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ANNEX XI: GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X

Annexes VII to X set out the information requirements for all substances manufactured or imported in quantities of:
— one tonne or more in accordance with Article 12(1)(a),
— 10 tonnes or more in accordance with Article 12(1)(c),
— 100 tonnes or more in accordance with Article 12(1)(d), and
— 1 000 tonnes or more in accordance with Article 12(1)(e).
In addition to the specific rules set out in column 2 of Annexes VII to X, a registrant may adapt the standard testing regime in accordance with the general rules set out in Section 1 of this Annex. Under dossier evaluation the Agency may assess these adaptations to the standard testing regime.
1. / TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY
2. / TESTING IS TECHNICALLY NOT POSSIBLE
3. / SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING