Division 3 Quality of the dataF1

In order to carry out an e.r.a. for a notification under Part C of this Directive, the notifier shall collate already available data from scientific literature or from other sources, including monitoring reports, and shall generate the necessary data by performing, where possible, appropriate studies. Where applicable, the notifier shall justify in the e.r.a. why generating data by studies is not possible.

The e.r.a. for notifications under Part B of the Directive shall be based at least on already available data from scientific literature or from other sources and may be supplemented by additional data generated by the notifier.

Where data generated outside Europe is provided in the e.r.a., its relevance to receiving environment(s) in the Union shall be justified.

Data provided in the e.r.a for notifications under part C of this Directive shall comply with the following requirements:

1. (a)

   where toxicological studies carried out to assess risk to human or animal health are provided in the e.ra., the notifier shall provide evidence to demonstrate that they were conducted in facilities which comply with:

   1. (i)

      the requirements of Directive 2004/10/EC; or

   2. (ii)

      the ‘ OECD Principles on Good Laboratory Practice ’ (GLP), if carried out outside the Union;

2. (b)

   where studies other than toxicological studies are provided in the e.r.a., they shall:

   1. (i)

      comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC, where relevant; or

   2. (ii)

      be conducted by organisations accredited under the relevant ISO standard; or

   3. (iii)

      in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards;

3. (c)

   information on the results obtained from the studies referred to in points (a) and (b) and on the study protocols used shall be reliable and comprehensive and shall include the raw data in an electronic format suitable for carrying out statistical or other analysis;

4. (d)

   the notifier shall specify, where possible, the size of effect that each study performed intends to detect and justify it;

5. (e)

   the selection of sites for field studies shall be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the GMO may be released. The selection shall be justified in the e.r.a.;

6. (f)

   the non-genetically modified comparator shall be appropriate for the relevant receiving environment(s) and shall have a genetic background comparable to the GMO. The choice of the comparator shall be justified in the e.r.a.