# Official Journal L 175/2011

| | ISSN 1725-2555
  doi:10.3000/17252555.L_2011.175.eng |
| --- | --- |
| Official Journal
  of the European Union | L 175 |
| | |
| English edition | Legislation | Volume 542 July 2011 |

ISSN 1725-2555

doi:10.3000/17252555.L_2011.175.eng

Official Journal

of the European Union

L 175

English edition

Legislation

Volume 542 July 2011

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) No 643/2011 of 1 July 2011 amending Regulation (EU) No 642/2010 as regards import duties on sorghum and rye | 1 |
| | * | Commission Implementing Regulation (EU) No 644/2011 of 1 July 2011 opening tendering procedure No 1/2011 EU for the sale of wine alcohol for new industrial uses | 3 |
| | | Commission Implementing Regulation (EU) No 645/2011 of 1 July 2011 establishing the standard import values for determining the entry price of certain fruit and vegetables | 6 |
| | | Commission Implementing Regulation (EU) No 646/2011 of 1 July 2011 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EU) No 867/2010 for the 2010/11 marketing year | 8 |
| | | DIRECTIVES |
| | * | Commission Directive 2011/66/EU of 1 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an active substance in Annex I thereto (
  1
  ) | 10 |
| | * | Commission Directive 2011/67/EU of 1 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include abamectin as an active substance in Annex I thereto (
  1
  ) | 13 |
| | * | Commission Implementing Directive 2011/68/EU of 1 July 2011 amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directives 2002/53/EC and 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species (
  1
  ) | 17 |
| | * | Commission Directive 2011/69/EU of 1 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include imidacloprid as an active substance in Annex I thereto (
  1
  ) | 24 |
| | | DECISIONS |
| | | 2011/390/CFSP |
| | * | Political and Security Committee Decision EUMM/1/2011 of 1 July 2011 on the appointment of the Head of Mission of the European Union Monitoring Mission in Georgia, EUMM Georgia | 27 |
| | | 2011/391/EU |
| | * | Commission Decision of 1 July 2011 concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market
  (notified under document C(2011) 4596)

   (
  1
  ) | 28 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) No 643/2011 of 1 July 2011 amending Regulation (EU) No 642/2010 as regards import duties on sorghum and rye

1

*

Commission Implementing Regulation (EU) No 644/2011 of 1 July 2011 opening tendering procedure No 1/2011 EU for the sale of wine alcohol for new industrial uses

3

Commission Implementing Regulation (EU) No 645/2011 of 1 July 2011 establishing the standard import values for determining the entry price of certain fruit and vegetables

6

Commission Implementing Regulation (EU) No 646/2011 of 1 July 2011 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EU) No 867/2010 for the 2010/11 marketing year

8

DIRECTIVES

*

Commission Directive 2011/66/EU of 1 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an active substance in Annex I thereto (
  1
  )

1

10

*

Commission Directive 2011/67/EU of 1 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include abamectin as an active substance in Annex I thereto (
  1
  )

1

13

*

Commission Implementing Directive 2011/68/EU of 1 July 2011 amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directives 2002/53/EC and 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species (
  1
  )

1

17

*

Commission Directive 2011/69/EU of 1 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include imidacloprid as an active substance in Annex I thereto (
  1
  )

1

24

DECISIONS

2011/390/CFSP

*

Political and Security Committee Decision EUMM/1/2011 of 1 July 2011 on the appointment of the Head of Mission of the European Union Monitoring Mission in Georgia, EUMM Georgia

27

2011/391/EU

*

Commission Decision of 1 July 2011 concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market
  (notified under document C(2011) 4596)

   (
  1
  )

(notified under document C(2011) 4596)

1

28

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

---

II Non-legislative acts

REGULATIONS

| 2.7.2011 | EN | Official Journal of the European Union | L 175/1 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/1

---

COMMISSION IMPLEMENTING REGULATION (EU) No 643/2011

of 1 July 2011

amending Regulation (EU) No 642/2010 as regards import duties on sorghum and rye

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 143 in conjunction with Article 4 thereof,

Whereas:

| (1) | Article 5(4) of Commission Regulation (EU) No 642/2010 of 20 July 2010 on rules of application (cereal sector import duties) for Council Regulation (EC) No 1234/2007 (2) stipulates that the representative cif import price determined for barley shall be used for calculating import duties on sorghum and rye. |
| --- | --- |

(1)

Article 5(4) of Commission Regulation (EU) No 642/2010 of 20 July 2010 on rules of application (cereal sector import duties) for Council Regulation (EC) No 1234/2007 (2) stipulates that the representative cif import price determined for barley shall be used for calculating import duties on sorghum and rye.

| (2) | Trends in the barley market and the minor importance of the United States on the world market for this product mean that barley no longer provides an estimate of the sorghum market. Furthermore, the sources of information on the sorghum market are too few or too unreliable to provide a basis for setting import duties for this product. Lastly, it appears from the sources available that the prices of sorghum and of maize exported from the United States are very close to one another. Consequently, the representative cif import price calculated for maize should be applied to sorghum. Furthermore, the existing equality between the duties that apply to rye and those that apply to sorghum should be maintained. |
| --- | --- |

(2)

Trends in the barley market and the minor importance of the United States on the world market for this product mean that barley no longer provides an estimate of the sorghum market. Furthermore, the sources of information on the sorghum market are too few or too unreliable to provide a basis for setting import duties for this product. Lastly, it appears from the sources available that the prices of sorghum and of maize exported from the United States are very close to one another. Consequently, the representative cif import price calculated for maize should be applied to sorghum. Furthermore, the existing equality between the duties that apply to rye and those that apply to sorghum should be maintained.

| (3) | Regulation (EU) No 642/2010 should therefore be amended accordingly. |
| --- | --- |

(3)

Regulation (EU) No 642/2010 should therefore be amended accordingly.

| (4) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 642/2010 is amended as follows:

| 1. | Article 5 shall be amended as follows:






  (a) | the introductory phrase of paragraph 1 is replaced by the following:

  ‘For common wheat of high quality, durum wheat and maize referred to in Article 2(1) of this Regulation, the components determining the representative cif import prices referred to in Article 136(2) of Regulation (EC) No 1234/2007 shall be:’; |
| --- | --- | --- |

1.

Article 5 shall be amended as follows:

(a)

the introductory phrase of paragraph 1 is replaced by the following:

‘For common wheat of high quality, durum wheat and maize referred to in Article 2(1) of this Regulation, the components determining the representative cif import prices referred to in Article 136(2) of Regulation (EC) No 1234/2007 shall be:’;

| (b) | paragraph 4 is replaced by the following:

  ‘4.   The representative cif import prices for durum wheat, high quality common wheat and maize shall be the sum of the components referred to in points (a), (b) and (c) of paragraph 1. The representative cif import prices for sorghum and rye shall be those calculated for maize.’; |
| --- | --- |

(b)

paragraph 4 is replaced by the following:

‘4.   The representative cif import prices for durum wheat, high quality common wheat and maize shall be the sum of the components referred to in points (a), (b) and (c) of paragraph 1. The representative cif import prices for sorghum and rye shall be those calculated for maize.’;

| 2. | Annex III is replaced by the text set out in the Annex to this Regulation. |
| --- | --- |

2.

Annex III is replaced by the text set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the third day following 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, 1 July 2011.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 299, 16.11.2007, p. 1.

1

(2)  
  OJ L 187, 21.7.2010, p. 5.

2

---

ANNEX

‘ANNEX III

Quotation exchanges and reference varieties

| Product | Common wheat | Durum wheat | Maize |
| --- | --- | --- | --- |
| Standard quality | High | | |
| Reference variety (type/grade) for exchange quotation | Hard Red Spring No 2 | Hard Amber Durum No 2 | Yellow Corn No 3 |
| Quotation exchange | Minneapolis
  Grain Exchange | Minneapolis
  Grain Exchange (1) | Chicago Board of Trade |

Product

Common wheat

Durum wheat

Maize

Standard quality

High

Reference variety (type/grade) for exchange quotation

Hard Red Spring No 2

Hard Amber Durum No 2

Yellow Corn No 3

Quotation exchange

Minneapolis

Grain Exchange

Minneapolis

Grain Exchange (1)

Chicago Board of Trade

---

(1)  Where no quotation is available that can be used to calculate a representative cif import price, fob quotations publicly available in the United States of America shall be used.’

1

---

| 2.7.2011 | EN | Official Journal of the European Union | L 175/3 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/3

---

COMMISSION IMPLEMENTING REGULATION (EU) No 644/2011

of 1 July 2011

opening tendering procedure No 1/2011 EU for the sale of wine alcohol for new industrial uses

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (1), and in particular Article 33 thereof,

Whereas:

| (1) | Article 3(2) of Council Regulation (EC) No 491/2009 of 25 May 2009 amending Regulation (EC) No 1234/2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (2) stipulates that Article 128(3) of Council Regulation (EC) No 479/2008 of 29 April 2008 on the common organisation of the market in wine, amending Regulations (EC) No 1493/1999, (EC) No 1782/2003, (EC) No 1290/2005 and (EC) No 3/2008 and repealing Regulations (EEC) No 2392/86 and (EC) No 1493/1999 (3) continues to apply even though the latter regulation has been repealed. |
| --- | --- |

(1)

Article 3(2) of Council Regulation (EC) No 491/2009 of 25 May 2009 amending Regulation (EC) No 1234/2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (2) stipulates that Article 128(3) of Council Regulation (EC) No 479/2008 of 29 April 2008 on the common organisation of the market in wine, amending Regulations (EC) No 1493/1999, (EC) No 1782/2003, (EC) No 1290/2005 and (EC) No 3/2008 and repealing Regulations (EEC) No 2392/86 and (EC) No 1493/1999 (3) continues to apply even though the latter regulation has been repealed.

| (2) | Article 128 of Council Regulation (EC) No 479/2008 stipulates that the measures concerning market mechanisms set out in Title III of Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (4) continue to apply even if the latter regulation is repealed, if those measures have been initiated or undertaken by 1 August 2008. Similarly, pursuant to Article 103 of Commission Regulation (EC) No 555/2008 of 27 June 2008 laying down detailed rules for implementing Council Regulation (EC) No 479/2008 on the common organisation of the market in wine (5) as regards support programmes, trade with third countries, production potential and on controls in the wine sector, the relevant rules set out in Commission Regulation (EC) No 1623/2000 of 25 July 2000 laying down detailed rules for implementing Regulation (EC) No 1493/1999 on the common organisation of the market in wine with regard to market mechanisms (6) continue to apply even though Regulation (EC) No 1623/2000 has been repealed, in so far as those rules relate to measures commenced before 1 August 2008. |
| --- | --- |

(2)

Article 128 of Council Regulation (EC) No 479/2008 stipulates that the measures concerning market mechanisms set out in Title III of Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (4) continue to apply even if the latter regulation is repealed, if those measures have been initiated or undertaken by 1 August 2008. Similarly, pursuant to Article 103 of Commission Regulation (EC) No 555/2008 of 27 June 2008 laying down detailed rules for implementing Council Regulation (EC) No 479/2008 on the common organisation of the market in wine (5) as regards support programmes, trade with third countries, production potential and on controls in the wine sector, the relevant rules set out in Commission Regulation (EC) No 1623/2000 of 25 July 2000 laying down detailed rules for implementing Regulation (EC) No 1493/1999 on the common organisation of the market in wine with regard to market mechanisms (6) continue to apply even though Regulation (EC) No 1623/2000 has been repealed, in so far as those rules relate to measures commenced before 1 August 2008.

| (3) | Stocks of wine alcohol acquired before 1 August 2008 must be disposed of. In accordance with Article 128(3)(b) of Regulation (EC) No 479/2008 and Article 103(1)(a) of Regulation (EC) No 555/2008, Article 31 of Regulation (EC) No 1493/1999 and Chapter IV of Regulation (EC) No 1623/2000 continue to apply for this measure. |
| --- | --- |

(3)

Stocks of wine alcohol acquired before 1 August 2008 must be disposed of. In accordance with Article 128(3)(b) of Regulation (EC) No 479/2008 and Article 103(1)(a) of Regulation (EC) No 555/2008, Article 31 of Regulation (EC) No 1493/1999 and Chapter IV of Regulation (EC) No 1623/2000 continue to apply for this measure.

| (4) | Regulation (EC) No 1623/2000 lays down, inter alia, the detailed rules for disposing of stocks of alcohol arising from distillation pursuant to Articles 27, 28 and 30 of Regulation (EC) No 1493/1999 held by intervention agencies. |
| --- | --- |

(4)

Regulation (EC) No 1623/2000 lays down, inter alia, the detailed rules for disposing of stocks of alcohol arising from distillation pursuant to Articles 27, 28 and 30 of Regulation (EC) No 1493/1999 held by intervention agencies.

| (5) | In accordance with Article 80 of Regulation (EC) No 1623/2000, a tendering procedure should be organised for the sale of wine alcohol for new industrial uses with a view to reducing the stocks of wine alcohol in the Union and enabling small-scale industrial projects to be carried out in the Union. The wine alcohol of EU origin in storage in the Member States consists of quantities produced from distillation pursuant to Articles 27, 28 and 30 of Regulation (EC) No 1493/1999. |
| --- | --- |

(5)

In accordance with Article 80 of Regulation (EC) No 1623/2000, a tendering procedure should be organised for the sale of wine alcohol for new industrial uses with a view to reducing the stocks of wine alcohol in the Union and enabling small-scale industrial projects to be carried out in the Union. The wine alcohol of EU origin in storage in the Member States consists of quantities produced from distillation pursuant to Articles 27, 28 and 30 of Regulation (EC) No 1493/1999.

| (6) | Minimum prices should be fixed for the submission of tenders, broken down according to the type of end-use. |
| --- | --- |

(6)

Minimum prices should be fixed for the submission of tenders, broken down according to the type of end-use.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

1.   Pursuant to this Regulation, which constitutes a notice of invitation to tender within the meaning of Article 81 of Regulation (EC) No 1623/2000, the sale shall take place of wine alcohol for new industrial uses.

The tendering procedure shall be No 01/2011 EU.

The alcohol concerned has been produced from distillation pursuant to Articles 27, 28 and 30 of Regulation (EC) No 1493/1999 and is held by the Cypriot and Hungarian intervention agencies.

2.   The volume put up for sale is 61 834,8931 hectolitres of alcohol at 100 % vol. The vat numbers, places of storage and the volume of alcohol at 100 % vol. contained in each vat are detailed in the Annex hereto.

Article 2

The sale shall be conducted in accordance with Articles 79, 81, 82, 83, 84, 85, 96, 97, 98, 99, 100, 101 and 102 of Regulation (EC) No 1623/2000.

Article 3

1.   Tenders must be submitted to the intervention agencies holding the alcohol concerned:

| | Hungarian intervention agency:





  Mezőgazdasági és Vidékfejlesztési Hivatal |
| --- | --- |
| Budapest |
| Soroksári út 22-24. |
| 1095 |
| HUNGARY |
| Tel. +36 12196260 |
| Fax +36 15771317 |
| Postal address: 1385 Budapest 62. Pf. 867 |
| E-mail: ertekesites@mvh.gov.hu |
| Internet: http://www.mvh.gov.hu/ |

Hungarian intervention agency:

Mezőgazdasági és Vidékfejlesztési Hivatal

Budapest

Soroksári út 22-24.

1095

HUNGARY

Tel. +36 12196260

Fax +36 15771317

Postal address: 1385 Budapest 62. Pf. 867

E-mail: ertekesites@mvh.gov.hu

Internet: http://www.mvh.gov.hu/

| | Cypriot intervention agency:





  Wine Products Council |
| --- | --- |
| Petra Business Centre |
| Franklin Roosevelt Street 86 |
| 3011 Limassol |
| CYPRUS |
| E-mail: extaff@wpc.org.cy |
| Internet: http://www.wpc.org.cy/en_index.html |

Cypriot intervention agency:

Wine Products Council

Petra Business Centre

Franklin Roosevelt Street 86

3011 Limassol

CYPRUS

E-mail: extaff@wpc.org.cy

Internet: http://www.wpc.org.cy/en_index.html

2.   Tenders shall be submitted in a sealed double envelope, the inside envelope marked: ‘Tender under procedure No 01/2011 EU for new industrial uses’, the outer envelope bearing the address of the intervention agency concerned.

3.   Tenders must reach the intervention agency concerned not later than 12:00 Brussels time on the third Tuesday following the date of publication of this Regulation.

4.   All tenders must be accompanied by proof that a tendering security of EUR 4 per hectolitre of alcohol at 100 % vol. has been lodged with the intervention agency concerned.

Article 4

The minimum prices which may be offered are EUR 5 per hectolitre of alcohol at 100 % vol. intended for use as fuel in boiler rooms and cement works and EUR 30 per hectolitre of alcohol at 100 % vol. intended for manufacturing other industrial products, particularly antifreezes and detergents.

Article 5

The formalities for sampling shall be as set out in Article 98 of Regulation (EC) No 1623/2000. The price of samples shall be EUR 10 per litre.

The intervention agency shall provide all the necessary information on the characteristics of the alcohol put up for sale.

Article 6

The performance guarantee shall be EUR 30 per hectolitre of alcohol at 100 % vol.

Article 7

This Regulation shall enter into force on the third day following 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, 1 July 2011.

For the Commission, On behalf of the President,

Dacian CIOLOŞ

Member of the Commission

---

(1)  
  OJ L 179, 14.7.1999, p. 1.

1

(2)  
  OJ L 154, 17.6.2009, p. 1.

2

(3)  
  OJ L 148, 6.6.2008, p. 1.

3

(4)  
  OJ L 179, 14.7.1999, p. 1.

4

(5)  
  OJ L 170, 30.6.2008, p. 1.

5

(6)  
  OJ L 194, 31.7.2000, p. 45.

6

---

ANNEX

INVITATION TO TENDER No 01/2011 EU FOR THE SALE OF ALCOHOL FOR NEW INDUSTRIAL USES

| Place of storage, volume and characteristics of the alcohol put up for sale |
| --- |
| Member State | Location and contact | Number of the vats/Number of the batches | Quantity in hectolitres of alcohol at 100 % vol. | Reference to the Article of Regulation (EC) No 1493/1999 | Type of alcohol | Alcoholic strength
  (in % vol.) |
| Hungary | Tartalégazdálkodási Kht |
| Szöke József |
| 7041 Vajta, |
| Kerekerdei telep |
| Hrsz.0179/7 |
| Tel./Fax +36 25229176 |
| County: Fejér |

Place of storage, volume and characteristics of the alcohol put up for sale

Member State

Location and contact

Number of the vats/Number of the batches

Quantity in hectolitres of alcohol at 100 % vol.

Reference to the Article of Regulation (EC) No 1493/1999

Type of alcohol

Alcoholic strength

(in % vol.)

Hungary

Tartalégazdálkodási Kht

Szöke József

7041 Vajta,

Kerekerdei telep

Hrsz.0179/7

Tel./Fax +36 25229176

County: Fejér

| T-3 | ALK01 |
| --- | --- |

T-3

ALK01

16 826,9197

29 + 30

raw

93-94,5 %

| T-8 | ALK02 |
| --- | --- |

T-8

ALK02

16 129,0143

29 + 30

raw

93-94,5 %

| Tartalégazdálkodási Kht |
| --- |
| Mihályi Zoltán |
| 5130 Jászapáti, |
| Tanya hrsz.266 |
| Tel./Fax +36 57540950 |
| County: Jász-Nagykun-Szolnok |

Tartalégazdálkodási Kht

Mihályi Zoltán

5130 Jászapáti,

Tanya hrsz.266

Tel./Fax +36 57540950

County: Jász-Nagykun-Szolnok

| 7 | ALK03 |
| --- | --- |

7

ALK03

4 503,8456

29 + 30

raw

93-94,5 %

| 8 | ALK04 |
| --- | --- |

8

ALK04

3 501,0925

29 + 30

raw

93-94,5 %

| 9 | ALK05 |
| --- | --- |

9

ALK05

4 607,8723

29 + 30

raw

93-94,5 %

| 10 | ALK06 |
| --- | --- |

10

ALK06

4 510,6906

29 + 30

raw

93-94,5 %

| 12 | ALK07 |
| --- | --- |

12

ALK07

4 558,2781

29 + 30

raw

93-94,5 %

Total

54 637,7131

Cyprus

Wine Products Council

(Zakaki, Limassol)

4

1 765,54

27

raw

94,23  %

2

1 484,27

27

raw

92,75  %

3

1 229,23

27

raw

93,79  %

5

1 356,93

27

raw

93,03  %

6

1 361,21

27

raw

93,93  %

Total

7 197,18

Grand total

61 834,8931

---

| 2.7.2011 | EN | Official Journal of the European Union | L 175/6 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/6

---

COMMISSION IMPLEMENTING REGULATION (EU) No 645/2011

of 1 July 2011

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex hereto.

Article 2

This Regulation shall enter into force on 2 July 2011.

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

Done at Brussels, 1 July 2011.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 299, 16.11.2007, p. 1.

1

(2)  
  OJ L 157, 15.6.2011, p. 1.

2

---

ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | AL | 49,0 |
| AR | 26,0 |
| EC | 26,0 |
| MK | 31,8 |
| TR | 40,0 |
| ZZ | 34,6 |
| 0707 00 05 | TR | 97,3 |
| ZZ | 97,3 |
| 0709 90 70 | EC | 28,8 |
| TR | 112,4 |
| ZZ | 70,6 |
| 0805 50 10 | AR | 63,8 |
| BR | 42,9 |
| CL | 88,7 |
| TR | 73,2 |
| UY | 59,6 |
| ZA | 86,1 |
| ZZ | 69,1 |
| 0808 10 80 | AR | 133,6 |
| BR | 79,2 |
| CL | 89,9 |
| CN | 75,7 |
| NZ | 111,7 |
| US | 140,0 |
| UY | 61,9 |
| ZA | 82,9 |
| ZZ | 96,9 |
| 0809 10 00 | AR | 89,7 |
| TR | 286,7 |
| XS | 152,4 |
| ZZ | 176,3 |
| 0809 20 95 | TR | 339,4 |
| ZZ | 339,4 |
| 0809 30 | TR | 179,1 |
| XS | 55,8 |
| ZZ | 117,5 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

AL

49,0

AR

26,0

EC

26,0

MK

31,8

TR

40,0

ZZ

34,6

0707 00 05

TR

97,3

ZZ

97,3

0709 90 70

EC

28,8

TR

112,4

ZZ

70,6

0805 50 10

AR

63,8

BR

42,9

CL

88,7

TR

73,2

UY

59,6

ZA

86,1

ZZ

69,1

0808 10 80

AR

133,6

BR

79,2

CL

89,9

CN

75,7

NZ

111,7

US

140,0

UY

61,9

ZA

82,9

ZZ

96,9

0809 10 00

AR

89,7

TR

286,7

XS

152,4

ZZ

176,3

0809 20 95

TR

339,4

ZZ

339,4

0809 30

TR

179,1

XS

55,8

ZZ

117,5

---

(1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘
  ZZ
  ’ stands for ‘of other origin’.

---

| 2.7.2011 | EN | Official Journal of the European Union | L 175/8 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/8

---

COMMISSION IMPLEMENTING REGULATION (EU) No 646/2011

of 1 July 2011

amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EU) No 867/2010 for the 2010/11 marketing year

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (single CMO Regulation) (1),

Having regard to Commission Regulation (EC) No 951/2006 of 30 June 2006 laying down detailed rules for the implementation of Council Regulation (EC) No 318/2006 as regards trade with third countries in the sugar sector (2), and in particular Article 36(2), second subparagraph, second sentence thereof,

Whereas:

| (1) | The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2010/11 marketing year are fixed by Commission Regulation (EU) No 867/2010 (3). These prices and duties have been last amended by Commission Implementing Regulation (EU) No 639/2011 (4). |
| --- | --- |

(1)

The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2010/11 marketing year are fixed by Commission Regulation (EU) No 867/2010 (3). These prices and duties have been last amended by Commission Implementing Regulation (EU) No 639/2011 (4).

| (2) | The data currently available to the Commission indicate that those amounts should be amended in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006, |
| --- | --- |

(2)

The data currently available to the Commission indicate that those amounts should be amended in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006,

HAS ADOPTED THIS REGULATION:

Article 1

The representative prices and additional duties applicable to imports of the products referred to in Article 36 of Regulation (EC) No 951/2006, as fixed by Regulation (EU) No 867/2010 for the 2010/11 marketing year, are hereby amended as set out in the Annex hereto.

Article 2

This Regulation shall enter into force on 2 July 2011.

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

Done at Brussels, 1 July 2011.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 299, 16.11.2007, p. 1.

1

(2)  
  OJ L 178, 1.7.2006, p. 24.

2

(3)  
  OJ L 259, 1.10.2010, p. 3.

3

(4)  
  OJ L 170, 30.6.2011, p. 34.

4

---

ANNEX

Amended representative prices and additional import duties applicable to white sugar, raw sugar and products covered by CN code 1702 90 95 from 2 July 2011

| (EUR) |
| --- |
| CN code | Representative price per 100 kg net of the product concerned | Additional duty per 100 kg net of the product concerned |
| 1701 11 10  (1) | 49,09 | 0,00 |
| 1701 11 90  (1) | 49,09 | 0,18 |
| 1701 12 10  (1) | 49,09 | 0,00 |
| 1701 12 90  (1) | 49,09 | 0,00 |
| 1701 91 00  (2) | 51,08 | 2,15 |
| 1701 99 10  (2) | 51,08 | 0,00 |
| 1701 99 90  (2) | 51,08 | 0,00 |
| 1702 90 95  (3) | 0,51 | 0,21 |

(EUR)

CN code

Representative price per 100 kg net of the product concerned

Additional duty per 100 kg net of the product concerned

1701 11 10  (1)

49,09

0,00

1701 11 90  (1)

49,09

0,18

1701 12 10  (1)

49,09

0,00

1701 12 90  (1)

49,09

0,00

1701 91 00  (2)

51,08

2,15

1701 99 10  (2)

51,08

0,00

1701 99 90  (2)

51,08

0,00

1702 90 95  (3)

0,51

0,21

---

(1)  For the standard quality defined in point III of Annex IV to Regulation (EC) No 1234/2007.

(2)  For the standard quality defined in point II of Annex IV to Regulation (EC) No 1234/2007.

(3)  Per 1 % sucrose content.

---

DIRECTIVES

| 2.7.2011 | EN | Official Journal of the European Union | L 175/10 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/10

---

COMMISSION DIRECTIVE 2011/66/EU

of 1 July 2011

amending Directive 98/8/EC of the European Parliament and of the Council to include 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes 4,5-Dichloro-2-octyl-2H-isothiazol-3-one. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes 4,5-Dichloro-2-octyl-2H-isothiazol-3-one.

| (2) | Pursuant to Regulation (EC) No 1451/2007, 4,5-Dichloro-2-octyl-2H-isothiazol-3-one has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, 4,5-Dichloro-2-octyl-2H-isothiazol-3-one has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive.

| (3) | Norway was designated as Rapporteur and submitted the competent authority report, together with a recommendation, to the Commission on 8 September 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Norway was designated as Rapporteur and submitted the competent authority report, together with a recommendation, to the Commission on 8 September 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 16 December 2010, in an assessment report. |
| --- | --- |

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 16 December 2010, in an assessment report.

| (5) | It appears from the evaluations that biocidal products used as wood preservatives and containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include 4,5-Dichloro-2-octyl-2H-isothiazol-3-one in Annex I to that Directive. |
| --- | --- |

(5)

It appears from the evaluations that biocidal products used as wood preservatives and containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include 4,5-Dichloro-2-octyl-2H-isothiazol-3-one in Annex I to that Directive.

| (6) | Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. |
| --- | --- |

(6)

Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

| (7) | In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established for products authorised for industrial or professional use, and that those products are used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means. |
| --- | --- |

(7)

In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established for products authorised for industrial or professional use, and that those products are used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means.

| (8) | In view of the risks identified for the aquatic and terrestrial compartments, it is appropriate to require that freshly treated timber is stored after treatment under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood preservatives and containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one are collected for reuse or disposal. |
| --- | --- |

(8)

In view of the risks identified for the aquatic and terrestrial compartments, it is appropriate to require that freshly treated timber is stored after treatment under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood preservatives and containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one are collected for reuse or disposal.

| (9) | Unacceptable risks for the environment were identified in various scenarios for in-service use of treated wood not covered and not in contact with the ground, which is either continually exposed to the weather or protected from the weather but subject to frequent wetting (use class 3 as defined by OECD (3)) and wood in contact with fresh water (use class 4b as defined by OECD (4)). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures. |
| --- | --- |

(9)

Unacceptable risks for the environment were identified in various scenarios for in-service use of treated wood not covered and not in contact with the ground, which is either continually exposed to the weather or protected from the weather but subject to frequent wetting (use class 3 as defined by OECD (3)) and wood in contact with fresh water (use class 4b as defined by OECD (4)). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

| (10) | It is important that the provisions of this Directive be applied simultaneously in all Member States in order to ensure equal treatment of biocidal products on the market containing the active substance 4,5-Dichloro-2-octyl-2H-isothiazol-3-one and also to facilitate the proper operation of the biocidal products market in general. |
| --- | --- |

(10)

It is important that the provisions of this Directive be applied simultaneously in all Member States in order to ensure equal treatment of biocidal products on the market containing the active substance 4,5-Dichloro-2-octyl-2H-isothiazol-3-one and also to facilitate the proper operation of the biocidal products market in general.

| (11) | A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion. |
| --- | --- |

(11)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

| (12) | After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(12)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

| (13) | Directive 98/8/EC should therefore be amended accordingly. |
| --- | --- |

(13)

Directive 98/8/EC should therefore be amended accordingly.

| (14) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(14)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.

Article 2

Transposition

1.   Member States shall adopt and publish, by 30 June 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 July 2013.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 1 July 2011.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 123, 24.4.1998, p. 1.

1

(2)  
  OJ L 325, 11.12.2007, p. 3.

2

(3)  OECD series on emission scenario documents, Number 2, Emission Scenario Document for Wood Preservatives, Part 2, p. 64.

3

(4)  Ibid.

4

---

ANNEX

In Annex I to Directive 98/8/EC, the following entry is added:

| No | Common Name | IUPAC Name
  Identification Numbers | Minimum purity of the active substance in the biocidal product as placed on the market | Date of inclusion | Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) | Expiry date of inclusion | Product type | Specific provisions (*1) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘44 | 4,5-Dichloro-2-octyl-2H-isothiazol-3-one | 4,5-Dichloro-2-octylisothiazol-3(2H)-one
  EC No: 264-843-8
  CAS No: 64359-81-5 | 950  g/kg | 1 July 2013 | 30 June 2015 | 30 June 2023 | 8 | When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
  Products shall not be authorised for treatment of wood that will be continually exposed to the weather, protected from the weather but subject to frequent wetting or in contact with fresh water, unless data have been submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.
  Member States shall ensure that authorisations are subject to the following conditions:






  (1) | for products authorised for industrial or professional use, safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means; |

No

Common Name

IUPAC Name

Identification Numbers

Minimum purity of the active substance in the biocidal product as placed on the market

Date of inclusion

Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

Expiry date of inclusion

Product type

Specific provisions (*1)

‘44

4,5-Dichloro-2-octyl-2H-isothiazol-3-one

4,5-Dichloro-2-octylisothiazol-3(2H)-one

EC No: 264-843-8

CAS No: 64359-81-5

950  g/kg

1 July 2013

30 June 2015

30 June 2023

8

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Products shall not be authorised for treatment of wood that will be continually exposed to the weather, protected from the weather but subject to frequent wetting or in contact with fresh water, unless data have been submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

Member States shall ensure that authorisations are subject to the following conditions:

(1)

for products authorised for industrial or professional use, safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means;

| (2) | labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing under roof, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.’ |
| --- | --- |

(2)

labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing under roof, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.’

---

(*1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

*1

---

| 2.7.2011 | EN | Official Journal of the European Union | L 175/13 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/13

---

COMMISSION DIRECTIVE 2011/67/EU

of 1 July 2011

amending Directive 98/8/EC of the European Parliament and of the Council to include abamectin as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes abamectin. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes abamectin.

| (2) | Pursuant to Regulation (EC) No 1451/2007, abamectin has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, abamectin has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

| (3) | The Netherlands was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 19 June 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

The Netherlands was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 19 June 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 18 February 2011, in an assessment report. |
| --- | --- |

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 18 February 2011, in an assessment report.

| (5) | It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing abamectin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include abamectin in Annex I to that Directive. |
| --- | --- |

(5)

It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing abamectin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include abamectin in Annex I to that Directive.

| (6) | Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. |
| --- | --- |

(6)

Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

| (7) | In the light of the risks identified for sediment when products are used with a certain application rate and emitted to a sewage treatment plant, it is appropriate to require that products are not authorised for such uses, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures. |
| --- | --- |

(7)

In the light of the risks identified for sediment when products are used with a certain application rate and emitted to a sewage treatment plant, it is appropriate to require that products are not authorised for such uses, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

| (8) | In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level. In particular, in the light of the possible risks for infants and children, appropriate risk mitigation measures should be taken to minimise the potential exposure of infants and children. |
| --- | --- |

(8)

In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level. In particular, in the light of the possible risks for infants and children, appropriate risk mitigation measures should be taken to minimise the potential exposure of infants and children.

| (9) | It is important that the provisions of this Directive be applied simultaneously in all Member States in order to ensure equal treatment of biocidal products on the market containing the active substance abamectin and also to facilitate the proper operation of the biocidal products market in general. |
| --- | --- |

(9)

It is important that the provisions of this Directive be applied simultaneously in all Member States in order to ensure equal treatment of biocidal products on the market containing the active substance abamectin and also to facilitate the proper operation of the biocidal products market in general.

| (10) | A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion. |
| --- | --- |

(10)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

| (11) | After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(11)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

| (12) | Directive 98/8/EC should therefore be amended accordingly. |
| --- | --- |

(12)

Directive 98/8/EC should therefore be amended accordingly.

| (13) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(13)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.

Article 2

Transposition

1.   Member States shall adopt and publish, by 30 June 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 July 2013.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 1 July 2011.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 123, 24.4.1998, p. 1.

1

(2)  
  OJ L 325, 11.12.2007, p. 3.

2

---

ANNEX

In Annex I to Directive 98/8/EC, the following entry is added:

| No | Common Name | IUPAC Name
  Identification Numbers | Minimum purity of the active substance in the biocidal product as placed on the market | Date of inclusion | Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) | Expiry date of inclusion | Product type | Specific provisions (*1) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘43 | Abamectin | Abamectin is a mixture of avermectin B1a and avermectin B1b | Abamectin: | IUPAC name: n.a. |

No

Common Name

IUPAC Name

Identification Numbers

Minimum purity of the active substance in the biocidal product as placed on the market

Date of inclusion

Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

Expiry date of inclusion

Product type

Specific provisions (*1)

‘43

Abamectin

Abamectin is a mixture of avermectin B1a and avermectin B1b

Abamectin:

IUPAC name: n.a.

| | EC No: n.a. |
| --- | --- |

EC No: n.a.

| | CAS No: 71751-41-2 |
| --- | --- |

CAS No: 71751-41-2

| | Avermectin B1a: | IUPAC name: (10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-6'-[(S)-secbutyl]-21,24-dihydroxy-5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabinohexopyranoside |
| --- | --- | --- |

Avermectin B1a:

IUPAC name: (10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-6'-[(S)-secbutyl]-21,24-dihydroxy-5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabinohexopyranoside

| | EC No: 265-610-3 |
| --- | --- |

EC No: 265-610-3

| | CAS No: 65195-55-3 |
| --- | --- |

CAS No: 65195-55-3

| | Avermectin B1b: | IUPAC name: (10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6'-isopropyl-5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabinohexopyranoside |
| --- | --- | --- |

Avermectin B1b:

IUPAC name: (10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6'-isopropyl-5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabinohexopyranoside

| | EC No: 265-611-9 |
| --- | --- |

EC No: 265-611-9

| | CAS No: 65195-56-4 |
| --- | --- |

CAS No: 65195-56-4

The active substance shall comply with all the following purities:

| | Abamectin:

  minimum 900 g/kg |
| --- | --- |

Abamectin:

minimum 900 g/kg

| | Avermectin B1a:

  minimum 830 g/kg |
| --- | --- |

Avermectin B1a:

minimum 830 g/kg

| | Avermectin B1b:

  maximum 80 g/kg |
| --- | --- |

Avermectin B1b:

maximum 80 g/kg

1 July 2013

30 June 2015

30 June 2023

18

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Products applied in such a way that emission to a sewage treatment plant cannot be prevented shall not be authorised for those application rates for which the Union level risk assessment showed unacceptable risks, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

Authorisations shall be subject to appropriate risk mitigation measures. In particular, appropriate risk mitigation measures shall be taken to minimise the potential exposure of infants and children.’

---

(*1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

*1

---

| 2.7.2011 | EN | Official Journal of the European Union | L 175/17 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/17

---

COMMISSION IMPLEMENTING DIRECTIVE 2011/68/EU

of 1 July 2011

amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directives 2002/53/EC and 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (1), and in particular Article 7(2)(a) and (b) thereof,

Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (2), and in particular Article 7(2)(a) and (b) thereof,

Whereas:

| (1) | Commission Directives 2003/90/EC (3) and 2003/91/EC (4) were adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination of the various species and the minimum conditions for examining the varieties, as far as such guidelines had been established. For other varieties those Directives provide that guidelines of the International Union for Protection of new Varieties of Plants (UPOV) are to apply. |
| --- | --- |

(1)

Commission Directives 2003/90/EC (3) and 2003/91/EC (4) were adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination of the various species and the minimum conditions for examining the varieties, as far as such guidelines had been established. For other varieties those Directives provide that guidelines of the International Union for Protection of new Varieties of Plants (UPOV) are to apply.

| (2) | The CPVO has since established further guidelines for one other species, and has updated existing ones. |
| --- | --- |

(2)

The CPVO has since established further guidelines for one other species, and has updated existing ones.

| (3) | Directives 2003/90/EC and 2003/91/EC should therefore be amended accordingly. |
| --- | --- |

(3)

Directives 2003/90/EC and 2003/91/EC should therefore be amended accordingly.

| (4) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, |
| --- | --- |

(4)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes I and II to Directive 2003/90/EC are replaced by the text in Part A of the Annex to this Directive.

Article 2

The Annexes to Directive 2003/91/EC are replaced by the text in Part B of the Annex to this Directive.

Article 3

For examinations started before 1 January 2012 Member States may apply Directives 2003/90/EC and 2003/91/EC in the version applying before their amendment by this Directive.

Article 4

Member States shall adopt and publish, by 31 December 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 January 2012.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 5

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 6

This Directive is addressed to the Member States.

Done at Brussels, 1 July 2011.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 193, 20.7.2002, p. 1.

1

(2)  
  OJ L 193, 20.7.2002, p. 33.

2

(3)  
  OJ L 254, 8.10.2003, p. 7.

3

(4)  
  OJ L 254, 8.10.2003, p. 11.

4

---

ANNEX

PART A

‘ANNEX I

List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

| Scientific name | Common name | CPVO protocol |
| --- | --- | --- |
| Pisum sativum L. | Field pea | TP 7/2 of 11.3.2010 |
| Brassica napus L. | Swede rape | TP 36/1 of 25.3.2004 |
| Helianthus annuus L. | Sunflower | TP 81/1 of 31.10.2002 |
| Linum usitatissimum L. | Flax/Linseed | TP 57/1 of 21.3.2007 |
| Avena nuda L. | Small naked oat, Hulless oat | TP 20/1 of 6.11.2003 |
| Avena sativa L. (includes A. byzantina K. Koch) | Oats and Red oat | TP 20/1 of 6.11.2003 |
| Hordeum vulgare L. | Barley | TP 19/2rev. of 11.3.2010 |
| Oryza sativa L. | Rice | TP 16/1 of 18.11.2004 |
| Secale cereale L. | Rye | TP 58/1 of 31.10.2002 |
| xTriticosecale Wittm. ex A. Camus | Hybrids resulting from the crossing of a species of the genus Triticum and a species of the genus Secale | TP 121/2 rev. 1 of 16.2.2011 |
| Triticum aestivum L. | Wheat | TP 3/4 rev. 2 of 16.2.2011 |
| Triticum durum Desf. | Durum wheat | TP 120/2 of 6.11.2003 |
| Zea mays L. | Maize | TP 2/3 of 11.3.2010 |
| Solanum tuberosum L. | Potato | TP 23/2 of 1.12.2005 |

Scientific name

Common name

CPVO protocol

Pisum sativum L.

Field pea

TP 7/2 of 11.3.2010

Brassica napus L.

Swede rape

TP 36/1 of 25.3.2004

Helianthus annuus L.

Sunflower

TP 81/1 of 31.10.2002

Linum usitatissimum L.

Flax/Linseed

TP 57/1 of 21.3.2007

Avena nuda L.

Small naked oat, Hulless oat

TP 20/1 of 6.11.2003

Avena sativa L. (includes A. byzantina K. Koch)

Oats and Red oat

TP 20/1 of 6.11.2003

Hordeum vulgare L.

Barley

TP 19/2rev. of 11.3.2010

Oryza sativa L.

Rice

TP 16/1 of 18.11.2004

Secale cereale L.

Rye

TP 58/1 of 31.10.2002

xTriticosecale Wittm. ex A. Camus

Hybrids resulting from the crossing of a species of the genus Triticum and a species of the genus Secale

TP 121/2 rev. 1 of 16.2.2011

Triticum aestivum L.

Wheat

TP 3/4 rev. 2 of 16.2.2011

Triticum durum Desf.

Durum wheat

TP 120/2 of 6.11.2003

Zea mays L.

Maize

TP 2/3 of 11.3.2010

Solanum tuberosum L.

Potato

TP 23/2 of 1.12.2005

The text of these protocols can be found on the CPVO web site (www.cpvo.europa.eu).

‘ANNEX II

List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines

| Scientific name | Common name | UPOV guideline |
| --- | --- | --- |
| Beta vulgaris L. | Fodder beet | TG/150/3 of 4.11.1994 |
| Agrostis canina L. | Velvet bent | TG/30/6 of 12.10.1990 |
| Agrostis gigantea Roth. | Red top | TG/30/6 of 12.10.1990 |
| Agrostis stolonifera L. | Creeping bent | TG/30/6 of 12.10.1990 |
| Agrostis capillaris L. | Brown top | TG/30/6 of 12.10.1990 |
| Bromus catharticus Vahl | Rescue grass | TG/180/3 of 4.4.2001 |
| Bromus sitchensis Trin. | Alaska brome grass | TG/180/3 of 4.4.2001 |
| Dactylis glomerata L. | Cocksfoot | TG/31/8 of 17.4.2002 |
| Festuca arundinacea Schreber | Tall fescue | TG/39/8 of 17.4.2002 |
| Festuca filiformis Pourr. | Fine-leaved sheep’s fescue | TG/67/5 of 5.4.2006 |
| Festuca ovina L. | Sheep’s fescue | TG/67/5 of 5.4.2006 |
| Festuca pratensis Huds. | Meadow fescue | TG/39/8 of 17.4.2002 |
| Festuca rubra L. | Red fescue | TG/67/5 of 5.4.2006 |
| Festuca trachyphylla (Hack.) Krajina | Hard fescue | TG/67/5 of 5.4.2006 |
| xFestulolium Asch. et Graebn. | Hybrids resulting from the crossing of a species of the genus Festuca with a species of the genus Lolium | TG/243/1 of 9.4.2008 |
| Lolium multiflorum Lam. | Italian ryegrass | TG/4/8 of 5.4.2006 |
| Lolium perenne L. | Perennial ryegrass | TG/4/8 of 5.4.2006 |
| Lolium x boucheanum Kunth | Hybrid ryegrass | TG/4/8 of 5.4.2006 |
| Phleum nodosum L. | Small timothy | TG/34/6 of 7.11.1984 |
| Phleum pratense L. | Timothy | TG/34/6 of 7.11.1984 |
| Poa pratensis L. | Smooth-stalked meadow grass | TG/33/6 of 12.10.1990 |
| Lupinus albus L. | White lupin | TG/66/4 of 31.3.2004 |
| Lupinus angustifolius L. | Narrow-leaved lupin | TG/66/4 of 31.3.2004 |
| Lupinus luteus L. | Yellow lupin | TG/66/4 of 31.3.2004 |
| Medicago sativa L. | Lucerne | TG/6/5 of 6.4.2005 |
| Medicago x varia T. Martyn | Sand lucerne | TG/6/5 of 6.4.2005 |
| Trifolium pratense L. | Red clover | TG/5/7 of 4.4.2001 |
| Trifolium repens L. | White clover | TG/38/7 of 9.4.2003 |
| Vicia faba L. | Field bean | TG/8/6 of 17.4.2002 |
| Vicia sativa L. | Common vetch | TG/32/6 of 21.10.1988 |
| Brassica napus L. var. napobrassica (L.) Rchb. | Swede | TG/89/6rev. of 4.4.2001 + 1.4.2009 |
| Raphanus sativus L. var. oleiformis Pers. | Fodder radish | TG/178/3 of 4.4.2001 |
| Arachis hypogea L. | Groundnut/Peanut | TG/93/3 of 13.11.1985 |
| Brassica rapa L. var. silvestris (Lam.) Briggs | Turnip rape | TG/185/3 of 17.4.2002 |
| Carthamus tinctorius L. | Safflower | TG/134/3 of 12.10.1990 |
| Gossypium spp. | Cotton | TG/88/6 of 4.4.2001 |
| Papaver somniferum L. | Poppy | TG/166/3 of 24.3.1999 |
| Sinapis alba L. | White mustard | TG/179/3 of 4.4.2001 |
| Glycine max (L.) Merrill | Soya bean | TG/80/6 of 1.4.1998 |
| Sorghum bicolor (L.) Moench | Sorghum | TG/122/3 of 6.10.1989 |

Scientific name

Common name

UPOV guideline

Beta vulgaris L.

Fodder beet

TG/150/3 of 4.11.1994

Agrostis canina L.

Velvet bent

TG/30/6 of 12.10.1990

Agrostis gigantea Roth.

Red top

TG/30/6 of 12.10.1990

Agrostis stolonifera L.

Creeping bent

TG/30/6 of 12.10.1990

Agrostis capillaris L.

Brown top

TG/30/6 of 12.10.1990

Bromus catharticus Vahl

Rescue grass

TG/180/3 of 4.4.2001

Bromus sitchensis Trin.

Alaska brome grass

TG/180/3 of 4.4.2001

Dactylis glomerata L.

Cocksfoot

TG/31/8 of 17.4.2002

Festuca arundinacea Schreber

Tall fescue

TG/39/8 of 17.4.2002

Festuca filiformis Pourr.

Fine-leaved sheep’s fescue

TG/67/5 of 5.4.2006

Festuca ovina L.

Sheep’s fescue

TG/67/5 of 5.4.2006

Festuca pratensis Huds.

Meadow fescue

TG/39/8 of 17.4.2002

Festuca rubra L.

Red fescue

TG/67/5 of 5.4.2006

Festuca trachyphylla (Hack.) Krajina

Hard fescue

TG/67/5 of 5.4.2006

xFestulolium Asch. et Graebn.

Hybrids resulting from the crossing of a species of the genus Festuca with a species of the genus Lolium

TG/243/1 of 9.4.2008

Lolium multiflorum Lam.

Italian ryegrass

TG/4/8 of 5.4.2006

Lolium perenne L.

Perennial ryegrass

TG/4/8 of 5.4.2006

Lolium x boucheanum Kunth

Hybrid ryegrass

TG/4/8 of 5.4.2006

Phleum nodosum L.

Small timothy

TG/34/6 of 7.11.1984

Phleum pratense L.

Timothy

TG/34/6 of 7.11.1984

Poa pratensis L.

Smooth-stalked meadow grass

TG/33/6 of 12.10.1990

Lupinus albus L.

White lupin

TG/66/4 of 31.3.2004

Lupinus angustifolius L.

Narrow-leaved lupin

TG/66/4 of 31.3.2004

Lupinus luteus L.

Yellow lupin

TG/66/4 of 31.3.2004

Medicago sativa L.

Lucerne

TG/6/5 of 6.4.2005

Medicago x varia T. Martyn

Sand lucerne

TG/6/5 of 6.4.2005

Trifolium pratense L.

Red clover

TG/5/7 of 4.4.2001

Trifolium repens L.

White clover

TG/38/7 of 9.4.2003

Vicia faba L.

Field bean

TG/8/6 of 17.4.2002

Vicia sativa L.

Common vetch

TG/32/6 of 21.10.1988

Brassica napus L. var. napobrassica (L.) Rchb.

Swede

TG/89/6rev. of 4.4.2001 + 1.4.2009

Raphanus sativus L. var. oleiformis Pers.

Fodder radish

TG/178/3 of 4.4.2001

Arachis hypogea L.

Groundnut/Peanut

TG/93/3 of 13.11.1985

Brassica rapa L. var. silvestris (Lam.) Briggs

Turnip rape

TG/185/3 of 17.4.2002

Carthamus tinctorius L.

Safflower

TG/134/3 of 12.10.1990

Gossypium spp.

Cotton

TG/88/6 of 4.4.2001

Papaver somniferum L.

Poppy

TG/166/3 of 24.3.1999

Sinapis alba L.

White mustard

TG/179/3 of 4.4.2001

Glycine max (L.) Merrill

Soya bean

TG/80/6 of 1.4.1998

Sorghum bicolor (L.) Moench

Sorghum

TG/122/3 of 6.10.1989

The text of these guidelines can be found on the UPOV web site (www.upov.int).

PART B

‘ANNEX I

List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

| Scientific name | Common name | CPVO protocol |
| --- | --- | --- |
| Allium cepa L. (Cepa group) | Onion and Echalion | TP 46/2 of 1.4.2009 |
| Allium cepa L. (Aggregatum group) | Shallot | TP 46/2 of 1.4.2009 |
| Allium fistulosum L. | Japanese bunching onion or Welsh onion | TP 161/1 of 11.3.2010 |
| Allium porrum L. | Leek | TP 85/2 of 1.4.2009 |
| Allium sativum L. | Garlic | TP 162/1 of 25.3.2004 |
| Allium schoenoprasum L. | Chives | TP 198/1 of 1.4.2009 |
| Apium graveolens L. | Celery | TP 82/1 of 13.3.2008 |
| Apium graveolens L. | Celeriac | TP 74/1 of 13.3.2008 |
| Asparagus officinalis L. | Asparagus | TP 130/2 of 16.2.2011 |
| Beta vulgaris L. | Beetroot including Cheltenham beet | TP 60/1 of 1.4.2009 |
| Brassica oleracea L. | Curly kale | TP 90/1 of 16.2.2011 |
| Brassica oleracea L. | Cauliflower | TP 45/2 of 11.3.2010 |
| Brassica oleracea L. | Sprouting broccoli or Calabrese | TP 151/2 of 21.3.2007 |
| Brassica oleracea L. | Brussels sprouts | TP 54/2 of 1.12.2005 |
| Brassica oleracea L. | Kohlrabi | TP 65/1 of 25.3.2004 |
| Brassica oleracea L. | Savoy cabbage, White cabbage and Red cabbage | TP 48/3 of 16.2.2011 |
| Brassica rapa L. | Chinese cabbage | TP 105/1 of 13.3.2008 |
| Capsicum annuum L. | Chilli or Pepper | TP 76/2 of 21.3.2007 |
| Cichorium endivia L. | Curled-leaved endive and Plain-leaved endive | TP 118/2 of 1.12.2005 |
| Cichorium intybus L. | Industrial chicory | TP 172/2 of 1.12.2005 |
| Cichorium intybus L. | Witloof chicory | TP 173/1 of 25.3.2004 |
| Citrullus lanatus (Thumb.) Matsum. et Nakai | Watermelon | TP 142/1 of 21.3.2007 |
| Cucumis melo L. | Melon | TP 104/2 of 21.3.2007 |
| Cucumis sativus L. | Cucumber and Gherkin | TP 61/2 of 13.3.2008 |
| Cucurbita pepo L. | Marrow or Courgette | TP 119/1 of 25.3.2004 |
| Cynara cardunculus L. | Globe artichoke and Cardoon | TP 184/1 of 25.3.2004 |
| Daucus carota L. | Carrot and Fodder carrot | TP 49/3 of 13.3.2008 |
| Foeniculum vulgare Mill. | Fennel | TP 183/1 of 25.3.2004 |
| Lactuca sativa L. | Lettuce | TP 13/5 of 16.2.2011 |
| Lycopersicon esculentum Mill. | Tomato | TP 44/3 of 21.3.2007 |
| Petroselinum crispum (Mill.) Nyman ex A. W. Hill | Parsley | TP 136/1 of 21.3.2007 |
| Phaseolus coccineus L. | Runner bean | TP 9/1 of 21.3.2007 |
| Phaseolus vulgaris L. | Dwarf French bean and Climbing French bean | TP 12/3 of 1.4.2009 |
| Pisum sativum L. (partim) | Wrinkled pea, Round pea and Sugar pea | TP 7/2 of 11.3.2010 |
| Raphanus sativus L. | Radish | TP 64/1 of 27.3.2002 |
| Solanum melongena L. | Aubergine or Egg plant | TP 117/1 of 13.3.2008 |
| Spinacia oleracea L. | Spinach | TP 55/3 of 11.3.2010 |
| Valerianella locusta (L.) Laterr. | Corn salad or Lamb’s lettuce | TP 75/2 of 21.3.2007 |
| Vicia faba L. (partim) | Broad bean | TP Broadbean/1 of 25.3.2004 |
| Zea mays L. (partim) | Sweet corn and Pop corn | TP 2/3 of 11.3.2010 |

Scientific name

Common name

CPVO protocol

Allium cepa L. (Cepa group)

Onion and Echalion

TP 46/2 of 1.4.2009

Allium cepa L. (Aggregatum group)

Shallot

TP 46/2 of 1.4.2009

Allium fistulosum L.

Japanese bunching onion or Welsh onion

TP 161/1 of 11.3.2010

Allium porrum L.

Leek

TP 85/2 of 1.4.2009

Allium sativum L.

Garlic

TP 162/1 of 25.3.2004

Allium schoenoprasum L.

Chives

TP 198/1 of 1.4.2009

Apium graveolens L.

Celery

TP 82/1 of 13.3.2008

Apium graveolens L.

Celeriac

TP 74/1 of 13.3.2008

Asparagus officinalis L.

Asparagus

TP 130/2 of 16.2.2011

Beta vulgaris L.

Beetroot including Cheltenham beet

TP 60/1 of 1.4.2009

Brassica oleracea L.

Curly kale

TP 90/1 of 16.2.2011

Brassica oleracea L.

Cauliflower

TP 45/2 of 11.3.2010

Brassica oleracea L.

Sprouting broccoli or Calabrese

TP 151/2 of 21.3.2007

Brassica oleracea L.

Brussels sprouts

TP 54/2 of 1.12.2005

Brassica oleracea L.

Kohlrabi

TP 65/1 of 25.3.2004

Brassica oleracea L.

Savoy cabbage, White cabbage and Red cabbage

TP 48/3 of 16.2.2011

Brassica rapa L.

Chinese cabbage

TP 105/1 of 13.3.2008

Capsicum annuum L.

Chilli or Pepper

TP 76/2 of 21.3.2007

Cichorium endivia L.

Curled-leaved endive and Plain-leaved endive

TP 118/2 of 1.12.2005

Cichorium intybus L.

Industrial chicory

TP 172/2 of 1.12.2005

Cichorium intybus L.

Witloof chicory

TP 173/1 of 25.3.2004

Citrullus lanatus (Thumb.) Matsum. et Nakai

Watermelon

TP 142/1 of 21.3.2007

Cucumis melo L.

Melon

TP 104/2 of 21.3.2007

Cucumis sativus L.

Cucumber and Gherkin

TP 61/2 of 13.3.2008

Cucurbita pepo L.

Marrow or Courgette

TP 119/1 of 25.3.2004

Cynara cardunculus L.

Globe artichoke and Cardoon

TP 184/1 of 25.3.2004

Daucus carota L.

Carrot and Fodder carrot

TP 49/3 of 13.3.2008

Foeniculum vulgare Mill.

Fennel

TP 183/1 of 25.3.2004

Lactuca sativa L.

Lettuce

TP 13/5 of 16.2.2011

Lycopersicon esculentum Mill.

Tomato

TP 44/3 of 21.3.2007

Petroselinum crispum (Mill.) Nyman ex A. W. Hill

Parsley

TP 136/1 of 21.3.2007

Phaseolus coccineus L.

Runner bean

TP 9/1 of 21.3.2007

Phaseolus vulgaris L.

Dwarf French bean and Climbing French bean

TP 12/3 of 1.4.2009

Pisum sativum L. (partim)

Wrinkled pea, Round pea and Sugar pea

TP 7/2 of 11.3.2010

Raphanus sativus L.

Radish

TP 64/1 of 27.3.2002

Solanum melongena L.

Aubergine or Egg plant

TP 117/1 of 13.3.2008

Spinacia oleracea L.

Spinach

TP 55/3 of 11.3.2010

Valerianella locusta (L.) Laterr.

Corn salad or Lamb’s lettuce

TP 75/2 of 21.3.2007

Vicia faba L. (partim)

Broad bean

TP Broadbean/1 of 25.3.2004

Zea mays L. (partim)

Sweet corn and Pop corn

TP 2/3 of 11.3.2010

The text of these protocols can be found on the CPVO web site (www.cpvo.europa.eu).

‘ANNEX II

List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines

| Scientific name | Common name | UPOV guideline |
| --- | --- | --- |
| Beta vulgaris L. | Spinach beet or Chard | TG/106/4 of 31.3.2004 |
| Brassica rapa L. | Turnip | TG/37/10 of 4.4.2001 |
| Cichorium intybus L. | Large-leaved chicory or Italian chicory | TG/154/3 of 18.10.1996 |
| Cucurbita maxima Duchesne | Gourd | TG/155/4rev. of 28.3.2007 + 1.4.2009 |
| Raphanus sativus L. | Black radish | TG/63/6 of 24.3.1999 |
| Rheum rhabarbarum L. | Rhubarb | TG/62/6 of 24.3.1999 |
| Scorzonera hispanica L. | Scorzonera or Black salsify | TG/116/4 of 24.3.2010 |

Scientific name

Common name

UPOV guideline

Beta vulgaris L.

Spinach beet or Chard

TG/106/4 of 31.3.2004

Brassica rapa L.

Turnip

TG/37/10 of 4.4.2001

Cichorium intybus L.

Large-leaved chicory or Italian chicory

TG/154/3 of 18.10.1996

Cucurbita maxima Duchesne

Gourd

TG/155/4rev. of 28.3.2007 + 1.4.2009

Raphanus sativus L.

Black radish

TG/63/6 of 24.3.1999

Rheum rhabarbarum L.

Rhubarb

TG/62/6 of 24.3.1999

Scorzonera hispanica L.

Scorzonera or Black salsify

TG/116/4 of 24.3.2010

The text of these guidelines can be found on the UPOV web site (www.upov.int).

---

| 2.7.2011 | EN | Official Journal of the European Union | L 175/24 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/24

---

COMMISSION DIRECTIVE 2011/69/EU

of 1 July 2011

amending Directive 98/8/EC of the European Parliament and of the Council to include imidacloprid as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes imidacloprid. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes imidacloprid.

| (2) | Pursuant to Regulation (EC) No 1451/2007, imidacloprid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, imidacloprid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

| (3) | Germany was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 15 September 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Germany was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 15 September 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 16 December 2010, in an assessment report. |
| --- | --- |

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 16 December 2010, in an assessment report.

| (5) | It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing imidacloprid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include imidacloprid in Annex I to that Directive. |
| --- | --- |

(5)

It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing imidacloprid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include imidacloprid in Annex I to that Directive.

| (6) | Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. |
| --- | --- |

(6)

Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

| (7) | In view of the risks identified for the aquatic compartment, it is appropriate to require that products are not authorised for uses in animal housings where emission to a sewage treatment plant or direct emission to surface water cannot be prevented, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures. |
| --- | --- |

(7)

In view of the risks identified for the aquatic compartment, it is appropriate to require that products are not authorised for uses in animal housings where emission to a sewage treatment plant or direct emission to surface water cannot be prevented, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

| (8) | In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level. In particular, in the light of the possible risk for non-professionals, appropriate risk mitigation measures should be taken to minimise the potential exposure of infants and children. |
| --- | --- |

(8)

In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level. In particular, in the light of the possible risk for non-professionals, appropriate risk mitigation measures should be taken to minimise the potential exposure of infants and children.

| (9) | In the light of the findings relating to possible indirect human exposure via consumption of food, it is appropriate to require, where relevant, verification of the need to set new or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (4). Measures should be adopted ensuring that the applicable MRLs are not exceeded. |
| --- | --- |

(9)

In the light of the findings relating to possible indirect human exposure via consumption of food, it is appropriate to require, where relevant, verification of the need to set new or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (4). Measures should be adopted ensuring that the applicable MRLs are not exceeded.

| (10) | It is important that the provisions of this Directive be applied simultaneously in all Member States in order to ensure equal treatment of biocidal products on the market containing the active substance imidacloprid and also to facilitate the proper operation of the biocidal products market in general. |
| --- | --- |

(10)

It is important that the provisions of this Directive be applied simultaneously in all Member States in order to ensure equal treatment of biocidal products on the market containing the active substance imidacloprid and also to facilitate the proper operation of the biocidal products market in general.

| (11) | A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion. |
| --- | --- |

(11)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

| (12) | After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(12)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

| (13) | Directive 98/8/EC should therefore be amended accordingly. |
| --- | --- |

(13)

Directive 98/8/EC should therefore be amended accordingly.

| (14) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(14)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.

Article 2

Transposition

1.   Member States shall adopt and publish, by 30 June 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 July 2013.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 1 July 2011.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 123, 24.4.1998, p. 1.

1

(2)  
  OJ L 325, 11.12.2007, p. 3.

2

(3)  
  OJ L 152, 16.6.2009, p. 11.

3

(4)  
  OJ L 70, 16.3.2005, p. 1.

4

---

ANNEX

In Annex I to Directive 98/8/EC, the following entry is added:

| No | Common name | IUPAC name, identification numbers | Minimum purity of the active substance in the biocidal product as placed on the market | Date of inclusion | Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) | Expiry date of inclusion | Product type | Specific provisions (*1) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘42 | imidacloprid | (2E)-1-[(6-chloropyridin-3-yl)methyl]-N-nitroimidazolidin-2-imine
  EC No: 428-040-8
  CAS No: 138261-41-3 | 970  g/kg | 1 July 2013 | 30 June 2015 | 30 June 2023 | 18 | When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
  Products shall not be authorised for uses in animal housings where emission to a sewage treatment plant or direct emission to surface water cannot be prevented, unless data is submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.
  Authorisations shall be subject to appropriate risk mitigation measures. In particular, appropriate risk mitigation measures shall be taken to minimise the potential exposure of infants and children.
  For products containing imidacloprid that may lead to residues in food or feed, Member States shall verify the need to set new or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.’ |

No

Common name

IUPAC name, identification numbers

Minimum purity of the active substance in the biocidal product as placed on the market

Date of inclusion

Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

Expiry date of inclusion

Product type

Specific provisions (*1)

‘42

imidacloprid

(2E)-1-[(6-chloropyridin-3-yl)methyl]-N-nitroimidazolidin-2-imine

EC No: 428-040-8

CAS No: 138261-41-3

970  g/kg

1 July 2013

30 June 2015

30 June 2023

18

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Products shall not be authorised for uses in animal housings where emission to a sewage treatment plant or direct emission to surface water cannot be prevented, unless data is submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

Authorisations shall be subject to appropriate risk mitigation measures. In particular, appropriate risk mitigation measures shall be taken to minimise the potential exposure of infants and children.

For products containing imidacloprid that may lead to residues in food or feed, Member States shall verify the need to set new or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.’

---

(*1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

*1

---

DECISIONS

| 2.7.2011 | EN | Official Journal of the European Union | L 175/27 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/27

---

POLITICAL AND SECURITY COMMITTEE DECISION EUMM/1/2011

of 1 July 2011

on the appointment of the Head of Mission of the European Union Monitoring Mission in Georgia, EUMM Georgia

(2011/390/CFSP)

THE POLITICAL AND SECURITY COMMITTEE,

Having regard to the Treaty on European Union, and in particular the third paragraph of Article 38 thereof,

Having regard to Council Joint Action 2008/736/CFSP of 15 September 2008 on the European Union Monitoring Mission in Georgia, EUMM Georgia (1), and in particular Article 10(2) thereof,

Whereas:

| (1) | On 15 September 2008 the Council adopted Joint Action 2008/736/CFSP establishing the European Union Monitoring Mission in Georgia, EUMM Georgia (‘EUMM Georgia’). |
| --- | --- |

(1)

On 15 September 2008 the Council adopted Joint Action 2008/736/CFSP establishing the European Union Monitoring Mission in Georgia, EUMM Georgia (‘EUMM Georgia’).

| (2) | On 12 August 2010 the Council adopted Decision 2010/452/CFSP (2) extending EUMM Georgia until 14 September 2011. |
| --- | --- |

(2)

On 12 August 2010 the Council adopted Decision 2010/452/CFSP (2) extending EUMM Georgia until 14 September 2011.

| (3) | Pursuant to Article 10(1) of Decision 2010/452/CFSP, the Political and Security Committee is authorised, in accordance with Article 38 of the Treaty, to take the relevant decisions for the purpose of exercising political control and strategic direction of EUMM Georgia, including the decision to appoint a Head of Mission, |
| --- | --- |

(3)

Pursuant to Article 10(1) of Decision 2010/452/CFSP, the Political and Security Committee is authorised, in accordance with Article 38 of the Treaty, to take the relevant decisions for the purpose of exercising political control and strategic direction of EUMM Georgia, including the decision to appoint a Head of Mission,

HAS ADOPTED THIS DECISION:

Article 1

Mr Andrzej TYSZKIEWICZ is hereby appointed Head of Mission of the European Union Monitoring Mission in Georgia, EUMM Georgia for the period from 18 July 2011 to 14 September 2011.

Article 2

Political and Security Committee Decision EUMM Georgia/1/2010 of 3 September 2010 extending the mandate of the Head of Mission of the European Union Monitoring Mission in Georgia, EUMM Georgia (3) is hereby repealed.

Article 3

This Decision shall enter into force on the day of its adoption.

Done at Brussels, 1 July 2011.

For the Political and Security Committee

The Chairperson

O. SKOOG

---

(1)  
  OJ L 248, 17.9.2008, p. 26.

1

(2)  
  OJ L 213, 13.8.2010, p. 43.

2

(3)  
  OJ L 234, 4.9.2010, p. 16.

3

---

| 2.7.2011 | EN | Official Journal of the European Union | L 175/28 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/28

---

COMMISSION DECISION

of 1 July 2011

concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market

(notified under document C(2011) 4596)

(Text with EEA relevance)

(2011/391/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC.

| (2) | For a number of substance/product type combinations included in that list, either all participants have discontinued their participation in the review programme, or no complete dossier was received within the time period specified in Articles 9 and 12(3) of Regulation (EC) No 1451/2007 by the Member State designated as rapporteur for the evaluation. |
| --- | --- |

(2)

For a number of substance/product type combinations included in that list, either all participants have discontinued their participation in the review programme, or no complete dossier was received within the time period specified in Articles 9 and 12(3) of Regulation (EC) No 1451/2007 by the Member State designated as rapporteur for the evaluation.

| (3) | Consequently, and pursuant to Articles 11(2), 12(1) and 13(5) of Regulation (EC) No 1451/2007, the Commission informed the Member States accordingly. That information was also made public by electronic means. |
| --- | --- |

(3)

Consequently, and pursuant to Articles 11(2), 12(1) and 13(5) of Regulation (EC) No 1451/2007, the Commission informed the Member States accordingly. That information was also made public by electronic means.

| (4) | Within the period of 3 months from those publications, a number of companies indicated an interest in taking over the role of participant for the substances and product-types concerned. However, those companies subsequently failed to submit a complete dossier. |
| --- | --- |

(4)

Within the period of 3 months from those publications, a number of companies indicated an interest in taking over the role of participant for the substances and product-types concerned. However, those companies subsequently failed to submit a complete dossier.

| (5) | Pursuant to Article 12(5) of Regulation (EC) No 1451/2007, the substances and product types concerned should therefore not be included in Annexes I, IA or IB to Directive 98/8/EC. |
| --- | --- |

(5)

Pursuant to Article 12(5) of Regulation (EC) No 1451/2007, the substances and product types concerned should therefore not be included in Annexes I, IA or IB to Directive 98/8/EC.

| (6) | In the interest of legal certainty, the date should be specified after which biocidal products containing active substances for the product-types indicated in the Annex to this Decision should no longer be placed on the market. |
| --- | --- |

(6)

In the interest of legal certainty, the date should be specified after which biocidal products containing active substances for the product-types indicated in the Annex to this Decision should no longer be placed on the market.

| (7) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(7)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DECISION:

Article 1

The substances indicated in the Annex to this Decision shall not be included for the product-types concerned in Annexes I, IA or IB to Directive 98/8/EC.

Article 2

For the purposes of Article 4(2) of Regulation (EC) No 1451/2007, biocidal products containing active substances for the product-types indicated in the Annex to this Decision shall no longer be placed on the market with effect from 1 July 2012.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 1 July 2011.

For the Commission

Janez POTOČNIK

Member of the Commission

---

(1)  
  OJ L 123, 24.4.1998, p. 1.

1

(2)  
  OJ L 325, 11.12.2007, p. 3.

2

---

ANNEX

Substances and product types not to be included in Annexes I, IA or IB to Directive 98/8/EC

| Name | EC number | CAS number | Product-type | Rapporteur Member State |
| --- | --- | --- | --- | --- |
| Formaldehyde | 200-001-8 | 50-00-0 | 1 | DE |
| Formaldehyde | 200-001-8 | 50-00-0 | 5 | DE |
| Formaldehyde | 200-001-8 | 50-00-0 | 9 | DE |
| Formaldehyde | 200-001-8 | 50-00-0 | 23 | DE |
| 2-chloroacetamide | 201-174-2 | 79-07-2 | 3 | EE |
| 2-chloroacetamide | 201-174-2 | 79-07-2 | 6 | EE |
| 2-chloroacetamide | 201-174-2 | 79-07-2 | 13 | EE |
| Thiabendazole | 205-725-8 | 148-79-8 | 2 | ES |
| Thiabendazole | 205-725-8 | 148-79-8 | 13 | ES |
| 2,2'-dithiobis[N-methylbenzamide] | 219-768-5 | 2527-58-4 | 13 | PL |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 1 | DE |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 2 | DE |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 5 | DE |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 6 | DE |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 13 | DE |
| Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide/Perestane | 432-790-1 | — | 4 | HU |
| Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride) | Polymer | 374572-91-5 | 1 | FR |
| Poly(hexamethylendiamine guanidinium chloride) | Polymer | 57028-96-3 | 1 | FR |
| Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride) | Polymer | 374572-91-5 | 5 | FR |
| Poly(hexamethylendiamine guanidinium chloride) | Polymer | 57028-96-3 | 5 | FR |
| Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride) | Polymer | 374572-91-5 | 6 | FR |
| Poly(hexamethylendiamine guanidinium chloride) | Polymer | 57028-96-3 | 6 | FR |
| Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride) | Polymer | 374572-91-5 | 13 | FR |
| Poly(hexamethylendiamine guanidinium chloride) | Polymer | 57028-96-3 | 13 | FR |

Name

EC number

CAS number

Product-type

Rapporteur Member State

Formaldehyde

200-001-8

50-00-0

1

DE

Formaldehyde

200-001-8

50-00-0

5

DE

Formaldehyde

200-001-8

50-00-0

9

DE

Formaldehyde

200-001-8

50-00-0

23

DE

2-chloroacetamide

201-174-2

79-07-2

3

EE

2-chloroacetamide

201-174-2

79-07-2

6

EE

2-chloroacetamide

201-174-2

79-07-2

13

EE

Thiabendazole

205-725-8

148-79-8

2

ES

Thiabendazole

205-725-8

148-79-8

13

ES

2,2'-dithiobis[N-methylbenzamide]

219-768-5

2527-58-4

13

PL

Sulphur dioxide

231-195-2

7446-09-5

1

DE

Sulphur dioxide

231-195-2

7446-09-5

2

DE

Sulphur dioxide

231-195-2

7446-09-5

5

DE

Sulphur dioxide

231-195-2

7446-09-5

6

DE

Sulphur dioxide

231-195-2

7446-09-5

13

DE

Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide/Perestane

432-790-1

—

4

HU

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride)

Polymer

374572-91-5

1

FR

Poly(hexamethylendiamine guanidinium chloride)

Polymer

57028-96-3

1

FR

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride)

Polymer

374572-91-5

5

FR

Poly(hexamethylendiamine guanidinium chloride)

Polymer

57028-96-3

5

FR

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride)

Polymer

374572-91-5

6

FR

Poly(hexamethylendiamine guanidinium chloride)

Polymer

57028-96-3

6

FR

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride)

Polymer

374572-91-5

13

FR

Poly(hexamethylendiamine guanidinium chloride)

Polymer

57028-96-3

13

FR

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