(1)

Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

(2)

Commission Implementing Regulation (EU) 2020/421 (3) extended the approval period of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad,Streptomyces K61 (formerly ‘S. griseoviridis’), Trichoderma asperellum (formerly ‘T. harzianum’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianum’) strain T11, Trichoderma gamsii (formerly ‘T. viride’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram until 30 April 2021.

(3)

Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4).

(4)

Due to the fact that the assessment of those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

(5)

In addition, an extension of the approval period is required for the active substances cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, pyrimethanil, spinosad, triclopyr, trinexapac, triticonazole and ziram also to provide the time necessary to carry out an assessment relating to endocrine disrupting properties of those active substances in accordance with the procedure set out in Articles 13 and 14 of Implementing Regulation (EU) No 844/2012.

(6)

As regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

(7)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, CEV SA submitted to the Netherlands on 7 June 2016 an application for the approval of the active substance aqueous extract from the germinated seeds of sweet Lupinus albus.

(2)

In accordance with Article 9(3) of Regulation (EC) No 1107/2009, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application on 18 January 2017.

(3)

On 1 April 2019, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(4)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of that Regulation, it requested that the applicant supplies additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 3 March 2020.

(5)

On 19 June 2020, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance aqueous extract from the germinated seeds of sweet Lupinus albus can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

(6)

On 23 October 2020, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed a review report and a draft regulation regarding aqueous extract from the germinated seeds of sweet Lupinus albus.

(7)

The applicant was given the possibility to submit comments on the review report.

(8)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(9)

The Commission further considers that aqueous extract from the germinated seeds of sweet Lupinus albus is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Aqueous extract from the germinated seeds of sweet Lupinus albus is not a substance of concern and it fulfils the conditions set out in point 5.1 of Annex II to Regulation (EC) No 1107/2009.

(10)

It is therefore appropriate to approve aqueous extract from the germinated seeds of sweet Lupinus albus.

(11)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions and restrictions. It is in particular appropriate to require further confirmatory information.

(12)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‘the commodities’). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

(2)

Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI).

(3)

In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (Withdrawal Agreement), and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, Directives 2002/99/EC and 2009/158/EC, as well as the Commission acts based on them, apply to and in the United Kingdom in respect of Northern Ireland after the end of the transition period provided for in the Withdrawal Agreement.

(4)

Therefore, the United Kingdom, excluding Northern Ireland, is listed in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of certain poultry commodities are authorised from certain parts of its territory depending on the presence of HPAI. That regionalisation of the United Kingdom is set out in Part 1 of Annex I to Regulation (EC) No 798/2008, as amended by Commission Implementing Regulation (EU) 2021/256 (4).

(5)

On 29 March 2021, the United Kingdom confirmed the presence of HPAI of subtype H5N8 in a poultry holding in East Staffordshire.

(6)

The veterinary authorities of the United Kingdom placed a 10 km control zone around the affected holding and implemented a stamping-out policy in order to control the presence of HPAI and limit the spread of that disease. Furthermore, the veterinary authorities of the United Kingdom confirmed that they immediately suspended issuing veterinary certificates for consignments of commodities intended for export to the Union from the whole of the territory of the United Kingdom, excluding Northern Ireland.

(7)

The United Kingdom has submitted information to the Commission on the epidemiological situation on its territory and the measures it has taken to prevent the further spread of HPAI which has now been evaluated by the Commission. On the basis of that evaluation, it is appropriate to place restrictions on the introduction into the Union of commodities from the area the veterinary authorities of the United Kingdom have placed under restrictions due to the current HPAI outbreak in East Staffordshire.

(8)

The entry for the United Kingdom in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should, therefore, be amended to take account of the current epidemiological situation in that third country.

(9)

Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,