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REACH: data sharing and SIEF (RIP 3.4)

REACH: data sharing and SIEF (RIP 3.4). Dr. Erwin Annys Sr. Advisor Product & Innovation Policy WERCS 2007 EU User group Napoli 31/05/07. Pre-registration. REACH makes a distiction between New substances (brought on the European market after 1981)

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REACH: data sharing and SIEF (RIP 3.4)

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  1. REACH: data sharing and SIEF (RIP 3.4) Dr. Erwin Annys Sr. Advisor Product & Innovation Policy WERCS 2007 EU User group Napoli 31/05/07

  2. 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 WERCS EU User group 2007 – Erwin Annys

  3. Registration Pre-registration >100 ton > 1 ton >1000 ton CMR >1 ton N, R50-53 > 100 ton 0 1 2 3 4 5 6 7 8 9 10 11 Non phase-in substances 01/06/08 01/12/08 01/06/18 01/12/10 01/06/07 01/06/13 WERCS EU User group 2007 – Erwin Annys

  4. 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! WERCS EU User group 2007 – Erwin Annys

  5. What to register? WERCS EU User group 2007 – Erwin Annys

  6. 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 WERCS EU User group 2007 – Erwin Annys

  7. 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 WERCS EU User group 2007 – Erwin Annys

  8. 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 WERCS EU User group 2007 – Erwin Annys

  9. 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 WERCS EU User group 2007 – Erwin Annys

  10. SIEF and consortia • Testing on vertebrate animals • Shall share information • Other testing • May share information WERCS EU User group 2007 – Erwin Annys

  11. 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 WERCS EU User group 2007 – Erwin Annys

  12. 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 WERCS EU User group 2007 – Erwin Annys

  13. Pre- Registration Pre- SIEF SIEF IdentifysimilarSubstances Pre- Registr.data ‘Contacts’ List Agency Industry Pre- Registrationdossiers SIEF AllocatePre-SIEF Facilitator SIEF Formation Data Exchange Study Substance Id. Analysis WERCS EU User group 2007 – Erwin Annys

  14. Pre- Registration Pre- SIEF SIEF • Identifier = EINECS # (encourage to use 3.10 guidance) IdentifysimilarSubstances Pre- Registr.data ‘Contacts’ List Agency Industry Pre- Registrationdossiers SIEF AllocatePre-SIEF Facilitator SIEF Formation Data Exchange Study Substance Id. Analysis WERCS EU User group 2007 – Erwin Annys

  15. Pre- Registration Pre- SIEF SIEF • Pre-SIEF • Updates will be done continuously • Companies will be notified: • by email • by query • Identifier = EINECS # (encourage to use 3.10 guidance) IdentifysimilarSubstances Pre- Registr.data ‘Contacts’ List Agency Industry Pre- Registrationdossiers SIEF AllocatePre-SIEF Facilitator SIEF Formation Data Exchange Study Substance Id. Analysis WERCS EU User group 2007 – Erwin Annys

  16. Pre-SIEF • Updates will be done continuously • Companies will be notified: • by email • by query Pre- Registration Pre- SIEF SIEF • Identifier = EINECS # (encourage to use 3.10 guidance) • 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 IdentifysimilarSubstances Pre- Registr.data ‘Contacts’ List Agency Industry Pre- Registrationdossiers SIEF AllocatePre-SIEF Facilitator SIEF Formation Data Exchange Study Substance Id. Analysis WERCS EU User group 2007 – Erwin Annys

  17. Thanks for your attention WERCS EU User group 2007 – Erwin Annys

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