
Article 1 
Implementing Regulation (EU) 2017/2469 is amended as follows:

((1)) Article 3 is amended as follows:

((a)) paragraph 1 is replaced by the following:
'
1. An application shall consist of the following:
(a) a cover letter;
(b) a technical dossier;
(c) a summary of the dossier.Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission, in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission in accordance with those standard data formats.';
((b)) paragraph 5 is replaced by the following:
'
5. In addition to the information referred to in points (a), (b) and (e) of Article 10(2) of Regulation (EU) 2015/2283, the summary of the dossier referred to in paragraph 1(c) of this Article shall set out the reasons why the use of the novel food complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283. The summary of the dossier shall not contain any information subject to a request for confidential treatment pursuant to Article 23 of Regulation (EU) 2015/2283 and Article 39a of Regulation (EC) No 178/2002.';
((2)) Article 4 is replaced by the following:
'
Article 4 
In addition to the information set out in Article 10(2) of Regulation (EU) 2015/2283, the application shall include the following administrative data:

((a)) the name(s) of the manufacturer(s) of the novel food, if different than the applicant’s, address and contact details;
((b)) the name, address and contact details of the person responsible for the dossier authorised to communicate on behalf of the applicant with the Commission and the Authority;
((c)) the date of submission of the dossier;
((d)) a table of contents of the dossier;
((e)) a detailed list of documents annexed to the dossier, including references to titles, volumes and pages;
((f)) where the applicant submits, in accordance with Article 23 of Regulation (EU) 2015/2283, a request to treat as confidential certain parts of the information of the dossier, including supplementary information, a list of the parts to be treated as confidential accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree;
((g)) where the production process contains confidential data, a non-confidential summary of the production process;
((h)) separately included information and explanations substantiating the existence of the applicant’s right of reference to the proprietary scientific evidence or scientific data in accordance with Article 26 of Regulation (EU) 2015/2283;
((i)) a list of the studies submitted to support the application, including information demonstrating compliance with Article 32b of Regulation (EC) No 178/2002.';
((3)) Article 6 is replaced by the following:
'
Article 6 

1. On receipt of an application, the Commission shall, without delay verify whether the application falls within the scope of Regulation (EU) 2015/2283 and whether the application fulfils the requirements set out in Article 10(2) of that Regulation, Articles 3 to 5 of this Regulation and in Article 32b of Regulation (EC) No 178/2002.
2. The Commission may consult the Authority on whether the application fulfils the relevant requirements referred to in paragraph 1. The Authority shall provide the Commission with its views within a period of 30 working days.
3. The Commission may request additional information from the applicant as regards the validity of the application and inform the applicant of the period within which that information has to be provided.
4. By way of derogation from paragraph 1 of this Article, and without prejudice to Article 10(2) of Regulation (EU) 2015/2283 and to Article 32b(4) and (5) of Regulation (EC) No 178/2002, an application may be considered valid even if it does not contain all the elements required under Articles 3 to 5 of this Regulation, provided that the applicant has submitted appropriate justification for each missing element.
5. The Commission shall inform the applicant, the Member States and the Authority whether the application is considered valid or not. Where the application is not considered valid, the Commission shall indicate the reasons for that finding.';
((4)) in Article 7(1), the following point (n) is added:
'
((n)) the results of consultations performed during the risk assessment process in accordance with Article 32c(2) of Regulation (EC) No 178/2002.';
((5)) Annex I is replaced in accordance with the Annex to this Regulation;
((6)) Annex II is deleted.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 27 March 2021 and to applications submitted to the Commission from that date.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 26 November 2020.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX

'
ANNEX 
EUROPEAN COMMISSION

Directorate-General

Directorate

Unit

Date: …

Subject: Application for authorisation of a novel food in accordance with Regulation (EU) 2015/2283

(Please indicate clearly by ticking one of the boxes)


☐ Application for an authorisation of a new novel food.
☐ Application for adding, removing or changing the conditions of use of an already authorised novel food. Please provide a reference to that authorisation.
☐ Application for adding, removing or changing the specifications of an already authorised novel food. Please provide a reference to that authorisation.
☐ Application for adding, removing or changing additional specific labelling requirements of an already authorised novel food. Please provide a reference to that authorisation.
☐ Application for adding, removing or changing post market monitoring requirements of an already authorised novel food. Please provide a reference to that authorisation.

The Applicant(s) or their Representative(s) in the Union

(name(s), address(es)…)

…

…

…

submit(s) this application in order to update the Union list on novel foods.

Identity of the novel food (Please provide information on the identity of the novel food depending on the category(ies) under which the novel food falls):

…

…

Confidentiality. Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283:


☐ Yes
☐ No

Data Protection. Where appropriate, state whether the application includes a request for the protection of proprietary data according to Article 26 of Regulation (EU) 2015/2283:


☐ Yes
☐ No

Food categories, conditions of use and labelling requirements

Food category Specific conditions of use Additional specific labelling requirement
  
  
Yours sincerely,

Signature …

Enclosures:


☐ Complete dossier
☐ Summary of the dossier (non-confidential)
☐ List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree
☐ Information supporting the protection of proprietary data relating to the novel food application
☐ Copy of administrative data of applicant(s)
☐ List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002
'
