REACH Debacle/Con

[DrP]

This REACH registration of chemicals in the EU is a F+*&(ing con! I said it would be trouble when it first came out. We have used, safely, for many years a chemical in one of our formulations and it is very important to us.... Because it is a chemical not widely used by anyone, except us, the manufacturers are not going to bother paying the £10K REACH registration fee for the chemical and have decided to pull it from the market. It is bloody stupid that we have COSHH in place to make sure the chemical hazards are known and safety protocol is adhered too, we have MSDS's to outline the hazards clearly and to advise on clean up/contamination... the only reason I can see to be made to pay £10K to REACH register is to make money for some f*)(ing con man in the EU who is getting rich by pulling the wool over some idiots eyes by insisting that companies need to register chemicals they use. What a complete con!

 

Rant over...

 

Can ANYONE AT ALL tell me why we actually need the REACH registration system other than to fleece companies of a bit more cash for the EU? F*)(ing despicable!

Hmm - Sorry - I was quite angry when I wrote this earlier. :-/

[John Cuthber]

You have had years of notice- why haven't you done something about it?

Also, if you are a big enough organisation to be paying £10,000 in fees then you must be a pretty big organisation. can't you afford it?

http://www.cirs-reach.com/reach/REACH_Registration_Fees.html

Incidentally, the 64 Euro fee probably doesn't even cover it's own processing costs.

 

So I'm not sure what you are on about.

Could you explain a bit?

[CharonY]

Well, the overarching issue is that toxicological regulation of industrial production is, at best, poor. Many useful products, such as organohalogens are now found to bioaccumulate and pose unrecognized risks to human and wildlife health. Then there are materials such as nanoparticles for which at best conflicting tox results are found in literature. Nonetheless, they are produced and released in high amounts and historically regulation are done in a reactionary fashion, if at all.

 

REACH, I think, was somewhat intended as a compromise as the only alternative would be a centralized tox-assessment, that would severely hamper the use and development of novel compounds and materials. As compromises go, they are excellent in pissing off everyone, as the tox information gathering and reporting would be mostly under the control of the companies (which have a clear interest to suppress potential issues), and on the other hand the companies have to deal with the added cost.

And of course there is on top the whole issue of how informative traditional testing for human health is to begin with. But that will not be touched with a ten-foot pole as we need the assumption that things we are exposed to are relatively safe.

 

The real issue is IMO that we do not have a good idea how to balance industrial use and production with a decent assessment of environmental and human health effects. If we do it as it is right now, we have to wait until after damage has occurred to do something, which is very bad for non-or very slowly degrading compounds. If we ant to test until we are certain that something is safe, material production and development will come to a grinding halt.

 

Yeah, I have no good solution except maybe developing improved, faster and more accurate tox test systems.

[DrP]

After an industrial meeting recently (I won't say which) - it was pointed out that only about a third of materials have been registered so far. The rest have to be registered by 2018 at the cost of £30k per raw material for full registration. For small companies that buy small lots of a niche chemicals it may mean that the manufacturers won't register them as it won't be financially viable for them. Great!

 

Also, what happens for research!? What if I want to try/test a theory around using different materials? If they aren't registered (because no-one wants to pay for it) then how do we get them? Then how do we purchase them if tests are successful?

 

Sorry - I still see it as a big con to make money for the EU. I have written the new style SDS's myself... when I called their helpline with questions the only answer I got was "we run a SDS writing service for £5k per sheet!"...

 

Also!!! it has come to light that the French want to ban TiO2! Apparently the dust might have induced cancer in some rats whose lungs they filled with TiO2 50 years ago in some very small scale test. Ok - if true then it needs labelling as hazardous... BUT!!! they want all paints with TiO2 labelled as a carcinogen!... dumb, as (if true) it is the dust that would be the hazard, not the material bound up in a paint formulation. Do they even know what they are talking about!?

 

Farcical, ill thought out money making scheme in my eyes. The EU could have adopted our COSHH system at much lesser cost and hassle.

[John Cuthber]

Did you read the bit about an exemption for testing/R+D purposes before you wrote all that?

" I have written the new style SDS's myself... when I called their helpline with questions the only answer I got was "we run a SDS writing service for £5k per sheet!"... "

What were the questions?

(I don't charge £5K per page)

 

"it has come to light that the French want to ban TiO2"

Where?

Or are you muddling up a general observation that nano particulates are often more toxic than larger particles with the fact that much white paint is TiO2?

Edited June 21, 2016 by John Cuthber

[DrP]

re: TiO2 - I can't find anything about this yet on the net... but watch that space - it is something they are driving for. Not nano TiO2, but any powdered form.

 

 

As for the R&D - I see your point about exemption.... but whereas now I can call up and get samples from a supplier of pretty much anything, what if the thing I want to test is un registered? Who will have access to it to send me a sample? Who will be interested in letting me try it out as they won't be able to sell it to me if it is unregistered and won't be interested in paying for registration to sell it to me in small amount?

 

John - can you honestly tell me that you think that REACH and the SDS is an improvement on our existing COSHH and MSDS system?

[CharonY]

But COSHH only covers workplace exposures i.e. applies to employers. Thus, they are site-specific. REACH otoh places the risk assessment of new compoounds into the hands of manufacturers and is purely substance (i.e. not process)-driven. It also includes elements of environmental and consumer protection. And even then you could easily argue that it is not sufficient from a public health/environmental perspective. Before that there was only a patchwork of regulations that often were implemented after issues arose.

 

Also, the only ban TiO2 I know about is the use as an inhalable powder. However, so far it is only classified as a group 2B carcinogen. There have been more scrutiny on the nanomaterials ~2011 but I have not seen anything definitive about it (though I am a bit out of the loop by now).

 

Edit: The reason why so few got registered is likely due to the staggered deadline, which called for registrations for substances produced in excess of 1000 tonnes/year by 2010, 100 tonnes/year by 2013 and 1 tonne/year by 2018. So, even in the last deadline, if you import less than a tonne/year for your purpose, you would also be fine. Also, if the manufacturer does not want to register, you can also do it yourself, and depending on size of the company and volume produced there are discounts. Also, it is possible to register substances collaboratively and share the cost between companies utilizing or producing the substance. Obviously, small companies are still hit hardest by the additional expenditure, though to be fair, I have not seen any better implementation yet. And again, from a public health perspective it is still not ideal, as e.g. the toxicity data would be entirely managed by the companies.

Edited June 22, 2016 by CharonY

[John Cuthber]

 

 

John - can you honestly tell me that you think that REACH and the SDS is an improvement on our existing COSHH and MSDS system?

Yes, because sometimes I'm not an employee.

And have you read the MSDS for salt?

Also, while I'm not a big fan of "animal rights" I do see the sense in the Reach method which expects the manufacturers to get together and only test a given compound once, rather than have each manufacturer kill another batch of rats.

(incidentally, that's what makes REACH cheaper in a lot of instances)

[DrP]

CharonY - So if TiO2 dust is to be listed as class 2B carcinogen, fine... it needs addressing and using accordingly - not banning completely. In a paint formulation it will be perfectly safe bound up in the formulation. The COSHH will have to cover the workers procedures, but the final tin of paint should not need labels. Should we include drowning warnings on tins of paint that contain water? Should we ban it? (am I creating a strawman here? lol..)

 

We had the same issue with Cd based dyes at a company I worked at in the 90's (admittedly nothing to do with REACH). 'Cd!! must be band as it is toxic - cannot use Cd based dyes on ceramic plates as it's poisonous'.... well... it would be if it was Cd metal... but it is in a massive complex bound up in the pigment and perfectly safe as a red dye.... "Still - it's Cd, we are banning it". - Dumb.

 

Also - regarding COSHH being exposure specific... that is true, and also the most relevant risk. The MSDS (which hasn't changed much since becoming the SDS) covers (or should) all aspects of hazards. I have no problem with making it stricter and more comprehensive.... I just fail to see the need to have to pay £30k to register the substance on a database.

 

John - good arguments, but I am not convinced the drive behind this is not money for the people setting it up. To play advocate - Multiple testings of a product is a good thing - any artifacts, errors or cover ups can be exposed if the material is tested by different groups. Also - whatever you say about it - we have still lost a very important raw material for our company which is not going to be registered.... oh, and we are not allowed to register it and make it our selves. (I suppose there would be no stopping us from developing the process ourselves and registering - but this is not feasible).

 

 

This aside - I am definitely voting to stay in the EU today after work. Mainly due to the employers laws that protect the employees with min pay, holiday, working hours, protection for part timers, human rights laws etc..

Edited June 23, 2016 by DrP

[CharonY]

Actually, what I meant is that because it is only on 2B it is unlikely that it is banned entirely. There could be a push to limit its use in food or personal care products. Either way, I have not heard anything official about any kind of ban.

 

The problem is that without REACH there is little incentive to provide extensive toxicity information on the products, as, afaik, there is no mandate to conduct any actual toxicity tests outside of specific regulated uses. As such someone else (such as academia) would have first to find an issue and often only then it would be put on a list for testing (may vary between countries, though). The idea of REACH was to preempt issues by having at least some degree of information (which the the manufacturers actually have some control over). Considering it only applies to relatively high production volumes the fees do not seem exorbitant, to be honest.

Edited June 23, 2016 by CharonY

[DrP]

Thanks for engaging in the discussion and sorry for my cynicism. I hope it works out fine and for the best in the end of course - it was just frustrating loosing our raw material and it seems to be more red tape than necessary in my book.

 

re-TiO2, I guess we will see what happens - I hope you are right and that what I heard about it was overblown. I think something about it is going to change soon - I guess we sit back and wait to see what happens as not much has been said or published about it yet. If what I heard (or read into what I heard) was true then it sounded like they were going for an all our ban like they are going to do with Borax.

[CharonY]

No worries, these things are somewhat byzantine and usually do not make intuitive sense. Maybe it helps if looking at things from the toxicological perspective. The standard practice was that for only for certain areas some level of toxicity information is required (e.g. food additives, pesticides, high production volume chemicals, and certain chemical groups known to be hazardous). The problem is that new varieties appear in a constant stream and most tox requirements are relatively loose and vague.

What currently happens is often that only after cumulative evidence from a wide area of research, which are typically underfunded because they are seen as anti-industrial, find evidence that some substances may not be harmless after all. For example groups looking at wildlife may find accumulation of the substance in fish, indicating that it contaminates water sources. Other groups working on human health may find it accumulate in blood. Then, other groups may be interested in testing those effects and utilize a variety of tox screens and animal tests. Usually this is not an coordinated effort as different groups all over the world may approach the issue from various background interest (e.g. endocrinological or carcinogenic effects, different target organs, developmental issues etc.) and of course because they may compete with each other for funding.

So usually over decades the weight of evidence goes toward harmful or not harmful. If the weight is toward the harmful side, policy makers may initiate additional studies or create some sort of limitations on their use (e.g. ban their use in food, for example).

The problem is that with increasing development of new materials, this cycle is going to fall further and further behind. Also there is a significant public health risk and massive costs, monetary and societal, if things go wrong. One of the biggest examples are probably the lead poisoning epidemic (and looking at Flint and other US cities it may still continue although now at least we know it is bad).

 

Interestingly, some (large) companies tried to get ahead of the curve in order to prevent consumer backlash in case they release something that turns out to be really bad in future. So they (instead of the government) started funding some academic work groups to look into effects of certain new materials in terms of toxicity, but also environmental dispersal and so on. The problem was that this approach is not only relatively costly, but it also meant that they had limited control over publication (most academic research agreements include the right to publish the data and at most the company can delay it for ~6 months on average).

 

One of the models that emerged was REACH to get ahead of the curve. Here, all the date would be generated and published by the manufacturers (who could collaborate and e.g. all pay a private testing lab to run the required tests) whilst providing policy makers with at least some modicum of initial tox data in case the fecal matter hits the rotating blades.

 

As a side note, wasn't borax only banned as food additive? I am pretty sure I saw it as cleaning powder in stores.

Edited June 23, 2016 by CharonY

[DrP]

this article doesn't make the roll out sound smooth. . http://www.coatings.org.uk/article/bcf-blog-survey-shows-reach-has-huge-impact-on-smes-211.aspx

re borax - I heard there are further bans coming.

[CharonY]

Can't open it, but I have no doubt that there will be issues. Also, I am not saying that the measure is perfect. But as all comprise regulations, it is very likely that all sides are unhappy to certain degrees. What I do appreciate is that at least in theory it starts looking at an issue that has been basically ignored.

[DrP]

Re - TiO2, the French are pushing for a 1B carcinogen classification by inhalation. If this were the case then would we not have seen many more cancer deaths in the paint manufacturing industry? If we label every substance as hazardous then we run the risk of warnings becoming so common that people will start to ignore them or dis believe them, which, in the long run is much more dangerous as people won't take the warnings seriously when it is really necessary.

 

 

Quote from BCF Digest September 2016:-

'The French (ANSES) dossier on TiO2 was made publically available on 31st May 2016. ECHA immediately announced a 45 day consultation period on this proposal to reclassify TiO2 as a class 1B carcinogen by inhalation. As expected the arguments by France were based upon the IARC classification from their monograph 93-7 published in 2009, and on the studies carried out in 1985 by Lee et al., where rats were subject to a severely overloaded dose of TiO2. There was no new evidence presented by the French authorities with regard to this proposal and all of the evidence in support of the French position falls outside the guidance for valid studies as set by ECHA, and also the limits that have been set by the OECD. In addition, it has been proven that studies of this nature on rats in relation to carcinogenicity and inhalation do not correspond to the potential for this to cause cancer in humans.'

[John Cuthber]

The classification related to the evidence that it may be a carcinogen; perhaps it is.

If it causes cancer then saying so is just telling the truth. Why do you see that as a problem?

It does not relate to any sensible controls on the material- far less banning it.

 

Obviously, if it's not a carcinogen (and there'es an interesting question about what variety they checked) then it's a bad idea to list it as one.

If there's insufficient evidence (Personally I think that's the case) then there's a separate category for that.

 

Why are you getting so upset about a proposal (which may well fail anyway) to put TiO2 in the same carcinogen category as

• sunshine,
• sand,
• beer
• the pill?

[DrP]

It definitely warrants further testing and of course if it is a carcinogen then we need to know about it, It needs proper testing though as it is currently thought of as fairly harmless.

[Endy0816]

What is happening with Reach in terms of BREXIT?

[CharonY]

Well, if they want to produce and sell in the EU they still have to conform to REACH standards. I do not know whether they intend to ditch it internally (and whether it would make any fiscal sense).

[DrP]

It isn't too different to what we have anyway. There's just the extended SDS and registration of material.

[Endy0816]

Well, if they want to produce and sell in the EU they still have to conform to REACH standards. I do not know whether they intend to ditch it internally (and whether it would make any fiscal sense).

 

yeah, I just wondering it it wouldn't be a nonissue post-Brexit. Your answer makes sense in terms of trade though.

[John Cuthber]

What is happening with Reach in terms of BREXIT?

Because Europe is our biggest trading partner most manufacturers will still have to comply with REACH.

However we will have given up our seat at the table so we will no longer be in a position to influence decisions, for example, to ask ECHA to think again about TiO2.

 

You may remember that the Brexiteers thought we were "taking back" power from Brussels.

[Endy0816]

Because Europe is our biggest trading partner most manufacturers will still have to comply with REACH.

However we will have given up our seat at the table so we will no longer be in a position to influence decisions, for example, to ask ECHA to think again about TiO2.

 

You may remember that the Brexiteers thought we were "taking back" power from Brussels.

 

Yeah, I understand the sentiment behind it, but the logic leaves much to be desired. I was honestly expecting more formalized coalitions of like-minded EU countries instead.

 

Now US is mostly puzzled, but also kind of miffed about losing our inside man. China is concerned their Silk Road project is going to flounder in the UK. Parts of the EU are now eyeing up London's financial business. Fallout boggles the mind.

[DrP]

Back to REACH. Another example it failing imo - I was looking for product/chemical to do a certain thing in a formulation of mine. I asked a supplier for suggestions and asked to try a particular chemical. They then tell me that I can/t have said sample because their company haven't bothered registering it as it didn't seem worth their while and won't be bothering to register it at all. No-one else makes it.

 

This will happen more and more for sure. It was so obvious that this sort of thing would happen when they revealed the system.

[CharonY]

So you needed over a tonne (per year) of it as a sample? I am not familiar with requirements in that order of magnitude but yes, if that is a common usage volume it could pose problems. Though I am pretty sure if sufficient companies start complaining, exemptions or changes will be made.

Still, it does seem like an awful lot, especially as one would have 11 years to register it and if it only happens once (rather than every year) I do not think there is actually need for registration. There is the possibility that there may be other issues at hand (such as lack of profitability).