I don’t often discuss draft regulations, as they often alter at the last minute, and sometimes don’t get published at the intended time, or even at all, but there is a draft to Annex II of the REACH regulation, which will affect EU Safety Data Sheets which looks like it is going to go ahead.
Safety Data Sheets (SDSs) in the EU don’t change very often, unlike CLP which can be amended several times a year through ATPs, so this is an unusual and important update.
There are two documents which are associated with this change, the regulation amending REACH, and the replacement Annex II document.
Both of these were sent to the World Trade Organisation, WTO, for comments on the 9th September 2019, and the regulation is due to be published in the first quarter of 2020. Many thanks to the team at Chemycal, who spotted that this had happened, as there has not been a lot of publicity about these proposed changes.
You can download the draft regulation here, and the draft replacement Annex II document here. As usual, please be aware that the contents may change between now and final publication, and you should only use the published version for making any important decisions.
This is particularly important for UK companies, as we may (or we may not) have left the EU by the time this legislation enters into effect, and if it does come into effect after Brexit, then it will not apply in the UK, although it will apply in the rest of the EU.
The EU describe 3 major changes in their letter to the WTO, with “some minor changes”. In other words, they can’t help themselves, they’re adding more than they are claiming.
Having reviewed the documents, I think there are actually 5 major changes:
- Aligning the SDS with GHS Revisions 6 and 7, which were brought into CLP earlier this year, mainly in Section 9 (physical and chemical properties) and Section 14 (Transport)
- Bringing in nanomaterials information as brought in by the “Nanoform Substances” regulation EU 2018/1881 in December last year, which includes information in Section 1, Section 3 (Composition/ information on ingredients) and Section 9
- Including the UFI in Section 1 for mixtures handled in bulk which require a UFI but do not have a CLP label
- Adding information on Specific Concentration Limits, M factors and ATEs in section 3.1 (substance identification)
- Information on Endocrine Disruptors (Section 2, Section 3, Section 11 and Section 12)
It is proposed that these changes are not adopted into use until 31st December 2022, except for bulk mixtures requiring an UFI. UK readers will be aware that under Duty of Care, it may be appropriate to pass on new information on hazards as soon as practical, and if this regulation is adopted while the UK is still part of the EU, they may want to update their SDSs sooner than this deadline.
This is a non-GHS designation which the EU have brought in as an addition to REACH, with requirements to report information in the dossier, and this is now being extended to information on the Safety Data Sheet.
The EU seem to be blind to the fact that many natural materials (foods such as flour, or milk; or rock and soil components such as clays) contain “nanomaterials”, but do not pose specific “nano” risks, unlike products which are deliberately made at nano scale to take advantage of their nano properties.
They have adopted a very broad definition of nanomaterials (against industry advice), which means that It is likely to affect a large number of powder products, not just the “intentionally made” nanomaterials.
It is interesting that the only mandatory requirement for a UFI on the Safety Data Sheet is for bulk mixtures which require one (that is excluding non-hazardous mixtures, or environmentally-classified mixtures). The UFI would go under “other means of identification” in Section 1.
There has been uncertainty over whether the UFI would be required to be placed on the SDS, and whether mixtures in mixtures would have to include the UFI in Section 3.2, so it is good to get clarification on this point.
It could be argued that the UFI should go on the Safety Data Sheet for use in an emergency, as it’s part of the safety information for a mixture with physical and/or health hazards, for example for situations where there is a spill which damages the label and means that the UFI can’t be read.
However, the UFI is primarily intended for consumers, who don’t have access to the more detailed safety information in the Safety Data Sheet, so maybe the EC think that it’s not as important for professional and industrial users who have (a) got more information on the SDS and (b) should be better prepared to deal with exposure.
SCLs, M-factors and ATEs
Although SCLs, M-factors and ATEs are all part of GHS, or allowed under GHS, there is no requirement under GHS to place this information on the Safety Data Sheet.
I can only think that the EU have decided to include this information on substance SDSs in order to make life easier for people making mixtures, who may otherwise forget to check for this type of information and therefore get their mixture classifications wrong.
Endocrine disruptors are brought in via the Plant Protection Products and Biocides Regulations. They are now required to be identified in the REACH dossier, and this amendment brings the relevant information into the Safety Data Sheet. There is a new sub-sub-section, Other (health) hazards 11.2.1 Endocrine disrupting properties, and a new sub-section Ecologicial properties 12.6 Endocrine disrupting properties.
I have to admit that I’ve not researched the endocrine disruptors side of things, as only a few of my clients are directly affected by this, but if you want to know more then the endocrine disruptors test methods were published in early 2018, followed by a corrigendum, and these two documents define what these substances are.
Overall, if you compare the EU Safety Data Sheet to a GHS Safety Data Sheet, it is clear that the EU are loading a lot more information above GHS onto the SDS, and it is evolving further away from the intentions of GHS.
Of course, all of these pieces of extra information, however well-intentioned, act as an extra burden of red tape on people making, importing and selling chemicals in the EU.
I hope this is useful, and will do my best to keep you up to date with progress on this regulation.
GHS Classification Courses from TT Environmental Ltd
16th September 2019
Like this article? You’ll love our free guide to CLP (and you’ll also get our articles delivered direct to your inbox every week!)