SUNIVO REACH Newsletter(4)

ISSUE 4-13th March 2009

The conference aims to inform authorities, industry and other stakeholders about the new provisions for classification, labelling and packaging in the EU, placing them in the global context of GHS. It will explain the main features of the new legislation, focusing on practical aspects. It will provide up-to-date information on the CLP guidance documents and tools.

The avoidance of unnecessary animal testing is a main concern underlying the provisions of REACH. One way of achieving this is to use data relating to another substance for your own substance, if it can be considered that the substances are similar enough to justify it. Reading data across different substances should always be carried out according to expert judgment. The Guidance on information requirements under REACH explains in detail how and when reading across can be made. Beyond the technical aspects of read across, other issues must be considered.

When pre-registering, a company manufacturing substance A has the possibility to indicate those other substances (e.g. substance B) with which reading across may be considered. ECHA will make this information available to the participants in the SIEF corresponding to the other substance, who will have the possibility to see the identity of the Pre-Registrants of substance A and send queries for data sharing. Similarly, Pre-Registrants of substance A will be able to see the identity of the participants in the SIEF of substance B and send data sharing queries. Indicating read-across is also still possible after the end of pre-registration (e.g. after checking the list of pre-registered substances).

It is worth noting that the fact that substance B is flagged as a potential read cross substance when pre-registering A does not necessarily mean that a pre-registrant of substance B has flagged the same opposite reading across with A. Reading across from A to B will consequently be indicated to the B SIEF, irrespective of the fact that no B participant has flagged this reading across in his own pre-registration. There is no cascading of reading across, though. In case SIEF A reads across with SIEF B and SIEF B reads across with SIEF C, there is no automatic connection between SIEF A and SIEF C. The validity of reading across is always based on an expert judgment and cascading across several substances cannot be assumed to be valid unless scientifically checked for validity. It is impossible to address all possible cases involving reading across, the validity of which should always be assessed on a case by case basis.

SUNIVO Recommendation: It is not mandatory for participants in different SIEFs to share data, even though it is encouraged by REACH in order to reduce animal testing and curb compliance costs. A direct consequence of this is that the data sharing provisions of REACH do not apply. Every request for access to studies across different SIEFs will have to be negotiated on a case by case basis by the concerned companies.

If you have any issue facing with REACH or trade in Europe,

Sources: European Chemicals Agency (ECHA)