No sooner have we got into 2020, when first ECHA publish four new SVHCs, see here, and then the HSE here in the UK issue an updated version of EH40: Workplace Exposure Limits, which includes some significant changes to workplace exposure limits in the UK.
In fact, I feel a bit like the lady in the picture at the top of the page, and you may feel like that too! There just doesn’t seem to be much stability around at the moment (and please, don’t get me started on Brexit….).
So if this newsletter is about CLP, why am I bothering with SVHCs, which come out of REACH, and Workplace Exposure Limits, which come out of the COSHH regulations in the UK, and several EU directives?
Well, it’s because both these sets of substances can trigger the requirement for a Safety Data Sheet for an otherwise non-classified product, and this means that even if they’re not directly related to CLP, they are part of GHS within the EU.
So if you have SVHCs at or above 0.1% in your product, or if you have substances which hold EU Workplace Exposure Limits (opinions vary as to whether this is for EU WELs at or above 0.1%, or in any quantity), then you will need to communicate the presence of this substance down the supply chain, which in practical terms means have a Safety Data Sheet (SDS), or very similar document. Note that country-only WELs do not attract the requirement for an SDS.
If you already have an SDS for a product which is affected, then you will need to update the SDS to include the new information.
Four new SVHCs
Starting with SVHCs first, these new ones are (extract from ECHA website):
Diixohexyl phthalate, CAS 71850-09-4, because it’s classified as toxic for reproduction. This is not registered under REACH. It’s likely that it has been brought in as part of the concern around phthalates, and the potential for them to migrate out of plastics.
2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone, CAS 119313-12-1, and 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one, CAS 71868-10-5, because they are both classified as Toxic for reproduction. These are also used in polymer production, and may presumably also migrate out of plastics.
Perfluorobutane sulfonic acid (PFBS) and its salts. These have been included because there is an “equivalent level of concern” about serious effects on teh environment and human health. This is comparing PFBS with PFOS (perfluorooctanesulfonate), which is known to build up in the environment and has already been given SVHC status.
The duties which apply to these new SVHCs are the same as for existing ones, that is:
- to provide an SDS for any substance or mixture containing an SVHC at or above 0.1% w/w
- this means that if your product is not classified for CLP, it will now require an SDS at 0.1% w/w of SVHC as impurity or component (on request)
- section 3 of the SDS must include the SVHC substance name, i.d. nos, hazard classification (if any) etc but there is no requirement to formally identify it as being an SVHC (although this is considered good practice, and is likely to become mandatory if the new update to Annex II of REACH comes into effect, more details here)
- there does not appear to be a requirement to identify an SVHC component substance on the CLP label
- to notify ECHA of any SVHCs made or imported into the EU at or above 1 tonnes per annum, as per ECHA guidance https://echa.europa.eu/support/dossier-submission-tools/reach-it/notifying-substances-in-articles, however this is not required where:
- where the total SVHC imported is less than 1 tonne per annum
- where humans and the environment will not be exposed to the SVHC during use and disposal of the article (although appropriate instructions shall be supplied to the article recipient)
- the substance has already been registered for that use
- In the future, to notify any SVHCs in articles, in any quantity, via the proposed SCIP database, ECHA information here, and our summary here.
The full SVHC list is available at https://echa.europa.eu/candidate-list-table .
The next step in the SVHC process is to recommend whether an SVHC should be considered for Authorisation, and you can check the lists of SVHCs which are being or have been considered for Authorisation at ECHA on this page: https://echa.europa.eu/previous-recommendations (remember that being on this list does not guarantee that an SVHC will be Authorised, this only happens for some substances, and they have to be formally added into the Authorisation List).
The actual Authorisation List is at https://echa.europa.eu/authorisation-list .
At this point, I should say that I find it very frustrating that substances which have gone through the Authorisation screening process but not Authorised currently stay on the SVHC list, as there is no mechanism to remove them, even though common sense would suggest that something which is not going to be Authorised should no longer be an SVHC (although that may just be my nerd liking for tidiness and consistency coming through!).
Another bugbear is that Authorised substances also remain on the SVHC list, I think because the SVHC list is named as triggering obligations under REACH, and if you want an SVHC-only list, you need to make one yourself. (Of course, we have done this for our CLP Mastery trainees and subscribers to the GHS Knowledgebase).
New and updated Workplace Exposure Limits
The new WELs are listed in the 4th Edition of EH40: Workplace Exposure Limits, download a free pdf copy here: https://www.hse.gov.uk/pUbns/priced/eh40.pdf
These changes are:
- Bromoethylene has been added, with long term TWA 1 ppm/ 4.4 mg/m3, and a note: “Carc”
- Respirable crystalline silica’s long term TWA of 0.1 mg/m3 is the same as in Edition 3 of EH40 , but it has a note: “Carc (where generated as a result of a work process)”
- Ethylene oxide’s long term TWA has reduced to 1 ppm/ 1.8 mg/m3 (it was 5 ppm/ 9.2 mg/m3), and it has a note “Carc, Sk” (it was “Carc” before).
- Ten other substances have had their WELs reduced:
- Hardwood dusts
- Chromium (VI) compounds
- to Refractory ceramic fibres
- Vinyl chloride monomer
The duties on these WELs depend on whether they are European WELs, or UK-only WELs.
European WELs trigger the requirement for an SDS if present in the product, but country-specific WELs do not.
The only new substance with a WEL, Bromoethylene does have an EU binding occupational exposure limit, according to the GESTIS database https://limitvalue.ifa.dguv.de/WebForm_ueliste2.aspx .
This means that it trigger the requirement for an SDS if it is present in the mixture (as bromoethylene as a substance is classed as hazardous under CLP and therefore requires and SDS anyway).
Any substance holding a WEL (regardless of whether it is an EU-WEL or country-specific WEL) must be listed on the SDS in section 3.1 (substance or impurity at 0.1% w/w or greater), or section 3.2 (component substance at 0.1% w/w or greater).
However, such a substance does not explicitly have to be identified as a WEL in section 3.1 or 3.2 of the SDS, (although this may also be brought in under the SDS changes mentioned above) but it will definitely be identified as such in section 8.1 of the SDS, along with its threshold(s).
This means that SDSs for the existing WELs where changes have been made will need to be updated with the new information.
If you are using classification and Safety Data Sheet software
If you use software for classifying, labelling and SDS authoring, your software may implement these changes semi-automatically for you, but it’s helpful to know about them, and make sure any updates go through in a timely way.
If you are classifying from first principles or using a manual system, you may need to make changes to your product information if you use any of the substances affected.
I hope this information is useful, and of course will do my best to bring you news of other changes to chemical designations as they happen.
GHS Classification Courses from TT Environmental Ltd
27th January 2020
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