7 mistakes in registration of chemical substances

Phil Black - PII Editor 30/05/2013

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Under REACH, the European Community Regulation, manufacturers and importers must register chemical substances. However, the quality of the data is inadequate in many of the registration dossiers that have been submitted to the European chemical agency ECHA so far. Within the scope of its SME (small and medium-sized enterprise) initiative, TÜV SÜD points out mistakes that should be avoided at all costs.

From June 2013 onwards, many companies will embark on the third phase of registration for substances produced in volumes of one tonne per year – particularly relevant for SMEs. “Among other information, the registration dossiers must include comprehensive information on the properties of the substances and their hazard and risk potential”, says Dr Dieter Reiml, REACH expert at TÜV SÜD Industrie Service GmbH. Poor data quality can even result in withdrawal of the registration number, meaning the substance can no longer be placed on the EU market. The 7 most common mistakes in practice are…

1. …Failure to observe the SIEF communication on substance identity.
The “Substance Information Exchange Forum” (SIEF) is a platform for the virtual exchange of important information about substance registration. However, stakeholders repeatedly fail to pay adequate attention to communication. This sometimes results in registration of the wrong substance, rendering registration invalid.

2. …Failure to observe the SIEF communication on substance use.
Stakeholders that do not use the substance as defined in the registration either need to prepare a separate chemical safety report (CSR) or must waive this use.

3. …Giving preference to guidance documents over the text of the regulation.
Only the text of the REACH regulation itself is of a legally binding character. While the “Guidance Documents” of the ECHA provide important assistance, the dossiers must be in compliance with the text of the regulation, which is also indispensable for understanding the REACH system.

4. …Overlooking reports in REACH-IT.
After submission of a registration dossier, stakeholders should check their REACH-IT-mailbox. The ECHA communicates exclusively via this system, so that important information, for example about registrations, is only accessible via this system.

5. …Failure to meet follow-up obligations.
Even after successful registration, dossiers must be kept up-to-date (Art. 22 REACH regulation). This also includes risk-management measures that must be permanently complied with and communicated.

6. …Restricting REACH to registration.
The regulation also includes the evaluation, authorisation and restriction of chemical substances. However, this results in further obligations and business risks along the supply chain, and concerns areas such as the required safety data sheets, SVHCs (Substances of Very High Concern) or reports to the classification and identification register of the ECHA. The REACH regulation also is closely interlinked with the CLP regulation (GHS).

7. …Addressing REACH and its effects too late.
Although the last deadline does not expire before 2018, the requirements defined in REACH are comprehensive and complex and may tie up important capacities, particularly in SMEs. In these cases rational interpretation of the regulation with foresight may prove a critical advantage in competition and even make all the difference to the survival of companies.

TÜV SÜD”s “SME Initiative” is a service specialising in REACH that ensures on-time, cost-efficient and successful registration of chemical substances. SMEs are generally “co-registrants”. TÜV SÜD manages the submission of the registration dossier on their behalf. SMEs thus do not have to worry about the time-consuming induction into IUCLID and REACH-IT and the continuous maintenance of these IT systems.

For further information on REACH go to www.tuev-sued.de/reach.