It’s the time of year to look back and see how far we’ve come (or not, in the case of Brexit!).
I’ll start with GHS, as it’s the “parent” of CLP, and what is decided at the UN is mostly adopted into CLP in the EU in due course.
GHS in 2019
GHS Revision 8 was published in hardback form in May 2019, and the pdf versions used by most people were not issued until October 2019. There’s a free-to-download pdf in English and French. It’s also available to purchase for $67.50 USD from the UN shop, but you only need to buy this if you need an unsecured pdf version which allows you to copy, cut and paste etc.
The summary of changes made in GHS Rev 8 is:
- new classification criteria, hazard communication elements, decision logics and guidance for chemicals under pressure;
- new provisions for the use of in vitro/ex vivo data and non-test methods to assess skin corrosion and skin irritation;
- miscellaneous amendments to clarify the classification criteria for Specific Target Organ Toxicity;
- revised and further rationalized precautionary statements and an editorial revision of Sections 2 and 3 of Annex 3;
- new examples of precautionary pictograms to convey the precautionary statement “Keep out reach of children”;
- a new example in Annex 7 addressing labelling of sets or kits; and
- guidance on the identification of dust explosion hazards and the need for risk assessment, prevention, mitigation, and hazard communication.
For more information on these changes, see our article https://www.ghsclassificationcourses.com/ghs-revision-8/
Revision 8 of GHS will have to go through the usual discussion procedure inside the EU before some, or all of it, is adopted into CLP, and this is likely to be in a year or two’s time. It is important not to use Revision 8 GHS changes in the EU and UK until they have been adopted into the relevant local regulation(s), as the UK may be out of the EU by the time this is brought into CLP.
By the way, have you noticed how the EU have been very “early adopters” of GHS revisions? They do seem to want to adopt these as we go along, where other jurisdictions wait and adopt several revisions at once. If you compare the EU’s implementation with other jurisdictions, which you can do here, you’ll see that a lot of other jurisdictions are on much earlier GHS revisions.
The USA very sensibly decided to adopt GHS Revision 3 in 2012, becoming mandatory in 2015, and I understand that they intend to adopt GHS Revision 7 in 2020. This places much less pressure on regulatory affairs professionals to change their classification methods, (and the USA don’t really have the pressure of REACH registration to contend with either!).
If we do get a “clean break” Brexit, where the UK does not slavishly copy all EU regulations, this is something which the HSE could usefully adopt. Adapting several GHS revisions into UK-CLP every 5 or 6 years would definitely be an improvement on the current situation.
CLP in 2019
CLP has undergone several important changes:
- The 12th ATP to CLP was published, confusingly after the 13th ATP. This brought GHS revisions 6 and 7 into CLP. At the moment, the 12th ATP changes are voluntary, and will become mandatory on 17 October 2020.
The headline changes in the 12th ATP are:
- New cut-off values for inhalation hazards in Table 1.1, and for including in mixture classification
- A whole new hazard class of desensitised explosives has been introduced
- The flammable gases/ pyrophoric gas/ chemically unstable gas categories have all been consolidated under the flammable gas category
- There have also been a number of other changes e.g. an addition to first principles classification for explosives and aerosols
For more details, see this article: https://www.ghsclassificationcourses.com/12th-atp-amendments-to-clp/
- Annex VIII to CLP, which brings in the Poison Centre Notification Portal, was brought into effect in the Spring, but has had teething problems. In fact, most EU member states were unprepared to receive information from the Portal by the first official deadline, so it has been extended so that the deadline for notifying hazardous mixtures used in consumer products from 1st January 2020 to 1st January 2021 (that is the same as hazardous mixtures used by professional users).
Full details here: https://poisoncentres.echa.europa.eu/-/commission-adopts-change-to-first-compliance-date-for-reporting-to-poison-centres.
This is the very first time any EU chemical deadline in a directly-acting regulation has been altered, to the best of my knowledge. Only a cynic would suggest that this is because it is the Member States who are pushing for it, rather than industry. We had to comply with ridiculously tight deadlines (pre-registration, for example) without there being any indication that such deadlines could be moved. So it’s interesting that there is flexibility, when the EU consider it to be in their own interests.
- The 14th ATP to CLP should have been published, but has been held up because of objections to the proposed Titanium Dioxide Harmonised Classification as a Category 2 carcinogen
You are probably aware that this proposed Harmonised Classification is based on very dubious science, and seems to be being promoted for political reasons (probably due to NGO pressure). For more information on the “science” behind this ruling, see our article: https://www.ghsclassificationcourses.com/titanium-dioxide-update-european-commission-standing-firm/
The most recent development was that there was a vote at the Environment Committee of the European Parliament, which went with the proposed Harmonised Classification. However, industry bodies are considering whether to appeal this decision. See https://chemicalwatch.com/85928/envi-committee-snubs-opposition-to-eu-titanium-dioxide-classification for details.
There is much more to the 14th ATP than the proposed Titanium Dioxide classification, (a further 16 other substances have new Harmonised Classifications, amongst other changes) and it would be a pragmatic approach to take it out and publish the 14th ATP to enable the other changes to be introduced, but, as we have already discussed, the EU is not known for its flexibility.
We will have to wait and see what happens.
REACH in 2019:
There were a number of significant changes to REACH in 2019:
- Nanomaterials added to REACH dossier
- Phase in period of REACH ends 31st December 2019
- SVHCs added to Candidate List
- No new Authorisations
- New Restrictions
- Guidance on 1-methyl-2-pyrrolidone (NMP) restriction was issued
- SDS changes were proposed to Annex II
Nanomaterials added to REACH Dossier
Nanomaterial information has been added as a requirement for REACH dossier, and guidance was issued in October 2019, see https://echa.europa.eu/-/get-ready-for-new-reach-requirements-for-nanomaterials .
Phase in period of REACH ends 31st December 2019
The phase-in period for REACH registration ends today, on 31st December 2019. This means that pre-registration is effectively over, and you will not be able to register a substance using its pre-registration number. You will have to make an Inquiry at ECHA to start the registration process.
It will also means that all substances made or imported into the EU must be registered as “non-phase-in substances”, which means that they must be registered before they are manufactured or imported into the EU at a quantity of 1 tonne per year or more. For more details see the ECHA website Q&A section here.
I understand that the calculation period for exceeding the threshold limits for registration under REACH, or changing tonnage band, will now be made on a per calendar year basis, that is January 1st to December 31st, rather than a rolling 3-year basis as we had during pre-registration.
So if you exceed 1 tonne in a calendar year, you will automatically become liable for REACH registration; or if you hold a 1 – 10 tonne registration and make 11 tonnes in a year, you will need to upgrade to a 10 – 100 tonne registration.
SVHCs added to the Candidate List
There were two tranches of new SVHCs, the first on 15th January 2019 covered:
The second SVHC additions on 16th July 2019 included:
- Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP),
- tris(4-nonylphenyl, branched) phosphite,
- Tris(nonylphenyl) phosphite,
- Phenol, 4-nonyl-, phosphite (3:1),
- 2-methoxyethyl acetate,
- 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides,
- 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid,
- Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate,
- Potassium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionate, and
- 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionyl fluoride.
For more details, see https://echa.europa.eu/candidate-list-table
No New Authorisations
No new substances were added to the Authorisation List in 2019, so the number of substances on this list remains at 43. The last time any substances were added to the Authorisation List was in 2017.
However, there were several applications for using substances under Authorisation, and more details are available here: https://echa.europa.eu/regulations/reach/authorisation/applications-for-authorisation.
There was a single new Restriction in 2019, number 73: (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silanetriol and any of its mono-, di- or tri-O-(alkyl) derivatives (TDFAs).
For more details, see https://echa.europa.eu/substances-restricted-under-reach
Guidance on 1-methyl-2-pyrrolidone (NMP) restriction
The NMP restriction which was implemented in 2018 is complex, because it requires products which have more than 0.3% of NMP to go through a risk assessment based on mandatory Derived No Effect Levels. (DNELs are usually found in REACH dossiers for substances which have a Chemical Safety Report, but can also be calculated for other substances if necessary).
As the DNELs may need to be calculated for exposure on a case-by-case basis, ECHA have issued the following guidance: https://echa.europa.eu/-/advice-on-how-to-comply-with-nmp-restriction .
While this seems a very complicated process, it is, in effect, a risk assessment allowing the continued use of NMP where you can demonstrate that it meets the Derived No Effect Levels, and as such is more helpful than an outright ban.
The restriction applies to the whole supply chain, whether you are using REACH-registered NMP or not.
Proposed SDS changes
There has been a 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 2019:
There have also been a lot of changes at ECHA:
- They have taken on responsibility for recommending Workplace Exposure Limits, see https://echa.europa.eu/-/echa-to-provide-recommendations-for-occupational-exposure-limits
- They are also looking at Persistent Organic Pollutants (POPs), see https://echa.europa.eu/-/echa-starts-work-on-persistent-organic-pollutants
- The SCIP database has been proposed (under Waste Framework directive), see https://echa.europa.eu/-/scip-database-will-improve-transparency-on-hazardous-substances-in-articles and for more information on what it means in practice, see our article https://www.ghsclassificationcourses.com/new-public-database-at-echa-for-articles-containing-svhcs/
- They are moving offices in Helsinki over the Christmas holiday, see https://echa.europa.eu/-/echa-s-year-end-services-and-relocation
- They are also looking at changing how they are funded, which may involve annual fees for REACH registration rather than the one-off payment which was originally envisaged
There have also been several research projects showing that there is a significant lack of compliance with chemical regulations in certain industry sectors, such as https://echa.europa.eu/-/44-of-hazardous-mixtures-not-compliant-with-classification-and-labelling-obligations and ECHA themselves have made compliance a priority, see https://echa.europa.eu/-/improving-compliance-is-echa-s-key-priority.
There is likely to be more enforcement and/or more regulation going forwards.
Delay in ECHA linking to new Consolidated Versions of regulations
We have also noticed that the Consolidated versions of regulations such as CLP are not being published straight away on the ECHA website, only on the EUR-lex website, so if you want the most up to date consolidated versions, you have to look there instead. Consolidated versions are usually contained in a link underneath the links to the initial legal text.
Brexit and the UK Chemical Industry in 2019:
Of course, the UK was supposed to leave the EU in 2019, but a deal was not able to be agreed by Parliament. Several dates were proposed and missed:
- 31st March 2019
- 22nd May 2019 (with a deal) or 12th April 2019 (without a deal)
- 31st October 2019
The EU eventually agreed to a leave date of 31st January 2020, and the stand-off between the two factions in Parliament was finally resolved when a General Election was called for 12th December, when the Conservatives won a decisive majority.
We will have to see if we do finally achieve Brexit on this date, and if we do, whether there is an interim period until the end of 2020, as the current Withdrawal Agreement proposes.
Frankly, it makes me tired just thinking of all of the work we have put in to prepare for Brexit without it actually happening – all of the preparation meetings with the HSE; companies setting up Only Representatives in the EU (if British) and UK (if European) in preparation for the change; the work the HSE and DEFRA have put in to try to prepare for No Deal, Deal, and all points in between.
And the dreadful uncertainty over when Brexit will (or won’t) happen has affected many of my friends and colleagues in companies all through the chemical supply chain in the UK. It has also adversely affected other companies like British Steel, who fell foul of the rules on energy taxes, and which may be taken over or closed as a result.
I can only hope that Brexit is resolved in 2020, and we can all start to come to terms with a new working relationship between the UK and the EU.
Wishing you, your family and your colleagues a very Happy New Year for 2020,
GHS Classification Courses from TT Environmental Ltd
31st December 2019
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