The food business operator shall consult the recipient Member State as provided for in Article 4(2) of Regulation (EU) 2015/2283 by submitting a consultation request to that Member State.

Where the food business operator intends to place the food on the market simultaneously in several Member States, the food business operator shall submit the consultation request only to one of those Member States.

The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.

The technical dossier referred to in paragraph 1(b) shall contain the information necessary to enable the recipient Member State to conclude on the novel food status and shall be drafted in accordance with the template provided in Annex II.

By way of derogation from paragraph 3, an applicant is not required to provide all the elements referred to in Annex II, provided that the applicant has submitted verifiable justification for the absence of each missing element.

The recipient Member State shall without delay verify whether the consultation request complies with the requirements of Article 4.

Where the food business operator submits insufficient information in the consultation request, the recipient Member State shall request the food business operator to provide additional information or make the relevant updates to the consultation request within the time period specified by the recipient Member State.

The recipient Member State shall decide on the validity of the consultation request and without delay inform the food business operator, the other Member States and the Commission of the decision. Where the consultation request is considered not valid, the recipient Member State shall provide the reasons for that conclusion.

The recipient Member State shall conclude on the novel food status of a food within 4 months from the date on which it decided on the validity of the consultation request.

Where the recipient Member State identifies that it does not have sufficient evidence to decide on the novel food status of a food, it may request the food business operator to provide additional information. The period of that request shall be determined together with the food business operator.

The recipient Member State may consult the other Member States and the Commission.

Without prejudice to paragraph 4, a request for additional information referred to in paragraph 2 shall not extend the time period referred to in paragraph 1.

In duly justified cases, the recipient Member State may extend the time period referred to in paragraph 1 by a maximum of 4 months. The recipient Member State shall inform the food business operator, the other Member States and the Commission of their decision and shall provide justification.

On concluding on the novel food status of a food, the recipient Member State shall without delay notify the food business operator, the other Member States and the Commission of the decision and shall provide justification in accordance with Article 7 of this Regulation.

The Commission shall without delay make the information on the novel food status publicly available on the Commission's website.

Food business operators may request the recipient Member State to agree that the disclosure of certain information submitted as part of the consultation request needs to benefit from confidential treatment where disclosure of such information may harm their competitive position.

For the purpose of paragraph 1, food business operators shall indicate to the recipient Member State the parts of the information provided that they wish to be treated as confidential and provide all the necessary details to substantiate their request for confidentiality.

In case of the consultation of other Member States pursuant to Article 6(2), second subparagraph, the recipient Member State shall inform the Commission and the Member States about its views on confidentiality of the consultation request.

After being informed pursuant to paragraph 3, the food business operator may withdraw its consultation request within 3 weeks during which the confidentiality of the information provided shall be observed.

The Commission and the Member States shall take necessary measures to ensure appropriate confidentiality of the information referred to in paragraphs 3 and received by them under this Regulation, except for information which is required to be made public in order to protect human health.

Where a food business operator withdraws or has withdrawn its consultation request in accordance with paragraph 5, neither the Commission nor the Member States shall disclose information for which confidentiality was requested by the food business operator pursuant to paragraph 1.

The application of paragraphs 1 to 7 shall not affect the exchange of information between the Commission and the Member States necessary to consider the consultation requests submitted under this Regulation.