# L_2018114EN.01001801.xml

| 4.5.2018 | EN | Official Journal of the European Union | L 114/18 |
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4.5.2018

EN

Official Journal of the European Union

L 114/18

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/679

of 3 May 2018

renewing the approval of the active substance forchlorfenuron 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 20(1) thereof,

Whereas:

| (1) | Commission Directive 2006/10/EC (2) included forchlorfenuron as an active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2006/10/EC (2) included forchlorfenuron as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
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(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The approval of the active substance forchlorfenuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2018. |
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(3)

The approval of the active substance forchlorfenuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2018.

| (4) | An application for the renewal of the approval of forchlorfenuron was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article. |
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(4)

An application for the renewal of the approval of forchlorfenuron was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State. |
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(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

| (6) | The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 27 May 2016. |
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(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 27 May 2016.

| (7) | The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public. |
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(7)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

| (8) | On 31 May 2017 the Authority communicated to the Commission its conclusion (6) on whether forchlorfenuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for forchlorfenuron to the Standing Committee on Plants, Animals, Food and Feed on 5 October 2017. |
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(8)

On 31 May 2017 the Authority communicated to the Commission its conclusion (6) on whether forchlorfenuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for forchlorfenuron to the Standing Committee on Plants, Animals, Food and Feed on 5 October 2017.

| (9) | The Commission invited the applicant to submit its comments on the review report for forchlorfenuron. The applicant submitted its comments which have been carefully examined. |
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(9)

The Commission invited the applicant to submit its comments on the review report for forchlorfenuron. The applicant submitted its comments which have been carefully examined.

| (10) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
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(10)

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

| (11) | The risk assessment for the renewal of the approval of forchlorfenuron is based on a limited number of representative uses, which however does not restrict the uses for which plant protection products containing forchlorfenuron may be authorised. It is therefore appropriate not to maintain the restriction to use as a plant growth regulator. |
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(11)

The risk assessment for the renewal of the approval of forchlorfenuron is based on a limited number of representative uses, which however does not restrict the uses for which plant protection products containing forchlorfenuron may be authorised. It is therefore appropriate not to maintain the restriction to use as a plant growth regulator.

| (12) | It is therefore appropriate to renew the approval of forchlorfenuron. |
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(12)

It is therefore appropriate to renew the approval of forchlorfenuron.

| (13) | In accordance with Article 14(1) 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. |
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(13)

In accordance with Article 14(1) 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.

| (14) | In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly. |
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(14)

In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

| (15) | Commission Implementing Regulation (EU) 2017/1511 (7) extended the expiry date of forchlorfenuron to 31 October 2018 in order to allow the renewal process to be completed before the expiry of the approval of that active substance. Given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 June 2018. |
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(15)

Commission Implementing Regulation (EU) 2017/1511 (7) extended the expiry date of forchlorfenuron to 31 October 2018 in order to allow the renewal process to be completed before the expiry of the approval of that active substance. Given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 June 2018.

| (16) | 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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(16)

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

Renewal of the approval of active substance

The approval of the active substance forchlorfenuron is renewed as set out 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 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.

Official Journal of the European Union

It shall apply from 1 June 2018.

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

Done at Brussels, 3 May 2018.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  Commission Directive 2006/10/EC of 27 January 2006 amending Council Directive 91/414/EEC to include forchlorfenuron and indoxacarb as active substances (OJ L 25, 28.1.2006, p. 24).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

(4)  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).

4

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

5

(6)  EFSA Journal 2017;15(6):4874, 18 pp. Available online: www.efsa.europa.eu.

6

(7)  Commission Implementing Regulation (EU) 2017/1511 of 30 August 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, cypermethrin, daminozide, deltamethrin, dimethenamid-p, flufenacet, flurtamone, forchlorfenuron, fosthiazate, indoxacarb, iprodione, MCPA, MCPB, silthiofam, thiophanate-methyl and tribenuron (OJ L 224, 31.8.2017, p. 115).

7

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
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| Forchlorfenuron
  CAS No 68157-60-8
  CIPAC No 633 | 1-(2-chloro-4-pyridyl)-3-phenylurea | ≥ 978 g/kg | 1.6.2018 | 31.5.2033 | 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 forchlorfenuron, 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 as regards the potential risk from metabolites in fruit crops with edible peels. |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Forchlorfenuron

CAS No 68157-60-8

CIPAC No 633

1-(2-chloro-4-pyridyl)-3-phenylurea

≥ 978 g/kg

1.6.2018

31.5.2033

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 forchlorfenuron, 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 as regards the potential risk from metabolites in fruit crops with edible peels.

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

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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

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in Part A, entry 118 on forchlorfenuron is deleted; |
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(1)

in Part A, entry 118 on forchlorfenuron 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘122 | Forchlorfenuron
  CAS No 68157-60-8
  CIPAC No 633 | 1-(2-chloro-4-pyridyl)-3-phenylurea | ≥ 978 g/kg | 1.6.2018 | 31.5.2033 | 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 forchlorfenuron, 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 as regards the potential risk from metabolites in fruit crops with edible peels. |

(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

‘122

Forchlorfenuron

CAS No 68157-60-8

CIPAC No 633

1-(2-chloro-4-pyridyl)-3-phenylurea

≥ 978 g/kg

1.6.2018

31.5.2033

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 forchlorfenuron, 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 as regards the potential risk from metabolites in fruit crops with edible peels.

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

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

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