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between receipt of complete application and initial assessment report.
The applicant may be asked for additional data.
between receipt of complete application and initial assessment report.
The applicant may be asked for additional data.
The Commission forwards a copy of the summary provided by the applicant to the other member States
(Article 6(2) second paragraph)
The Commission forwards a copy of the summary provided by the applicant to the other member States
(Article 6(2) second paragraph)
of whether the application complies with the criteria of Article 3(1) and contains a labelling proposal in accordance with Article 8, and issue of a report which concludes on whether a further assessment is needed or not (Article 6(3))
of whether the application complies with the criteria of Article 3(1) and contains a labelling proposal in accordance with Article 8, and issue of a report which concludes on whether a further assessment is needed or not (Article 6(3))
An additional assessment is required
An additional assessment is required
An additional assessment is not required
An additional assessment is not required
submitted to the competent authority ("CA") of the member State where the Novel Food should be placed on the market for the first time (so-called "lead CA") with copy to the Commission (Article 4(1), first paragraph)
submitted to the competent authority ("CA") of the member State where the Novel Food should be placed on the market for the first time (so-called "lead CA") with copy to the Commission (Article 4(1), first paragraph)
The CA that has received the application
notifies the Commission the competent food assessment authority responsible for preparing the initial assessment report or
asks the Commission to arrange with another MS for its competent food assessment
The CA that has received the application
notifies the Commission the competent food assessment authority responsible for preparing the initial assessment report or
asks the Commission to arrange with another MS for its competent food assessment
Normally the Commission consults the SCF (now EFSA) (Article 11).
The applicant may be asked for additional data
The lead CA forwards the initial assessment report to the Commission which circulates it to the other member States (Article 6(4))
Normally the Commission consults the SCF (now EFSA) (Article 11).
The applicant may be asked for additional data
The lead CA forwards the initial assessment report to the Commission which circulates it to the other member States (Article 6(4))
Request for further information, comments or reasoned objections by the Commission or the member States
Request for further information, comments or reasoned objections by the Commission or the member States
No request for further information, comments or reasoned objections by the Commission or the member States
No request for further information, comments or reasoned objections by the Commission or the member States
for the placing on the market taken by CA that received the application (Article 4(2))
for the placing on the market taken by CA that received the application (Article 4(2))
CONTINUE
Commission presents a draft decision to the Regulatory Committee
*before being issued, each Commission act has to be agreed among the services (Directorate Generals) concerned (so-called "inter-service consultations")
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