CHAPTER II

CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION

Content of an application
Article 2
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.