Ref.

Ares(2017)4513123 - 15/09/2017

EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Deputy Director General for the Food chain

Brussels,
SANTE/E4/SH/df (2017)4995956

Dear Dr Uri,

Subject: Mandate for technical assistance to assess the emergency

authorisations for the use of clothianidin, imidacloprid and/or
thiamethoxam granted by Romania, Bulgaria, Estonia, Finland,
Latvia, Lithuania and Hungary

In 2013, the Commission severely restricted the placing on the market and the use of
plant protection products containing clothianidin, imidacloprid or thiamethoxam, and
seeds treated with these substances (Regulation (EU) No 485/2013), affecting many
vegetable and fruit crops. This decision was based on assessments provided by EFSA.

On 28 March 2017, Romania notified the Commission of four emergency authorisations

covering uses on maize and sunflower which were granted for the period between
1 February and 16 May 2017. In May 2017, upon request of the Commission, Romania
provided additional information, in support of these emergency authorisations, mainly by
arguing that the neonicotinoid substances are very efficacious in order to combat some
pests and that there are no alternatives available to contain them otherwise. Similar
emergency authorisations were granted by Romania every year since 2013.

On 13 September 2017, Romania notified the Commission of 2 new emergency

authorisations covering uses on rape which were granted for the period between 21 July
and 16 October 2017.

Romania is not the only Member State that granted emergency authorisations for plant
protection products containing these three neonicotinoid substances for uses which were
restricted in 2013. Also Bulgaria, Estonia, Finland, Hungary, Latvia and Lithuania
repeatedly granted such emergency authorisations.

Article 53(2) of Regulation (EC) No 1107/2009 foresees that the Commission may ask
EFSA to examine the emergency authorisations granted by Member States and that EFSA
has to deliver its opinion within one month.

Dr Bernhard Uri
Executive Director
European Food Safety Authority
1A via Carlo Magno
IT-43126 PARMA

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111

Therefore, in accordance with this provision, the Commission would like that EFSA
examine the emergency authorisations granted by Romania, Bulgaria, Estonia, Finland,
Latvia, Lithuania and Flungary in 2017, as specified in the Annex to this mandate, in light
of the situation in these specific Member States concerning pests and available
alternatives.

In particular, EFSA is asked to assess whether the granting of these emergency

authorisations and their wide scope were necessary because of a danger which could not
be contained by any other reasonable means. EFSA should review the summary provided
by each concerned Member State, and produce a Technical Report on the Member State
notifications regarding their considerations justifying the need due to a danger which
cannot be contained by any other reasonable means. The concerned Member States
should have the possibility for commenting on the EFSA draft report before its
finalisation. After receipt of the EFSA assessment for the 2017 emergency authorisations,
the Commission may consider the need for the assessment of similar emergency
authorisations granted in previous years.

In this exercise, EFSA may consider making use of the protocol for the evaluation of data
concerning the necessity of the application of insecticide active substances to control a
serious danger to plant health which cannot be contained by other available means,
including non-chemical methods, which was published on 5 April 2017. This protocol
was developed in the framework of a mandate concerning the application of Article 4(7)
of Regulation (EC) No 1107/2009, providing an exemption from the application of some
cut-off criteria in cases of a serious danger that cannot be contained by other available
means. The Commission is of the opinion that the scope of both articles is sufficiently
comparable to justify such approach.

Most notifications under evaluation were issued by the concerned Member States before
5 April 2017, date of publication of the above mentioned insecticide protocol. It is
therefore considered necessary that these Member States are be given the opportunity to
update their notification in relation to the data requirements and methodology proposed
in this protocol. The updated notification should be made available by the concerned
Member States within 3 months from request by EFSA. For this purpose, EFSA should
provide the concerned Member States a reporting template (including data collection
forms) within 1 month of receipt of this mandate. Finally, EFSA should prepare one
Technical Report for each concerned Member State which should discuss if the provided
justifications indicate the need for the emergency authorisation due to a danger which
cannot be contained by any other reasonable means.

Given the high number of emergency authorisations concerned, the retrospective

character of this evaluation and the required input of the concerned Member States, the
Commission would like to ask EFSA to deliver its conclusions within 8 months of the
date of this request.

Yours sincerely,

f Director
DGįHealth and Food Safety
2 for the DDG absent
Contact: Ms S. Hofkens (SANTE.E4), @+32-2-297-66-50
Ms M. Marini (SANTE.D1) @+32-2-299-33-07

Cc: J. Tarazona (EFSA)

S. Jülicher, K. Berend, W. Reinert, L. Cordier, E. Rademakers, S. Hofkens,
P. Bokor, M. Marini (SANTE)

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 Annex

1. Romania notifications 2017

- Cruiser 350 FS containing thiamethoxam in sunflower and maize from 1

February until 16 May 2017 against Tanymecus dilaticollis and Agriotes
spp.

- NUPRID AL 600 FS containing imidacloprid in sunflower and maize

from 1 February until 16 May 2017 against Tanymecus dilaticollis and
Agriotes spp..

- Seedoprid 600 FS containing imidacloprid in sunflower and maize from 1

February until 16 May 2017 against Tanymecus dilaticollis and Agriotes
spp.

- PONCFIO 600 FS containing clothianidin in sunflower and maize from 1

February until 16 May 2017 against Tanymecus dilaticollis and Agriotes
spp.

- NUPRID AL 600 FS containing imidacloprid in rape from 21 July until 16

October 2017 against Phyllotreta spp. and Phylloides spp..

- MODESTO 480 FS containing clothianidin in rape from 21 July until 16

October 2017 against Phyllotreta spp. and Phylloides spp..

2. Bulgaria notifications 2017

- Seedoprid 600 FS containing imidacloprid in maize and sunflower from

27 March until 27 May 2017 against Tanymecus dilaticollis and Agriotes
spp.

3. Estonia notification 2017

- Modesto FS containing clothianidin and beta-cyfluthrin in oilseed rape

seed, spring rape and spring turnip rape seed from 13 February until 3
June 2017 against Phyllotreta spp.

- Cruiser OSR containing thiamethoxam in spring oilseed rape seed from 15

February until 15 June 2016 against Albugo candida, Aiternaria
brassicae, Brevicoryne brassicae, Myzus persicae, Peronospora
parasitica, Phoma Ungarn, Phyllotreta sp., Psydiodes chrysocephala,
Pythium ultimum, Thrips angusticeps.

4. Finland notification 2017

- Cruiser OSR containing thiamethoxam in oil seed rape from 15 February

until 14 June 2017 against aaltojuovakirppa, mutkajuovakirppa.

- Eladó FS containing clothianidin and beta-cyfluthrin in oilseed rape from

15 February until 14 June 2017 against Phyllotreta undulate and
Phyllotreta vittata.

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 5. Latvia notification 2017

- Modesto FS containing clothianidin in spring rape from 20 February until

1 June 2017 against Phyllotreta nemorum and Phyllotreta spp.

- Cruiser OSR containing thiamethoxam in spring rape from 20 February

until 1 June 2017 against Phyllotreta nemorum and Phyllotreta spp

6. Lithuania notification 2017

- Modesto FS containing clothianidin in spring rape from 1 March until 28

June 2017 against Athalia rosae, Delia radicum, Phyllotreta sp. and
Psyliiodes sp.

- Cruiser OSR containing thiamethoxam in spring rape from 1 March until

28 June 2017 against Aiternaria brassicae, Fusarium sp., Peronospora
sp., Phoma Ungarn, Phyllotreta nemorum, Psylliodes chrysocephala and
Pythium sp.

7. Hungary notification 2017

- Poncho FS 600 containing clothianidin in maize from 23 February until 30

May 2017 against Agriotes, Diabrótica virgifera virgifera, Tanymecus
dilaticollis and Tanymecus palliates.

- Cruiser 350 FS containing thiamethoxam in maize and sunflower from 23

February until 30 May 2017 against Aphididae, maize weevil, sunflower
root weevil and western corn rootworm.

- Nuprid 600 FS containing imidacloprid in maize and sunflower from 23

February until 31 May 2017 against Agriotes, Aphididae, Diabrótica
virgifera, Tanymecus dilaticollis and Tanymecus palliates.

- Cruiser OSR containing thiamethoxam in rapeseed from 30 June until 30

September 2017 against Agriotes, Athalia rosae, Melolontha melolontha,
Phyllotreta and Psylliodes chrysocephala.

- Ellado containing clothianidin in rapeseed from 30 June until 30

September 2017 against Agriotes, Athalia rosae, Melolontha melolontha,
Phyllotreta and Psylliodes chrysocephala.

- Poncho Pro containing clothianidin in maize from 15 February until 31

May 2017 against Agriotes, Diabrotica virgifera virgifera, Tanymecus
dilaticollis and Tanymecus palliates.

- Cruiser 350 FS containing thiamethoxam in maize from 22 February until

31 May 2017 against Agriotes, Diabrotica virgifera virgifera, Melolontha
melolontha, T anymecus dilaticollis and Tanymecus palliates

- Cruiser 350 FS containing thiamethoxam in maize from 21 February until

31 May 2017 against Agriotes. maize weevil and western corn rootworm.

- Poncho Pro containing clothianidin in maize from 21 February until 31

May 2017 against Agriotes, maize weevil and western corn rootworm.
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Electronically signed on 15/09/2017 10:22 (UTC+02) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563