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Dr Reach - Who are you? – By a REACH consultant

“Enhancing competitiveness and innovation” is a primary objective of REACH. So far, this seems to be most evident in the field of REACH consultancy. But did politicians ever intend this ‘by-product’ of implementation to be most prominent?

There has been exponential growth in the number of REACH consultants over the last few years. Many new firms have been formed. Of course, this is sometimes necessary, for example, if a company wants to limit liability for ‘only representative’ operations.

Pre-registration good earner

Rumour has it that some consultants have already retired; pre-registration was a sufficient earner. This gives a new meaning to “REACH on the beach”– a phrase coined by service provider REACHReady when MEPs reviewed the draft legislative text over summer holidays.

That said, veterans are tighter than ever. And there are many experienced players in the field. Support networks between chemical experts may prove critical when the upcoming 2010 deadline must be met.

From 36 or so often referenced business impact assessments conducted on REACH, I do not recall an analysis of the market effect on consultancies, or even Contract Research Organisations (CROs) for that matter. Manfred Fleischer of WZB Research produced the now often cited paper comparing testing costs across CROs, which examined some capacity issues. (WZB Research Paper)

Further references on this subject would be most welcome!

Pre-registration has revealed a large number of new faces. Many pre-SIEF members are, quite literally, asking “who are you?” This is particularly the case when consultancies that are relatively unknown in the chemical market send out SIEF questionnaires and even declare themselves as ‘SIEF formation facilitator’.

This phenomenon prompted the recent statement by the European Chemicals Agency: “Where the current SFF isn’t working, or is perhaps using the pre-SIEF as an opportunity to earn money or blocking or slowing down the process, SIEF members may ask the SFF to give up the role and set a deadline for a response.”

As if REACH wasn’t complicated enough! To add to the hundreds or thousands of pre-SIEF members, now companies have to deal with fictional characters and overflowing inboxes.

Some of the web-based questionnaires bandied about can look quite impressive. However, many are not on secure sites.

Implicit agreements

Moreover, some significantly deviate from the standard questionnaire issued by the European Chemical industry Council. Cases exist where a response other than ‘dormant’ seems to implicitly indicate some sort of agreement to commissioning work (and sharing the costs) without any further formal approval process!

It appears that some consultancies are possibly even using pre-registration contact details to market their services. My view is that this is not allowed! Pre-registration information is confidential and for the purposes established in the Regulation only.

In this age of austerity, many companies are seeking to do most REACH work in house. My prediction has always been that the market size in consultancy is not very large, and that was well before the economic downturn.

CRO testing

By comparison, testing is where demand for REACH-related services will be highest, and supply lowest. For those interested, I am presenting a paper on “Managing the CRO Bottleneck” at the next Rapra REACH conference in June. An example of the anticipated impact of REACH on the US and European environmental testing CRO market is shown in the figure here courtesy of Springborn Smithers Laboratories.".

What is particularly interesting in this figure on the CRO market, is that the introduction of environmental testing to pharmaceutical products under EMEA in 2007 resulted in a 10% increase in market demand in the USA and Europe. It took two years for CROs to adjust to this. The limit to growth is not lab space, it is the experts.

Market growth

The CRO market is itself growing at high rates, particularly in central and eastern Europe, as well as in Asia. However, most operate in the pharmaceutical field, followed by biotechnology and medical devices. Many CROs are therefore not knowledgeable on REACH and do not base their business on the type of studies required for REACH.

CROs should be reminded by consultants that testing which does not follow REACH requirements may be illegal, even if the study is itself required for REACH registration. It seems that potential clients do not necessarily always realise this, with some requests for testing way off the legal text. So if the CRO is also ignorant, this could potentially result in a product that can no longer be marketed in Europe – at least for that supply chain, while other producers can continue to trade the same substance and potentially use the ex-competitor’s study test data for free!

Generating confusion

Too often the complexities of REACH appear to generate confusion.

Perhaps REACH consultants will eventually require certification. Let me rephrase that: REACH consultants should require certification.

Perhaps there will be an approval scheme, such as the notified bodies under the New Approach Directives.

The recently established Brussels-based Only Representatives Organisation demonstrates a proactive approach to ensuring some level of best-practice (CW 17 October 2008).

Unfortunately for some, I think this is coming all too late.