Art.

53 - Italian procedure (update April 2022)

GENERAL POINTS

The procedure applies to Plant Protection Products (PPPs) containing chemical, natural or m.o. active substances,
according to Reg. EC 1107/2009:

 approved (for crops/targets not authorized on the labels or for products not authorized in Italy);
 pending (new active substance under evaluation in a RMS for the representative formulation);
 not approved.

No authorization could be granted for PPPs containing substances listed in points from 3.6.2 to 3.6.5 and from 3.7.1 to
3.7.2 of Annex II of Reg. EC 1107/2009

PGR could be considered case by case for emergency situation

For not approved active substances for which no MRL is fixed according to Reg. EC 396/2005, no authorization
according to Art. 53 of Reg. EC 1107/2009 could be granted

The application has to be done first through PPPAMS and then through Italian application form FTS-PPP-16 available
on MoH website

For each company, it is not possible to authorize more than one PPP containing the same active substance for the
same target/crop.
WORK-FLOW/PROCEDURE

1. A stakeholder reports an emergency situation according to Art. 53 of Reg. EC 1107/2009

The stakeholder has to fill the Annex 1 document with all information about the active substance, the crops and
targets requested, data on alternative methods available and agronomic details/information, and submits to Italian
Authorities (Ministero della Salute, Ministero delle Politiche Agricole Alimentari e Forestali, Ministero della Transizione
Ecologica, Ministero delle Sviluppo Economico).

In order to better evaluate the applications according to treatment timing, the phytosanitary emergency situation has
to be submitted by the stakeholders following the schedule:

From 1st to 30th September of the previous year  for treatments starting from 1st February
From 1st to 31st January  for treatments starting from 1st June
From 1st to 31st May  for treatments starting from 1st October

The authorization is limited in time and may be limited in space

2. An interested company submits the application form

The application form identified by the code FTS-PPP-16 has to be filled in each part and submitted to Ministero della
Salute and to the responsible person in charge for the procedure through Electronic Certified Mail.

The application form should report the intended period of application in accordance with the stakeholder request. In
case of requests including treatments exceeding the 120-day period established by the regulation (on the same crop
or on different crops), separate applications have to be submitted with the respective authority fee.

2.1 Data/documents for the application

a) Application form FTS-PPP-16 and in attachment copy of Annex I of Guideline SANCO/10087/2013 rev.1
filled in English, proving that the data has already been loaded into PPPAMS

b) Information on manufacturing site of the active substance and, if different from the notified source,
information on technical equivalence

c) Efficacy data of the PPP on the crops involved in the application

d) Residue data of the active substance on the edible crops involved in the application to properly perform
the consumer risk assessment

e) Data on human risk assessment, environmental fate and ecotoxicological risk assessment of the proposed
uses, included any information available on surveys carried out in soil and water

f) Draft label, containing all details about the proposed uses (application rate, timing and number, mitigation
measures if necessary)

g) If available, information on on-going research activities on alternative pest management

3. Consultation activity by “Sezione consultiva per i fitosanitari”

Evaluation of each section is collected by Italian Authorities.

4. Outcome of the application evaluation

If the outcome is positive, a decree containing all details on the emergency uses granted is issued (for a maximum
period of 120 days that cannot be divided).

If the outcome is negative, a motivated justification is provided to the applicant.

ART. 53 – APPLICATION

PPP containing an approved active substance, authorized in Italy on crops/targets different from the ones
proposed according to Art. 53
a) extension of target on
crops already authorized
on the label
The Applicant has to
submit application form
for final authorization (FTS- assessment have to be
PPP-20a). No change in the attached to the
application details
(application rate and
number of treatments) is
allowed.
b) extension of the
c) extension of crops for
application details (change d) extension of crops and
targets already authorized
in application rate, targets
on the label
number, timing)
New PEC calculations and Crops are divided into 3 New PEC calculations and
ecotoxicological risk groups: orchards, ecotoxicological risk
herbaceous crops, assessment have to be
vegetables. If the new crop attached to the
application, besides data at belongs to the same group application, besides data at
point 2.1c, 2.1d, 2.1e, of the ones authorized on point 2.1c, 2.1d, 2.1e,
reported above. the label, data at points reported above.
2.1c, 2.1d, 2.1e have to be The application can be
submitted. submitted for more than 2
The application can be times only if a final
submitted for more than 2 authorization label
times only if a final extension has been
authorization label submitted according to art.
extension has been 33, art. 40, art. 51 or art.
submitted according to art. 34.
33, art. 40, art. 51 or art. For CfS active substances,
34. applications are not
For CfS active substances, allowed unless the lack of
applications are not alternative PPPs has been
allowed unless the lack of demonstrated.
products has been
demonstrated.

PPP containing an approved active substance, not authorized in Italy

The application can be taken into account only if the lack of other products or the presence of resistance cases has
been demonstrated.
If the available dossier of the product has already been assessed in other MSs of Southern zone and suitable
mitigation measures are needed, the Applicant has to take into account mitigation measures for relevant scenarios at
national level.
The application can be submitted for more than 2 times only if a final authorization label extension has been
submitted according to art. 33, art. 40, art. 51 or art. 34.
For CfS active substances, applications are not allowed unless the lack of products has been demonstrated.
If the active substance has been renewed at EU level, no application can be done for products previously withdrawn
because an application for renewal according to Art. 43 for the formulation has not been presented.

PPP containing a pending active substance

It is mandatory to submit detailed data about human and environmental risk assessment based on the endpoints
available in the active substance dossier. If available, EFSA conclusion needs to be taken into account, or the draft
assessment report evaluated by the RMS, or the endpoints proposed by the Applicant in the active substance dossier.
It has to be specified if the product required for art. 53 application is the representative product submitted for the
active substance approval.
If the approval of the active substance is not granted, the application cannot be repeated.
PPP containing a not approved active substance
The application for a PPP containing a not approved active substance must contain all details about its status at EU
level (never approved as no application for approval has ever been submitted; non-approval decision as a new
substance; substance no longer approved due to decision of non-renewal), about risks on human and environmental
factors that led to the non-approval.
The emergency authorization of PPPs containing not approved active substances (with particular attention to
withdrawn active ingredient) must be the last resort, only when there are no other alternatives.
A monitoring program should be set up during the application period
Given that the reiteration of art.53 authorisation for non-approved active substance should be avoided, only in the
following circumstances such procedure can be repeated:
 The result of the monitoring program must demonstrate that no risk was observed for worker, operator,
bystander, consumer and environment;
 It is possible to demonstrate that:
a) The danger cannot be contained by any other reasonable means.
b) The socio-economic system cannot adapt within a year, and the repetition of the temporary use of
the non-approved active substance is necessary to avoid unacceptable damage to the local
economy.
c) The use is minimize by combining any available means that can limit the frequency of the
treatments.
d) A research program aimed at defining acceptable alternative solutions has already been launched.