15th July 2016
Please note that this email was written on 14th July 2016, but delivery was delayed until Monday 18th July 2016, as we all came to terms with the news of the terrorist atrocity in Nice.
COMAH change to calculations based on CLP rather than CHIP
The deadline for re-notifying your COMAH liability (if you come into COMAH scope) has now passed, but we are aware that the HSE are following up with questions for sites where they would like further information, especially on sites which are outside COMAH scope.
If you are in this position, you may find our Sevaluate software programme helpful, see https://ttenvironmenta.wpengine.com/comah/sevaluate/ . If you need more help in carrying out the calculations, please contact us for a chat (details at the end of this newsletter).
HCF Catch are running the Humber Major Hazards Conference on 21st July, which this year is focussing on cyber security, including for process control systems. There will also be a talk about functional safety KPIs.
COMAH ERA reminder – Upper Tier sites
If you intend to use the CDOIF Environmental Risk Assessment methodology for your 5-year review, we recommend you start looking at this at least 1 year before your deadline date, to give you time to gather the relevant information and have any new modelling which may be required carried out.
The updated CDOIF guidance hasn’t been put on the HSE website at the time of writing this newsletter, so you may need to ask your COMAH Inspector for an up to date copy, so that you are using the correct methodology.
If you need help with understanding what the ERA means and how it works, feel free to get in touch with me (details below).
New version of REACH-IT and IUCLID6
The new REACH-IT system is up and apparently running well for most people we know who are using it. If you are having problems such as being logged-out, it may be helpful to clear your browser cache, or even to use a different browser.
It has been updated to allow IUCLID6 to be used for REACH registrations. However, what hasn’t been well-publicised is that REACH-IT can now be used for registering if you are a Member Registrant. IUCLID6 will only be mandatory to use if you are a Lead Registrant, or are opting-out of any end-points in a dossier. However, you can still continue to use IUCLID6 as a Member Registrant if you prefer to register this way.
If you have data in IUCLID5, and intend to use IUCLID6 for registration, you should consider downloading IUCLID6 and start to migrate your data across as soon as possible, because (as regular IUCLID users know), you have to install every update to avoid losing data or running the risk of it being corrupted.
IUCLID6 can be downloaded from https://iuclid6.echa.europa.eu/ .
There is also a new version of the QSAR toolbox available, http://echa.europa.eu/view-article/-/journal_content/title/update-of-qsar-toolbox-now-available , which uses the new use codes developed by CEFIC.
Benzo-α-pyrene has been added to the SVHC Candidate List, see http://echa.europa.eu/view-article/-/journal_content/title/a-new-substance-of-very-high-concern-added-to-the-candidate-list .
The full SVHC candidate list can be found at http://echa.europa.eu/web/guest/registry-of-current-svhc-intentions, and a list of SVHCs with submitted dossiers is available at http://echa.europa.eu/web/guest/registry-of-submitted-svhc-intentions.
The list of actual SVHCs which have been confirmed as such (the “authorisation list”) is available at http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list/authorisation-list .
REACH cost share news
If you are having difficulties with what seems like excessive data costs for your REACH registrations, you may find some good arguments to use in discussions with Lead Registrants in the draft data sharing guidance from ECHA. http://echa.europa.eu/documents/10162/13564/dsv3_draft_for_peg_en.pdf . This is version 3.0, published in April 2016.
ECHA are also open to receiving comments on this document, which is due to be published in December 2016.
You may be aware that the Infocards which summarise CLP classification when you search for chemical information at ECHA can be misleading, as where the classifications are based on the Classification and Labelling Inventory, the results are aggregated. For more details on the problem, see https://ttenvironmenta.wpengine.com/echa-infocard-classifications-may-be-misleading/
At Stakeholder Day (see below), I was able to ask Eoin Brennan whether this situation was going to be addressed, and he has said that they are changing the algorithms so that only classifications which are chosen by 10% of the companies notifying will be included, but this will still mean that many substances will show an “over-classification” on the Infocard itself, and if readers don’t dig deeper into the information, they could be misled.
ECHA’s cunning plan to get round this is that they are going to require companies who have notified to the Classification and Labelling Inventory to update their notification to match the REACH registration (where one exists), or to match the classification they think is most appropriate.
In other words, they have created a problem, and now expect industry to take the time to sort it out for them. Sometimes, words fail me.
Stakeholder Day at ECHA
As mentioned in the last newsletter, I had my arm twisted by the Chemical Regulations Self Help Group to go to ECHA at Helsinki to talk about the experiences of SMEs with REACH, and give some advice based on what the members have discovered.
The day was jam-packed with useful information, as there were three sets of presentations, and I was able to ask some questions on behalf of the group as well as giving the presentation.
The presentations (and video, which I haven’t dared watch) are available at: http://echa.europa.eu/view-article/-/journal_content/title/missed-our-stakeholders-day-watch-the-video-and-presentations .
I will be speaking at the Lisam Systems InfoDay and User Meeting on Thursday August 11th at Crowne Plaza, Birmingham NEC, which will give an overview of the latest regulations and also a chance to meet the Lisam team. Further information and the agenda are available at http://www.lisam.co.uk/news-events/events/ . My presentation will be on “Limitations on the data available from ECHA”.
The 8th ATP to CLP has been published (not to be confused with the proposed 8th Annex to CLP, which is out for consultation – that’s the legislation which will bring in the Poison Centres, and is still being discussed within Europe as far as I’m aware).
The 8th ATP can be downloaded from http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0918&from=EN
Briefly, the changes include:
- Changes to the definition of corrosive to skin and corrosive to eyes, bringing back the concept of corrosive category 1, with corrosive 1A, 1B and 1C becoming sub-categories.
- A change in terminology for aquatic toxicity, so that instead of “acute (short-term) aquatic hazard”, it is now “short-term (acute) aquatic hazard”. Similarly, “long term aquatic hazard” is replaced by “long term (chronic) aquatic hazard”.
- A large number of changes to P statements
Note that the chapters on the classification of corrosive to skin and corrosive to eyes are completely replaced by those in the 8th ATP, and this may mean that the classifications may change if you are classifying for either of these effects for substances or mixtures. If you are potentially affected, it would be sensible to read this part of the 8th ATP to CLP carefully.
The biggest number of changes is to the P statements, as a total of 58 have either been added; had their text changed and/or had their notes changed (which tells you when or how a P statement should be applied); or have been deleted.
For individual P statements, 9 have had their text alone changed, 16 have had their notes alone changed, 12 have had both their text and notes changed, and 3 have been deleted.
For compound P statements, 4 have been added, 3 have had their text alone changed, 4 have had their notes alone changed, 3 have had both their text and notes changed, and 4 have been deleted.
Note that there are no changes to Harmonised Classifications in this ATP, so the excel list of Harmonised Classifications updated to the 7th ATP to CLP is still valid. You can get this from ECHA at http://echa.europa.eu/information-on-chemicals/annex-vi-to-clp .
As usual, you don’t need to make these changes immediately, there is a phase-out period, for the 8th ATP to CLP the deadline is 1st February 2018.
If you have been on one of our CLP training courses over the past few years and would like a complimentary copy of the updated list of P statements and “cheat sheets” (summary of classification and H Statements with associated symbol, signal word, and P statements), please email me and I will send these across to you. (I can also send out the skin corrosion and eye corrosion, and aquatic toxicity classification worksheets once these have been produced and checked).
Brexit considerations – a personal view
Brexit is of particular interest to the chemical and process industries because we are affected by so much EU legislation. However, while some environmental consultants seem to think that it will mean a return to the days of “dark satanic mills”, they seem to have forgotten a key point, which is that most environmental legislation (that is based on directives) is directly transposed into British law (England, Scotland, Wales and Northern Ireland), and will remain part of our laws unless repealed. Examples relevant to the chemical industries include COMAH (Seveso III directive), Environmental Permitting (IPPC and various other directives), the Waste regulations (Waste framework directive) etc.
However there are some “directly acting” EU regulations which will need to be resolved prior to Brexit, including REACH, CLP and the Biocides Regulation. This is because they have not been transposed into British law (although their enforcement regulations have been).
In the event that we end up with a Norway-style relationship, then I understand that these Regulations would still apply; but a different relationship with the EU would mean that these directly acting Regulations would either need to be transposed into British law in full, or partially, or a different set of British laws would need to be written to cover these areas.
To comply with World Trade Organisation rules, a version of GHS will need to be brought into the UK, and CLP is the obvious candidate as the successor to CHIP (although CLP could be improved in some ways, and I hope to discuss this in the next newsletter).
Similarly, biocides will probably still need regulating, although whether this should take the same shape as the hideously expensive registration under the Biocides Regulation, at a time when we are facing drug-resistant and biocide-resistant pathogens and need new biocides to combat this resistance, is open to debate.
However, the real change is potentially the REACH regulation. This leviathan of legislation has already over-run the total predicted cost to industry, with less than 50% of substances registered to date. Anecdotally, the costs are often at the expense of investment in R&D and in new staff, which is always worrying in terms of long-term survival for any industry.
The authorisation and restriction process potentially removes very valuable chemicals from the EU marketplace which may be required for vital products such as pharmaceuticals and biocides precursors, and seems to be driven as much by political lobbying by NGOs as by risk-based evidence.
It is almost as if people working in the NGOs have forgotten that the usefulness of chemicals comes from their hazardous properties, whether this is explosion, flammability, toxicity, or their ability to react. We are never going to get to the point where all chemicals are “safe”, so it makes sense to ensure that we do not deny ourselves potentially useful chemicals.
In my view, REACH in its current incarnation seems to be taking us to a point where the chemicals available on the marketplace will be hugely reduced, which in turn would likely see the death of the EU chemical industry within 20 – 30 years, with concomitant risks for the security of the water supply, pharmaceuticals, fertilisers, pesticides, pharmaceuticals, biocides, weaponry etc, and leave a weakened EU dependent on chemicals being manufactured and used overseas, with long term consequences for the EU population.
If you think that I am exaggerating these risks, consider what would happen if a particular chemical which has been effectively banned under REACH is found to be an important precursor in a new vaccine against the next serious flu epidemic (the equivalent of the Spanish Flu outbreak of 1919). If this chemical is only made in China or India, are they going to release it to Europe for manufacture into the vaccine, when their own populations need protecting?
Although it is likely that some form of control of hazardous chemicals will be required for the UK chemicals marketplace, calling “time” on REACH in the UK would achieve several things: it would remove the costs of REACH for anyone manufacturing or importing only into the UK; it would keep the current British chemical company “ecosystem” which is in place, where big and small companies interact, and which is at risk from excessive costs under REACH; it would enable our regulators to work on a new, less costly, and more agile version of the regulations, perhaps based on other countries who are seen to be “best practice”, such as Australia; and it would make the cost of manufacturing or importing chemicals cheaper than EU countries, and attract inward investment.
Clearly such a strategy is not without risks – for example, it is important that, if possible, REACH registrations made by, or purchased by UK companies remain valid in the EU, as part of our access to that marketplace. After all, those companies have already paid for that access directly, and it would be unfair to ask them to pay twice.
However, the EU may object strenuously to having a more open marketplace for chemicals on their doorstep, if the reaction to George Osborne’s proposals to cut Corporation Tax significantly (now shelved, it seems), were anything to go by. And it is possible that UK REACH registration holders might find that their money has been spent for nothing, if the EU got into a “tit for tat” situation in trade negotiations.
It is also possible that the money spent on REACH registrations is considered less important than regaining our territorial waters for our fishing fleet (and for defence purposes), and that the chemical industry’s investment in REACH has to be written off.
However, if this were to happen and all our UK REACH registrations were null and void, it might not be as bad as we might think, because there would not be the costs of lower tonnage band registrations for chemicals made and used in the UK; and there would likely be a large boost to the industry as India and China would be much more willing to trade with us at the EU’s expense. It should also be remembered that the current REACH registration holders are generally (but not always) larger companies, who are in a better position to be able to write off these losses than SMEs.
Stop press – in the news on 14th July 2016, Philip Hammond, the new Chancellor of the Exchequer, has apparently said that we will be pulling out of the single market and negotiating a new trade deal with the EU, so that may mean we are not going down the Norway route, although I don’t think anyone really knows what’s going to happen yet.
(Here ends the personal opinion bit).
Brexit links for the “regulatory enthusiast”
In the meantime, if you’re interested in Brexit, or simply suffering from insomnia, there are quite a few articles going around a which may be of interest:
Andreas Herdina has been appointed as ECHA’s “point of contact” for Brexit, https://chemicalwatch.com/48300/echa-appoints-senior-official-as-brexit-contact-point
Robin Foster of the HSE sent an email to UKCPI: “For now it is business as usual. That was the case yesterday when I was at a routine meeting of CARACAL. The UK is still a member of the EU, HSE is the competent authority for REACH, CLP and biocides, and businesses in the UK remain subject to these requirements and should continue to comply. What happens in the longer terms depends on the outcome of the negotiations on the terms of the exit.
I do not expect HSE to put any messages on its website concerning the outcome of the referendum or on implications. I suggest you look to the Cabinet Office or No 10 websites for this,. We are looking to the centre for guidance, and in that context things should start to come together soon; see for example https://www.gov.uk/government/news/permanent-secretary-appointed-to-lead-the-new-eu-unit-in-cabinet-office.”
There is a good summary of the legal position at ChemicalWatch: https://chemicalwatch.com/48252/brexit-vote-raises-legal-questions
Freshfields article on Brexit and general chemical regulations: http://www.lexgo.be/fr/articles/droit-fiscal/droit-europeen/brexit-impact-on-compliance-with-eu-chemicals-legislation,105285.html .
Eversheds overview (written before Brexit happened):
Dentons’ video on the process of notifying under Article 50:
And if you are already fed up with the whole thing, you may enjoy this vintage clip from Yes Minister – https://vimeo.com/135166094
Chemical Regulations Self Help Group News
The Chemical Regulations Self Help Group is having a Brexit discussion meeting on Tuesday 9th August, and our next scheduled meeting is on Tuesday 20th September.
Membership of the Self Help Group is by invitation, and if you’re interested in joining, email me and I’ll pass the request on to the management team. More information is available at www.chemselfhelp.co.uk .
I hope this information is useful, and if you need any help with any of these regulations, please contact me on 01422 24 22 22, or on firstname.lastname@example.org
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Disclaimer: The advice we can give in newsletters like this is generic, and given in good faith based on our understanding at the time of writing. You should check your own situation, and any applicable regulations, before deciding whether to take any actions based on advice in this newsletter.
To download a pdf version of this newsletter click TTE Newsletter no. 25 18-07-2016