Chemical Watch Forum

A Chemical Watcher · September 2010

Posted on behalf of a Chemical Watch reader:

"As an avid reader of Chemical Watch I thought I would share some personal observations on the whole REACH mess.

We have pre-registered a relatively limited number of chemicals (58) and we are now getting very close to the November deadline. The chemicals which we are involved in are principally imported and we have allowed the various consortia to work through the process of compiling the notification dossiers. This has been a very time consuming and thankless task not helped by commercial interests which run through these consortia. The need to compensate overseas trade associations for data which has been publically available for years has also resulted in long drawn out exchanges. The members of a number of the SIEFs we are involved with have still not had formal communication from the lead registrants service provider for the costs of letters of access and the clock continues to tick.

Other SIEFs have been pushing out letter of access emails and the transparency on the costs have varied. The problems on estimating a fee for a letter of access is difficult as there is no clear understanding on the real commitment of the SIEF pre-registrants to push forward with a full registration, surveys and educated guesses have been made to calculate a fee. Companies will only decide on registration once they have the costs clearly defined. These fees are varying widely depending upon the number of pre-registrants. The lower the cost for a letter of access will obviously mean potentially more registrants pushing forward but where there are a small pool of companies these fees may be the deciding factor to stop selling leaving a monopolistic position in place.

I do not lie awake in my bed worrying about this but I do foresee major supply chain disruptions and a major reduction in competition due to the high costs of notification. Recent notes from CEFIC and ECHA are, I believe, misinformed and are painting a too rosy picture. The high fees to ECHA together with reimbursement costs for the lead registrant and payment of letter of access fees for each chemical is just horrendous. ECHA is obtaining money from data which is repeatedly being submitted by the registration process. In a time of financial austerity this is not helpful for industry. I also think this legislation undermines confidence in the whole EU institution as it is overly complex and virtually unworkable. The REACH regulation like the previous ELINCS legislation continues to inhibit innovation in the chemical industry.

I speak to many industry colleagues and have not heard one person having a positive word to say about REACH, the majority roll their eyes and groan in resigned despair."

A Chemical Watcher · October 2010

Posted on behalf of another Chemical Watch reader:

Dear Chemical Watch Reader

It is true that the cost of letters of access to REACH dossiers are varied and, given the wide range of prices, a cause for concern and confusion. Clearly the location and dedication of the lead companies may have a bearing as well as the amount of work getting the dossier together, and this should be transparent. However I think it should be stressed that the principal reason behind the variations comes down to the substance properties. Some substances can have multiple waivers in the IUCLID dossier; others may be able to use publicly available studies (with all due consideration to copyright law!), others may qualify for waivers on the basis of no exposure; others even owing to the substance being a CAT 1 CMR which entails some normal studies to be not required.

Therefore with some of the really expensive end points waived the cost of LoAs will come down.

There could be two extremes envisaged:

1. A gaseous substance, not classified as hazardous, used as an on-site isolated intermediate with a lot of companies registering. Lots of waivers, no CSR.

2. A liquid classified as a CAT 3 CMR/PBT with wide dispersive use through numerous applications leading to a very extensive CSR, all applications requiring exposure scenarios, existing and recent multi-generation reprotox study to GLP available, with just a few registrants all but one of which have no ownership of the key studies (none of which are publicly available). If the only study for a REACH required end point with animal studies is very expensive then there is very little that can be done.

You can check some of the prices from the Fleisher index; its not hard to see where the costs come from. As for the estimates of LoA costs, speaking as a lead registrant it is very important that these costs are not under-estimated. Going back to SIEF members after registration and asking for more money in cases where not enough registrants come forward, would be very difficult and would leave consortium members out of pocket. A recent trend has been to use a "Consortium members + 1" rule. All registration costs should be shared equally (assuming the same tonnage band). Since all consortium members, for example 10, will register, if one company outside of the consortium buys a LoA, then the sharing rises to 11; if 2, then 12 and so on. Consortia cannot know for sure how many companies will buy until 30th November, so the fairest way is to price the LoA on the basis of ONE company buying it, in this case 11, and committing to refund purchasers should more take up the offer. On this basis the LoA cost must be an absolute maximum for the purchasers, and in many cases the final reconciled cost will be lower. I am involved in one consortium which has priced a LoA in this way and on this basis has "sold" 10 LoAs already. All of these companies will receive a significant refund in the new year since their final cost will be 1/20th of the cost as opposed to the 1/11th charged initially.

Other consortia have estimated the quotient for their costs sharing based on SIEF surveys. This is particularly true of commodity substances with large consortia where the cost sharing of the consortium is a few thousand €s.

I realise the situation is complex (we have had to pay out a lot ourselves even as consortium members where we did not own key data) but the requirements are challenging and we are still very much finding our way in this exceedingly complex and demanding regulation.

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