Commission Implementing Regulation (EU) 2017/407 of 8 March 2017 renewing the approval of the active substance iodosulfuron 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) 2017/407
• Articles: 5

Article 1 Renewal of the approval of active substance

The approval of the active substance iodosulfuron, 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 2017.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Iodosulfuron

CAS No 185119-76-0 (parent)

CAS No 144550-36-7 (iodosulfuron-methyl-sodium)

CIPAC No 634 (parent)

CIPAC No 634.501 (iodosulfuron-methyl-sodium)

4-iodo-2-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoylsulfamoyl]benzoic acid

(iodosulfuron)

sodium ({[5-iodo-2-(methoxycarbonyl)phenyl]sulfonyl}carbamoyl)(4-methoxy-6-methyl-1,3,5-triazin-2-yl)azanide

(iodosulfuron-methyl-sodium)

≥ 910 g/kg (expressed as iodosulfuron-methyl-sodium)

1 April 2017

31 March 2032

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 iodosulfuron, 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 risk to consumers,

—

the risk to non-target terrestrial plants,

—

the risk to aquatic plants.

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:

(1)

the genotoxic potential of the metabolite triazine-amine (IN-A4098), in order to confirm that this metabolite is not genotoxic and not relevant for the risk assessment;

(2)

the effect of water treatment processes on the nature of residues present in drinking water.

The applicant shall submit the information requested under point (1) by 1 October 2017 and the information requested under point (2) by two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

( 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 66 on iodosulfuron 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

‘107

Iodosulfuron

CAS No 185119-76-0 (parent)

CAS No 144550-36-7 (iodosulfuron-methyl-sodium)

CIPAC No 634 (parent)

CIPAC No 634.501 (iodosulfuron-methyl-sodium)

4-iodo-2-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoylsulfamoyl]benzoic acid

(iodosulfuron)

sodium ({[5-iodo-2-(methoxycarbonyl)phenyl]sulfonyl}carbamoyl)(4-methoxy-6-methyl-1,3,5-triazin-2-yl)azanide

(iodosulfuron-methyl-sodium)

≥ 910 g/kg (expressed as iodosulfuron-methyl-sodium)

1 April 2017

31 March 2032

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 iodosulfuron, 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 risk to consumers,

—

the risk to non-target terrestrial plants,

—

the risk to aquatic plants.

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:

(1)

the genotoxic potential of the metabolite triazine-amine (IN-A4098), in order to confirm that this metabolite is not genotoxic and not relevant for the risk assessment;

(2)

the effect of water treatment processes on the nature of residues present in drinking water.

The applicant shall submit the information requested under point (1) 1 October 2017 and the information requested under point (2) by two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’

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