Notification of an Emergency Authorisation Issued by Spain

Notification of an Emergency Authorisation issued by Spain

1. Member State, and MS notification number

ES-ES-2021-21

2. In case of repeated derogation: no. of previous derogation(s)

None

3. Names of active substances

Azoxystrobin - 20.0000 g/l Difenoconazole - 12.5000 g/l

4. Trade name of Plant Protection Product

AMISTAR TOP

5. Formulation type

6. Authorisation holder

Dirección General de la Producción Agrícola y Ganadera de la Junta de Andalucía

7. Area permitted to be treated

8. Time period for authorisation

15/07/2021 - 15/10/2021

9. Further limitations

Autonomous Communities of Cataluña and Valencia: Entry into force date: 5/07/2021 Expiry date: 15/09/2021. Area permitted to be treated: COMUNIDAD AUTÓNOMA DE CATALUÑA: Provincia de Tarragona: L’Ampolla, Deltebre, Camarles, L’Aldea, Amposta, Sant Carles de la Ràpita y Sant Jaume d’Enveja. COMUNIDAD AUTÓNOMA DE ANDALUCÍA: Provincia de Cádiz: Barbate, Benalup-Casas Viejas, Medina Sidonia, Tarifa y Vejer de la Frontera. Provincia de Sevilla: Aznalcázar, Las Cabezas de San Juan, Coria del Río, Dos Hermanas, Isla Mayor, La Puebla del Río, Lebrija, Los Palacios, Villafranca y Utrera. COMUNIDAD AUTÓNOMA DE VALENCIA: Provincia de Alicante: Denia y Pego. Provincia de Castellón: La Llosa y Xilxes. Provincia de Valencia: Alfafar, Massanassa, Oliva, Sedavi, Silla, Sollana, Sueca y Valencia Generated by PPPAMS - Published on 23/07/2021 - Page 1 of 6

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11. Value of tMRL if needed, including information on the measures taken in order to confine the commodities resulting from the treated crop to the territory of the notifying MS pending the setting of a tMRL on the EU level. (PRIMO EFSA model to be attached)

12. Measures taken to ensure consumer safety

Used at the described GAP

13. Validated analytical method for monitoring of residues in plants and plant products.

14. Function of the product (E.g. systemic long acting insecticide; foliar fungicide, used for regular control, elimination scenario etc)

fungicide

15. Type of danger to plant production or ecosystem (Provide reasoning for what category the 120 day authorisation is given: quarantine pest; emergent pest, either invading non-native, or native; emerging resistance in a pest, etc. Whereas reference to the EU quarantine legislation may suffice for quarantine pests elaborate reasoning should be provided for the category 'any harmful pest')

Pyricularia oryzae is present in the rice fields of Andalusia, affecting the cultivation of rice every year and causing considerable production losses in those cultivation plots where effective control is not carried out. Likewise, the application of fungicides for the control of pyriculariosis in rice cultivation is carried out at a time when the crop is of a size that does not allow the terrestrial application of phytosanitary products, since this would cause serious damage to it, which makes it necessary to have phytosanitary products expressly authorised for aerial application

16. Size and effect of danger (Describe shortly the area affected, the development over time of the infestation, and the agronomic and economic effects it has)

Rice cultivation occupies an area of approximately 40,000 ha in Andalusia, mostly concentrated in the marshes of the Guadalquivir river in the province of Seville, and a small part in the environment of the Laguna de la Janda in Cadiz. This autonomous community is a pioneer in the application of integrated production techniques in the cultivation of rice. By 2019, 90% of Andalusia's surface area was cultivated under this production system, which ensures a rational use of phytosanitary products and the monitoring of crops by technicians specialized in monitoring pests and diseases specific to this crop.

17. Absence of any other reasonable means (Describe the alternative control measures (chemical, non-chemical and cultural) and indicate why they do not (in combination) suffice. Describe which, if any, authorisations for the pest to be controlled exist in other Member States.

Rice cultivation has been greatly affected by the drastic reduction in active substances caused by the implementation of Directive 91/414/EC, so the pests that affect the crop every year in Andalusia do not currently have any authorised plant protection product to control them. On the other hand, it should be noted that rice cultivation requires the aerial application of phytosanitary products and that, since the publication of Royal Decree 1311/2012, of 14 September, these have been carried out in strict compliance with all the requirements demanded by the same, which has meant a very exhaustive control by the Administration on the aerial applications carried out, as well as a great commitment and responsibility on the part of the farmers and associations that group them. In this sense, it is necessary that the promoters of aerial applications present a request addressed to the corresponding Territorial Delegation in accordance with the provisions of Articles 27 and 28 of the aforementioned Royal Decree and that this request fulfils all the requirements established in its Annexes VI and VII; only in these cases is its approval and its execution allowed.

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18. Rationale (Reason the risk management decision based on the findings of 15 to 18, containing especially a description of measures taken to ensure consumer protection).

The active substances azoxystrobin and difenoconazole are approved under Regulation (EC) No 1107/2009, and a plant protection product formulated on the basis of these substances is available for the control of pyricularia in rice cultivation by land application, as referred to in the Register of Plant Protection Products.

19. Mitigation measures (Describe what mitigation measures are taken if needed for minimising risk to humans, animals, and the environment, attach summary risk assessment. Describe what measures are taken to limit and control use)

The use of plant protection products with fungicidal action that combine two active substances from different chemical families is very interesting as they are more effective and also help to prevent the appearance of resistance

20. Applications in progress (The use notified may have been applied for already, or a suitable alternative PPP may be in the process of authorisation. Describe such applications, including a possible date of authorisation)

Rice application is authorized for AMISTAR TOP and Syngenta in order to have a more suitable GAP for the current practice in the field submitted in January 2020 a dossier in order to change the BBCH from 47-49 to 47-81. The rest of the parameters in the GAP are the same as the ones authorized. The requested GAP in this application is the same GAP requested in this dossier.

21. Research activities (Describe the research efforts undertaken and/or in progress, their aims, their funding, and their expected date of results. This is needed for all categories of dangers, except quarantine pests that can still be eliminated, or infrequent pests, for which no official application for a normal authorisation or extension of use of the plant protection product exists. In case of a repeated notification: indicate the state of works of the research projects.)

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22 GAP

1 3 4 5 6 7 8/9 10 a/b 11 a/b 12 13 Use-No. Crop and/ Pests or Group of Application Application Rate PHI Remarks: or situation pests controlled Method / Timing / Max. number kg, L product g, kg as/ha Water (days) (crop destination (additionally: Kind Growth stage [min. interval / ha L/ha e.g. safener/synergist per ha F / purpose of developmental of crop & between a) max. rate a) max. rate e.g. recommended or crop) G stages of the pest season applications(days)] per appl. per appl. min / max mandatory tank mixtures or or pest group) I a) per use b) max. total b) max. total rate per rate per b) per crop/ crop/season crop/season season a) 20 g/ha (Azoxystrobin) [15] (days) 12.5 g/ha (Difenoconazole) a) 1 l/ha 1 ORYSA rice (Oryza sativa) F PYRIOR Pyricularia oryzae (Pyricularia oryzae) aerial spraying 47 to 81 a) 1 100 / 200 28 b) 2 l/ha Major Use b) 2 b) 40 g/ha(Azoxystrobin) 25 g/ha(Difenoconazole)

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23 MRL: Reference to product code number in Annex I of regulation (EC) No 396/2005 Consumer safety Pesticide residues EPPO Code for CROP Product Azoxystrobin Difenoconazole ORYSA rice 5 3 Rice Reg. (EU) 2019/552 Reg. (EU) 2019/552 (Oryza sativa)

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