Commission Implementing Regulation (EU) 2016/147 of 4 February 2016 renewing the approval of the active substance iprovalicarb 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 Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2016/147
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance iprovalicarb, 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

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 April 2016.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Iprovalicarb

CAS No 140923-17-7

CIPAC No 620

isopropyl [(1S)-2-methyl-1-{[(1RS)-1-p-tolylethyl]carbamoyl}propyl]carbamate

≥ 950 g/kg

Impurities:

Toluene: not more than 3 g/kg

1 April 2016

31 March 2031

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 iprovalicarb, 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 groundwater from the relevant soil metabolite PMPA  ( *1 ) when the active substance is applied in regions with low clay containing soil types,

—

the safety of operators and workers,

—

the protection of aquatic organisms in the case of formulated products containing other active substances.

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

The applicant shall submit to the Commission, the Member States and the Authority, confirmatory information as regards the genotoxic potential of soil metabolite PMPA. This information shall be submitted by 30 September 2016.

( *1 )

p -methyl-phenethylamine

( 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, entry 30 on iprovalicarb is deleted;

(2)

in Part B, the following entry is added:

Number

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘96

Iprovalicarb

CAS No 140923-17-7

CIPAC No 620

isopropyl [(1S)-2-methyl-1-{[(1RS)-1-p-tolylethyl]carbamoyl}propyl]carbamate

≥ 950 g/kg

Impurities:

Toluene: not more than 3 g/kg

1 April 2016

31 March 2031

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 iprovalicarb, 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 groundwater from the relevant soil metabolite PMPA  ( *1 ) when the active substance is applied in regions with low clay containing soil types,

—

the safety of operators and workers,

—

the protection of aquatic organisms in the case of formulated products containing other active substances.

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

The applicant shall submit to the Commission, the Member States and the Authority, confirmatory information as regards the genotoxic potential of soil metabolite PMPA. This information shall be submitted by 30 September 2016.

( *1 )

p -methyl-phenethylamine’

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