http://www.sdn.sap.com/irj/sdn/weblogs?blog=/pub/u/251778053 [original link is broken] [original link is broken] [original link is broken] [original link is broken] [original link is broken] [original link is broken] is a Chemist with more than 20 years of experience in business processes related to the chemical industry.
Part one of a two part series on REACh
Now it has happened. After years of discussions the European Council and the European Parliament passed the REACh legislation last December. REACh stands for Registration, Evaluation and Authorization of Chemicals. It is a new legislation you could say even a new system – that requires from every producer or importer of chemicals to submit data to the European Chemical Agency (ECHA). The ECHA will evaluate this submitted data and can limit the usage of a substance or request a substitution of it.
Although REACh does not become effective until June 2007, what can I do now and what must I do now in order to be prepared from an organizational point of view?
REACh requires chemical companies to register the vast majority of their substance portfolio within eleven years. As future production and import opportunities are dependent on successful registration, it is vital that the registration process itself is efficient in every regard. As of summer, companies will have hundreds and sometimes even thousands of individual projects to organize if they are to achieve this aim.
The majority of registration procedures concerned involve a complex range of tasks. IT-based project management provides the appropriate solution to ensure end-to-end planning, control, and monitoring of all registrations. The concept behind any project-oriented compliance management process has to satisfy a range of requirements. Due to the complex and time-consuming nature of the registration process, project managers must be able to monitor the registration status throughout. They will need to know precise answers to a wide range of questions, including:
– Which documents are in which stage of processing?
– What information has been required for a particular registration and why?
– Are the companys own employees advancing the registration process?
– What are the responsibilities of importers and service providers?
I see many parties involved in the REACh registration related activities. On the one hand you have the internal stakeholders. The most important is of course the product safety department. But also Product Management and Purchasing are involved. The first wants to ensure that the right substances for the right usages are registered the second have to purchase services like toxicoligal and eco-toxicological tests.
And I have external stakeholders. Besides the European Chemical Agency (ECHA), I think about the service providers and perhaps even more important other companies who want to register the same substance than me. According to REACh I´m obliged to create SIEFs (Substance Information Exchange Forum) with those companies to share existing substance data and gain missing substance data commonly.
How can I bring all these parties together?
To ensure the entire process is handled consistently, both internal and external parties must be granted access rights relevant to their role. It is useful to establish a cross-team communications platform that provides a standardized structure for exchanging information. Such a platform should also enable various different sites to work together, while ensuring all documentation remains consistent.
In addition, all parties should have a clear understanding of their roles, knowing who should be doing what, when, and keeping track of the status of documents. If agreed processes are skipped, it may be useful to activate incremental escalation management in order to minimize the risk of bottlenecks.
Beside the number of parties involved, the complexity of the REACh legislation comes also from the high amount of data. It is on the one hand the high amount of substance data I have to handle and to submit in the process. But you must not forget that the status of all these data and, as a result of it, the status of a registration needs also to be tracked. Otherwise, you can not rely on your registration process. Therefore you need a registration database that handles the status tracking of every registration with its many data points, including information, such as where the submitted information comes from.
But what about the substance data?
The registration process uses large amounts of data from the companys operational management systems and, as a result, project management should be understood as a portal that supports automatic data exchange with all the appropriate sources of information. These sources include the TechniData CSM (Chemicals Safety Management) compliance solution, which is based on SAP EH&S (Environment, Health and Safety). Chemical companies use this solution for processes, including the creation of their safety data sheets.
The majority of substance data required by this process is also incorporated into the REACh registration dossier, which is generated using the IUCLID substance database. A subset of these data may already be available in many SAP EH&S systems and should exhchanged with the IUCLID5 application that is provided by the ECHA.
REACh is about registration of chemicals or, in other words, substances. But this is not equal to a company´s materials.
It is the volume of substances that counts for the amount of data and the timeframe I have for the registration right?
Project management will begin with an 18-month pre-registration phase. The new regulation offers three different timeframes related to annual substance volumes. If a company handles more than 1,000 metric tons of a substance in a year, registration must be carried out within 42 months from the time REACh comes into force. This period is extended to six years for over 100 metric tons, and by more than one ton, to eleven years.
As a result, management teams have far greater scope for planning than in the case of a new registration, thus providing two advantages. First, companies can make well-informed decisions as to whether and when it is worthwhile to register. Second, it enables the necessary resources to be planned and financed well in advance by stretching out compliance management over a long period.
Good to know how much time I have. But this requires the monitoring of my substance volumes. Looking at my material movements will not provide me with the information needed.
However, substance volume tracking represents a completely new IT territory for compliance managers, since existing controlling tools do not supply the substance data that is needed. Working in partnership, the ERP capabilities of SAP and the compliance specialist capabilities TechniData have developed just the tool to close this information gap.
Substance Volume Tracking (SVT) has been seamlessly integrated into mySAP ERP as a standard component and became available in mid-2006. SVT determines the required substance volume data from the operational ERP applications. The solution accurately indicates which substances are used in which products and what substance volumes are involved in which import and production processes.
Because SVT functions as an automated early-warning system, companies avoid the risk of unknowingly exceeding volume limits. Early identification of developments in substance volumes and flows also enables management teams to optimize their budget, resource, partner, and portfolio planning. At the same time, specialist departments can determine, on a substance by substance basis, when and to what extent it makes operational sense to press ahead with registration. In view of the huge outlays each individual substance can involve six and seven-figure sums this head start in planning can also be a head start on the competition. Consequently, companies gain the flexibility to organize their compliance management at minimum cost.
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