Potential developments in CLP, GHS and REACH for 2020

Happy New Year! I hope you had a lovely time over the Christmas period, and have returned to work refreshed and ready to face the challenges which 2020 will inevitably bring us.

After my article last week summarising changes in these regulations for 2019 (available to view here), I thought I’d look forward to what may happen to them in 2020, starting with GHS.

GHS in 2020

The current version of GHS, Revision 8, is not expected to change significantly in 2020, unless errors are found.

GHS, Revision 9 will be discussed at the UN, and is probably going to be adopted in December 2020, for publication in mid 2021.

The UN are also responsible for the Transport of Dangerous Goods, that is ADR, IATA, IMDG etc, and the next revision of this is also due to be implemented on 1st January 2021 (although it will presumably be published in 2020).

Interestingly, ADR, which used to only cover Europe, will have its name changed in 2021 to remove the word European, but I don’t know how significant this may be.  Details here: https://www.unece.org/fr/trans/danger/danger.html​ .

It is theoretically possible that there may be changes to some of the test methods for Transport, in the UN RTDG, Manual of Tests and Criteria​ (which also covers many physical tests used in GHS), see https://www.unece.org/trans/danger/publi/manual/manual_e.html​.  The current version is Revision 6.

OECD tests for health and environmental hazards

While we’re on the topic of international changes which may affect CLP-GHS, it’s possible (if not likely) that there may be new health and environmental tests, particularly in vitro tests, published by the OECD, see http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm​.  We are also seeing the development of “in silico” computer models, and other new types of modelling.

At this point, speaking as an “experienced” person (or an “oldie”, if you like), I’d like to warn any younger readers that in vitro tests and models are unlikely to replace in vivo, that is tests on live animals completely, at least for the forseeable future.

John Hibbs, BACS (British Association of Chemical Specialities) Chair, summed up the situation perfectly on LinkedIn a couple of weeks ago, in response to this LinkedIn article about animal tests being banned in cosmetics:

“It’s a great ambition, but sadly the science is a long way behind the dream. Reliable methods (which can mean providing answers equivalent to existing animal based methods which in turn may not be reliable indicators of human response…) for higher end points are many years away, as detailed in Reinhard Kreiling’s excellent paper in October’s EFfCI conference. The complexity of biological response in endpoints such as sensitisation and endocrine modulation are not fully understood, and therefore cannot be modelled, either in vitro or in silico. 

While we must continue to drive towards the ideal situation of being able to give full safety data for chemicals without animal testing, we should look to ECHA (and other chemical agencies) to be more reasonable in their demands for data which they will only accept if animal methods are used. Wider use of read-across, use of developing methods and consideration of the value of the data versus the societal impact of use of animals. They must allow the widest possible use of existing data & methods 

I can’t say this any more plainly. I do not know of ANY chemical business who chooses animal testing willingly, or who would choose to use an animal method if an alternative were available.​”

I would add that, as scientists, we must be very careful that the desire to reduce the amount of testing on live animals does not compromise human safety.

CLP in 2020​

New ATP for 8th Revision of GHS

CLP may potentially adopt the 8th Revision of GHS in 2020, but this will depend on ECHA’s priorities and getting the agreement of the EU member states.  If the changes are not considered to be very significant, it is possible that the adoption may be delayed, for example until the 9th Revision is published.  The Revision 8 changes are summarised here:  https://www.ghsclassificationcourses.com/ghs-revision-8/​

Poison Centre Notification

In 2020, the Poison Centre Notification Portal should finally be up and running in full, and all of the EU Member States will (hopefully) be able to accept submissions via this method by around the middle of the year (although if past experience is anything to go by, this tentative deadline may not be achieved).

We are expecting the Portal to be able to accept notifications via third party software, such as SAP, by March or April.  This should make Poison Centre Notification much easier for software users, but I would anticipate the usual “bedding in” issues with new software to occur.

The first two deadlines for Poison Centre Notification, for hazardous mixtures sold to consumers and to professional users is officially the 1st January 2021, so effectively the 31st December 2020.

14th ATP to CLP

It is going to be very interesting to see what happens to the 14th ATP to CLP, which contains the controversial proposed Harmonised Classification for Titanium Dioxide as a Category 2 Carcinogen.  Will there be an appeal by industry against this?  Will the regulators back down? Or will bad science be used to push through this highly politicised classification?

Whatever the decision on Titanium Dioxide, I do feel that we in industry need to start debating science with the NGOs and people who think that there is a “magic chemicals tree” where we can find safe chemicals which are also effective (as I wrote about last year).

In particular, we need to stand up for our own knowledge within industry, and stop people using the argument that “industry paid for that research, so it must be flawed”.

As John Hibbs wrote in a LinkedIn post on Palau banning “toxic” sunscreen, “Just another case where any “expert” who says a thing is bad is instantly believed, while any number of experts who say a thing is ok are “bound to say that, because they are in the pay of big business”.​

Trying to shut down the debate by claiming that research should be ignored because of who funds it is going against the scientific method, which is why we don’t use it against e.g. people in the NGOs who may have funded research.  Instead, we look at the results of that research before deciding whether it is flawed or not (spoiler alert: most scientific research is flawed to some extent), and I think we should start to insist that the NGOs extend the same courtesy to us.

I don’t make New Year’s resolutions, but I hope to be able to emulate John’s approach to take industry’s arguments to a wider audience.

Other Harmonised Classifications (not part of 14th ATP)

Other Harmonised Classifications may be brought into CLP during 2020.

REACH in 2020

Registration

ECHA have announced that there will be new completeness checks on REACH dossiers from April 2020, including on Chemical Safety Reports, details: https://echa.europa.eu/-/revised-completeness-check-to-be-launched-in-april-2020​ .

SVHCs proposed for the Candidate List

We are likely to see more SVHCs under REACH in 2020. There are currently 228 chemicals on the REgistry of SVHC intentions until outcome, which tracks proposed SVHCs as they go through the process of going onto the Candidate List, details here: https://echa.europa.eu/registry-of-svhc-intentions​

Proposed Authorisations

The last new Authorisations were made in 2017 (that is Candidate List substances, SVHCs, being upgraded to Authorisation status), and no new ones were added in 2018 and 2019.  

ECHA have made up for this lost time by proposing 18 substances for Authorisation in October 2019, under the 9th Recommendation.  

• Bisphenol A (BPA)
• Dechlorane plus
• RP-HP
• DOTE
• reaction mass of DOTE and MOTE
  
• 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)​
  
• Dioxobis(stearato)trilead​
  
• Fatty acids, C16-18, lead salts ​
  
• Trilead dioxide phosphonate ​
  
• Sulfurous acid, lead salt, dibasic ​
  
• [Phthalato(2-)]dioxotrilead​
  
• Trilead bis(carbonate) dihydroxide​
  
• Lead oxide sulfate​
  
• HHPA​
  
• MHHPA​
  
• Tetraethyllead ​
  
• 2-methoxyethanol​
  
• 2-ethoxyethanol​
  

The full list is given here: https://echa.europa.eu/documents/10162/27489283/annex_9th_recommendation_annex_xiv.pdf/8a13e1d2-10f1-cd12-61c1-b6b7b726222f​ . 

Of course, not all of these proposals may be accepted, and the Authorisation approval process can take more than a year, but we may start to see some of these substances added to the Authorisation List in 2020.  Details here: https://echa.europa.eu/-/echa-proposes-18-substances-for-authorisation​ .

Proposed Restrictions

There are a number of restrictions in the pipeline at ECHA (which will then have to go through further approvals):

• N,N-dimethylformamide (DMF)
• Siloxanes (D4, D5, D6)​
  
• Intentionally added microplastics
• PAHs in granules and mulches
• Lead shot used for fishing and shooting
• hazardous substances in tattoo inks

Some or all of these may be implemented in 2020 or beyond.

Proposed SDS changes

As discussed in my previous article, we are currently waiting for the proposed change to Annex II of REACH, covering SDSs, to bring them into compliance with GHS Rev 6 and 7, and also to include the nanonmaterial information, but this has not been brought into effect yet.

For details of the changes, see our article: https://www.ghsclassificationcourses.com/changes-to-eu-safety-data-sheets-in-the-pipeline/

ECHA in 2020:

ECHA reopens today, 6th January 2020, in their new office in Helsinki.

It will be interesting to see how ECHA get on with their new duties for Workplace Exposure Limits and Persisten Organic Pollutants.  The SCIP database is not due to come in until 2022, so there may not be much information on this project.

It will also be very interesting to see the proposals of how ECHA will be funded in the future.

Ongoing problems with ECHA’s chemical databases

On a personal note, I would like to see ECHA sort out the glitches with the Classification and Labelling Inventory.  These problems occurred after the ECHA chemical databases were updated in early July 2019, see https://echa.europa.eu/-/major-update-to-echa-s-information-on-chemicals-database​ and although some individual errors have been corrected, there seems to be an underlying problem with the link between the C&L inventory and the REACH dossiers.

Some C&L inventory entries are not picking up that a substance holds a REACH registration, although it can be seen on the Infocard that a registration does exist.

What this means is that if you want to see all of the published CLP classifications for that substance, you need to check the C&L inventory, and then the REACH dossier, to get the full picture, when you should be able to see everything from the C&L inventory.

This is particularly time-consuming if you are importing mixtures from outside the EU, and want to check what the most up to date CLP classification is for your component substances.

Brexit and the UK Chemical Industry in 2020

This is potentially the greatest upheaval in regulations for UK companies, or companies selling chemicals into the UK.

At the time of writing, the current Prime Minister, Boris Johnson, has stated that the UK “will not be aligned with EU rules” (presumably including ECHA and our chemical regulations) after the UK leaves the EU, although this may simply be a negotiating position.

There is the prospect of a period until the end of 2020 when the UK will still be paying into ECHA and following EU-REACH and EU-CLP etc, but we will not know until the 31st January, or perhaps a few days beforehand.

Well, whatever happens with chemical regulations in 2020, it’s going to be another “interesting” year, and I hope that we can all get through it safely.  I will do my best to keep you informed of developments.

GHS Classification Courses from TT Environmental Ltd

6th January 2020

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P.S. In the event that the UK does end up not being aligned with EU rules, it’s likely that people will make suggestions for simplifying chemical legislation, such as my friend Neil Hollis’s proposals on simplifying UK-REACH, https://www.linkedin.com/posts/neil-hollis-4473313…​