# L_2013309EN.01001701.xml

| 19.11.2013 | EN | Official Journal of the European Union | L 309/17 |
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19.11.2013

EN

Official Journal of the European Union

L 309/17

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COMMISSION IMPLEMENTING REGULATION (EU) No 1165/2013

of 18 November 2013

approving the active substance orange oil, 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) and Article 78(2) thereof,

Whereas:

| (1) | In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For orange oil the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2009/438/EC (3). |
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(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For orange oil the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2009/438/EC (3).

| (2) | In accordance with Article 6(2) of Directive 91/414/EEC France received on 22 February 2008 an application from Oro Agri for the inclusion of the active substance orange oil in Annex I to Directive 91/414/EEC. Decision 2009/438/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. |
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(2)

In accordance with Article 6(2) of Directive 91/414/EEC France received on 22 February 2008 an application from Oro Agri for the inclusion of the active substance orange oil in Annex I to Directive 91/414/EEC. Decision 2009/438/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

| (3) | For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 12 August 2009. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 13 June 2012. The evaluation of the additional data by France was submitted in the format of an updated draft assessment report in November 2012. |
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(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 12 August 2009. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 13 June 2012. The evaluation of the additional data by France was submitted in the format of an updated draft assessment report in November 2012.

| (4) | The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion (5) on the pesticide risk assessment of the active substance orange oil on 1 March 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 3 October 2013 in the format of the Commission review report for orange oil. |
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(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion (5) on the pesticide risk assessment of the active substance orange oil on 1 March 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 3 October 2013 in the format of the Commission review report for orange oil.

| (5) | It has appeared from the various examinations made that plant protection products containing orange oil may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve orange oil. |
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(5)

It has appeared from the various examinations made that plant protection products containing orange oil may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve orange oil.

| (6) | 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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(6)

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.

| (7) | A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval. |
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(7)

A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

| (8) | Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing orange oil. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles. |
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(8)

Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing orange oil. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

| (9) | The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances. |
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(9)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

| (10) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (7) 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 (7) should be amended accordingly.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Approval of active substance

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

Article 2

Re-evaluation of plant protection products

1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing orange oil as an active substance by 31 October 2014.

By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing orange oil as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 April 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.

Following that determination Member States shall:

| (a) | in the case of a product containing orange oil as the only active substance, where necessary, amend or withdraw the authorisation by 31 October 2015 at the latest; or |
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(a)

in the case of a product containing orange oil as the only active substance, where necessary, amend or withdraw the authorisation by 31 October 2015 at the latest; or

| (b) | in the case of a product containing orange oil as one of several active substances, where necessary, amend or withdraw the authorisation by 31 October 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest. |
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(b)

in the case of a product containing orange oil as one of several active substances, where necessary, amend or withdraw the authorisation by 31 October 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

Article 3

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 4

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 May 2014.

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

Done at Brussels, 18 November 2013.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  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).

2

(3)  Commission Decision 2009/438/EC of 8 June 2009 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of orange oil in Annex I to Council Directive 91/414/EEC (OJ L 145, 10.6.2009, p. 47).

3

(4)  Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).

4

(5)  
  EFSA Journal 2013; 11(2):3090. Available online: www.efsa.europa.eu

5

EFSA Journal

(6)  Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10).

6

(7)  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).

7

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Orange oil
  CAS No 8028-48-6 (Orange extract)
  5989-27-5 (D-limonene)
  CIPAC No 902 | (R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene | ≥ 945 g/kg (of D-limonene)
  The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E) | 1 May 2014 | 30 April 2024 | 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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the protection of operators and workers; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Orange oil

CAS No 8028-48-6 (Orange extract)

5989-27-5 (D-limonene)

CIPAC No 902

(R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene

≥ 945 g/kg (of D-limonene)

The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E)

1 May 2014

30 April 2024

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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.

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

(a)

the protection of operators and workers;

| (b) | the risk to birds and mammals. |
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(b)

the risk to birds and mammals.

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

The applicant shall submit confirmatory information as regards

| (1) | the metabolite fate of orange oil and the route and rate of degradation in soil; |
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(1)

the metabolite fate of orange oil and the route and rate of degradation in soil;

| (2) | the validation of endpoints used in the ecotoxicological risk assessment. |
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(2)

the validation of endpoints used in the ecotoxicological risk assessment.

The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016.

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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:

| Number | Common Name, Identification Numbers | IUPAC Name | Purity (*1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘56 | Orange oil
  CAS No 8028-48-6 (Orange extract)
  5989-27-5 (D-limonene)
  CIPAC No 902 | (R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene | ≥ 945 g/kg (of D-limonene)
  The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E) | 1 May 2014 | 30 April 2024 | 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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the protection of operators and workers; |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (*1)

Date of approval

Expiration of approval

Specific provisions

‘56

Orange oil

CAS No 8028-48-6 (Orange extract)

5989-27-5 (D-limonene)

CIPAC No 902

(R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene

≥ 945 g/kg (of D-limonene)

The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E)

1 May 2014

30 April 2024

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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.

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

(a)

the protection of operators and workers;

| (b) | the risk to birds and mammals. |
| --- | --- |

(b)

the risk to birds and mammals.

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

The applicant shall submit confirmatory information as regards the metabolite fate of orange oil and the route and rate of degradation in soil and on the validation of endpoints used in the ecotoxicological risk assessment.

The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016.’

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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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