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SIEF

SIEF: Key Principles and Roles

REACH provides for the formation of a SIEF which is a forum to share data and other information among manufacturers, importers and exporters of the same "phase-in" substances for the purpose of registration. As a general rule, there shall be one SIEF for each pre-registered substance with the same chemical identity. It is important to note that all potential registrants including Only Representatives (OR) who represent Non-EU Manufacturers and the Data Holders will essentially be the participants in the SIEF.

Pre registrants, through their “only representative” should work towards forming SIEFs as soon as possible to ensure sufficient time remains available to organise data sharing and prepare the registration dossiers, in particular for high volume substances considering the registration deadline of 30th November 2010.

It is important to note that the OR may have to be kept informed in a transparent and timely manner by the non-EU manufacturers about their interests / positions on the issues such as data sharing, status of their role in SIEF etc., so that the OR can adequately represent such positions in SIEF on their behalf. It is equally important that the OR maintains a regular update to his clients (non-EU manufacturers) on the activities that are being organized within the SIEF and what are the key decisions being made.

As a first step, pre-registrants of substances with the same identifiers (CAS No or EINECS No) in the list of pre-registered substances will have to establish whether their substances are indeed the same for the purpose of SIEF formation and registration. In order to reach an agreement on the sameness of a substance, Pre-Registrants must enter into pre-SIEF discussions. As a consequence of this, a SIEF is formed when the Potential Registrants of a substance in the pre-registration list, actually agree that they effectively manufacture, intend to manufacture or import a substance that is sufficiently similar to allow a valid joint submission of data. ECHA will not participate in the discussions between potential registrants and there will be no role of ECHA in confirming or rejecting the creation of a particular SIEF.

FROM PRE-SIEF TO DATA SHARING

Pre-SIEF

  • The concept of the pre-SIEF was not foreseen in the REACH Regulation, but was introduced, with support from industry, in order to bring pre-registrants together to facilitate SIEF formation.
  • REACH-IT automatically placed companies who pre-registered substances with either the same name or chemical identifiers in the same pre-SIEF.
  • Companies in each pre-SIEF must decide, based on detailed consideration of the substance identity, whether the substance in question can in fact be regarded as the same.
    • Pre-registrants of the same substance will form one SIEF.
    • Those pre-registrants who discover they have different substances should seek to form or join other SIEFs. The pre-SIEF page in REACH-IT has a “Similar to” box to help companies identify the most appropriate pre-SIEF.
  • The contact information of all other pre-SIEF members is available in REACH-IT. This information can be downloaded from REACH-IT into an XML file.
SIEF Formation Facilitator

  • The SIEF Formation Facilitator (SFF) role was created to initiate and conduct discussions after pre-registration, and to facilitate the exchange of information and data which is required in order to form a SIEF.
  • Any pre-registrant may volunteer via REACH-IT to be the SFF.
  • Any companies volunteering to be a SFF must be willing to take the initiative to contact the other participants within their pre-SIEF with a view to forming the SIEF.
  • SFFs have no management role beyond facilitating discussions and they have no legal basis to force other pre-SIEF participants to co-operate with them.
  • SFFs cannot demand information or fees for their services unless mutually agreed.
  • The SFF role is not formally recognized under REACH; therefore pre-registrants have no obligation to use a SFF to form a SIEF.
  • Data in REACH-IT may only be used for the purposes of meeting legal obligations under the REACH Regulation. The data may not be used for other purposes.
  • A SFF can review their position at any time and decide not to continue in this role.
  • ECHA advises all companies to decide what role they wish to take in the SIEF. The chemical manufacturers’ association (CEFIC) and distributors’ association (FECC) have agreed on a proposal that includes the harmonized classification of pre-registrants according to their desired level of SIEF involvement and an early identification of SFFs.
SIEF Formation

  • A SIEF is formed when companies have agreed that their substance is the same.
  • Companies in the SIEF are free to choose how they communicate and organize themselves
  • ECHA will not participate in discussions between potential registrants and will not confirm or disallow the creation of a particular SIEF.
  • ECHA recommends that companies contact their relevant trade associations for further advice on how best to proceed from pre-SIEFs to SIEFs
SIEF Formation Facilitator

  • The SIEF Formation Facilitator (SFF) role was created to initiate and conduct discussions after pre-registration, and to facilitate the exchange of information and data which is required in order to form a SIEF.
  • Any pre-registrant may volunteer via REACH-IT to be the SFF.
  • Any companies volunteering to be a SFF must be willing to take the initiative to contact the other participants within their pre-SIEF with a view to forming the SIEF.
  • SFFs have no management role beyond facilitating discussions and they have no legal basis to force other pre-SIEF participants to co-operate with them.
  • SFFs cannot demand information or fees for their services unless mutually agreed.
  • The SFF role is not formally recognized under REACH; therefore pre-registrants have no obligation to use a SFF to form a SIEF.
  • Data in REACH-IT may only be used for the purposes of meeting legal obligations under the REACH Regulation. The data may not be used for other purposes.
  • A SFF can review their position at any time and decide not to continue in this role.
  • ECHA advises all companies to decide what role they wish to take in the SIEF. The chemical manufacturers’ association (CEFIC) and distributors’ association (FECC) have agreed on a proposal that includes the harmonized classification of pre-registrants according to their desired level of SIEF involvement and an early identification of SFFs.
Lead Registrant

  • All SIEF participants must select a Lead Registrant. This is a mandatory role laid down by the REACH Regulation. The role is not automatically given to the company that facilitated the formation of the SIEF.
  • REACH does not specify rules as to how the Lead Registrant should be selected. The Lead Registrant must act with the agreement of the other assenting registrants and submit the Joint Dossier, which contains information on the intrinsic properties of the substance. The other registrants then only have to submit their company-specific information.
  • Lead Registrants are perhaps more likely to submit their registrations well before the first registration deadline in 2010.
  • The Lead Registrants preparing for the first registration deadline are advised to inform ECHA of their nomination.
Consortia

  • Consortia are a more formal type of co-operation between registrants set up in order to provide practical help with SIEF data-sharing obligations and the preparation of registrations. There is however no requirement to form consortia under the REACH Regulation. It is possible that several consortia could be formed among the members of one SIEF or that one consortium could cover registrants from different SIEFs, e.g. in the case of related substances.
SIEF Roles

  • In order to achieve an efficient registration and communication process, CEFIC classifies the pre-registrants into 4 different SIEF Codes:
  1. Leading
    • This pre-registration concerns a substance of high strategic importance and your company has adequate resource to (co)-lead.
    • Your company (co)-leads the SIEF with the cooperation of a few others.
    • Your company assumes responsibilities as a leader and will be active in the SIEF Leadership Team (SLT). The SLT will be usually formed by the SIEF Formation Facilitator, the Lead Registrant and some few other companies that play a key role in the production/import of the substance.
  2. Involved
    • This pre-registration concerns a substance of strategic importance, but your company cannot commit resource to lead.
    • Level of activity may vary as appropriate from being consulted to being actively involved and helping the SIEF leader in technical discussions.
    • You want to be regularly updated.
  3. Passive
    • This pre-registration concerns a substance of lower strategic importance.
    • You expect other players to take the lead.
    • You want to minimize use of your resources. And you may be active near the registration deadline.
  4. Dormant
    • You have no intention to register
    • You do not want to be involved

  5. For formal reasons you had to pre-register:

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