This Annex describes in general terms the additional information to be provided in the case of notification for placing on the market and information for labelling requirements regarding GMOs as or in product to be placed on the market, and GMO exempted under Article2(4), second subparagraph. It will be supplemented by guidance notes, as regards i.a. the description of how the product is intended to be used, to be developed in accordance with the procedure laid down in Article 30(2). The labelling of exempted organisms as required by Article 26 shall be met by providing appropriate recommendations for, and restrictions on, use:

A. The following information shall be provided in the notification for placing on the market of GMOs as or in product in addition to that of Annex III

1. Proposed commercial names of the products and names of GMOs contained therein, and any specific identification, name or code used by the notifier to identify the GMO. After the consent any new commercial names should be provided to the competent authority;

2. name and full address of the person established in the Community who is responsible for the placing on the market, whether it be the manufacturer, the importer or the distributor;

3. name and full address of the supplier(s) of control samples;

4. description of how the product and the GMO as or in product are intended to be used. Differences in use or management of the GMO compared to similar non-genetically modified products should be highlighted;

5. description of the geographical area(s) and types of environment where the product is intended to be used within the Community, including, where possible, estimated scale of use in each area;

6. intended categories of users of the product e.g. industry, agriculture and skilled trades, consumer use by public at large;

7. information on the genetic modification for the purposes of placing on one or several registers modifications in organisms, which can be used for the detection and identification of particular GMO products to facilitate post-marketing control and inspection. This information should include where appropriate the lodging of samples of the GMO or its genetic material, with the competent authority and details of nucleotide sequences or other type of information which is necessary to identify the GMO product and its progeny, e.g. the methodology for detecting and identifying the GMO product, including experimental data demonstrating the specificity of the methodology. Information that cannot be placed, for confidentiality reasons, in the publicly accessible part of the register should be identified;

8. proposed labelling on a label or in an accompanying document. This must include, at least in summarised form, a commercial name of the product, a statement that "this product contains genetically modified organisms", the name of the GMO and the information referred to in point 2, the labelling should indicate how to access the information in the publicly accessible part of the register.

B. The following information shall be provided in the notification, when relevant, in addition to that of point A, in accordance with Article 13 of this Directive:

1. measures to take in case of unintended release or misuse;

2. specific instructions or recommendations for storage and handling;

3. specific instructions for carrying out monitoring and reporting to the notifier and, if required, the competent authority, so that the competent authorities can be effectively informed of any adverse effect. These instructions should be consistent with Annex VII part C;

4. proposed restrictions in the approved use of the GMO, for example where the product may be used and for what purposes;

5. proposed packaging;

6. estimated production in and/or imports to the Community;

7. proposed additional labelling. This may include, at least in summarised form, the information referred to in points A4, A5, B1, B2, B3 and B4.