SIEF Activities for an Impending Deadline

Mar 23, 2009 | Contact Author | By: Annelie Struessmann, PhD, CONUSBAT
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Title: SIEF Activities for an Impending Deadline
  • Article

Under the REACH regulation, chemicals must be registered before being brought into the EU market under the credo, "no data, no market." As a consequence of the preregistration process, an extended period for registration was granted to manufacturers or importers of phase-in substances in Europe. With the end of the preregistration processes in 2018, any new substance being brought into the EU market in quantities of 1 ton or more must be registered before being manufactured or imported. This applies to both phase-in substances introduced by a new supplier and nonphase-in substances.

For preregistered substances, three different registration deadlines exist: Dec. 1, 2010; June 1, 2013, and June 1, 2018. The applicable date mainly depends on the tonnage manufactured or imported within one calendar year. The Dec. 1, 2010, deadline applies to substances manufactured or imported in quantities of 1,000 tons or more; to substances classified as very toxic to aquatic organisms in accordance with Directive 67/548/EEC in quantities of 100 ton or more; and to substances classified as carcinogenic, mutagenic or toxic to reproduction (categories 1 or 2) in quantities of 1 ton or more. The registration requirements include a technical dossier according to the provisions of annexes VII, VIII, IX and X of the REACH regulation and a Chemicals Safety Report (CSR).

The cosmetics industry is affected by this first deadline since it uses many ingredients in personal care products in large quantities. As such, manufacturing volumes in Europe as well as import volumes of raw materials and consumer goods often exceed the threshold of 1,000 tons per year. The deadline also accounts to one of the most important monomers used in ingredient manufacturing: ethylene oxide (EO) (EINECS 200-849-9), which is being classified according to Directive 67/548/EEC as carcinogenic (category 2, R45) and mutagenic (catategory 2, R46). Based on volumes and hazard potentials, requirements for other monomers must be carefully researched. Since there are only 22 months left to prepare for the comprehensive registration requirements, there is no time to lose to begin taking the necessary steps.

In order to avoid duplication of tests, the REACH regulation requires the exchange of data among the potential registrants in a substance information exchange forum (SIEF). The European Chemical Industry Council (CEFIC) published a methodology to facilitate the start of activities required by the SIEF and a projected schedule in the "Gannt Chart on SIEF Timing." CEFIC recommends SIEF members open the REACH-IT system and identify the SIEF Formation Facilitator (SFF). The council believes the SFF should first inquire about the registration intentions and available resources of the other SIEF members. The recommendations include a SIEF status classification for participants in four categories: dormant, no intention to register; passive, only interested in the final part of the joint-registration; involved, participation with no resources available; leading, leading the work and discussions of the SIEF.

REACH-IT, contrary to the CEFIC classification, recognizes only the statuses "active" or "deactivated." Preregistrations can be deactivated from the pre-SIEF forum in REACH-IT to indicate that the company has no interest in actively participating in the pre-SIEF discussions. The preregistration and the future registration are not affected by this deactivation.

Many self-appointments of companies as SIEF facilitators have led to an enormous e-mail traffic imposed on preregistrants. SIEF participants are not legally bound to take any action towards these SIEF facilitators unless such queries relate to the availability of specific studies "in order to meet the information requirements for the purpose of registration" (Article 30(1)).

Key Summary:
• The first registration deadline for preregistered substance is Dec. 1, 2010 .
• A short time period for fulfilling comprehensive registration requirements forces the immediate start of Substance Information  Exchange Forums (SIEFs).
• Two further registration deadlines are in June 1, 2013, and in June 1, 2018.
• With the end of the preregistration processes in 2018, even phase-in substances newly entering the EU market must be registered before marketing these for the first time.
• The cosmetics industry is affected by the first registration deadline.
• EO, other important monomers and the most voluminous ingredients in personal care have to be registered at latest by Dec.1, 2010.
• Preregistrations can be de-activated in REACH-IT to indicate that no interest in active participation in the pre-SIEF exists.
• The future registration is not affected by the deactivation from the pre-SIEF forum.
• Participants in SIEFs are not legally bound to take any action toward requests resulting from self-appointments of companies as SIEF Facilitators.
• Only requests in "order to meet the information requirements for the purpose of registration" must be replied to, by law.

Readers are reminded that the text of the REACH Regulation (EC) No 1907/2006 is the only authentic legal reference. The information in this document does not constitute legal advice.