# L_2014145EN.01002801.xml

| 16.5.2014 | EN | Official Journal of the European Union | L 145/28 |
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16.5.2014

EN

Official Journal of the European Union

L 145/28

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COMMISSION IMPLEMENTING REGULATION (EU) No 504/2014

of 15 May 2014

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance plant oils/citronella oil

(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)(c) and Article 78(2) thereof,

Whereas:

| (1) | The active substance plant oils/citronella oil was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (5). |
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(1)

The active substance plant oils/citronella oil was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (5).

| (2) | In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for plant oils/citronella oil (6) on 16 December 2011. The Authority communicated its view on plant oils/citronella oil to the notifier. The Commission invited the notifier to submit comments on the draft review report for plant oils/citronella oil. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft review report was finalised on 3 October 2013 in the format of the Commission review report for plant oils/citronella oil. |
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(2)

In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for plant oils/citronella oil (6) on 16 December 2011. The Authority communicated its view on plant oils/citronella oil to the notifier. The Commission invited the notifier to submit comments on the draft review report for plant oils/citronella oil. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft review report was finalised on 3 October 2013 in the format of the Commission review report for plant oils/citronella oil.

| (3) | It is confirmed that the active substance plant oils/citronella oil is to be deemed to have been approved under Regulation (EC) No 1107/2009. |
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(3)

It is confirmed that the active substance plant oils/citronella oil is to be deemed to have been approved under Regulation (EC) No 1107/2009.

| (4) | 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 necessary to amend the conditions of approval. It is, in particular, appropriate to require further confirmatory information. |
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(4)

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 necessary to amend the conditions of approval. It is, in particular, appropriate to require further confirmatory information.

| (5) | The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(5)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (6) | Member States should be provided with time to amend or withdraw authorisations for plant protection products containing plant oils/citronella oil. |
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(6)

Member States should be provided with time to amend or withdraw authorisations for plant protection products containing plant oils/citronella oil.

| (7) | For plant protection products containing plant oils/citronella oil, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest eighteen months after the date of entry into force of the regulation. |
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(7)

For plant protection products containing plant oils/citronella oil, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest eighteen months after the date of entry into force of the regulation.

| (8) | 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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(8)

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

Amendment to Implementing Regulation (EU) No 540/2011

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

Transitional measures

Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing plant oils/citronella oil as active substance by 5 December 2014.

Article 3

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire 5 December 2015 at the latest.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

Done at Brussels, 15 May 2014.

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 Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89).

3

(4)  Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 379, 24.12.2004, p. 13).

4

(5)  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).

5

(6)  Conclusion on the peer review of the pesticide risk assessment of the active substance plant oils/citronella oil. EFSA Journal 2012; 10(2):2518. [42 pp.] doi:10.2903/j.efsa.2012.2518 Available online: www.efsa.europa.eu/efsajournal

6

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ANNEX

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 240 on the active substance plant oils/citronella oil is replaced by the following:

| Number | Common Name,
  Identification Numbers | IUPAC Name | Purity | Date of approval | Expiration of approval | Specific provisions |
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| ‘240 | Plant oils/citronella oil
  CAS No 8000-29-1
  CIPAC No 905 | Citronella Oil is a complex mixture of chemical substances.
  The main components are: | Citronellal (3,7-dimethyl-6-octenal). |

Number

Common Name,

Identification Numbers

IUPAC Name

Purity

Date of approval

Expiration of approval

Specific provisions

‘240

Plant oils/citronella oil

CAS No 8000-29-1

CIPAC No 905

Citronella Oil is a complex mixture of chemical substances.

The main components are:

Citronellal (3,7-dimethyl-6-octenal).

| | Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol). |
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Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).

| | Citronellol (3,7-dimethyl-6-octan-2-ol). |
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Citronellol (3,7-dimethyl-6-octan-2-ol).

| | Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate). |
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Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).

The sum of the following impurities must not exceed 0,1 % of technical material: methyl eugenol and methyl-isoeugenol.

1 September 2009

31 August 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

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

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

| — | the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; |
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—

the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

| — | the protection of groundwater, when the substance is applied in regions with vulnerable soil; |
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—

the protection of groundwater, when the substance is applied in regions with vulnerable soil;

| — | the risk to non-target organisms. |
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—

the risk to non-target organisms.

The notifier shall submit confirmatory information as regards:

| (a) | the technical specification; |
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(a)

the technical specification;

| (b) | data comparing natural background exposure situations of plant oils/citronella oil and methyl eugenol and methyl isoeugenol in relation to exposure from the use of plant oils/citronella oil as a plant protection product. This data shall cover human exposure as well as exposure of non-target organisms; |
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(b)

data comparing natural background exposure situations of plant oils/citronella oil and methyl eugenol and methyl isoeugenol in relation to exposure from the use of plant oils/citronella oil as a plant protection product. This data shall cover human exposure as well as exposure of non-target organisms;

| (c) | the groundwater exposure assessment for potential metabolites of plant oils/citronella oil, in particular for methyl eugenol and methyl isoeugenol. |
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(c)

the groundwater exposure assessment for potential metabolites of plant oils/citronella oil, in particular for methyl eugenol and methyl isoeugenol.

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

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