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1. Food referred to in Article 3(1) must not:

(a) have adverse effects on human health, animal health or the environment;

(b) mislead the consumer;

(c) differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.

2. No person shall place on the market a GMO for food use or food referred to in Article 3(1) unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.

3. No GMO for food use or food referred to in Article 3(1) shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1 of this Article.

4. The authorisation referred to in paragraph 2 may cover:

(a) a GMO and foods containing or consisting of that GMO as well as foods produced from or containing ingredients produced from that GMO; or (b) food produced from a GMO as well as foods produced from or containing that food;

(c) an ingredient produced from a GMO as well as food containing that ingredient.

5. An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

6. The applicant for an authorisation as referred to in paragraph 2 and, after the authorisation is granted, the authorisation-holder or his representative, shall be established in the Community.

7. Authorisation under this Regulation shall be without prejudice to Directive 2002/53/EC, Directive 2002/55/EC and Directive 68/193/EEC.