REACH: data sharing and SIEF (RIP 3.4) WERCS 2007 US User group Albany 27/06/2007 Dr. Erwin Annys Sr. Advisor Product & Innovation Policy

Event – Erwin Annys Pre-registration REACH makes a distiction between New substances (brought on the European market after 1981) Substances on the European market before 1981 Phase-in substances

Event – Erwin Annys > 1 ton Registration >100 ton 01/06/07 01/12/10 01/06/13 01/06/18 01/06/08 01/12/08 >1000 ton CMR >1 ton N, R50-53 > 100 ton Pre-registration Non phase-in substances

Event – Erwin Annys Pre-registration Pre-registration is CRUCIAL if you wants to use the mentioned delays for registration What to pre-register? Everything you have to register!

Event – Erwin Annys What to register?

Event – Erwin Annys Pre-registration Only for phase-in substances EINECS Manufactured but not brought on the market the last 15 years before the entry into force No-longer polymers

Event – Erwin Annys Pre-registration Between 12 and 18 months after the entry into force of REACH Name of the substance and EINECS and CAS number Name and address contact person Envisaged deadline for the registration and the tonnage band Name of substance(s) and EINECS and CAS number(s) for which the available information is relevant for (Q)SAR or grouping or read-across

Event – Erwin Annys Pre-registration Agency: 1 month after the deadline, publication on the website of Name of the substances CAS and EINECS number Agency: non publicly available list of those that pre- registered the same substance

Event – Erwin Annys SIEF and consortia Pre-registration brings you into Substance Information Exchange Forum (SIEF) SIEF has two objectives Facilitate the exchange of information hence avoiding duplication of the studies Agree on classification and labelling

Event – Erwin Annys SIEF and consortia Testing on vertebrate animals Shall share information Other testing May share information

Event – Erwin Annys SIEF and consortia From 12 untill 18 months pre-registration After 19 months list(s) agency SIEF member Ask for tests on vertebrate animals available within SIEF Within one month Proof of cost Determined in a fair, transparant and non-discriminatory way

Event – Erwin Annys SIEF and consortia SIEF Sharing of data Consortia Not mentioned in REACH text But the sharing of data will make this necessary Experience with High Production Volume (HPV) programm, but this was voluntary

Event – Erwin Annys Pre- Registration Pre- SIEFSIEF Identify similar Substances Pre- Registration dossiers Pre- Registr. data Industry Agency ‘Contacts’ List Allocate Pre-SIEF Facilitator Substance Id. Analysis SIEF Formation Data Exchange Study

Event – Erwin Annys Pre- Registration Pre- SIEFSIEF Identify similar Substances Pre- Registration dossiers Pre- Registr. data Industry Agency ‘Contacts’ List Allocate Pre-SIEF Facilitator Substance Id. Analysis SIEF Formation Data Exchange Study Identifier = EINECS # (encourage to use 3.10 guidance)

Event – Erwin Annys Pre- Registration Pre- SIEFSIEF Identify similar Substances Pre- Registration dossiers Pre- Registr. data Industry Agency ‘Contacts’ List Allocate Pre-SIEF Facilitator Substance Id. Analysis SIEF Formation Data Exchange Study Identifier = EINECS # (encourage to use 3.10 guidance) Pre-SIEF Updates will be done continuously Companies will be notified: by by query

Event – Erwin Annys Pre- Registration Pre- SIEFSIEF Identify similar Substances Pre- Registration dossiers Pre- Registr. data Industry Agency ‘Contacts’ List Allocate Pre-SIEF Facilitator Substance Id. Analysis SIEF Formation Data Exchange Study Identifier = EINECS # (encourage to use 3.10 guidance) Pre-SIEF Updates will be done continuously Companies will be notified: by by query Pre-SIEF: Pre-SIEF facilitator is first notifier (by default) Facilitator role can be passed on to someone else Facilitator expectations: Manage Pre-SIEF agreement Distribute 3.10 guidance template Assign to SIEF based on 3.10 Id. Communicate Allocate SIEF facilitator

Event – Erwin Annys