Commission Implementing Regulation (EU) 2015/306 of 26 February 2015 renewing the approval of the active substance Isaria fumosorosea strain Apopka 97 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 Text with EEA relevance

• CELEX: Implementing Regulation (EU) 2015/306
• Articles: 5

Article 1 Renewal of the approval of active substance

The approval of the active substance Isaria fumosorosea strain Apopka 97, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

1.   In Article 1 of Implementing Regulation (EU) No 540/2011 the second paragraph is replaced by the following paragraph:

‘The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex to this Regulation. The basic substances approved under Regulation (EC) No 1107/2009 are as set out in Part C of the Annex to this Regulation. The low-risk active substances approved under Regulation (EC) No 1107/2009 are as set out in Part D of the Annex to this Regulation.’

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2.   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3 Entry into force and date of application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 1 January 2016.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Isaria fumosorosea strain Apopka 97

Deposited in the American Type Culture Collection (ATCC) under the name Paecilomyces fumosoroseus Apopka ATCC 20874

Not applicable

Minimum concentration: 1,0 × 10 8 CFU/ml

Maximum concentration: 2,5 × 10 9 CFU/ml

1 January 2016

31 December 2030

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Isaria fumosorosea strain Apopka 97, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014, shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Isaria fumosorosea strain Apopka 97 is to be considered as a potential sensitiser.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX II

ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

in Part A, the entry relating to Isaria fumosorosea strain Apopka 97 is deleted;

(2)

the following Part D is added:

‘PART D

Low-risk active substances'

General provisions applying to all substances listed in this Part: the Commission shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make them available to them on specific request.

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

1

Isaria fumosorosea strain Apopka 97

Deposited in the American Type Culture Collection (ATCC) under the name Paecilomyces fumosoroseus Apopka ATCC 20874

Not applicable

Minimum concentration: 1,0 × 10 8 CFU/ml

Maximum concentration: 2,5 × 10 9 CFU/ml

1 January 2016

31 December 2030

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Isaria fumosorosea strain Apopka 97, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014, shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Isaria fumosorosea strain Apopka 97 is to be considered as a potential sensitiser.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

( 1 )   Further details on identity and specification of active substance are provided in the review report.’