- the information required in Annex II, extended as necessary to take into account the diversity of sites of use of the product, including information on data and results obtained from research and developmental releases concerning the ecosystems which could be affected by the use of the product and an assessment of any risks for human health and the environment related to the GMOs or a combination of GMOs contained in the product, including information obtained from the research and development stage on the impact of the release on human health and the environment;
- the conditions for the placing on the market of the product, including specific conditions of use and handling and a proposal for labelling and packaging which should comprise at least the requirements laid down in Annex III.
If on the basis of the results of any release notified under Part B of this Directive, or on substantive, reasoned scientific grounds, a notifier considers that the placing on the market and use of a product do not pose a risk to human health and the environment, he may propose not to comply with one or more of the requirements of Annex III B.
2. The notifier shall include in this notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and /or carried out by the notifier either inside or outside the Community.
3. The notifier may also refer to data or results from notifications previously submitted by other notifiers, provided that the latter have given their agreement in writing.
4. Each new product which, containing or consisting of the same GMO or combination of GMOs, is intended for a different use, shall be notified separately.
5. The notifier may proceed with the release only when he has received the written consent of the competent authority in accordance with Article 13, and in conformity with any conditions, including reference to particular ecosystems/environments, required in that consent.
6. If new information has become available with regard to the risks of the product to human health or the environment, either before or after the written consent, the notifier shall immediately:
- revise the information and conditions specified in paragraph 1,
- inform the competent authority, and
- take the measures necessary to protect human health and the environment.