Regulation (EU) 2019/1381 of the European Parliament and of the CouncilShow full title

Article 4 Amendments to Regulation (EC) No 2065/2003

Regulation (EC) No 2065/2003 is amended as follows:

(1)

Article 7 is amended as follows:

(a)

in paragraph 2, point (c) is replaced by the following:

‘(c) The Authority shall:

(i)

inform without delay the Commission and the other Member States of the application and shall make the application and any supplementary information supplied by the applicant available to them; and

(ii)

make public the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 14 and 15.’;

(b)

paragraph 4 is replaced by the following:

‘4. The Authority shall publish detailed guidance, following the agreement with the Commission, concerning the preparation and the submission of the application, referred to in paragraph 1 of this Article, taking into account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) No 178/2002.’;

(2)

in Article 14, paragraph 1 is replaced by the following:

‘1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant as well as its scientific opinions, in accordance with Articles 38 to 39e of Regulation (EC) No 178/2002.’;

(3)

Article 15 is replaced by the following:

‘Article 15 Confidentiality

1. In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002:

(a) the applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification; and

(b) the Authority shall assess the confidentiality request submitted by the applicant.

2. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.’.