+Artikel 12 Mengenabhängige Informationsanforderungen
---+Article 12 1.
---+Article 12 2.
---+Article 12 3.
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Artikel 12 Mengenabhängige Informationsanforderungen
1. Übersicht
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Regulierung |
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Article 12 1.
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The technical dossier referred to in Article 10(a) shall include under points (vi) and (vii) of that provision all physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant and as a minimum the following:
(a)
the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;
(b)
the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III;
(c)
the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;
(d)
the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer;
(e)
the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer.
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Article 12 2.
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As soon as the quantity of a substance per manufacturer or importer that has already been registered reaches the next tonnage threshold, the manufacturer or importer shall inform the Agency immediately of the additional information he would require under paragraph 1. Article 26(3) and (4) shall apply adapted as necessary.
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Article 12 3.
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This Article shall apply to producers of articles adapted as necessary.
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1.1 Referenzen
1.2 Identifizierte Anforderungen
1.3 Zugehörige Standards
2. Identifizierte Anforderungen
Anforderungen
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Anforderung |
3. Zugehörige Standards
Standards
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Anforderung |
- Builddate: 22.06.2026 00:00:00 -Doknr: CELEX:32006R1907
- EULAW -
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