CHAPTER IICONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION
Article 2Content of an application
1.
The application referred to in Article 1 shall consist of the following:
(a)
a letter;
(b)
a technical dossier;
(c)
a summary of the dossier.
2.
The letter referred to in paragraph 1(a) shall be drafted in accordance with the model provided in the Annex.
3.
The technical dossier referred to in paragraph 1(b) shall contain:
(a)
the administrative data as provided for in Article 4;
(b)
the data required for risk assessment as provided for in Articles 5, 6, 8 and 10; and
(c)
the data required for risk management as provided for in Articles 7, 9 and 11.
4.
In case of an application for a modification of the conditions of use of an already authorised food additive, food enzyme or flavouring all the data mentioned in Articles 5 to 11 may not be required. The applicant shall submit a verifiable justification why the proposed changes do not affect the results of the existing risk assessment.
5.
In case of an application for a modification of the specifications of an already authorised food additive, food enzyme or flavouring:
(a)
the data may be limited to the justification of the request and the changes in the specification;
(b)
the applicant shall submit a verifiable justification why the proposed changes do not affect the results of the existing risk assessment.
6.
The summary of the dossier referred to in paragraph 1(c) shall include a reasoned statement that the use of the product complies with the conditions laid down in:
(a)
Article 6 of Regulation (EC) No 1332/2008; or
(b)
Articles 6, 7 and 8 of Regulation (EC) No 1333/2008; or
(c)
Article 4 of Regulation (EC) No 1334/2008.