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)
Article 1
Renewal of the approval of active substance
Article 2
Amendments to Implementing Regulation (EU) No 540/2011
Article 3
Entry into force and date of application
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 × 108 CFU/ml Maximum concentration: 2,5 × 109 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. |
ANNEX II
‘PART D
Low-risk active substances'
|
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 × 108 CFU/ml Maximum concentration: 2,5 × 109 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. |