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Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (Text with EEA relevance)

article  18

CELEX:  02003R1831-20210327

Transparency and confidentiality
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, which shall apply mutatis mutandis.
2. In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002 and in this Article, the applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification. The Authority shall assess the confidentiality request submitted by the applicant.
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (Text with EEA relevance)

article  18

CELEX:  02003R1831-20210327

3. In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:
(a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) of, and Annex I to, this Regulation; and (b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.
4. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.