Commission Implementing Regulation (EU) 2021/917 of 7 June 2021 approving the low-risk active substances Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 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 Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/917
• Articles: 5

Article 1 Approval of the active substances

The active substances Pepino Mosaic Virus , EU strain, mild isolate Abp1 and Pepino Mosaic Virus , CH2 strain, mild isolate Abp2 are approved subject to the conditions laid down in Annex I.

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

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

Article 3 Entry into force

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

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity

( 1 )

Date of approval

Expiration of approval

Specific provisions

Pepino Mosaic Virus , EU strain, mild isolate Abp1

Not applicable

The impurity nicotine shall not exceed the following values in the technical material:

max. 0,005 mg/L in Abp1 TK

max. 3,87 x 10 -5 mg/kg in MPCP

(Nicotine has been reported to be present in tomato plants, therefore, as the microbial pest control agent (MPCA) is produced in tomato plants, nicotine is present as a consequence of the production method).

28 June 2021

28 June 2036

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 , EU strain, mild isolate Abp1 and Pepino Mosaic Virus , CH2 strain, mild isolate Abp2, and in particular Appendices I and II thereto, shall be taken into account.

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

a)

the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 2 ) ;

b)

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

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

Common Name, Identification Numbers

IUPAC Name

Purity

( 3 )

Date of approval

Expiration of approval

Specific provisions

Pepino Mosaic Virus , CH2 strain, mild isolate Abp2

Not applicable

The impurity nicotine shall not exceed the following values in the technical material:

max. 0,007 mg/L in Abp2 TK

max. 3,87 x 10 -5 mg/kg in MPCP

(Nicotine has been reported to be present in tomato plants, therefore, as the microbial pest control agent (MPCA) is produced in tomato plants, nicotine is present as a consequence of the production method).

28 June 2021

28 June 2036

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 , EU strain, mild isolate Abp1 and Pepino Mosaic Virus , CH2 strain, mild isolate Abp2, and in particular Appendices I and II thereto, shall be taken into account.

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

a)

the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 4 ) ;

b)

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

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

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

( 2 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf

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

( 4 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf.

ANNEX II

ANNEX II

In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entries are added:

No

Common Name, Identification Numbers

IUPAC Name

Purity

( 1 )

Date of approval

Expiration of approval

Specific provisions

‘29

Pepino Mosaic Virus , EU strain, mild isolate Abp1

Not applicable

The impurity nicotine shall not exceed the following values in the technical material:

max. 0,005 mg/L in Abp1 TK

max. 3,87 x 10 -5 mg/kg in MPCP

(Nicotine has been reported to be present in tomato plants, therefore, as the microbial pest control agent (MPCA) is produced in tomato plants, nicotine is present as a consequence of the production method).

28 June 2021

28 June 2036

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 , EU strain, mild isolate Abp1 and Pepino Mosaic Virus , CH2 strain, mild isolate Abp2, and in particular Appendices I and II thereto, shall be taken into account.

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

a)

the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 2 ) .

b)

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

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

No

Common Name, Identification Numbers

IUPAC Name

Purity

( 3 )

Date of approval

Expiration of approval

Specific provisions

‘30

Pepino Mosaic Virus , CH2 strain, mild isolate Abp2

Not applicable

The impurity nicotine shall not exceed the following values in the technical material:

max. 0,007 mg/L in Abp2 TK

max. 3,87 x 10 -5 mg/kg in MPCP

(Nicotine has been reported to be present in tomato plants, therefore, as the microbial pest control agent (MPCA) is produced in tomato plants, nicotine is present as a consequence of the production method).

28 June 2021

28 June 2036

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 , EU strain, mild isolate Abp1 and Pepino Mosaic Virus , CH2 strain, mild isolate Abp2, and in particular Appendices I and II thereto, shall be taken into account.

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

a)

the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 4 ) .

b)

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

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

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

( 2 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf.

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

( 4 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf.