BREXIT: Hot topic
Worried about Brexit fallout on chemicals regulation?
Find what experts have to say on this topic. Learn how to prepare for all potential Brexit outcomes.

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