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1 Preparing for registration Kerstin Heitmann Margarethe von Bismarck UMCO Umwelt Consult GmbH

2 content Why pre-registration? What are phase-in-substances? How to pre-register? What happens in the SIEF?

3 Why pre-registration? Prerequisite to benefit from prolonged registration deadlines for phase-in-substances Allows to continue to manufacture/import/sale these substances during preparation of registration Saves time for data collection and negotiation on data sharing Saves time for decision making on registration and/or the final role related to a specific substance

4 Registration deadlines: Why pre-registration? Substances > 1000 t/a CMR-Substances > 1 t/a 1 December 2010 Substances dangerous for the environment > 100 t/a Substances t/a 1 June 2013 Substances t/a 1 June 2018

5 Article 3, 20: What are phase-in-substances? phase-in substance: means a substance which meets at least one of the following criteria: (a) it is listed in the European Inventory of Existing Commercial Chemical Substances EINECS-Substances; substances consisting by 100% of EINECSsubstances

6 What are phase-in-substances? Article 3, 20: (b) it was manufactured in the Community, (...), but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this; substances manufactured only for export onsite isolated intermediates

7 What are phase-in-substances? Article 3, 20: (c) it was placed on the market in the Community, (...) and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this; no longer polymers (NLP)

8 What are phase-in-substances? guidance for identification and naming of substances under REACH: Well defined substances by chemical composition Substances of unknown or variable composition, complex reaction products or biological material = UVCBs

9 What are phase-in-substances? guidance for identification and naming of substances: Well defined substances by chemical composition Mono-constituent substances, e.g. - benzene (95%) - nickel (99%) Multi-constituent substances, e.g. defined reaction products like Reaction mass of 2-, 3-, and 4-chlorotoluene (30% each) Substances defined by more than the chemical composition, e.g. Graphite and diamond

10 What are phase-in-substances? guidance for identification and naming of substances: UVCBs Biological material (B) Extracts of biological materials e.g. natural fragrances, natural oils, natural dyes and pigments Complex biological macromolecules e.g. enzymes, proteins, DNA or RNA-fragments, hormones, antibiotics Fermentation products antibiotics, biopolymers, enzyme mixtures, vinasses (products of sugar fermentation) etc.

11 What are phase-in-substances? guidance for identification and naming of substances: UVCBs Chemical and mineral substances with poorly defined, complex or variable composition (UVC) Reaction mixtures with poorly predictable and/or variable composition Fractions or distillates, e.g. petroleum substances Clay e.g. bentonite Tars Concentrates or melts, e.g. metallic minerals, or residues of various melting or metallurgic processes, e.g. slags

12 What are phase-in-substances? After 1 June 2008 manufacturers and importers of non-phase-in-substances are obliged to send a complete registration dossier to the ECHA

13 Information for pre-registration: How to pre-register? a) the name of the substance, including EINECS and CAS number b) name and address of the company and the name of the contact person and, where appropriate, the name and address of the 3rd party representative (according to article 4); c) the envisaged deadline for the registration and the tonnage band; d) the name(s) of substance(s), for which the available information is relevant for the application of QSAR or cross reading (according to Annex XI).

14 How to pre-register? Pre-requisite: identification of concerned legal entities of a company! Each legal entity of a company needs to pre-register to benefit from transition period!

15 How to pre-register? Two options By microsoft office template Table listing all substances to be pre-registered by one legal entity Template will be available on the ECHA homepage Advisable if registration of the substances listed is uncertain or improbable By IUCLID 5 IUCLID 5 data base already available on the ECHA homepage Download and installation of software free of charge after user identification as legal entity object (LEO) Installation, data input and pre-registration in IUCLID 5 Advisable if company intends to register the substance

16

17 What happens in the SIEF? As soon as the first company pre-registers a specific phasein-substance a website for this substance will be activated; Every pre-registrant of the same phase-in-substance gets access to this website; Pre-SIEF is formed: pre-registrants discuss whether their substances are in fact identical according to the guidance; based on the results of the pre-sief one or more final SIEFs are formed.

18 What happens in the SIEF? Potential registrants in the same SIEF should register jointly in order to reduce costs and administrative burdens: Agree on a lead registrant; Collect data and share the relevant data for registration; Agree on reimbursement for data owners; Submit a common registration dossier; Each registrant submits a dossier containing the individual information. Opt-out of a registration consortia is possible, but needs to be justified.

19 What happens in the SIEF? Remarks: Negotiations on consortia forming for high production volume chemicals like metals, solvents and basic chemicals are already ongoing; One EINECS number may cover more than one substance resulting in more than one SIEF, e.g. EINECS covers two different substances: phosphoric acid, dipentyl ester, branched and phosphoric acid, dipentyl ester, linear Different EINECS-numbers may represent the same substance, e.g. hydrates and water free forms shall be regarded as the same substance resulting in one registration of the water free form

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