SUNIVO REACH Newsletter(2)

ISSUE 2-16th February 2009

SUNIVO's REACH core team is composed of regulatory consultants, specialized in EU regulations and experts in chemicals. We offer consulting service to help manufacturers and importers to support you in thoroughly preparing and implementing REACH compliance.

ECHA published on 13 February 2009: Currently the main REACH obligation for companies which pre-registered substances last year is to form SIEFs (Substance Information Exchange Forums). These should be operational as soon as possible, particularly in those cases where companies need to submit their registrations to ECHA before 1 December 2010. The purpose of a Substance Information Exchange Forum (SIEF) is to help registrants of the same substance to share information about the substance and to avoid duplication of testing.

In assessing the identity of the substances, Potential Registrants are invited to read and use the Guidance on substance identification carefully. For substances with a well-defined composition (i.e. mono-constituent and multi-constituents substances) the sameness of the naming is in principle sufficient to be able to share data even though certain impurities might lead to a different classification/hazard profile. Only in cases where all data is clearly not suitable for the other substance these substances can be regarded as different (e.g. in case of very different physical properties which have essential impact on the hazard properties, like water solubility). For UVCB substances also – in general - the name is leading to determine the 'sameness'. If the name is the same, the substance is regarded the same, unless available data shows the contrary. In most of the cases the substances that have been pre-registered under the same entry in EINECS (either defined by its EINECS or CAS number, or its description of the entry) will be the same substance and, after a quick check by Potential Registrants for gross errors, there will be a general agreement that a joint submission of data is possible and cooperation between Potential Registrants can start immediately. In certain cases, however, the exact nature of the substance covered by an EINECS entry will have to be scrutinized in order to ascertain whether it can be covered by the same joint submission of data and that the relevant hazard data can be purposefully exchanged. Typically, this may happen in the following situations:

● The description in EINECS given for a substance can be very broad to the extend that the physical-chemical and (eco) toxicological properties of the different substances covered by this one entry are not sufficiently similar to use the same data to describe it. This may particularly be the case for UVCBs.

● Substances for which there is more than one entry in EINECS and that are considered the same based on the Guidance on substance identification.

SUNIVO Recommendation: If parties disagree on substance identity/sameness and a party considers that it should be part of a SIEF created by other parties for a given substance, that party has the possibility to formally request to join the SIEF and request access to the data he is missing to proceed with his Registration. If you have any issue facing with REACH or trade in Europe, please feel free to contact us: reach@sunivo.com

Sources: European Chemicals Agency (ECHA).