# L_2015090EN.01000101.xml

| 2.4.2015 | EN | Official Journal of the European Union | L 90/1 |
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2.4.2015

EN

Official Journal of the European Union

L 90/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/543

of 1 April 2015

approving the active substance COS-OGA, 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 22(1) in conjunction with Article 13(2) thereof,

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Whereas:

| (1) | In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Belgium received on 28 June 2012 an application from FytoFend SA for the approval of the active substance COS-OGA. In accordance with Article 9(3) of that Regulation, Belgium, as rapporteur Member State, notified the Commission on 5 December 2012 of the admissibility of the application. |
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(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Belgium received on 28 June 2012 an application from FytoFend SA for the approval of the active substance COS-OGA. In accordance with Article 9(3) of that Regulation, Belgium, as rapporteur Member State, notified the Commission on 5 December 2012 of the admissibility of the application.

| (2) | On 19 December 2013 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority (hereinafter ‘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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(2)

On 19 December 2013 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority (hereinafter ‘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.

| (3) | 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 in September 2014. |
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(3)

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 in September 2014.

| (4) | On 1 October 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance COS-OGA can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public. |
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(4)

On 1 October 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance COS-OGA can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public.

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| (5) | The applicant was given the possibility to submit comments on the review report. |
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(5)

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

| (6) | On 11 December 2014 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for COS-OGA and a draft Regulation providing that COS-OGA is approved. |
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(6)

On 11 December 2014 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for COS-OGA and a draft Regulation providing that COS-OGA is approved.

| (7) | 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 review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve COS-OGA. |
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(7)

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 review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve COS-OGA.

| (8) | The Commission further considers that COS-OGA is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. COS-OGA is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. COS-OGA consists of compounds naturally contained in plants and in some microorganisms and ubiquitous in the environment. The additional exposure of humans, animals and the environment by the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure expected through realistic natural situations. |
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(8)

The Commission further considers that COS-OGA is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. COS-OGA is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. COS-OGA consists of compounds naturally contained in plants and in some microorganisms and ubiquitous in the environment. The additional exposure of humans, animals and the environment by the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure expected through realistic natural situations.

| (9) | It is therefore appropriate to approve COS-OGA as a low risk substance. 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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(9)

It is therefore appropriate to approve COS-OGA as a low risk substance. 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) | 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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(10)

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 active substance

The active substance COS-OGA, as specified in Annex I, is approved 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.

Official Journal of the European Union

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

Done at Brussels, 1 April 2015.

For the Commission

The President

Jean-Claude JUNCKER

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

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(2)  EFSA Journal 2014;12(10):3868.

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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).

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| COS-OGA
  CAS No: not allocated
  CIPAC No: 979 | Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues). | ≥ 915 g/kg






  — | OGA/COS ratio comprised between 1 and 1,6 |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

COS-OGA

CAS No: not allocated

CIPAC No: 979

Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues).

≥ 915 g/kg

—

OGA/COS ratio comprised between 1 and 1,6

| — | Degree of polymerisation of COS comprised between 5 and 10 |
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—

Degree of polymerisation of COS comprised between 5 and 10

| — | Degree of polymerisation of OGA comprised between 9 and 20 |
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—

Degree of polymerisation of OGA comprised between 9 and 20

| — | Degree of methylation of OGA < 10 % |
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—

Degree of methylation of OGA < 10 %

| — | Degree of acetylation of COS < 50 % |
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—

Degree of acetylation of COS < 50 %

22 April 2015

22 April 2030

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 COS-OGA, and in particular Appendices I and II thereof, shall be taken into account.

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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 D 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 |
| --- | --- | --- | --- | --- | --- | --- |
| ‘2 | COS-OGA
  CAS No: not allocated
  CIPAC No: 979 | Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues). | ≥ 915 g/kg






  — | OGA/COS ratio comprised between 1 and 1,6 |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘2

COS-OGA

CAS No: not allocated

CIPAC No: 979

Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues).

≥ 915 g/kg

—

OGA/COS ratio comprised between 1 and 1,6

| — | Degree of polymerisation of COS comprised between 5 and 10 |
| --- | --- |

—

Degree of polymerisation of COS comprised between 5 and 10

| — | Degree of polymerisation of OGA comprised between 9 and 20 |
| --- | --- |

—

Degree of polymerisation of OGA comprised between 9 and 20

| — | Degree of methylation of OGA < 10 % |
| --- | --- |

—

Degree of methylation of OGA < 10 %

| — | Degree of acetylation of COS < 50 % |
| --- | --- |

—

Degree of acetylation of COS < 50 %

22 April 2015

22 April 2030

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 COS-OGA, and in particular Appendices I and II thereof, shall be taken into account.’

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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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