/)01S,2!0+ /)01S,2,0+ /)01S,2$0+ 3a#e A-& ANNEX A-3 RE !"A#I$N %&'(9)* EC A+,INI-#RA#I.E /R$CE+!

RE 0$R RAN#IN C$N-EN#- 0$R N$.E" 0$$+- AN+ N$.E" 0$$+ IN RE+IEN#-

between receipt of complete application and initial assessment report( procedure Comitolo1y )he applicant may asked for 9 additional data( (Article !$ be and Article Council 1ecision !2220 &%0-C)

Application

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 (!)" first para#raph)

90-day period

)he CA that has received the application (a) notifies the Commission the competent food assessment authority responsible for preparin# the initial assessment report or (b) asks the Commission to arran#e with another .S for its competent food assessment body to prepare such report

)he Commission forwards a copy of the summary provided by the applicant to the other member States (Article &(,) second para#raph)

of whether the application complies with the criteria of Article $(!) and contains a labellin# proposal in accordance with Article %" and issue of a report which concludes on whether a further assessment is needed or not (Article &($))

Initial assessment by lead CA

An additional assessment is re'uired

An additional assessment is not re'uired

Commission presents a draft decision to the +e#ulatory Committee 7before bein# issued" each Commission act has to be a#reed amon# the services (1irectorate 8enerals) concerned (so-called "inter-service consultations") Normally the Commission consults the )he lead CA forwards the initial SCF (now -FSA) (Article !!)( assessment report to the Commission )he applicant may be asked for which circulates it to the other member additional data States (Article &( )) +e#ulatory Committee re*ects" or does not decide on" Commission proposal +e'uest for further information" comments or reasoned ob*ections by the Commission or the member States Commission presents the proposal to Council +e#ulatory Committee delivers a positive opinion on the Commission proposal No re'uest for further information" comments or reasoned ob*ections by the Commission or the member States

Council (a) approves (b) opposes" or (c) does not decide on" Commission proposal within $ months

for the placin# Authorization on the market taken by CA that for the placin# on the market taken by received the application (Article (,)) the Council or the Commission (Article !$) C4N)5N6-

Authorization

Commission has to (b) revise or (c) adopt its proposal

Re2ection

from date of circulation of assessment report to make comments or reasoned ob*ections (Article &( ))

60-day period

/)01S,2!0+ /)01S,2,0+ /)01S,2$0+ 3a#e A-:

Re2ection