Part D Low-risk active substances'F1

Isaria fumosorosea strain Apopka 97

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

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

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

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.

COS-OGA

CAS No: not allocated

CIPAC No: 979

≥ 915 g/kg

• OGA/COS ratio comprised between 1 and 1,6

• Degree of polymerisation of COS comprised between 5 and 10

• Degree of polymerisation of OGA comprised between 9 and 20

• Degree of methylation of OGA < 10 %

• Degree of acetylation of COS < 50 %

Cerevisane (no ISO name adopted)

CAS No: not allocated

CIPAC No: 980

Pepino mosaic virus strain CH2 isolate 1906

GenBank, accession number JN835466

CIPAC No: not allocated

Only the use in greenhouses may be authorised.

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 Pepino mosaic virus strain CH2 isolate 1906, and in particular Appendices I and II thereof, 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 Pepino mosaic virus strain CH2 isolate 1906 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate.

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

Ferric phosphate

CAS No: 10045-86-0

CIPAC No: 629

Saccharomyces cerevisae strain LAS02

Accession number in the collection of the ‘Collection Nationale de Cultures de Microorganismes’ (CNCM) of the Pasteur Institute: CNCM I-3936

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 Saccharomyces cerevisiae strain LAS02, and in particular Appendices I and II thereof, 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 Saccharomyces cerevisiae strain LAS02 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.

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

Trichoderma atroviride strain SC1

Accession number CBS 122089 in the collection of the Centraalbureau voor Schimmelcultures (CBS) in Utrecht, The Netherland

CIPAC No: 988

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 Trichoderma atroviride strain SC1, and in particular Appendices I and II thereof, 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 microorganisms are considered as potential sensitizers. Conditions of use shall include risk mitigation measures, where appropriate.

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

Mild Pepino Mosaic Virus isolate VC1

Reference number DSM 26973 in the German Collection of Micro-organisms and Cell Cultures (DSMZ)

Only the use in greenhouses may be authorised.

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 Mild Pepino Mosaic Virus isolate VC1, and in particular Appendices I and II thereof, 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 Mild Pepino Mosaic Virus isolate VC1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.

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

Mild Pepino Mosaic Virus isolate VX1

Reference number DSM 26974 in the German Collection of Micro-organisms and Cell Cultures (DSMZ)

Only the use in greenhouses may be authorised.

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 Mild Pepino Mosaic Virus isolate VX1, and in particular Appendices I and II thereof, 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 Mild Pepino Mosaic Virus isolate VX1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.

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

Bacillus amyloliquefaciens strain FZB24.

Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: 10271

Accession number at the Agricultural Research Service Culture Collection (NRRL), USA: B-50304

Minimum concentration:

2 × 10 ¹⁴ CFU/kg

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 Bacillus amyloliquefaciens strain FZB24, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

• specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites;

• the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers.

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

Conditions of use shall include risk mitigation measures, where appropriate.

Coniothyrium minitans strain CON/M/91-08

Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: DSM 9660

CIPAC No 614

X1Minimum content of viable spores:

1,17 × 10 ¹² CFU/kg

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Coniothyrium minitans strain CON/M/91-08, and in particular Appendices I and II thereof, 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 microorganisms are considered as potential sensitizers.

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

Conditions of use shall include risk mitigation measures, where appropriate.

Laminarin

CAS No 9008-22-4

CIPAC No 671

(1→3)-β-D-glucan

(according to IUPAC-IUB Joint Commission on Biochemical Nomenclature)

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on laminarin, and in particular Appendices I and II thereto, shall be taken into account.

Conditions of use shall include risk mitigation measures, where appropriate.

Pasteuria nishizawae Pn1

Culture collection: ATCC Safe Deposit (SD-5833)

CIPAC No

Not allocated

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 Pasteuria nishizawae Pn1, and in particular Appendices I and II thereof, 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 Pasteuria nishizawae Pn 1 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.

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

Minimum content of viable spores:

3,0 × 10 ¹² CFU/kg

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Ampelomyces quisqualis strain AQ10, and in particular Appendices I and II thereof, 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 microorganisms are per se considered as potential sensitizers and ensuring that adequate personal protective equipment is included as a condition of use.

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

Conditions of use shall include risk mitigation measures, where appropriate.

Clonostachys rosea strain J1446

Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212

Not applicable

Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA.

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Clonostachys rosea strain J1446, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

• the specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern;

• the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;

• the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbial contamination as referred to in the Working Document SANCO/12116/2012^f2.

Conditions of use shall include risk mitigation measures, where appropriate.

Bacillus subtilis strain IAB/BS03

Accession number in the Spanish Type Culture Collection (CECT), Spain: CECT 7254

Accession number in the German Type Culture Collection (DSMZ), Germany: DSM 24682

Minimum concentration:

1 × 10 ¹³ CFU/kg

Maximum concentration:

5 × 10 ¹³ CFU/kg

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 Bacillus subtilis strain IAB/BS03, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. a))

   the specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites;

2. b))

   the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers, and ensuring that adequate personal protective equipment is included as a condition of use.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Working Document SANCO/12116/2012.

Conditions of use shall include risk mitigation measures, where appropriate.

Minimum concentration:

0,7 × 10 ⁷ CFU/ml distilled water

Maximum concentration:

1,5 × 10 ⁷ CFU/ml distilled water

No relevant impurity

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Verticillium albo-atrum strain WCS850, and in particular Appendices I and II thereto, 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 Verticillium albo-atrum strain WCS850 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, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Commission Working Document SANCO/12116/2012.

Lavandulyl senecioate

CAS No: 23960-07-8

CIPAC No: n.a.

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 Lavandulyl senecioate, and in particular Appendices I and II thereto, shall be taken into account.

Member State shall assess any extension of the use pattern beyond passive dispensers, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Commission Regulation (EU) No 546/2011^f3.

Ferric pyrophosphate

CAS No: 10058-44-3

CIPAC No: —

≥ 802 g/kg

The following impurities are of toxicological and enviromental concern and must not exceed the following levels in the technical material:

• Lead: 3 mg/kg

• Mercury: 0,1 mg/kg

• Cadmium: 1 mg/kg

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Phlebiopsis gigantea strain VRA 1835, and in particular Appendices I and II thereto, shall be taken into account.

Member States shall pay particular attention to the protection of operators and workers.

Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Phlebiopsis gigantea strain VRA 1984, and in particular Appendices I and II thereto, shall be taken into account.

Member States shall pay particular attention to the protection of operators and workers.

Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Phlebiopsis gigantea strain FOC PG 410.3, and in particular Appendices I and II thereto, shall be taken into account.

Member States shall pay particular attention to the protection of operators and workers.

Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.

Sodium hydrogen carbonate

CAS No: 144-55-8

≥ 990 g/kg

Arsenic ≤ 3 mg/kg

Lead ≤ 2 mg/kg

Mercury ≤ 1 mg/kg