Annex XI GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO XX1

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.

F1The requirements specific to nanoforms in this Annex are without prejudice to requirements applicable to other forms of a substance.