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Reach - What's happened and what's next?

“Pre-registration was a great success” (Geert Dancet, Director General of ECHA, 2 December 2008). Whether you agree with Mr Dancet’s assessment may depend on how much difficulty you experienced with REACH-IT. However, irrespective of ECHA’s viewpoint, pre-registration was certainly a success for Caleb Management Services. During the six months from the start of pre-registration in June to its end on 1 December, Caleb successfully pre-registered 1176 substances, on behalf of 11 clients for whom Caleb is acting as Only Representative, and a further 15 for whom Caleb is Third Party Representative or consultants. To put this into perspective, this is more than the combined pre-registration total of Iceland and Malta . For a company employing only 10 people, this was a success by any measure.

As everyone breathes a sigh of relief after the completion of pre-registration, the question is: “what’s next”. The next (30 November 2010) deadline looks a long way off, but consider how long 1 December 2008 seemed when pre-registration began, and how short 6 months seemed to be when work began. So, what has to be achieved during this time frame?

•  The challenge of managing multiple SIEFS. We already know that some substances have been pre-registered by several hundred organisations, and one pre-SIEF consortium, for methanol already has around 2000 members! And, by the way, this problem won’t get any easier after the 1000 tonne substances are out of the way – expect more of the same in the lower tonnage bands!

•  REACH requires that companies in SIEFs work towards compiling a common dossier. For companies that are going to be lead registrants, they will have to have the lead dossier ready by June 2010. Given that this will require an extensive trawl of available data, and a gap analysis, together with running studies to fill gaps in mandatory test requirements, plus writing a proposal for the other tests, this is already challenging. Add to this the need to gather exposure scenario data, conduct risk assessments down the supply chain, carry out chemical safety assessments, write chemical safety reports, rewrite SDSs, and the task may seem herculean.

•  REACH is a moving target in one aspect. Companies have pre-registered based on indicative tonnages, based on which the registration deadlines were assigned. However, REACH also requires ongoing volume tracking and reporting at the substance level in order to determine data requirements going forward. Most companies already have volume tracking systems for products but to translate this into substance data may prove problematical.

•  There is another issue with volume tracking. In the past, the decision to sell or not sell a product was based on purely commercial criteria (will we make money if we sell an extra tonne of Product X?) Now that commercial decision has been made more complex by the addition of the question: “if I sell (and therefore manufacture or import) an additional tonne of Product X, will that sale push any of the component substances from one tonnage band to a higher one? And, if it does, how does this additional tonnage affect the profitability of Product X, given that we may have to run hundreds of thousands of dollars worth of testing to support it?”

So, where is a company to turn in these situations? The chemical industry has not been as profitable in recent years as in the past, and consultancy costs were often seen as a readily dispensable luxury. Given that a REACH test battery for say 100-1000 tonnes could run to almost $2 million, this equation has changed. Caleb offers a full range of consultancy services, and has the skills and expertise to address these issues and act on behalf of clients in a very cost-effective manner. These include readily available tools which have been specifically developed for carrying out REACH impact assessments. Caleb has over 10 years of experience in consortium management and is therefore ideally placed to represent clients in SIEFs and consortia.

Want to know more? Give us a call on +44 (0) 1454 269330 or e-mail reach@calebgroup.net

Chemical Risk Appraisal and Management

There are tens of thousands industrial chemicals, pharmaceuticals and naturally occurring compounds that collectively act as building blocks for many valuable and life enhancing products and services enjoyed by most societies. However, there are also potential health and environmental impacts during extraction, manufacture and conversion of chemicals into useful items. In some cases, these can extend into the use and decommissioning phases of the lifecycle, creating the need for informed management techniques and policies. Part of the problem is that, the datasets for many long-standing industrial chemicals are incomplete with uses being 'grandfathered' from previous generations. In addition, the use of naturally occurring starting materials can lead to greater complexity because many such starting materials are complex mixtures in themselves. What we do know is that society has a problem to be managed if we want to continue to benefit from these materials and their products. National and international regulators and public opinion are now rightly demanding more transparency from industry and a higher degree of scrutiny in most cases. However, balanced with this trend is the fact that there would be no need to manufacture these chemicals in current quantities if society were less profligate. Accordingly, just as all stakeholders have a responsibility for the problem, all have a role to play in the solution.

Caleb is well placed to act in the area of 'Chemical Risk Appraisal and Management' where this involves the engagement of stakeholders and the building of consensus on regulatory issues. The company has strong relationships with regulators throughout the world. However, because of our geographic location, these are probably at their strongest in the European Union where, the increasing expression of the precautionary principle in European Chemical Policy development is causing much angst at this time. Caleb has positioned itself to provide, not only alerting services, but also, more importantly, the capability to engage with regulators in order to provide balance to the argument and develop mutual understanding. We feel passionately that the chemical industry has failed to communicate its value to society and this often forms the first plank of our approach with regulators who are often looking for an over-simplistic answer to their perceived problems. In parallel, however, we do not shy away from explaining the stark responsibilities faced by an industry which has taken its 'license to operate' for granted for too long.

Among the chemicals that we are currently working with are phenol, resorcinol, formaldehyde and alkyl phenols. This takes us into the 'mysterious world' of endocrine disruption and the even more mysterious efforts to harmonise test protocols and regulatory approaches. Other areas of specific interest are halogenated chemicals and particularly their persistent and bio-accumulative characteristics. Of course, a sub-set of this sector is the family of chlorfluorocarbons, which as ozone depleting substances have become a business unit all of their own!

REACH - The Registration, Evaluation & Authorisation of Chemicals

Caleb manages a number of chemical-specific global task forces whose target is to assess data/data-gaps and manage projects to fill these data gaps prior to submission of dossiers to programmes such as the US HPV Challenge and the OECD SIDS process. These activities are a clear forerunner to the requirements of REACH and, building on this experience, Caleb anticipates being a future leader in the field of REACH consortium management and other related REACH support activities.

Building on this experience, we can therefore offer the following expertise and services:

Services

• REACH Impact Assessment (Info Link) to:
• identify the critical substances in a product portfolio
• assess the commercial implications of the legislation on each of the substances identified
• develop appropriate registration strategies in each instance
• Search capability to identify potential consortium members for specific substances, where appropriate
• Management of consortium formation & operation for specific chemicals through well-established procedures and structures
• Representation Services in other consortia for individual companies
• Only Representative services for non-EU producers, including liaison with the importers who thereby become downstream users

Expertise

• Strong analytical skills to assist consortium members in assessing available data and identifying critical data gaps
• Negotiating and commercial skills to balance the interest of consortia members in order to meet the demands of REACH as cost effectively as possible
• Proven reputation in successfully dealing with the European Commission and Member State authorities on chemical regulatory issues
• Established links with a number of laboratories, toxicologists and potential CSR writers to ensure adequate support for consortium activities
• Established partnerships with specialist legal practices to provide the necessary legal support and guidance to consortium members
• A continuing enhancement of the resource available for consortium management through the recruitment of suitably qualified staff to ensure Caleb maintains its leading position on all aspects of REACH implementation

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