SVHC and Authorisation process was created under REACH, and runs parallel to Restrictions which existed prior to REACH.  In some cases, the outcome of an Authorisation also includes a new Restriction.

The new SVHC substances are:

• 2-methoxyethyl acetate;
• tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP);
• 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof);
• 4-tert-butylphenol

The full details are at https://echa.europa.eu/-/four-new-substances-added-to-the-candidate-list .

So what does adding these substances to the Candidate List mean for CLP-GHS?

Well, you need to know whether a substance is SVHC or not, because if you are making or importing a substance which is an SVHC or contains SVHCs, a mixture or article containing SVHCs, you will need to provide a Safety Data Sheet to your customers under Article 31 of REACH, regardless whether the product is classified under CLP or not.

The SDS is required for products containing one or more SVHC at a threshold of 0.1% (per individual SVHC).

Also, if you’re making or importing Articles, you’re probably exempt from REACH registration.

Unfortunately, if you’re importing an Article which contains an SVHC at or above 1 tonne per annum, you need to notify this to ECHA on a specific reporting system https://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles .

And, if you’re worried about SVHCs, or your customers are worried about them, you may have a voluntary ban on using SVHC substances in your mixtures.  I know of several large retailers who take this approach, e.g. for their scented candles and similar products.

So you need to know whether an SVHC substance is at or above 0.1% w/w as:

• an impurity in any of your substances
• a component substance in your mixture
• a component substance in your article

And once you have identified any SVHCs, you may then need to:

• consider whether you need to stop using the SVHC, e.g. change a substance supplier, remove the SVHC from a mixture or article
• produce a Safety Data Sheet if the product is not classified for CLP and otherwise does not require one
• (importers of articles only) review whether you need to notify the import of an SVHC to ECHA if an individual SVHC is at or above 1 tonne per annum
• If a substance is Authorised by you or your supplier, it will have a unique Authorisation Number which must be placed on the label and on the Safety Data Sheet
• If a substance is an SVHC without being Authorised, it’s good practice to identify this on the Safety Data Sheet, to help your downstream users deal with their SVHC obligations

It is also very important to keep any eye on the Authorisation list, in case an existing SVHC you handle becomes Authorised, as you may need to apply for an Authorisation to keep using it, or stop using it altogether.

When a Sunset Date kicks in, it’s an absolute date, a guillotine, so you can’t use up any old stocks or sell them, and you’ll have a “triple whammy” of costs:

• You paid for the product, but can’t use it (cost 1)
• You’ll have to pay for a replacement substance (cost 2)
• And you’ll have to pay to dispose of the SVHC as hazardous waste (cost 3)

Authorisation is one reason why some companies immediately stop using new SVHCs as they are added to the Candidate List, because it “future proofs” their product range against having to removed Authorised substances at a later date.

Another reason is the loss of confidence their customers might have if they thought they were selling them un-necessarily hazardous materials, and as you may imagine, this is particularly important to people making or importing consumer products.

While reformulating away from using SVHCs is often a viable strategy for companies formulating consumer products, it can be much less viable for the makers of industrial chemicals.

It is sometime the case that there is a sound reason why you don’t need an Authorisation, but these are very few and far between, and if you are in this situation it is sensible to get advice from an experienced and reputable REACH consultant.  Even then, you may find that suppliers outside the EU don’t want to sell into the EU because of the complexity of the regulations.

And in most cases, Authorisation means you will need to change to a non-Authorised alternative substance, or purchase a very expensive and time-consuming Authorisation.

This, of course, is exactly what the SVHC and Authorisation process is designed to do, to remove the substances which are seen as particularly hazardous from the EU market.

But nobody seems to question whether this is actually a good thing, and I will discuss this in my next post.

GHS Classification Courses from TT Environmental Ltd

6th August 2019

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