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Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC

article  20

CELEX:  02004R1935-20210327

Confidentiality
1. 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:
(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.
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC

article  20

CELEX:  02004R1935-20210327

2. 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) any information provided in detailed descriptions of starting substances and mixtures used to manufacture the substance subject to the authorisation, the composition of mixtures, materials or articles in which the applicant intends to use that substance, the manufacturing methods of those mixtures, materials or articles, impurities, and migration testing results, except for information which is relevant to the assessment of safety;
(b) the trademark under which the substance shall be marketed as well as the tradename of the mixtures, material or articles in which it shall be used, where applicable; and (c) any other information deemed confidential within the specific procedural rules referred to in point (n) of Article 5(1) of this Regulation.
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC

article  20

CELEX:  02004R1935-20210327

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