# L_2016231EN.01003001.xml

| 26.8.2016 | EN | Official Journal of the European Union | L 231/30 |
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26.8.2016

EN

Official Journal of the European Union

L 231/30

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1425

of 25 August 2016

approving the active substance isofetamid 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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) thereof,

Whereas:

| (1) | In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Belgium received on 22 January 2013 an application from ISK Biosciences Europe NV for the approval of the active substance isofetamid. |
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(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Belgium received on 22 January 2013 an application from ISK Biosciences Europe NV for the approval of the active substance isofetamid.

| (2) | In accordance with Article 9(3) of that Regulation, Belgium, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) of the admissibility of the application on 3 April 2013. |
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(2)

In accordance with Article 9(3) of that Regulation, Belgium, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) of the admissibility of the application on 3 April 2013.

| (3) | On 3 October 2014, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
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(3)

On 3 October 2014, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (4) | The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report of 31 August 2015. |
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(4)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report of 31 August 2015.

| (5) | On 28 October 2015, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance isofetamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public. |
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(5)

On 28 October 2015, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance isofetamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

| (6) | On 8 March 2016, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for isofetamid and a draft Regulation providing that isofetamid is approved. |
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(6)

On 8 March 2016, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for isofetamid and a draft Regulation providing that isofetamid is approved.

| (7) | The applicant was given the possibility to submit comments on the review report. |
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(7)

The applicant was given the possibility to submit comments on the review report.

| (8) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the Commission review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
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(8)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the Commission review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

| (9) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information. |
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(9)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

| (10) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly. |
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(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Approval of the active substance

The active substance isofetamid, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Amendment 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 25 August 2016.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 309, 24.11.2009, p. 1.

1

(2)  
  EFSA Journal 2015;13(10):4265. Available online: www.efsa.europa.eu

2

EFSA Journal

(3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

3

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Isofetamid
  CAS No: 875915-78-9
  CIPAC No: 972 | N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide | ≥ 950 g/kg | 15 September 2016 | 15 September 2026 | 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 isofetamid, 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 risk to operators, workers and aquatic organisms, in particular fish.
  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 technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Isofetamid

CAS No: 875915-78-9

CIPAC No: 972

N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide

≥ 950 g/kg

15 September 2016

15 September 2026

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 isofetamid, 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 risk to operators, workers and aquatic organisms, in particular fish.

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 technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

| (2) | the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification; |
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(2)

the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;

| (3) | the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water. |
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(3)

the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water.

The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 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.

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

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ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

| | Common Name, Identification Numbers | IUPAC Name | Purity (*1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘100 | Isofetamid
  CAS No: 875915-78-9
  CIPAC No: 972 | N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide | ≥ 950 g/kg | 15 September 2016 | 15 September 2026 | 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 isofetamid, 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 risk to operators, workers and aquatic organisms, in particular fish.
  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 technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; |

Common Name, Identification Numbers

IUPAC Name

Purity (*1)

Date of approval

Expiration of approval

Specific provisions

‘100

Isofetamid

CAS No: 875915-78-9

CIPAC No: 972

N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide

≥ 950 g/kg

15 September 2016

15 September 2026

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 isofetamid, 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 risk to operators, workers and aquatic organisms, in particular fish.

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 technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

| (2) | the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification; |
| --- | --- |

(2)

the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;

| (3) | the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water. |
| --- | --- |

(3)

the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water.

The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 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.’

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

*1

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