Paragraph 4 Step 1: Intended and unintended changesF1

As part of the identification and evaluation of the potential adverse effects referred to in Part A of this schedule, the environmental risk assessment must identify the intended and unintended changes resulting from the genetic modification and must evaluate their potential to cause adverse effects on human health and on the environment.

Intended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification.

Unintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification.

Intended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.