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2.
The Commission shall examine as soon as possible, where
appropriate after obtaining an opinion from the Authority, within
the Committee referred to in Article 23(1) the grounds adduced
by the Member State referred to in paragraph 1 and shall deliver
its opinion without delay and take appropriate measures.
3.
If the Commission considers that amendments to the rel-
evant specific measures are necessary in order to remedy the dif-
ficulties referred to in paragraph 1 and to ensure the protection
of human health, those amendments shall be adopted in accor-
dance with the procedure referred to in Article 23(2).
4.
The Member State referred to in paragraph 1 may retain the
suspension or restriction until the amendments referred to in
paragraph 3 have been adopted or the Commission has declined
to adopt such amendments.
Article 19
Public access
1.
Applications for authorisation, supplementary information
from applicants and opinions from the Authority, excluding con-
fidential information, shall be made accessible to the public in
accordance with Articles 38, 39 and 41 of Regulation (EC) No
178/2002.
2.
Member States shall process applications for access to docu-
ments received under this Regulation in accordance with Article 5
of Regulation (EC) No 1049/2001.
Article 20
Confidentiality
1.
The applicant may indicate which information submitted
under Articles 9(1), 10(2) and 12(2) is to be treated as confiden-
tial on the ground that its disclosure might significantly harm its
competitive position. Verifiable justification must be given in such
cases.
2.
Information relating to the following shall not be consid-
ered confidential:
(a) the name and address of the applicant and the chemical name
of the substance;
(b) information of direct relevance to the assessment of the safety
of the substance;
(c) the analytical method or methods.
3.
The Commission shall determine, after consultation with
the applicant, which information should be kept confidential and
shall inform the applicant and the Authority of its decision.
4.
The Authority shall supply the Commission and the Mem-
ber States with all information in its possession on request.
5.
The Commission, the Authority and the Member States shall
take the necessary measures to ensure appropriate confidentiality
of the information received by them under this Regulation, except
for information which must be made public if circumstances so
require in order to protect human health.
6.
If an applicant withdraws or has withdrawn an application,
the Authority, the Commission and the Member States shall
respect the confidentiality of commercial and industrial informa-
tion provided, including research and development information
as well as information on which the Commission and the appli-
cant disagree as to its confidentiality.
Article 21
Sharing of existing data
Information given in an application submitted in accordance with
Articles 9(1), 10(2) and 12(2) may be used for the benefit of
another applicant, provided that the Authority considered that the
substance is the same as the one for which the original applica-
tion was submitted, including the degree of purity and the nature
of impurities, and that the other applicant has agreed with the
original applicant that such information may be used.
Article 22
Amendments to Annexes I and II
Amendments to Annexes I and II shall be adopted in accordance
with the procedure referred to in Article 23(2).
Article 23
Committee procedure
1.
The Commission shall be assisted by the Standing Commit-
tee on the Food Chain and Animal Health instituted by Article
58(1) of Regulation (EC) No 178/2002.
2.
Where reference is made to this paragraph, Articles 5 and 7
of Decision 1999/468/EC shall apply, having regard to the pro-
visions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.
3.
The Committee shall adopt its rules of procedure.
Article 24
Inspection and control measures
1.
Member States shall carry out official controls in order to
enforce compliance with this Regulation in accordance with rel-
evant provisions of Community law relating to official food and
feed controls.
13.11.2004
EN
Official Journal of the European Union
L 338/13