Isolated Intermediate Registration
A Cost Reducing REACh Registration Alternative
Just a Reach away - Focusing on a smart registration approach, any company should assess the option - especially in the last months remaining of the Tier 1 REACh registration deadline - if some of their substances can be registered not as a substance, but as an isolated intermediate. This can reduce cost of registration significantly.
Costs are always an issue, especially when REACh stepped into force and companies had to realize what kind of burden was laid upon them, if they don't want to loose their marketability of their chemical products. Despite the fact of the internal costs covering the individual work efforts to deal with the REACh requirements, external costs add up the total costs of registration. Such costs are membership fees to a consortia, or costs to acquire the Letter of Access (LoA) from the lead registrant. At the end, the ECHA registration fees are the final cost pool. But these external costs could be significantly reduced, up to 2/3rd, if the substance in focus qualifies to the intermediate definition.
Fundamentals On Intermediates
Talking of a REACh registration usually refers to the standard registration of a substance according to Art. 10. But the regulation offers a second registration type, the registration of intermediates. REACh distinguishes between chemical substances according to Art. 3 (1) and isolated intermediates according to Art. 3 (15). Consequently, the REACh regulation explicitly exempts intermediates from the general obligation of the Registration of Substances under Art. 2 (1, c) and Art. 2 (8).
By legal definition, an intermediate is: "a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance". Intermediates are divided into 3 types (a) non-isolated intermediate, (b) on-site isolated intermediate and (c) transported isolated intermediate.
Only the isolated intermediates (b and c) are subject to the obligation of registration and information requirements according to REACh Title II Chapter 3 referred to in Art. 17 for on site isolated intermediates and Art.18 for transported isolated intermediates.
Also, due to the fact that there are two types of registration, the option of two lead registrants (LR) is also possible; one LR responsible for the joint submission of the standard registration according to Art. 11, and another LR responsible for the joint submission of the registration of isolated intermediates according to Art. 19. ECHA recently has acknowledged this fact - but has the moment not technically implemented this in REACh-IT.
One specific distinction for transported isolated intermediates has to be pointed out. A declaration of strict containment has to be provided by and between the receiving party and the sending party of the product. That means that each customer has to be approached and the strict containment has to be documented and added in the submission of the individual registration dossier.
This additional activity holds the opportunity to tighten the customer relationship and also this additional work effort is easily compensated by the cost savings potential of isolated intermediates.
Cost Cutting Potential of Isolated Intermediate Registration
As mentioned before - the purchase of a LoA (Letter of Access) or a consortia membership are a form of compensation for the data requirements in order to create the LR dossier. But, lower data requirements mean lower cost for dossier data. According to their limited use (consumed in or used for chemical processing) and the strong requirement of strict technical containment, the registration requirement for isolated intermediates described in the specific articles are significantly reduced, compared to the standard registration for substances.
The highest requirements apply for a transported isolated intermediate - above 1.000 mTo (Art. 18 (3)). Next to the some limited information described in Annex VI, the registrant shall also include information specified in Annex VII.
Still, there is no need to provide cost intensive new studies, robust study summaries, nor an extensive CSR (Chemical Safety Report) that boost up cost in the dossier creation and has to be compensated in the costs of the LoA or bared alone in an individual submission.
The other relevant external costs are the ECHA registration fees according to Regulation EC No.340/2008.
Here isolated intermediates offer an obvious cost cutting potential, the maximum fee for an isolated intermediate registration is 1,600 Euro and this fee can be even drop to 1,200 Euro, if a joint submission (JS) was established.
Table 1: Comparison registration fees in € - Isolated Intermediates vs. substance acc. Regulation EC No.340/2008.
Also the company size matters and fees can drop, if a registrant qualifies to a SME (Small and Medium size Enterprise) definition. The fee for an isolated intermediate can even go down to 120 Euro for a JS of a micro enterprise. Compared to the fees of standard registration, a closer look at the substances to be registered might be a well invested time.
A company should consider the registration of an isolated intermediate, if the following applies:
- my substance is used for further synthesis of another substance and completely consumed
- my substance is prepared, stored, handled and used under strict technical containment
- Usually these handling conditions apply for many gases - but if the technically option is out there, to implement the strictly controlled conditions (SCC) a cost benefit analysis should be conducted.
- Typical industries where an isolated intermediate registration may apply are:
- production of semiconductors by photolithographic processes,
- synthesis of active pharmaceutical ingredients,
- preparation and use of surface treatment products,
- formation of highly reactive Grignard's reagents, lithium organyls and other organometallic compounds for organic synthesis.
Excurse ECHA and Intermediates
It should be mentioned, that ECHA still has not technically implement a procedure to issue two different registration numbers according to the dossier type "isolated intermediate registration" and "substance registration". This certainly is a technical and regulatory disadvantage for isolated intermediate registrants.
Also ECHA announced a new release of the guidance on intermediates after November 2010. This rewriting of the guidelines on intermediates especially after the end of the first registration phase is very critically seen by some legal and industry stakeholders.
But despite the fact on the ongoing discussion of intermediate guidelines and technical obstacles, the REACh regulation is the legal basis for all involved.
Examples And Conclusion
An example for a good practice of an isolated intermediate registration can be found at www.fit4reach.net R22 SIEF. This is the SIEF Web portal for Chlorodifluoromethane (R22). In this case, R22 is in the focus of regulation EC 1005/2009 (substances that deplete the ozone layer) and the range of use was reduced. The potential registrants have agreed to register R22 as an isolated intermediate because R22 can still be produced, imported and used as feedstock for the synthesis of other substances. Also, the handling and use of R22 is usually done in a closed system so the intermediate registration is an elegant and cost efficient way to secure the future marketability of this product.
In another case it was possible in an assessment of intermediate identification, to significantly reduce the registration costs of an industrial customer to one fifth of the original estimated costs. By monitoring the real process conditions, and find-out of the intermediate status of several chemical substances the number of substances liable to standard registration according to Art. 10 could be reduced significantly.
As a conclusion it must be pointed out that carefully reviewing the conditions of manufacture, storage, handling, transport and use can optimise the portfolio of substances liable to registration and other REACh obligations. If the isolated intermediates conditions apply, any potential registrant should re-assess the individual registration strategy in order to sustain cost saving potentials. Reducing the external costs for data acquisition and ECHA registration fees are a measurable benefit of an isolated intermediate registration.
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