Division 2 Long-term adverse effects and cumulative long-term adverse effects in the e.r.a. of Part C notificationsF1

Long-term effects of a GMO are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a GMO or from an extensive use of a GMO in time and space.

The identification and evaluation of the potential long-term adverse effects of a GMO on human health and on the environment shall take into account the following:

1. (a)

   the long-term interactions of the GMO and the receiving environment;

2. (b)

   the characteristics of the GMO which become important on a long-term basis;

3. (c)

   data obtained from repeated deliberate releases or placings on the market of the GMO over a long period.

The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introductory part of Annex II shall also take into account the GMOs deliberately released or placed on the market in the past.