Document: WT/DS291/R WT/DS292/R WT/DS293/R Page A-6 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 4(1), first paragraph) Initial assessment by lead CA 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 not requiredAn additional assessment is required 90-day period
Document codes: WT/DS291/R; WT/DS292/R; WT/DS293/R
Complainant: Argentina
Respondent: EU
Third parties: Australia, Brazil, Canada, Chile, China, Taiwan, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand, Uruguay, U.S.
Dispute stage: Mutually Agreed Solution
Agreements cited: Art. 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8, 10.1, Annex B, Annex C  Sanitary and Phytosanitary Measures (SPS)Art. III:4, X:1, X:3(a), XI:1  GATT 1994Art. 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2, 5.6, 5.8, 12  Technical Barriers to Trade (TBT)Art. 4.2  AgricultureArt. I:1  GATT 1994

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 4(1), first paragraph)
Initial assessment by lead CA
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 not requiredAn additional assessment is required
90-day period
 between receipt of complete application and
initial assessment report.
The applicant may be asked for additional data.
60-day period
from date of
circulation of
assessment report to
make comments or
reasoned objections
(Article 6(4))
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
Authorization
for the placing on the market taken by CA that
received the application (Article 4(2))
Normally the Commission consults the
SCF (now EFSA) (Article 11).
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 CA that has received the application
(a) notifies the Commission the competent
food assessment authority responsible for
preparing the initial assessment report or
(b) asks the Commission to arrange with
another MS for its competent food assessment
No request for further
information, comments
or reasoned objections by
the Commission or the
member States
ANNEX A-3

REGULATION 258/97: EC ADMINISTRATIVE PROCEDURE FOR GRANTING
CONSENTS FOR NOVEL FOODS AND NOVEL FOOD INGREDIENTS

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")