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HAZIRLAMA HATTI 
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MBDF
 

 

Hizmetinize ait açıklamaları buraya yazın. Resmi hizmetinize uygun olarak değiştirin.
Substance Information Exchange Forum (MBDF-Madde Bilgi Değişim Forumu)

Companies that intend to notify the same phase-in substance will join a Substance Information Exchange Forum (SIEF) to share data on the intrinsic properties of the substance and to avoid the duplication of studies. In particular, they have the obligation to share all test data on vertebrate animals. The members of the SIEF should also agree, if possible, on the classification and labelling of the substance.

The work of a SIEF leads to one joint submission for each substance, therefore reducing costs and avoiding unnecessary animal testing.

Joining a SIEF is a legal obligation for all registrants of notified phase-in substances. Potential registrants must get active in their SIEFs now if they intend to register by 01 June 2015.

Members of a SIEF have to share existing studies, react to requests for information and work collectively to identify and carry out additional studies or submit testing proposals when needed.

In addition to potential registrants, downstream users and any person or organisation holding data relevant to a phase-in substance can participate in the SIEF if they have identified themselves as a data holder and are willing to share their information.

SIEFs have no prescribed legal form and they are independently managed by industry. ECHA is not involved in their operations.

Pre-SIEFs

Companies who have pre-registered a substance will automatically become listed on a pre-SIEF. These companies need to agree on the identity of the substance to be registered and to find out if there is sufficient similarity to allow data sharing and a valid joint submission of data.

As a result of the discussions on the substance identity, some pre-SIEFs will merge or split to form a final SIEF. In both cases, the decision needs to be clearly documented.

Therefore, companies are strongly encouraged to look at the list of pre-registered substances to ensure their substance does not appear in multiple entries. Similar substances may have been pre-registered using different chemical identifiers.

Lead registrants

SIEF members need to appoint a lead registrant who must act with the agreement of the other co-registrants and submit the lead dossier of the joint submission. The lead registrant also usually coordinates the activities within the SIEF.

A lead dossier is a complete dossier that includes the classification and labelling of the substance, (robust) study summaries and proposals for further testing, if applicable. The registrants can decide if they submit the guidance on the safe use of the substance and the chemical safety report, jointly or separately.

REACH does not specify rules on how the lead registrant should be selected. For example, the lead registrant may be the registrant who plans to submit their registration dossier by the earliest registration deadline.

Lead registrants are advised to inform ECHA of their nomination.

Lead registrants nomination web form



Member registrants

Member registrants submit dossiers containing only information specific to their company and their substance, for example, information about substance identity, their identified uses and their production volumes. These submissions do not need to include the information already provided by the lead registrant.