REACH: Taking Steps to Register Preregistered Substances
By: Annelie Struessmann, PhD, CONUSBAT
Posted: January 13, 2009
The preregistration of phase-in chemicals, which ended on Dec. 1, 2008, allows preregistrants to benefit from extended registration deadlines. However, to ensure sufficient time to organize data-sharing and prepare registration dossiers, potential registrants are recommended to perform the necessary follow-up steps as soon as possible. This is particularly important for the three substance categories whose first registration deadline is Nov. 30, 2010:
1) CMR substances: Substances classified as carcinogenic, mutagenic or toxic to reproduction (Categories 1 and 2) in quantities of 1 ton/year or more;
2) Substances classified as R50-53: Very toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment in quantities of 100 ton/year or more; and
3) High volume substances of 1,000 ton/year or more.
The testing requirements for these substance categories are described in the Annexes VII, VIII, IX and X of the REACH Regulation. Additionally a Chemical Safety Report (CSR) is necessary for registration, according to Article 14. REACH mandates that all available in vitro and in vivo data, historical human data, data from valid (Q)SARs and from structurally related substances (read-across approach) must be assessed before new tests are conducted to determine the properties listed in these annexes.
Concerning the exchange of data, Substance Information Exchange Forums (SIEFs) will be formed for each preregistered substance with the same chemical identity. Several arrangements are possible for companies to organize their cooperation in a SIEF. Companies may decide for a loose approach, e.g. using IT tools to communicate between all SIEF members. More structured and binding arrangements include consortia; several of these have been founded already and their cooperation is usually based on firm, contractual agreements. Another cooperation structure may be that a manufacturer within a SIEF provides a full data set to the other manufacturers in the SIEF and authorizes their access to the data in a simple written statement.
REACH does not require formal legal agreements; however, ECHA advises that parties should agree in writing on the main rules of data sharing. The practice for determining the costs of sharing information is a part of the provisions of REACH in Article 30, and is requested to be determined in a fair, transparent and non-discriminatory way.