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Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

article  39b

CELEX:  02002R0178-20240701

1. The Authority shall:
(a) make public the non-confidential version of the application as submitted by the applicant without delay once that application has been considered valid or admissible;
(b) proceed, without delay, to a concrete and individual examination of the confidentiality request in accordance with this Article;
(c) inform the applicant in writing of its intention to disclose information and the reasons for that, before the Authority formally takes a decision on the confidentiality request. If the applicant disagrees with the assessment of the Authority, the applicant may state its views or withdraw its application within two weeks of the date on which it was notified of the Authority's position;
(d) adopt a reasoned decision on the confidentiality request, taking into account the observations of the applicant, within 10 weeks of the date of receipt of the confidentiality request with respect to applications and without delay in the case of supplementary data and information; notify the applicant of its decision and provide information on the right to submit a confirmatory application in accordance with paragraph 2; and inform the Commission and the Member States, where appropriate, of its decision; and (e) make public any additional data and information for which the confidentiality request has not been accepted as justified at the earliest two weeks after the notification of its decision to the applicant has taken place pursuant to point (d).
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

article  39b

CELEX:  02002R0178-20240701

2. Within two weeks of the notification of the Authority's decision on the confidentiality request to the applicant pursuant to paragraph 1, the applicant may submit a confirmatory application asking the Authority to reconsider its decision. The confirmatory application shall have suspensive effect. The Authority shall examine the grounds for the confirmatory application and shall adopt a reasoned decision on that confirmatory application. It shall notify the applicant of that decision within three weeks of submitting the confirmatory application and shall include in that notification information on the available remedies, namely an action before the Court of Justice of the European Union (the ‘Court of Justice’) against the Authority pursuant to paragraph 3. The Authority shall make public any additional data and information for which the confidentiality request has not been accepted by the Authority as justified, at the earliest two weeks after the notification of the Authority's reasoned decision on the confirmatory application to the applicant has taken place pursuant to this paragraph.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

article  39b

CELEX:  02002R0178-20240701

3. Decisions taken by the Authority pursuant to this Article may be subject to an action before the Court of Justice, under the conditions laid down in Articles 263 and 278 of the Treaty on the Functioning of the European Union (TFEU) respectively.