SIEF / SIEF Agreements

Date: 7 January 2019


The EU Regulation on chemicals “REACH” (Regulation (EC) No. 1907/2006) stipulates that Substance Information Exchange Forums (SIEFs) had to be operational until 1 June 2018, the day after the last REACH registration deadline.
Nonetheless, the registrants of a substance are still bound by the obligation to submit the information on their substance jointly and as of 1 January 2019, co-registrants have to coordinate the reply to ECHA, and speak with one voice during the entire process if they receive an ECHA decision, due to testing proposal evaluation or incompleteness of their dossiers.

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History: The aim of the SIEFs was to help the registrants of the same substance to cooperate with regards to exchange of chemical substance data required for joint registration and so to avoid unnecessary testing, especially on animals and – if possible – to agree on C&L.

But what about the future of the SIEFs and SIEF(-based) Agreements?

In many cases the contractual cooperation basis for co-registrants, the “SIEF Agreement”, was terminated on 1 June 2018. Moreover, SIEF Agreements that are still in place often do not fully comply with the regulation on joint submission and data sharing (Commission Implementing Regulation (EU) 2016/9), which came into force several years after many contracts had been prepared.

However, the legal obligation to cooperate among the co-registrants for the joint registration and for data sharing related tasks persists. This cooperation, e.g. on managing update needs and updates of the registration dossiers (Article 22, REACH), as well as coordinated responses to potential regulatory requests related to dossier and substance evaluation, might become more intensive, depending on the regulatory and scientific issues that might arise and which – as of 2019 – ECHA will address to all non-compliant registrants (no longer mainly to the LR) of a substance.

Furthermore, the dynamic of EU chemicals market, political decisions such as BREXIT, etc. require ongoing data management and lead registrants who should be prepared for cost sharing requests of new registrants and reimbursements to existing registrants.

Even if the number of co-registrants per substance is lower than the number of SIEF members (some SIEFs now comprise hundreds or even thousands of members), the administrative burden and time for communication should not be underestimated.

Considering all the tasks mentioned above, amendments to existing contracts might be necessary or – as recommended by The Directors’ Contact Group – “SIEF Agreements” should be replaced by new cooperation contracts, addressing the “after-deadline” obligations and ensuring compliance with the available regulations.