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The Clock is Ticking: Form your SIEF Now

 

Pre-registration

The process of pre-registration ended on 1st December 2008. During a 6 month period, 2.5million pre-registrations were submitted to the European Chemicals Agency (ECHA). Industries that submitted a valid pre-registration for their manufactured/imported substances can take advantage of the phased registration deadlines for their phase-in substances. The List of pre-registered substances is published on the ECHA website. More detailed information on pre-registration can be found at the following link

Late Pre-registration

Potential registrants who manufacture or import a phase-in substance for the first time in quantities of one tonne or more per year after 1 December 2008, can submit a late pre-registration provided the pre-registration is submitted:

  • At the latest 6 months after manufacturing or importing a substance above the 1 tonne threshold per year and
  • At least 12 months before the relevant transitional deadline for registration

Late pre-registration does NOT apply to companies that failed to meet the pre-registration deadline. These companies cannot continue manufacturing or importing the substance until they have submitted a full registration dossier for the relevant tonnage.

Late pre-registrations can only be submitted via REACH-IT. Further details can be found on the ECHA Website

From Pre-registration to pre-SIEF

The process of registration of a pre-registered phase-in substance begins with the formation of a collection of potential registrants and data holders called a Substance Information Exchange Forum (SIEF). The formation and operation of the SIEF is crucial within REACH and the registration process. Following pre-registration, potential registrants of a substance were automatically placed into what is called a pre-SIEF within the REACH IT platform with other potential registrants for the same substance. ECHA provides more information on pre-SIEF at ECHA website.

From Pre-SIEF to SIEF

The transition from pre-SIEF to SIEF is the responsibility of the potential registrants of the same substance and it should occur outside of the REACH IT platform. As the deadlines for registration are fast approaching (Dec 2010 for substances > 1000t/yr) it is important for potential registrants to become actively involved in their SIEF's as soon as possible.

A SIEF has no prescribed legal form, but is a forum to share data and other information on a given substance. While ECHA do not ‘own’ or manage SIEF's they are committed to provide guidance and disseminate best practice. The ECHA SIEF Fact Sheet will assist potential registrants with the formation of their SIEF's.

SIEF - Key Elements

The purpose of a SIEF is to help registrants of the same substance to share information about the substance and to avoid duplication of testing that is required for registration. A SIEF also aims to prepare a joint lead registration dossier and to agree where possible, the classification and labelling of the substance.

SIEF - Formation

The SIEF begins when 2 or more potential registrants have agreed that their pre-registered substance is the same. Potential registrants should consult the Guidance document for the identification and naming of substances under REACH and CLP when making a decision on the ‘sameness’ of substances.

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Roles within the SIEF

SIEF Formation Facilitator (SFF)

Members of the Pre-SIEF can volunteer to become the SIEF Formation Facilitator (SFF). This role is not legally defined within REACH but was introduced in the REACH IT platform to facilitate the commencement of the SIEF formation. Where 2 or more participants volunteer to become a SFF then the SIEF must decide who will take the role. Where a SFF has volunteered but is ‘silent’ or inactive, other members of the SIEF can begin the process and bypass the SFF.

The Lead Registrant (LR)

A SIEF must have a Lead Registrant. Unlike the SFF the LR is a mandatory role laid down under REACH. The Regulation does not specify rules as to how the LR is selected; however the LR is expected to be the member with the earliest Registration deadline. The LR must act with the agreement of the other participants of the SIEF and submit a Joint Registration Dossier which contains information on the intrinsic properties of the substance. The other registrants then only have to submit their company specific information e.g. identified uses. LR who have been nominated by the SIEF are advised to inform ECHA of their nomination using the link Lead Registrant Nomination

SIEF Members

All pre-registrants of the same substance will be members of a SIEF; however the decision to participate fully in a SIEF will be a business decision for the individual companies themselves. For example if a pre-registrant of a recovered substance does not intend to register the substance, they can become ‘inactive’ participants within the SIEF. LRs and SFFs may contact SIEF members asking them to specify the intended status of their pre-registration during the SIEF organisation.

SIEF Operation

The modus operandi of a particular SIEF is up to the SIEF members themselves to decide; ECHA or the MS Helpdesks will not participate in discussions between SIEF participants and will not confirm or disagree with the creation of a SIEF.
Further Information ECHA Guidance on Data Sharing.

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