# Official Journal L 201/2009

| | ISSN 1725-2555
  doi:10.3000/17252555.L_2009.201.eng |
| --- | --- |
| Official Journal
  of the European Union | L 201 |
| | |
| English edition | Legislation | Volume 521 August 2009 |

ISSN 1725-2555

doi:10.3000/17252555.L_2009.201.eng

Official Journal

of the European Union

L 201

English edition

Legislation

Volume 521 August 2009

---

| Contents | | I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | | Commission Regulation (EC) No 695/2009 of 31 July 2009 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | | Commission Regulation (EC) No 696/2009 of 31 July 2009 fixing the import duties in the cereals sector applicable from 1 August 2009 | 3 |
| | * | Commission Regulation (EC) No 697/2009 of 31 July 2009 amending Regulation (EC) No 1913/2006 laying down detailed rules for the application of the agrimonetary system for the euro in agriculture, as regards the operative events in the School Fruit Scheme, and derogating from that Regulation | 6 |
| | * | Commission Regulation (EC) No 698/2009 of 31 July 2009 derogating, for information and promotion programmes for milk and milk products aimed at the internal market, from Regulation (EC) No 501/2008 laying down detailed rules for the application of Council Regulation (EC) No 3/2008 on information provision and promotion measures for agricultural products on the internal market and in third countries | 8 |
| | * | Commission Regulation (EC) No 699/2009 of 31 July 2009 establishing a prohibition of fishing for Greenland halibut in EC waters of IIa and IV; EC and international waters of VI by vessels flying the flag of Spain | 9 |
| | | DIRECTIVES |
| | * | Directive 2009/66/EC of the European Parliament and of the Council of 13 July 2009 on the steering equipment of wheeled agricultural or forestry tractors (Codified version) (
  1
  ) | 11 |
| | * | Directive 2009/76/EC of the European Parliament and of the Council of 13 July 2009 relating to the driver-perceived noise level of wheeled agricultural or forestry tractors (Codified version) (
  1
  ) | 18 |
| | * | Directive 2009/79/EC of the European Parliament and of the Council of 13 July 2009 on passenger hand-holds on two-wheel motor vehicles (Codified version) (
  1
  ) | 29 |
| | * | Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of the European Parliament and of the Council, technical specifications for chemical analysis and monitoring of water status (
  1
  ) | 36 |
| | * | Commission Directive 2009/91/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include disodium tetraborate as an active substance in Annex I thereto (
  1
  ) | 39 |
| | * | Commission Directive 2009/92/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include bromadiolone as an active substance in Annex I thereto (
  1
  ) | 43 |
| | * | Commission Directive 2009/93/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include alphachloralose as an active substance in Annex I thereto (
  1
  ) | 46 |
| | * | Commission Directive 2009/94/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include boric acid as an active substance in Annex I thereto (
  1
  ) | 50 |
| | * | Commission Directive 2009/95/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include aluminium phosphide releasing phosphine as an active substance in Annex I thereto (
  1
  ) | 54 |
| | * | Commission Directive 2009/96/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include disodium octaborate tetrahydrate as an active substance in Annex I thereto (
  1
  ) | 58 |

Contents

I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

page

REGULATIONS

Commission Regulation (EC) No 695/2009 of 31 July 2009 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

Commission Regulation (EC) No 696/2009 of 31 July 2009 fixing the import duties in the cereals sector applicable from 1 August 2009

3

*

Commission Regulation (EC) No 697/2009 of 31 July 2009 amending Regulation (EC) No 1913/2006 laying down detailed rules for the application of the agrimonetary system for the euro in agriculture, as regards the operative events in the School Fruit Scheme, and derogating from that Regulation

6

*

Commission Regulation (EC) No 698/2009 of 31 July 2009 derogating, for information and promotion programmes for milk and milk products aimed at the internal market, from Regulation (EC) No 501/2008 laying down detailed rules for the application of Council Regulation (EC) No 3/2008 on information provision and promotion measures for agricultural products on the internal market and in third countries

8

*

Commission Regulation (EC) No 699/2009 of 31 July 2009 establishing a prohibition of fishing for Greenland halibut in EC waters of IIa and IV; EC and international waters of VI by vessels flying the flag of Spain

9

DIRECTIVES

*

Directive 2009/66/EC of the European Parliament and of the Council of 13 July 2009 on the steering equipment of wheeled agricultural or forestry tractors (Codified version) (
  1
  )

1

11

*

Directive 2009/76/EC of the European Parliament and of the Council of 13 July 2009 relating to the driver-perceived noise level of wheeled agricultural or forestry tractors (Codified version) (
  1
  )

1

18

*

Directive 2009/79/EC of the European Parliament and of the Council of 13 July 2009 on passenger hand-holds on two-wheel motor vehicles (Codified version) (
  1
  )

1

29

*

Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of the European Parliament and of the Council, technical specifications for chemical analysis and monitoring of water status (
  1
  )

1

36

*

Commission Directive 2009/91/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include disodium tetraborate as an active substance in Annex I thereto (
  1
  )

1

39

*

Commission Directive 2009/92/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include bromadiolone as an active substance in Annex I thereto (
  1
  )

1

43

*

Commission Directive 2009/93/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include alphachloralose as an active substance in Annex I thereto (
  1
  )

1

46

*

Commission Directive 2009/94/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include boric acid as an active substance in Annex I thereto (
  1
  )

1

50

*

Commission Directive 2009/95/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include aluminium phosphide releasing phosphine as an active substance in Annex I thereto (
  1
  )

1

54

*

Commission Directive 2009/96/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include disodium octaborate tetrahydrate as an active substance in Annex I thereto (
  1
  )

1

58

| | | II   Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory |
| --- | --- | --- |
| | | DECISIONS |
| | | Council |
| | | 2009/583/EC, Euratom |
| | * | Council Decision of 27 July 2009 appointing one Hungarian member of the European Economic and Social Committee | 62 |
| | | Commission |
| | | 2009/584/EC |
| | * | Commission Decision of 31 July 2009 establishing the High Level Steering Group on SafeSeaNet
  (Notified under document C(2009) 5924)

   (
  1
  ) | 63 |
| | | 2009/585/EC |
| | * | Commission Decision of 31 July 2009 amending Decision 2008/965/EC on financial aid from the Community for the year 2009 for certain Community reference laboratories in the field of animal health and live animals
  (Notified under document C(2009) 5947) | 65 |

II   Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory

DECISIONS

Council

2009/583/EC, Euratom

*

Council Decision of 27 July 2009 appointing one Hungarian member of the European Economic and Social Committee

62

Commission

2009/584/EC

*

Commission Decision of 31 July 2009 establishing the High Level Steering Group on SafeSeaNet
  (Notified under document C(2009) 5924)

   (
  1
  )

(Notified under document C(2009) 5924)

1

63

2009/585/EC

*

Commission Decision of 31 July 2009 amending Decision 2008/965/EC on financial aid from the Community for the year 2009 for certain Community reference laboratories in the field of animal health and live animals
  (Notified under document C(2009) 5947)

(Notified under document C(2009) 5947)

65

| | |
| --- | --- |
| | (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.

---

I Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

REGULATIONS

| 1.8.2009 | EN | Official Journal of the European Union | L 201/1 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/1

---

COMMISSION REGULATION (EC) No 695/2009

of 31 July 2009

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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 1580/2007 of 21 December 2007 laying down implementing rules for Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (2), and in particular Article 138(1) thereof,

Whereas:

Regulation (EC) No 1580/2007 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 XV, Part A thereto,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 138 of Regulation (EC) No 1580/2007 are fixed in the Annex hereto.

Article 2

This Regulation shall enter into force on 1 August 2009.

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

Done at Brussels, 31 July 2009.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  OJ L 350, 31.12.2007, 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 | MK | 27,8 |
| XS | 31,8 |
| ZZ | 29,8 |
| 0707 00 05 | MK | 25,2 |
| TR | 100,7 |
| ZZ | 63,0 |
| 0709 90 70 | TR | 98,7 |
| ZZ | 98,7 |
| 0805 50 10 | AR | 57,8 |
| UY | 54,4 |
| ZA | 63,0 |
| ZZ | 58,4 |
| 0806 10 10 | EG | 146,9 |
| MA | 136,8 |
| TR | 87,6 |
| ZA | 127,1 |
| ZZ | 124,6 |
| 0808 10 80 | AR | 74,7 |
| BR | 76,7 |
| CL | 89,2 |
| CN | 81,7 |
| NZ | 101,3 |
| US | 105,4 |
| ZA | 89,2 |
| ZZ | 88,3 |
| 0808 20 50 | AR | 83,2 |
| CL | 77,9 |
| TR | 153,3 |
| ZA | 106,6 |
| ZZ | 105,3 |
| 0809 20 95 | CA | 324,1 |
| TR | 267,9 |
| US | 318,6 |
| ZZ | 303,5 |
| 0809 30 | TR | 159,0 |
| ZZ | 159,0 |
| 0809 40 05 | BA | 39,5 |
| ZZ | 39,5 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MK

27,8

XS

31,8

ZZ

29,8

0707 00 05

MK

25,2

TR

100,7

ZZ

63,0

0709 90 70

TR

98,7

ZZ

98,7

0805 50 10

AR

57,8

UY

54,4

ZA

63,0

ZZ

58,4

0806 10 10

EG

146,9

MA

136,8

TR

87,6

ZA

127,1

ZZ

124,6

0808 10 80

AR

74,7

BR

76,7

CL

89,2

CN

81,7

NZ

101,3

US

105,4

ZA

89,2

ZZ

88,3

0808 20 50

AR

83,2

CL

77,9

TR

153,3

ZA

106,6

ZZ

105,3

0809 20 95

CA

324,1

TR

267,9

US

318,6

ZZ

303,5

0809 30

TR

159,0

ZZ

159,0

0809 40 05

BA

39,5

ZZ

39,5

---

(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’.

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/3 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/3

---

COMMISSION REGULATION (EC) No 696/2009

of 31 July 2009

fixing the import duties in the cereals sector applicable from 1 August 2009

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 1249/96 of 28 June 1996 laying down detailed rules for the application of Council Regulation (EEC) No 1766/92 in respect of import duties in the cereals sector (2), and in particular Article 2(1) thereof,

Whereas:

| (1) | Article 136(1) of Regulation (EC) No 1234/2007 states that the import duty on products falling within CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002, ex 1005 other than hybrid seed, and ex 1007 other than hybrids for sowing, is to be equal to the intervention price valid for such products on importation increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff. |
| --- | --- |

(1)

Article 136(1) of Regulation (EC) No 1234/2007 states that the import duty on products falling within CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002, ex 1005 other than hybrid seed, and ex 1007 other than hybrids for sowing, is to be equal to the intervention price valid for such products on importation increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff.

| (2) | Article 136(2) of Regulation (EC) No 1234/2007 lays down that, for the purposes of calculating the import duty referred to in paragraph 1 of that Article, representative cif import prices are to be established on a regular basis for the products in question. |
| --- | --- |

(2)

Article 136(2) of Regulation (EC) No 1234/2007 lays down that, for the purposes of calculating the import duty referred to in paragraph 1 of that Article, representative cif import prices are to be established on a regular basis for the products in question.

| (3) | Under Article 2(2) of Regulation (EC) No 1249/96, the price to be used for the calculation of the import duty on products of CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002 00, 1005 10 90, 1005 90 00 and 1007 00 90 is the daily cif representative import price determined as specified in Article 4 of that Regulation. |
| --- | --- |

(3)

Under Article 2(2) of Regulation (EC) No 1249/96, the price to be used for the calculation of the import duty on products of CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002 00, 1005 10 90, 1005 90 00 and 1007 00 90 is the daily cif representative import price determined as specified in Article 4 of that Regulation.

| (4) | Import duties should be fixed for the period from 1 August 2009 and should apply until new import duties are fixed and enter into force, |
| --- | --- |

(4)

Import duties should be fixed for the period from 1 August 2009 and should apply until new import duties are fixed and enter into force,

HAS ADOPTED THIS REGULATION:

Article 1

From 1 August 2009, the import duties in the cereals sector referred to in Article 136(1) of Regulation (EC) No 1234/2007 shall be those fixed in Annex I to this Regulation on the basis of the information contained in Annex II.

Article 2

This Regulation shall enter into force on 1 August 2009.

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

Done at Brussels, 31 July 2009.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  OJ L 161, 29.6.1996, p. 125.

2

---

ANNEX I

Import duties on the products referred to in Article 136(1) of Regulation (EC) No 1234/2007 applicable from 1 August 2009

| CN code | Description | Import duties (1)

  (EUR/t) |
| --- | --- | --- |
| 1001 10 00 | Durum wheat, high quality | 0,00 |
| medium quality | 0,00 |
| low quality | 0,00 |
| 1001 90 91 | Common wheat seed | 0,00 |
| ex 1001 90 99 | High quality common wheat, other than for sowing | 0,00 |
| 1002 00 00 | Rye | 65,86 |
| 1005 10 90 | Maize seed other than hybrid | 33,54 |
| 1005 90 00 | Maize, other than seed (2) | 33,54 |
| 1007 00 90 | Grain sorghum other than hybrids for sowing | 70,85 |

CN code

Description

Import duties (1)

(EUR/t)

1001 10 00

Durum wheat, high quality

0,00

medium quality

0,00

low quality

0,00

1001 90 91

Common wheat seed

0,00

ex 1001 90 99

High quality common wheat, other than for sowing

0,00

1002 00 00

Rye

65,86

1005 10 90

Maize seed other than hybrid

33,54

1005 90 00

Maize, other than seed (2)

33,54

1007 00 90

Grain sorghum other than hybrids for sowing

70,85

---

(1)  For goods arriving in the Community via the Atlantic Ocean or via the Suez Canal the importer may benefit, under Article 2(4) of Regulation (EC) No 1249/96, from a reduction in the duty of:

| — | 3 EUR/t, where the port of unloading is on the Mediterranean Sea, or |
| --- | --- |

—

3 EUR/t, where the port of unloading is on the Mediterranean Sea, or

| — | 2 EUR/t, where the port of unloading is in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom or the Atlantic coast of the Iberian peninsula. |
| --- | --- |

—

2 EUR/t, where the port of unloading is in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom or the Atlantic coast of the Iberian peninsula.

(2)  The importer may benefit from a flatrate reduction of EUR 24 per tonne where the conditions laid down in Article 2(5) of Regulation (EC) No 1249/96 are met.

---

ANNEX II

Factors for calculating the duties laid down in Annex I

16.7.2009-30.7.2009

| 1. | Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:











  (EUR/t) |
| --- | --- |
| | Common wheat (1) | Maize | Durum wheat, high quality | Durum wheat, medium quality (2) | Durum wheat, low quality (3) | Barley |
| Exchange | Minnéapolis | Chicago | — | — | — | — |
| Quotation | 169,99 | 88,81 | — | — | — | — |
| Fob price USA | — | — | 170,60 | 160,60 | 140,60 | 71,58 |
| Gulf of Mexico premium | — | 18,56 | — | — | — | — |
| Great Lakes premium | 6,22 | — | — | — | — | — |

1.

Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:

(EUR/t)

Common wheat (1)

Maize

Durum wheat, high quality

Durum wheat, medium quality (2)

Durum wheat, low quality (3)

Barley

Exchange

Minnéapolis

Chicago

—

—

—

—

Quotation

169,99

88,81

—

—

—

—

Fob price USA

—

—

170,60

160,60

140,60

71,58

Gulf of Mexico premium

—

18,56

—

—

—

—

Great Lakes premium

6,22

—

—

—

—

—

| 2. | Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:






  Freight costs: Gulf of Mexico–Rotterdam: | 21,11 EUR/t |
| --- | --- | --- |
| Freight costs: Great Lakes–Rotterdam: | 19,59 EUR/t |

2.

Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:

Freight costs: Gulf of Mexico–Rotterdam:

21,11 EUR/t

Freight costs: Great Lakes–Rotterdam:

19,59 EUR/t

---

(1)  Premium of 14 EUR/t incorporated (Article 4(3) of Regulation (EC) No 1249/96).

(2)  Discount of 10 EUR/t (Article 4(3) of Regulation (EC) No 1249/96).

(3)  Discount of 30 EUR/t (Article 4(3) of Regulation (EC) No 1249/96).

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/6 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/6

---

COMMISSION REGULATION (EC) No 697/2009

of 31 July 2009

amending Regulation (EC) No 1913/2006 laying down detailed rules for the application of the agrimonetary system for the euro in agriculture, as regards the operative events in the School Fruit Scheme, and derogating from that Regulation

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 2799/98 of 15 December 1998 establishing agrimonetary arrangements for the euro (1), and in particular Article 9 thereof,

Whereas:

| (1) | Council Regulations (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (2) and (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) (3) both as amended by Regulation (EC) No 13/2009 (4), set up a School Fruit Scheme co-financed by the Community. |
| --- | --- |

(1)

Council Regulations (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (2) and (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) (3) both as amended by Regulation (EC) No 13/2009 (4), set up a School Fruit Scheme co-financed by the Community.

| (2) | The allocations of Community aid referred to in Commission Regulation (EC) No 288/2009 of 7 April 2009 laying down detailed rules for applying Council Regulation (EC) No 1234/2007 as regards Community aid for supplying fruit and vegetables, processed fruit and vegetables and banana products to children in educational establishments, in the framework of a School Fruit Scheme (5), are expressed in euro. Therefore, the operative event for the exchange rates of currencies of Member States that have not adopted the euro should be laid down. |
| --- | --- |

(2)

The allocations of Community aid referred to in Commission Regulation (EC) No 288/2009 of 7 April 2009 laying down detailed rules for applying Council Regulation (EC) No 1234/2007 as regards Community aid for supplying fruit and vegetables, processed fruit and vegetables and banana products to children in educational establishments, in the framework of a School Fruit Scheme (5), are expressed in euro. Therefore, the operative event for the exchange rates of currencies of Member States that have not adopted the euro should be laid down.

| (3) | Commission Regulation (EC) No 1913/2006 (6) provides for operative events for the exchange rates applicable in Community legislation related to the implementation of the common agricultural policy. It is appropriate to provide for operative events that are specifically linked to the implementation of the School Fruit Scheme. A specific operative event should however be provided for the only period running from 1 August 2009 to 31 July 2010. |
| --- | --- |

(3)

Commission Regulation (EC) No 1913/2006 (6) provides for operative events for the exchange rates applicable in Community legislation related to the implementation of the common agricultural policy. It is appropriate to provide for operative events that are specifically linked to the implementation of the School Fruit Scheme. A specific operative event should however be provided for the only period running from 1 August 2009 to 31 July 2010.

| (4) | Regulation (EC) No 1913/2006 should therefore be amended accordingly. |
| --- | --- |

(4)

Regulation (EC) No 1913/2006 should therefore be amended accordingly.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(5)

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

In Regulation (EC) No 1913/2006 the following Article 5a is inserted after Article 5:

‘Article 5a

Amounts and payments of aid linked to the implementation of the School Fruit Scheme

For aid granted for the supply of fruit and vegetable, processed fruit and vegetable and banana products to children as referred to in Article 1 of Commission Regulation (EC) No 288/2009 (7), the operative event for the exchange rate shall be 1 January preceding the period referred to in Article 4(1) of that Regulation.

Article 2

By way of derogation from Article 5a of Regulation (EC) No 1913/2006 as amended by this Regulation, for the period running from 1 August 2009 to 31 July 2010, the operative event provided for in that Article shall be 31 May 2009.

Article 3

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

Official Journal of the European Union

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

Done at Brussels, 31 July 2009.

For the Commission

Mariann FISCHER BOEL

Member of the Commission

---

(1)  OJ L 349, 24.12.1998, p. 1.

1

(2)  OJ L 209, 11.8.2005, p. 1.

2

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

3

(4)  OJ L 5, 9.1.2009, p. 1.

4

(5)  OJ L 94, 8.4.2009, p. 38.

5

(6)  OJ L 365, 21.12.2006, p. 52.

6

(7)  OJ L 94, 8.4.2009, p. 38.’

7

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/8 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/8

---

COMMISSION REGULATION (EC) No 698/2009

of 31 July 2009

derogating, for information and promotion programmes for milk and milk products aimed at the internal market, from Regulation (EC) No 501/2008 laying down detailed rules for the application of Council Regulation (EC) No 3/2008 on information provision and promotion measures for agricultural products on the internal market and in third countries

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 3/2008 of 17 December 2007 on information provision and promotion measures for agricultural products on the internal market and in third countries (1), and in particular Article 5(1) and Article 15 thereof,

Whereas:

| (1) | Article 3(1)(c) of Regulation (EC) No 3/2008 specifies that the sectors or products which may be the subject of information and promotion actions financed in full or in part from the Community budget are to be determined bearing in mind in particular the need to tackle specific or short-term difficulties in individual sectors. |
| --- | --- |

(1)

Article 3(1)(c) of Regulation (EC) No 3/2008 specifies that the sectors or products which may be the subject of information and promotion actions financed in full or in part from the Community budget are to be determined bearing in mind in particular the need to tackle specific or short-term difficulties in individual sectors.

| (2) | The milk and milk products sector is currently experiencing a period of acute economic difficulty which is likely to endanger the economic survival of a large number of holdings. |
| --- | --- |

(2)

The milk and milk products sector is currently experiencing a period of acute economic difficulty which is likely to endanger the economic survival of a large number of holdings.

| (3) | In this context it is appropriate to offer trade organisations in the milk and milk products sector the opportunity to benefit from Community co-financing under Regulation (EC) No 3/2008, and to that end they should be allowed to submit information and promotion programmes to the competent national authorities within the next few weeks, with a view to their selection and possible adoption by the Commission before the end of this year, thereby derogating from the annual timing for adopting programmes and the usual timetable laid down in Articles 8 and 11 of Commission Regulation (EC) No 501/2008 (2). |
| --- | --- |

(3)

In this context it is appropriate to offer trade organisations in the milk and milk products sector the opportunity to benefit from Community co-financing under Regulation (EC) No 3/2008, and to that end they should be allowed to submit information and promotion programmes to the competent national authorities within the next few weeks, with a view to their selection and possible adoption by the Commission before the end of this year, thereby derogating from the annual timing for adopting programmes and the usual timetable laid down in Articles 8 and 11 of Commission Regulation (EC) No 501/2008 (2).

| (4) | There is therefore reason to derogate, for information and promotion programmes for milk and milk products aimed at the internal market, and for 2009, from Article 11(1) and (3) of Regulation (EC) No 501/2008. |
| --- | --- |

(4)

There is therefore reason to derogate, for information and promotion programmes for milk and milk products aimed at the internal market, and for 2009, from Article 11(1) and (3) of Regulation (EC) No 501/2008.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(5)

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

Notwithstanding the usual annual timetable provided for in Regulation (EC) No 501/2008, for information and promotion programmes for milk and milk products aimed at the internal market submitted by trade organisations in the sector to the Member States before 15 October 2009, derogations shall be made as follows from the said timetable:

| (a) | notwithstanding Article 11(1), first paragraph, the Member States shall send the Commission a provisional list of the programmes selected by 31 October at the latest; |
| --- | --- |

(a)

notwithstanding Article 11(1), first paragraph, the Member States shall send the Commission a provisional list of the programmes selected by 31 October at the latest;

| (b) | notwithstanding Article 11(3), second paragraph, the Commission shall decide by 15 December at the latest which programmes it is able to co-finance. |
| --- | --- |

(b)

notwithstanding Article 11(3), second paragraph, the Commission shall decide by 15 December at the latest which programmes it is able to co-finance.

Article 2

This Regulation shall enter into force on the seventh 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, 31 July 2009.

For the Commission

Mariann FISCHER BOEL

Member of the Commission

---

(1)  OJ L 3, 5.1.2008, p. 1.

1

(2)  OJ L 147, 6.6.2008, p. 3.

2

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/9 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/9

---

COMMISSION REGULATION (EC) No 699/2009

of 31 July 2009

establishing a prohibition of fishing for Greenland halibut in EC waters of IIa and IV; EC and international waters of VI by vessels flying the flag of Spain

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (1), and in particular Article 26(4) thereof,

Having regard to Council Regulation (EEC) No 2847/93 of 12 October 1993 establishing a control system applicable to common fisheries policy (2), and in particular Article 21(3) thereof,

Whereas:

| (1) | Council Regulation (EC) No 43/2009 of 16 January 2009 fixing for 2009 the fishing opportunities and associated conditions for certain fish stocks and groups of fish stocks applicable in Community waters and for Community vessels, in waters where catch limitations are required (3), lays down quotas for 2009. |
| --- | --- |

(1)

Council Regulation (EC) No 43/2009 of 16 January 2009 fixing for 2009 the fishing opportunities and associated conditions for certain fish stocks and groups of fish stocks applicable in Community waters and for Community vessels, in waters where catch limitations are required (3), lays down quotas for 2009.

| (2) | According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2009. |
| --- | --- |

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2009.

| (3) | It is therefore necessary to prohibit fishing for that stock and its retention on board, transhipment and landing, |
| --- | --- |

(3)

It is therefore necessary to prohibit fishing for that stock and its retention on board, transhipment and landing,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2009 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. It shall be prohibited to retain on board, tranship or land such stock caught by those vessels after that date.

Article 3

Entry into force

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

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

Done at Brussels, 31 July 2009.

For the Commission

Fokion FOTIADIS

Director-General for Maritime Affairs and Fisheries

---

(1)  OJ L 358, 31.12.2002, p. 59.

1

(2)  OJ L 261, 20.10.1993, p. 1.

2

(3)  OJ L 22, 26.1.2009, p. 1.

3

---

ANNEX

| No | 4/T&Q |
| --- | --- |
| Member State | Spain |
| Stock | GHL/2A-C46 |
| Species | Greenland halibut (Reinhardtius hippoglossoides) |
| Zone | EC waters of IIa and IV; EC and international waters of VI |
| Date | 15 June 2009 |

No

4/T&Q

Member State

Spain

Stock

GHL/2A-C46

Species

Greenland halibut (Reinhardtius hippoglossoides)

Zone

EC waters of IIa and IV; EC and international waters of VI

Date

15 June 2009

---

DIRECTIVES

| 1.8.2009 | EN | Official Journal of the European Union | L 201/11 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/11

---

DIRECTIVE 2009/66/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 13 July 2009

on the steering equipment of wheeled agricultural or forestry tractors

(Codified version)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

| (1) | Council Directive 75/321/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to the steering equipment of wheeled agricultural or forestry tractors (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Directive should be codified. |
| --- | --- |

(1)

Council Directive 75/321/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to the steering equipment of wheeled agricultural or forestry tractors (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Directive should be codified.

| (2) | Directive 75/321/EEC is one of the separate Directives of the EC type-approval system provided for in Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to type-approval of wheeled agricultural or forestry tractors, as replaced by Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (5) and lays down technical prescriptions concerning the design and construction of wheeled agricultural or forestry tractors as regards the steering equipment. Those technical prescriptions concern the approximation of the laws of the Member States to enable the EC type-approval procedure provided for in Directive 2003/37/EC to be applied in respect of each type of tractor. Consequently, the provisions laid down in Directive 2003/37/EC relating to agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units, apply to this Directive. |
| --- | --- |

(2)

Directive 75/321/EEC is one of the separate Directives of the EC type-approval system provided for in Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to type-approval of wheeled agricultural or forestry tractors, as replaced by Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (5) and lays down technical prescriptions concerning the design and construction of wheeled agricultural or forestry tractors as regards the steering equipment. Those technical prescriptions concern the approximation of the laws of the Member States to enable the EC type-approval procedure provided for in Directive 2003/37/EC to be applied in respect of each type of tractor. Consequently, the provisions laid down in Directive 2003/37/EC relating to agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units, apply to this Directive.

| (3) | This Directive should be without prejudice to the obligations of the Member States concerning the time-limits for transposition into national law and application of the Directives set out in Annex II, Part B, |
| --- | --- |

(3)

This Directive should be without prejudice to the obligations of the Member States concerning the time-limits for transposition into national law and application of the Directives set out in Annex II, Part B,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

1.   ‘Tractor’ (agricultural or forestry) means any motor vehicle fitted with wheels or endless tracks and having at least two axles, the main function of which lies in its tractive power and which is specially designed to tow, push, carry or power certain tools, machinery or trailers intended for agricultural or forestry use. It may be equipped to carry a load and passengers.

2.   This Directive shall apply only to tractors defined in paragraph 1 which are equipped with pneumatic tyres and have a maximum design speed of between 6 and 40 km/h.

Article 2

1.   No Member State may refuse to grant EC type-approval, to issue the document provided for in Article 2(u) of Directive 2003/37/EC, or to grant national type-approval in respect of a type of tractor on grounds relating to its steering equipment, if this satisfies the requirements set out in Annex I.

2.   Member States may no longer issue the document referred to in Article 2(u) of Directive 2003/37/EC for any type of tractor that does not meet the requirements of this Directive.

Member States may refuse to grant national type-approval in respect of a type of tractor that does not meet the requirements of this Directive.

Article 3

No Member State may refuse registration or prohibit the sale, initial entry into service or use of tractors on grounds relating to the steering equipment if this satisfies the requirements set out in Annex I.

Article 4

Any amendments necessary to adapt to technical progress the requirements of Annex I shall be adopted in accordance with the procedure referred to in Article 20(3) of Directive 2003/37/EC.

Article 5

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 6

Directive 75/321/EEC, as amended by the Directives listed in Part A of Annex II, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives set out in Annex II, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 7

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

It shall apply from 1 January 2010.

Article 8

This Directive is addressed to the Member States.

Done at Brussels, 13 July 2009.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

E. ERLANDSSON

---

(1)  OJ C 161, 13.7.2007, p. 38.

1

(2)  Opinion of the European Parliament of 19 June 2007 (OJ C 146 E, 12.6.2008, p. 73) and Council Decision of 22 June 2009.

2

(3)  OJ L 147, 9.6.1975, p. 24.

3

(4)  See Annex II, Part A.

4

(5)  OJ L 171, 9.7.2003, p. 1.

5

---

ANNEX I

1.   DEFINITIONS

1.1.   ‘Steering equipment’

‘Steering equipment’ means all the equipment the purpose of which is to alter the direction of movement of the tractor.

The steering equipment may be considered to include:

| — | the steering control, |
| --- | --- |

—

the steering control,

| — | the steering gear, |
| --- | --- |

—

the steering gear,

| — | the steered wheels, |
| --- | --- |

—

the steered wheels,

| — | where applicable, special equipment to produce additional or independent power, |
| --- | --- |

—

where applicable, special equipment to produce additional or independent power,

1.1.1.   Steering control

‘Steering control’ means the part directly operated by the driver in order to steer the tractor.

1.1.2.   Steering gear

‘Steering gear’ means all the components between the steering control and the steered wheels, with the exception of the special equipment defined in point 1.1.4. The steering gear may be mechanical, hydraulic, pneumatic, electric or a combination of any of these.

1.1.3.   Steered wheels

‘Steered wheels’ means:

| — | the wheels the alignment of which may be altered directly or indirectly in relation to that of the tractor in order to obtain a change in the direction of movement of the tractor, |
| --- | --- |

—

the wheels the alignment of which may be altered directly or indirectly in relation to that of the tractor in order to obtain a change in the direction of movement of the tractor,

| — | all wheels of articulated tractors, |
| --- | --- |

—

all wheels of articulated tractors,

| — | wheels on the same axle, the speed of which may be varied in order to obtain a change in the direction of movement of the tractor, |
| --- | --- |

—

wheels on the same axle, the speed of which may be varied in order to obtain a change in the direction of movement of the tractor,

Self-tracking castor wheels are not steered wheels.

1.1.4.   Special equipment

‘Special equipment’ means that part of the steering equipment by which additional or independent power is produced. Additional or independent power may be produced by any mechanical, hydraulic, pneumatic or electrical system, or by any combination of these (for example by an oil pump, air pump or battery, etc.).

1.2.   ‘Different types of steering equipment’

| 1.2.1. | Depending on the source of power which is necessary for the deflection of the steered wheels, the following types of steering equipment are identified:






  1.2.1.1. | Manual steering equipment, in which the steering power is provided solely by the muscular power of the driver; |
| --- | --- | --- |

1.2.1.

Depending on the source of power which is necessary for the deflection of the steered wheels, the following types of steering equipment are identified:

1.2.1.1.

Manual steering equipment, in which the steering power is provided solely by the muscular power of the driver;

| 1.2.1.2. | Assisted steering equipment, in which the steering power is provided both by the muscular power of the driver and by the special equipment defined in point 1.1.4;
  Steering equipment where the steering power is normally provided solely by the special equipment defined in point 1.1.4, but which in the event of failure of the special equipment enables the muscular power of the driver to be used for steering, shall be considered as ‘assisted steering equipment’. |
| --- | --- |

1.2.1.2.

Assisted steering equipment, in which the steering power is provided both by the muscular power of the driver and by the special equipment defined in point 1.1.4;

Steering equipment where the steering power is normally provided solely by the special equipment defined in point 1.1.4, but which in the event of failure of the special equipment enables the muscular power of the driver to be used for steering, shall be considered as ‘assisted steering equipment’.

| 1.2.1.3. | Servo-steering equipment, in which the steering power is provided solely by the special equipment defined in point 1.1.4. |
| --- | --- |

1.2.1.3.

Servo-steering equipment, in which the steering power is provided solely by the special equipment defined in point 1.1.4.

1.3.   Steering effort

‘Steering effort’ means the force exerted by the driver on the steering control in order to steer the tractor.

2.   CONSTRUCTION, FITTING AND INSPECTION REQUIREMENTS

2.1.   General requirements

| 2.1.1. | The steering equipment must ensure easy and safe handling of the tractor and must comply with the detailed requirements set out in point 2.2. |
| --- | --- |

2.1.1.

The steering equipment must ensure easy and safe handling of the tractor and must comply with the detailed requirements set out in point 2.2.

2.2.   Detailed requirements

2.2.1.   Steering control

| 2.2.1.1. | The steering control must be easy to use and grip. It must be designed in such a way as to permit gradual deflection. The direction of movement of the steering control must correspond to the desired change in the direction of the tractor. |
| --- | --- |

2.2.1.1.

The steering control must be easy to use and grip. It must be designed in such a way as to permit gradual deflection. The direction of movement of the steering control must correspond to the desired change in the direction of the tractor.

| 2.2.1.2. | The steering effort required to achieve a turning circle of 12 m radius, starting from the straight ahead position, must not exceed 25 daN. In the case of assisted steering equipment that is not connected to other equipment, if the auxiliary power supply fails the steering effort required must not exceed 60 daN. |
| --- | --- |

2.2.1.2.

The steering effort required to achieve a turning circle of 12 m radius, starting from the straight ahead position, must not exceed 25 daN. In the case of assisted steering equipment that is not connected to other equipment, if the auxiliary power supply fails the steering effort required must not exceed 60 daN.

| 2.2.1.3. | In order to check compliance with the requirement in point 2.2.1.2, the tractor shall describe a spiral movement at a speed of 10 kilometres per hour, starting from the straight ahead position, on a dry, flat road surface offering good tyre adhesion. The steering effort on the steering control shall be noted until it reaches the position corresponding to the tractor entering a turning circle of 12 m radius. The duration of the manoeuvre (time between the moment when the steering control is first operated and the moment when it reaches the position where the measurements are taken) must not exceed five seconds in normal cases and eight seconds if the special equipment fails. One manoeuvre must be made to the left and one to the right.
  For the test, the tractor must be loaded to its technically permissible maximum weight; tyre pressures and weight distribution between the axles must conform to the manufacturer’s instructions. |
| --- | --- |

2.2.1.3.

In order to check compliance with the requirement in point 2.2.1.2, the tractor shall describe a spiral movement at a speed of 10 kilometres per hour, starting from the straight ahead position, on a dry, flat road surface offering good tyre adhesion. The steering effort on the steering control shall be noted until it reaches the position corresponding to the tractor entering a turning circle of 12 m radius. The duration of the manoeuvre (time between the moment when the steering control is first operated and the moment when it reaches the position where the measurements are taken) must not exceed five seconds in normal cases and eight seconds if the special equipment fails. One manoeuvre must be made to the left and one to the right.

For the test, the tractor must be loaded to its technically permissible maximum weight; tyre pressures and weight distribution between the axles must conform to the manufacturer’s instructions.

2.2.2.   Steering gear

| 2.2.2.1. | The steering equipment may not include either electrical or wholly pneumatic steering gear. |
| --- | --- |

2.2.2.1.

The steering equipment may not include either electrical or wholly pneumatic steering gear.

| 2.2.2.2. | The steering gear must be so designed as to meet any operational requirements. It must be easily accessible for maintenance and inspection. |
| --- | --- |

2.2.2.2.

The steering gear must be so designed as to meet any operational requirements. It must be easily accessible for maintenance and inspection.

| 2.2.2.3. | In the case of steering gear which is not wholly hydraulic, it must be possible to drive the tractor even in the event of failure of the hydraulic or pneumatic components of the steering gear. |
| --- | --- |

2.2.2.3.

In the case of steering gear which is not wholly hydraulic, it must be possible to drive the tractor even in the event of failure of the hydraulic or pneumatic components of the steering gear.

| 2.2.2.4. | Steering gear which is operated purely hydraulically and the special equipment defined in point 1.1.4 must meet the following requirements:






  2.2.2.4.1. | One or more pressure limitation devices must protect the whole or part of the circuit against excess pressure; |
| --- | --- | --- |

2.2.2.4.

Steering gear which is operated purely hydraulically and the special equipment defined in point 1.1.4 must meet the following requirements:

2.2.2.4.1.

One or more pressure limitation devices must protect the whole or part of the circuit against excess pressure;

| 2.2.2.4.2. | The pressure limitation devices must be set so as not to exceed a pressure T equal to the maximum operating pressure stated by the manufacturer; |
| --- | --- |

2.2.2.4.2.

The pressure limitation devices must be set so as not to exceed a pressure T equal to the maximum operating pressure stated by the manufacturer;

| 2.2.2.4.3. | The characteristics and dimensions of the pipe work must be such that the pipes withstand four times the pressure T (permitted by the pressure limitation devices), and must be protected in places and arranged in such a way that the risks of damage by impact or interference are reduced to a minimum, and the risks of damage by rubbing can be considered negligible. |
| --- | --- |

2.2.2.4.3.

The characteristics and dimensions of the pipe work must be such that the pipes withstand four times the pressure T (permitted by the pressure limitation devices), and must be protected in places and arranged in such a way that the risks of damage by impact or interference are reduced to a minimum, and the risks of damage by rubbing can be considered negligible.

2.2.3.   Steered wheels

| 2.2.3.1. | All the wheels may be steered wheels. |
| --- | --- |

2.2.3.1.

All the wheels may be steered wheels.

2.2.4.   Special equipment

| 2.2.4.1. | The special equipment defined in point 1.1.4, used in the types of steering equipment defined in points 1.2.1.2 and 1.2.1.3, shall be acceptable in the following circumstances:






  2.2.4.1.1. | If the tractor is equipped with assisted steering equipment as defined in point 1.2.1.2, it must be possible to drive it even in the event of failure of the special equipment as already stated in point 2.2.1.2. If the assisted steering equipment does not have its own source of power, it must be fitted with a power reservoir. This power reservoir may be replaced by a self-contained device providing power supply to the steering equipment with priority over the other systems which are linked to the common energy source. Without prejudice to the provisions of Council Directive 76/432/EEC of 6 April 1976 on the approximation of the laws of the Member States relating to the braking devices of wheeled agricultural or forestry tractors (1), if there is a hydraulic connection between the hydraulic steering equipment and the hydraulic braking equipment, and if both are supplied from the same energy source, the force required to activate the steering equipment shall not exceed 40 daN if either of the systems should fail. If the source of power is compressed air, the air reservoir must be protected by a non-return valve.
  Where the steering power is normally provided solely by the special equipment defined in point 1.1.4, the assisted steering equipment must be fitted with a device such that if, in the event of failure of the special equipment, the steering effort exceeds 25 daN, a visual or acoustic signal must give warning of such failure. |
| --- | --- | --- |

2.2.4.1.

The special equipment defined in point 1.1.4, used in the types of steering equipment defined in points 1.2.1.2 and 1.2.1.3, shall be acceptable in the following circumstances:

2.2.4.1.1.

If the tractor is equipped with assisted steering equipment as defined in point 1.2.1.2, it must be possible to drive it even in the event of failure of the special equipment as already stated in point 2.2.1.2. If the assisted steering equipment does not have its own source of power, it must be fitted with a power reservoir. This power reservoir may be replaced by a self-contained device providing power supply to the steering equipment with priority over the other systems which are linked to the common energy source. Without prejudice to the provisions of Council Directive 76/432/EEC of 6 April 1976 on the approximation of the laws of the Member States relating to the braking devices of wheeled agricultural or forestry tractors (1), if there is a hydraulic connection between the hydraulic steering equipment and the hydraulic braking equipment, and if both are supplied from the same energy source, the force required to activate the steering equipment shall not exceed 40 daN if either of the systems should fail. If the source of power is compressed air, the air reservoir must be protected by a non-return valve.

Where the steering power is normally provided solely by the special equipment defined in point 1.1.4, the assisted steering equipment must be fitted with a device such that if, in the event of failure of the special equipment, the steering effort exceeds 25 daN, a visual or acoustic signal must give warning of such failure.

| 2.2.4.1.2. | If the tractor is fitted with servo-steering equipment as defined in point 1.2.1.3, and provided that such equipment has a wholly hydraulic steering gear, it must be possible, should the special device or motor fail, to carry out the two manoeuvres specified in point 2.2.1.3 using a special additional device. The special additional device may be a compressed air or gas reservoir. An oil pump or compressor may be used as the special additional device if that device is worked by the rotation of the tractor wheels and cannot be disconnected from them. In the event of failure of the special equipment, a visual or acoustic signal must give warning of such failure.






  2.2.4.1.2.1. | If the special device is pneumatic, it must be fitted with a compressed air reservoir protected by a non-return valve. The capacity of the compressed air reservoir must be calculated so that at least seven complete turns (from lock to lock) are possible before the reservoir pressure falls to half its operating pressure; the test must be carried out with the steered wheels off the ground. |
| --- | --- | --- |

2.2.4.1.2.

If the tractor is fitted with servo-steering equipment as defined in point 1.2.1.3, and provided that such equipment has a wholly hydraulic steering gear, it must be possible, should the special device or motor fail, to carry out the two manoeuvres specified in point 2.2.1.3 using a special additional device. The special additional device may be a compressed air or gas reservoir. An oil pump or compressor may be used as the special additional device if that device is worked by the rotation of the tractor wheels and cannot be disconnected from them. In the event of failure of the special equipment, a visual or acoustic signal must give warning of such failure.

2.2.4.1.2.1.

If the special device is pneumatic, it must be fitted with a compressed air reservoir protected by a non-return valve. The capacity of the compressed air reservoir must be calculated so that at least seven complete turns (from lock to lock) are possible before the reservoir pressure falls to half its operating pressure; the test must be carried out with the steered wheels off the ground.

---

(1)  OJ L 122, 8.5.1976, p. 1.

---

ANNEX II

PART A

Repealed Directive with its successive amendments

(referred to in Article 6)

| Council Directive 75/321/EEC
  (OJ L 147, 9.6.1975, p. 24). | |
| --- | --- |
| Council Directive 82/890/EEC
  (OJ L 378, 31.12.1982, p. 45). | Only as regards the references to Directive 75/321/EEC in Article 1(1) |
| Commission Directive 88/411/EEC
  (OJ L 200, 26.7.1988, p. 30). | |
| Directive 97/54/EC of the European Parliament and of the Council
  (OJ L 277, 10.10.1997, p. 24). | Only as regards the references to Directive 75/321/EEC in the first indent of Article 1 |
| Commission Directive 98/39/EC
  (OJ L 170, 16.6.1998, p. 15). | |

Council Directive 75/321/EEC

(OJ L 147, 9.6.1975, p. 24).

Council Directive 82/890/EEC

(OJ L 378, 31.12.1982, p. 45).

Only as regards the references to Directive 75/321/EEC in Article 1(1)

Commission Directive 88/411/EEC

(OJ L 200, 26.7.1988, p. 30).

Directive 97/54/EC of the European Parliament and of the Council

(OJ L 277, 10.10.1997, p. 24).

Only as regards the references to Directive 75/321/EEC in the first indent of Article 1

Commission Directive 98/39/EC

(OJ L 170, 16.6.1998, p. 15).

PART B

List of time-limits for transposition into national law and application

(referred to in Article 6)

| Directive | Time-limit for transposition | Date of application |
| --- | --- | --- |
| 75/321/EEC | 22 November 1976 | — |
| 82/890/EEC | 22 June 1984 | — |
| 88/411/EEC | 30 September 1988 (1) | — |
| 97/54/EC | 22 September 1998 | 23 September 1998 |
| 98/39/EC | 30 April 1999 (2) | — |

Directive

Time-limit for transposition

Date of application

75/321/EEC

22 November 1976

—

82/890/EEC

22 June 1984

—

88/411/EEC

30 September 1988 (1)

—

97/54/EC

22 September 1998

23 September 1998

98/39/EC

30 April 1999 (2)

—

---

(1)  In conformity with Article 2 of Directive 88/411/EEC:

‘1.   From 1 October 1988 no Member State may:

| — | refuse, in respect of a type of tractor, to grant EEC type-approval, to issue the document referred to in Article 10(1), final indent, of Directive 74/150/EEC, or to grant national type approval, or, |
| --- | --- |

—

refuse, in respect of a type of tractor, to grant EEC type-approval, to issue the document referred to in Article 10(1), final indent, of Directive 74/150/EEC, or to grant national type approval, or,

| — | prohibit the entry into service of tractors, |
| --- | --- |

—

prohibit the entry into service of tractors,

if the steering equipment of this type of tractor or tractors complies with the provisions of this Directive.

2.   From 1 October 1989 Member States:

| — | shall no longer issue the document referred to in Article 10(1), final indent, of Directive 74/150/EEC for a type of tractor the steering equipment of which does not comply with the provisions of this Directive, |
| --- | --- |

—

shall no longer issue the document referred to in Article 10(1), final indent, of Directive 74/150/EEC for a type of tractor the steering equipment of which does not comply with the provisions of this Directive,

| — | may refuse to grant national type approval for a type of tractor, the steering equipment of which does not comply with the provisions of this Directive.’, |
| --- | --- |

—

may refuse to grant national type approval for a type of tractor, the steering equipment of which does not comply with the provisions of this Directive.’,

(2)  In conformity with Article 2 of Directive 98/39/EC:

2

‘1.   From 1 May 1999 no Member State may:

| — | refuse, in respect of a type of tractor, to grant EC type-approval, to issue the document referred to in the third indent of Article 10(1) of Directive 74/150/EEC, or to grant national type-approval, or, |
| --- | --- |

—

refuse, in respect of a type of tractor, to grant EC type-approval, to issue the document referred to in the third indent of Article 10(1) of Directive 74/150/EEC, or to grant national type-approval, or,

| — | to prohibit the entry into service of tractors, |
| --- | --- |

—

to prohibit the entry into service of tractors,

if these tractors meet the requirements of Directive 75/321/EEC, as amended by this Directive.

2.   From 1 October 1999, Member States:

| — | may no longer issue the document referred to in the third indent of Article 10(1) of Directive 74/150/EEC for any type of tractor that does not meet the requirements of Directive 75/321/EEC, as amended by this Directive, |
| --- | --- |

—

may no longer issue the document referred to in the third indent of Article 10(1) of Directive 74/150/EEC for any type of tractor that does not meet the requirements of Directive 75/321/EEC, as amended by this Directive,

| — | may refuse to grant national type-approval in respect of a type of tractor that does not meet the requirements of Directive 75/321/EEC, as amended by this Directive.’ |
| --- | --- |

—

may refuse to grant national type-approval in respect of a type of tractor that does not meet the requirements of Directive 75/321/EEC, as amended by this Directive.’

---

ANNEX III

Correlation table

| Directive 75/321/EEC | Directive 98/39/EC | This Directive |
| --- | --- | --- |
| Article 1 | | Article 1 |
| | Article 2 | Article 2 |
| Articles 3 and 4 | | Articles 3 and 4 |
| Article 5(1) | | — |
| Article 5(2) | | Article 5 |
| — | | Article 6 |
| — | | Article 7 |
| Article 6 | | Article 8 |
| Annex | | Annex I |
| — | | Annex II |
| — | | Annex III |

Directive 75/321/EEC

Directive 98/39/EC

This Directive

Article 1

Article 1

Article 2

Article 2

Articles 3 and 4

Articles 3 and 4

Article 5(1)

—

Article 5(2)

Article 5

—

Article 6

—

Article 7

Article 6

Article 8

Annex

Annex I

—

Annex II

—

Annex III

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/18 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/18

---

DIRECTIVE 2009/76/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 13 July 2009

relating to the driver-perceived noise level of wheeled agricultural or forestry tractors

(Codified version)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

| (1) | Council Directive 77/311/EEC of 29 March 1977 on the approximation of the laws of the Member States relating to the driver-perceived noise level of wheeled agricultural or forestry tractors (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Directive should be codified. |
| --- | --- |

(1)

Council Directive 77/311/EEC of 29 March 1977 on the approximation of the laws of the Member States relating to the driver-perceived noise level of wheeled agricultural or forestry tractors (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Directive should be codified.

| (2) | Directive 73/311/EEC is one of the separate Directives of the EC type-approval system provided for in Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors, as replaced by Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (5), and lays down technical prescriptions concerning the design and construction of agricultural or forestry tractors, as regards driver-perceived noise level. Those technical prescriptions concern the approximation of the laws of the Member States to enable the EC-type approval procedure provided for in Directive 2003/37/EC to be applied in respect of each type of tractor. Consequently, the provisions laid down in Directive 2003/37/EC relating to agricultural and forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units, apply to this Directive. |
| --- | --- |

(2)

Directive 73/311/EEC is one of the separate Directives of the EC type-approval system provided for in Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors, as replaced by Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (5), and lays down technical prescriptions concerning the design and construction of agricultural or forestry tractors, as regards driver-perceived noise level. Those technical prescriptions concern the approximation of the laws of the Member States to enable the EC-type approval procedure provided for in Directive 2003/37/EC to be applied in respect of each type of tractor. Consequently, the provisions laid down in Directive 2003/37/EC relating to agricultural and forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units, apply to this Directive.

| (3) | This Directive should be without prejudice to the obligations of the Member States concerning the time-limits for transposition into national law and application of the Directives set out in Part B of Annex IV, |
| --- | --- |

(3)

This Directive should be without prejudice to the obligations of the Member States concerning the time-limits for transposition into national law and application of the Directives set out in Part B of Annex IV,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

1.   For the purposes of this Directive, ‘tractor’ (agricultural or forestry) means any motor vehicle, fitted with wheels or endless tracks and having at least two axles, the main function of which lies in its tractive power and which is specially designed to tow, push, carry or power certain tools, machinery or trailers intended for agricultural or forestry use. It may be equipped to carry a load and passengers.

2.   This Directive shall apply only to tractors defined in paragraph 1 which are equipped with pneumatic tyres and have a maximum design speed of between 6 and 40 km/h.

Article 2

1.   No Member State may refuse to grant EC type-approval or national type-approval of any type of tractor on grounds relating to the driver-perceived noise level if that level is within the following limits:

| — | 90 dB(A) in accordance with Annex I,
  or |
| --- | --- |

—

90 dB(A) in accordance with Annex I,

or

| — | 86 dB(A) in accordance with Annex II. |
| --- | --- |

—

86 dB(A) in accordance with Annex II.

2.   With respect to vehicles which do not comply with the requirements laid down in this Directive, and on grounds relating to the subject-matter of this Directive, Member States:

| — | shall no longer grant EC type-approval, |
| --- | --- |

—

shall no longer grant EC type-approval,

| — | may refuse to grant national type-approval. |
| --- | --- |

—

may refuse to grant national type-approval.

3.   With respect to new vehicles which do not comply with the requirements laid down in this Directive, and on grounds relating to the subject-matter of this Directive, Member States:

| — | shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 2003/37/EC to be no longer valid for the purposes of Article 7(1) of that Directive, |
| --- | --- |

—

shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 2003/37/EC to be no longer valid for the purposes of Article 7(1) of that Directive,

| — | may refuse the registration, sale or entry into service of those new vehicles. |
| --- | --- |

—

may refuse the registration, sale or entry into service of those new vehicles.

4.   No Member State may refuse to register or prohibit the sale, entry into service or use of any tractor on grounds relating to the driver-perceived noise level if that level is within the following limits:

| — | 90 dB(A) in accordance with Annex I,
  or |
| --- | --- |

—

90 dB(A) in accordance with Annex I,

or

| — | 86 dB(A) in accordance with Annex II. |
| --- | --- |

—

86 dB(A) in accordance with Annex II.

Article 3

For the purposes of this Directive, ‘cab’ means any structure built of rigid components, transparent or not, which totally encloses the driver and isolates him from the outside, and is capable of being kept permanently closed during service.

Article 4

Member States shall take all necessary measures to ensure that in both the sales presentation and advertising there is nothing to suggest that the tractors have features regarding the driver-perceived noise level which they do not in fact possess.

Article 5

The amendments necessary to adapt to technical progress the requirements of Annexes I, II and III shall be adopted in accordance with the procedure referred to in Article 20(3) of Directive 2003/37/EC.

Article 6

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 7

Directive 77/311/EEC, as amended by the acts listed in Part A of Annex IV, is repealed, without prejudice to the obligations of the Member States concerning the time-limits for transposition into national law and application of the Directives set out in Part B of Annex IV.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex V.

Article 8

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

It shall apply from 1 January 2010.

Article 9

This Directive is addressed to the Member States.

Done at Brussels, 13 July 2009.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

E. ERLANDSSON

---

(1)  OJ C 120, 16.5.2008, p. 15.

1

(2)  Opinion of the European Parliament of 19 February 2008 (not yet published in the Official Journal) and Council Decision of 25 June 2009.

2

(3)  OJ L 105, 28.4.1977, p. 1.

3

(4)  See Annex IV, Part A.

4

(5)  OJ L 171, 9.7.2003, p. 1.

5

---

ANNEX I

APPARATUS, CONDITIONS AND METHOD OF MEASUREMENT

1.   UNIT OF MEASUREMENT AND MEASURING APPARATUS

1.1.   Unit of measurement

Noise level LA shall be measured in dB with A-weighting, expressed as dB(A).

1.2.   Measuring apparatus

Driver-perceived noise level shall be measured by means of a sound-level meter as described in the first edition of Publication No 179/1965 of the International Electrotechnical Commission.

In the case of variable readings, the average of the maximum values must be taken.

2.   CONDITIONS OF MEASUREMENT

Measurements shall be made under the following conditions:

| 2.1. | the tractor must be unladen, i.e. without optional accessories, but must include coolant, lubricant, full fuel tank, tools and driver. The latter may not wear any abnormally thick clothing, scarf or hat. There may be no object on the tractor likely to distort the noise level; |
| --- | --- |

2.1.

the tractor must be unladen, i.e. without optional accessories, but must include coolant, lubricant, full fuel tank, tools and driver. The latter may not wear any abnormally thick clothing, scarf or hat. There may be no object on the tractor likely to distort the noise level;

| 2.2. | the tyres must be inflated to the pressure recommended by the tractor manufacturer, the engine, transmission and drive axles must be at normal running temperature and radiator blinds when fitted must be kept open during measurements; |
| --- | --- |

2.2.

the tyres must be inflated to the pressure recommended by the tractor manufacturer, the engine, transmission and drive axles must be at normal running temperature and radiator blinds when fitted must be kept open during measurements;

| 2.3. | if it is liable to affect the noise level, extra equipment powered by the engine or self-powered such as windscreen wipers, warm air fan or power take-off, may not be in operation when measurements are being made; parts which normally operate at the same time as the engine, such as the engine cooling fan, must be in operation when measurements are being made; |
| --- | --- |

2.3.

if it is liable to affect the noise level, extra equipment powered by the engine or self-powered such as windscreen wipers, warm air fan or power take-off, may not be in operation when measurements are being made; parts which normally operate at the same time as the engine, such as the engine cooling fan, must be in operation when measurements are being made;

| 2.4. | the test area must be in an open and sufficiently silent location; it may take the form, for instance, of an open space of 50-metre radius, having a central part with a radius of at least 20 m which is practically level, or of a level section having a solid track with as flat a surface and as few gullies as possible. The track must be as clean and dry as possible (e.g. free of gravel, leaves, snow, etc.). Slopes and irregularities are acceptable only if the variations in noise level caused by them lie within the error tolerances of the measuring equipment; |
| --- | --- |

2.4.

the test area must be in an open and sufficiently silent location; it may take the form, for instance, of an open space of 50-metre radius, having a central part with a radius of at least 20 m which is practically level, or of a level section having a solid track with as flat a surface and as few gullies as possible. The track must be as clean and dry as possible (e.g. free of gravel, leaves, snow, etc.). Slopes and irregularities are acceptable only if the variations in noise level caused by them lie within the error tolerances of the measuring equipment;

| 2.5. | the surface of the track must be such as not to cause excessive tyre noise; |
| --- | --- |

2.5.

the surface of the track must be such as not to cause excessive tyre noise;

| 2.6. | the weather must be fine and dry with little or no wind.
  The driver-perceived ambient noise level due to the wind or other sources of noise must be at least 10 dB(A) below the noise level of the tractor; |
| --- | --- |

2.6.

the weather must be fine and dry with little or no wind.

The driver-perceived ambient noise level due to the wind or other sources of noise must be at least 10 dB(A) below the noise level of the tractor;

| 2.7. | if a vehicle is used for measurements, it must be towed or driven at a sufficient distance from the tractor to avoid all interference. During measurements no object interfering with the measurements or reflective surfaces may be located within 20 m of each side of the test track or less than 20 m to the front or rear of the tractor. This condition can be considered fulfilled if the variations in noise level thus caused remain within the error tolerances; if not, the measurements must be discontinued for the duration of the interference; |
| --- | --- |

2.7.

if a vehicle is used for measurements, it must be towed or driven at a sufficient distance from the tractor to avoid all interference. During measurements no object interfering with the measurements or reflective surfaces may be located within 20 m of each side of the test track or less than 20 m to the front or rear of the tractor. This condition can be considered fulfilled if the variations in noise level thus caused remain within the error tolerances; if not, the measurements must be discontinued for the duration of the interference;

| 2.8. | all measurements in a given series must be carried out on the same track. |
| --- | --- |

2.8.

all measurements in a given series must be carried out on the same track.

3.   METHOD OF MEASUREMENT

| 3.1. | The microphone must be located 250 mm to the side of the centre plane of the seat, the side being that on which the higher noise level is encountered.
  The microphone diaphragm must face forward and the centre of the microphone must be 790 mm above and 150 mm forward of the seat reference point described in Annex III. Excessive vibration of the microphone must be avoided. |
| --- | --- |

3.1.

The microphone must be located 250 mm to the side of the centre plane of the seat, the side being that on which the higher noise level is encountered.

The microphone diaphragm must face forward and the centre of the microphone must be 790 mm above and 150 mm forward of the seat reference point described in Annex III. Excessive vibration of the microphone must be avoided.

| 3.2. | The maximum noise level in dB(A) shall be determined as follows:






  3.2.1. | all openings (e.g. doors, windows) in tractors having a closed series-produced cab structure must be closed during an initial series of measurements;






  3.2.1.1. | during a second series of measurements, they must be left open, provided that, when open, they do not create a road safety hazard, but fold-down or fold-up windscreens must remain closed; |
| --- | --- | --- | --- |

3.2.

The maximum noise level in dB(A) shall be determined as follows:

3.2.1.

all openings (e.g. doors, windows) in tractors having a closed series-produced cab structure must be closed during an initial series of measurements;

3.2.1.1.

during a second series of measurements, they must be left open, provided that, when open, they do not create a road safety hazard, but fold-down or fold-up windscreens must remain closed;

| 3.2.2. | noise must be measured using slow sound-level meter response at the load corresponding to the maximum noise in the gear giving the forward speed nearest to 7.5 km/h.
  The governor control lever must be fully open. Starting with no load, the load applied must be increased until the maximum noise level is found. After each increase of load, time must be allowed for the noise level to stabilise before making the measurement; |
| --- | --- |

3.2.2.

noise must be measured using slow sound-level meter response at the load corresponding to the maximum noise in the gear giving the forward speed nearest to 7.5 km/h.

The governor control lever must be fully open. Starting with no load, the load applied must be increased until the maximum noise level is found. After each increase of load, time must be allowed for the noise level to stabilise before making the measurement;

| 3.2.3. | noise must be measured using slow sound-level meter response at the load corresponding to the maximum noise in any gear other than that referred to in point 3.2.2 in which the noise level recorded is at least 1 dB(A) above that recorded in the gear referred to in point 3.2.2.
  The governor control lever must be fully open. Starting with no load, the load applied must be increased until the maximum noise level is found. After each increase of load, time must be allowed for the noise level to stabilise before making the measurement; |
| --- | --- |

3.2.3.

noise must be measured using slow sound-level meter response at the load corresponding to the maximum noise in any gear other than that referred to in point 3.2.2 in which the noise level recorded is at least 1 dB(A) above that recorded in the gear referred to in point 3.2.2.

The governor control lever must be fully open. Starting with no load, the load applied must be increased until the maximum noise level is found. After each increase of load, time must be allowed for the noise level to stabilise before making the measurement;

| 3.2.4. | noise must be measured at the maximum design speed of the unladen tractor. |
| --- | --- |

3.2.4.

noise must be measured at the maximum design speed of the unladen tractor.

| 3.3. | The test report shall include noise-level measurements carried out under the following conditions:






  3.3.1. | in the gear giving the speed nearest to 7.5 km/h; |
| --- | --- | --- |

3.3.

The test report shall include noise-level measurements carried out under the following conditions:

3.3.1.

in the gear giving the speed nearest to 7.5 km/h;

| 3.3.2. | in any gear, if the conditions described in point 3.2.3 are fulfilled; |
| --- | --- |

3.3.2.

in any gear, if the conditions described in point 3.2.3 are fulfilled;

| 3.3.3. | at maximum design speed. |
| --- | --- |

3.3.3.

at maximum design speed.

4.   ASSESSMENT CRITERIA

The measurements described in points 3.2.1, 3.2.2, 3.2.3 and 3.2.4 may not exceed the values laid down in Article 2.

---

ANNEX II

APPARATUS, CONDITIONS AND METHOD OF MEASUREMENT

1.   UNIT OF MEASUREMENT AND MEASURING APPARATUS

1.1.   Unit of measurement

Noise level LA shall be measured in dB with A-weighting, expressed as dB(A).

1.2.   Measuring apparatus

Driver-perceived noise level shall be measured by means of a sound-level meter as described in the first edition of publication 179/1965 of the International Electrotechnical Commission.

In the case of variable readings, the average of the maximum values must be taken.

2.   CONDITIONS OF MEASUREMENT

Measurements shall be made under the following conditions:

| 2.1. | the tractor must be unladen, i.e. without optional accessories, but must include coolant, lubricant; full fuel tank, tools and driver. The latter may not wear any abnormally thick clothing, scarf or hat. There may be no object on the tractor likely to distort the noise level; |
| --- | --- |

2.1.

the tractor must be unladen, i.e. without optional accessories, but must include coolant, lubricant; full fuel tank, tools and driver. The latter may not wear any abnormally thick clothing, scarf or hat. There may be no object on the tractor likely to distort the noise level;

| 2.2. | the tyres must be inflated to the pressure recommended by the tractor manufacturer, the engine, transmission and drive axles must be at normal running temperature and, if the engine has cooling louvres, these must remain completely open; |
| --- | --- |

2.2.

the tyres must be inflated to the pressure recommended by the tractor manufacturer, the engine, transmission and drive axles must be at normal running temperature and, if the engine has cooling louvres, these must remain completely open;

| 2.3. | if it is liable to affect the noise level, extra equipment powered by the engine or self-powered such as windscreen wipers, warm air fan or power take-off, for example, may not be in operation when measurements are being made; parts which normally operate at the same time as the engine, such as the engine cooling fan, for example, must be in operation when measurements are being made; |
| --- | --- |

2.3.

if it is liable to affect the noise level, extra equipment powered by the engine or self-powered such as windscreen wipers, warm air fan or power take-off, for example, may not be in operation when measurements are being made; parts which normally operate at the same time as the engine, such as the engine cooling fan, for example, must be in operation when measurements are being made;

| 2.4. | the test area must be in an open and sufficiently silent location: it may take the form, for instance, of an open space of 50-metre radius, having a central part with a radius of at least 20 m which is practically level, or of a level section having a solid track with as flat a surface and as few gullies as possible. The track must be as clean and dry as possible (e.g. free of gravel, leaves, snow, etc.). Slopes and irregularities are acceptable only if the variations in noise level caused by them lie within the error tolerances of the measuring equipment; |
| --- | --- |

2.4.

the test area must be in an open and sufficiently silent location: it may take the form, for instance, of an open space of 50-metre radius, having a central part with a radius of at least 20 m which is practically level, or of a level section having a solid track with as flat a surface and as few gullies as possible. The track must be as clean and dry as possible (e.g. free of gravel, leaves, snow, etc.). Slopes and irregularities are acceptable only if the variations in noise level caused by them lie within the error tolerances of the measuring equipment;

| 2.5. | the surface of the track must be such as not to cause excessive tyre noise; |
| --- | --- |

2.5.

the surface of the track must be such as not to cause excessive tyre noise;

| 2.6. | the weather must be fine and dry with little or no wind.
  The driver-perceived ambient noise level due to the wind or other sources of noise must be at least 10 dB(A) below the noise level of the tractor; |
| --- | --- |

2.6.

the weather must be fine and dry with little or no wind.

The driver-perceived ambient noise level due to the wind or other sources of noise must be at least 10 dB(A) below the noise level of the tractor;

| 2.7. | if a vehicle is used for measurements, it must be towed or driven at a sufficient distance from the tractor to avoid all interference. During measurements no object interfering with the measurements or reflective surfaces may be located within 20 m of each side of the test track or less than 20 m to the front or rear of the tractor. This condition can be considered fulfilled if the variations in noise level thus caused remain within the error tolerances; if not, the measurements must be discontinued for the duration of the interference; |
| --- | --- |

2.7.

if a vehicle is used for measurements, it must be towed or driven at a sufficient distance from the tractor to avoid all interference. During measurements no object interfering with the measurements or reflective surfaces may be located within 20 m of each side of the test track or less than 20 m to the front or rear of the tractor. This condition can be considered fulfilled if the variations in noise level thus caused remain within the error tolerances; if not, the measurements must be discontinued for the duration of the interference;

| 2.8. | all measurements in a given series must be carried out on the same track. |
| --- | --- |

2.8.

all measurements in a given series must be carried out on the same track.

3.   METHOD OF MEASUREMENT

| 3.1. | The microphone must be located 250 mm to the side of the central plane of the seat, the side being that on which the higher noise level is encountered.
  The microphone diaphragm must face forward and the centre of the microphone shall be 790 mm above and 150 mm forward of the seat reference point described in Annex III. Excessive vibration of the microphone must be avoided. |
| --- | --- |

3.1.

The microphone must be located 250 mm to the side of the central plane of the seat, the side being that on which the higher noise level is encountered.

The microphone diaphragm must face forward and the centre of the microphone shall be 790 mm above and 150 mm forward of the seat reference point described in Annex III. Excessive vibration of the microphone must be avoided.

| 3.2. | Noise level shall be determined as follows:






  3.2.1. | the tractor must travel along the section at the same test speed at least three times for at least 10 seconds; |
| --- | --- | --- |

3.2.

Noise level shall be determined as follows:

3.2.1.

the tractor must travel along the section at the same test speed at least three times for at least 10 seconds;

| 3.2.2. | all openings (e.g. doors, windows) in tractors having a closed series-produced cab structure must be closed during an initial series of measurements;






  3.2.2.1. | during a second series of measurements they must be left open, provided that when open they do not create a road safety hazard, but fold-down or fold-up windscreens must remain closed; |
| --- | --- | --- |

3.2.2.

all openings (e.g. doors, windows) in tractors having a closed series-produced cab structure must be closed during an initial series of measurements;

3.2.2.1.

during a second series of measurements they must be left open, provided that when open they do not create a road safety hazard, but fold-down or fold-up windscreens must remain closed;

| 3.2.3. | noise must be measured at the maximum rpm using slow sound-level meter response i.e. in the gear giving the speed nearest to 7.5 km/h at the rated rpm. The tractor must be unladen when measurements are being made. |
| --- | --- |

3.2.3.

noise must be measured at the maximum rpm using slow sound-level meter response i.e. in the gear giving the speed nearest to 7.5 km/h at the rated rpm. The tractor must be unladen when measurements are being made.

4.   ASSESSMENT CRITERIA

The measurements described in points 3.2.2 and 3.2.3 may not exceed the values laid down in Article 2.

---

ANNEX III

DETERMINATION OF SEAT REFERENCE POINT

1.   DEFINITION

| 1.1. | The seat reference point (S) shall be the point in the central longitudinal plane of the seat where the tangential plane of the lower backrest and a horizontal plane intersect. This horizontal plane cuts the lower surface of the seat-pan board 150 mm in front of the seat reference point. |
| --- | --- |

1.1.

The seat reference point (S) shall be the point in the central longitudinal plane of the seat where the tangential plane of the lower backrest and a horizontal plane intersect. This horizontal plane cuts the lower surface of the seat-pan board 150 mm in front of the seat reference point.

2.   DETERMINATION OF SEAT REFERENCE POINT

| 2.1. | The reference point shall be obtained using the device illustrated in figures 1 and 2 of the Appendix to this Annex, which makes it possible to simulate loading by a human occupant. |
| --- | --- |

2.1.

The reference point shall be obtained using the device illustrated in figures 1 and 2 of the Appendix to this Annex, which makes it possible to simulate loading by a human occupant.

| 2.2. | The seat must be set at the mid-point of the range allowed for vertical adjustment, this adjustment being independent of the horizontal adjustment. For the purposes of determining the microphone location referred to in point 3 of Annexes I and II, the seat must be at or as near as possible to the mid-point of the horizontal adjustment range. |
| --- | --- |

2.2.

The seat must be set at the mid-point of the range allowed for vertical adjustment, this adjustment being independent of the horizontal adjustment. For the purposes of determining the microphone location referred to in point 3 of Annexes I and II, the seat must be at or as near as possible to the mid-point of the horizontal adjustment range.

3.   DESCRIPTION OF THE DEVICE

| 3.1. | The device referred to in point 2.1 shall consist of a seat-pan board and two backrest boards. |
| --- | --- |

3.1.

The device referred to in point 2.1 shall consist of a seat-pan board and two backrest boards.

| 3.2. | The lower backrest board shall be jointed in the region of the ischium humps (A) and loin (B), the joint (B) being adjustable in height (see figure 2). |
| --- | --- |

3.2.

The lower backrest board shall be jointed in the region of the ischium humps (A) and loin (B), the joint (B) being adjustable in height (see figure 2).

4.   SETTING UP THE DEVICE

The device shall be set up as follows:

| 4.1. | the device shall be positioned on the seat; |
| --- | --- |

4.1.

the device shall be positioned on the seat;

| 4.2. | it shall then be loaded with a force of 550 N at a point 50 mm in front of joint (A), and the two backrest boards shall be lightly pressed tangentially against the backrest; |
| --- | --- |

4.2.

it shall then be loaded with a force of 550 N at a point 50 mm in front of joint (A), and the two backrest boards shall be lightly pressed tangentially against the backrest;

| 4.3. | if it is not possible to determine a definite tangent to the lower area of the backrest, the lower backrest board in vertical position must be lightly pressed against the backrest; |
| --- | --- |

4.3.

if it is not possible to determine a definite tangent to the lower area of the backrest, the lower backrest board in vertical position must be lightly pressed against the backrest;

| 4.4. | in the case of seats with a suspension adjustable to the driver’s weight, the suspension shall be set so that the seat is at a point equidistant from its two extreme positions. |
| --- | --- |

4.4.

in the case of seats with a suspension adjustable to the driver’s weight, the suspension shall be set so that the seat is at a point equidistant from its two extreme positions.

Appendix

Image

Image

---

ANNEX IV

PART A

Repealed Directive with list of its successive amendments

(referred to in Article 7)

| Council Directive 77/311/EEC
  (OJ L 105, 28.4.1977, p. 1). | |
| --- | --- |
| Council Directive 82/890/EEC
  (OJ L 378, 31.12.1982, p. 45). | Only the references made by Article 1(1) to Directive 77/311/EEC |
| Directive 97/54/EC of the European Parliament and of the Council
  (OJ L 277, 10.10.1997, p. 24). | Only the references made by Article 1, first indent, to Directive 77/311/EEC |
| Commission Decision 96/627/EC
  (OJ L 282, 1.11.1996, p. 72). | |
| Commission Decision 2000/63/EC
  (OJ L 22, 27.1.2000, p. 66). | |
| Commission Directive 2006/26/EC
  (OJ L 65, 7.3.2006, p. 22). | Only Article 2 and Annex II |

Council Directive 77/311/EEC

(OJ L 105, 28.4.1977, p. 1).

Council Directive 82/890/EEC

(OJ L 378, 31.12.1982, p. 45).

Only the references made by Article 1(1) to Directive 77/311/EEC

Directive 97/54/EC of the European Parliament and of the Council

(OJ L 277, 10.10.1997, p. 24).

Only the references made by Article 1, first indent, to Directive 77/311/EEC

Commission Decision 96/627/EC

(OJ L 282, 1.11.1996, p. 72).

Commission Decision 2000/63/EC

(OJ L 22, 27.1.2000, p. 66).

Commission Directive 2006/26/EC

(OJ L 65, 7.3.2006, p. 22).

Only Article 2 and Annex II

PART B

List of time-limits for transposition into national law and application

(referred to in Article 7)

| Act | Time-limit for transposition | Date of application |
| --- | --- | --- |
| 77/311/EEC | 1 October 1978 | — |
| 82/890/EEC | 22 June 1984 | — |
| 97/54/EC | 22 September 1998 | 23 September 1998 |
| 96/627/EC | 29 September 1999 | — |
| 2006/63/EC | 30 September 2001 | — |
| 2006/26/EC | 31 December 2006 (1) | — |

Act

Time-limit for transposition

Date of application

77/311/EEC

1 October 1978

—

82/890/EEC

22 June 1984

—

97/54/EC

22 September 1998

23 September 1998

96/627/EC

29 September 1999

—

2006/63/EC

30 September 2001

—

2006/26/EC

31 December 2006 (1)

—

---

(1)  In accordance with Article 5 of Directive 2006/26/EC:

‘1.   With effect from 1 January 2007, with respect to vehicles which comply with the requirements laid down respectively in Directives 74/151/EEC, 78/933/EEC, 77/311/EEC and 89/173/EEC, as amended by this Directive, Member States shall not, on grounds relating to the subject-matter of the Directive concerned:

| (a) | refuse to grant EC type-approval or to grant national type-approval; |
| --- | --- |

(a)

refuse to grant EC type-approval or to grant national type-approval;

| (b) | prohibit the registration, sale or entry into service of such a vehicle. |
| --- | --- |

(b)

prohibit the registration, sale or entry into service of such a vehicle.

2.   With effect from 1 July 2007, with respect to vehicles which do not comply with the requirements laid down respectively in Directives 74/151/EEC, 78/933/EEC, 77/311/EEC and 89/173/EEC, as amended by this Directive, and on grounds relating to the subject-matter of the Directive concerned, Member States:

| (a) | shall no longer grant EC type-approval; |
| --- | --- |

(a)

shall no longer grant EC type-approval;

| (b) | may refuse to grant national type-approval. |
| --- | --- |

(b)

may refuse to grant national type-approval.

3.   With effect from 1 July 2009, with respect to vehicles which do not comply with the requirements laid down respectively in Directives 74/151/EEC, 78/933/EEC, 77/311/EEC and 89/173/EEC, as amended by this Directive, and on grounds relating to the subject-matter of the Directive concerned, Member States:

| (a) | shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 2003/37/EC to be no longer valid for the purposes of Article 7(1); |
| --- | --- |

(a)

shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 2003/37/EC to be no longer valid for the purposes of Article 7(1);

| (b) | may refuse the registration, sale or entry into service of those new vehicles.’. |
| --- | --- |

(b)

may refuse the registration, sale or entry into service of those new vehicles.’.

---

ANNEX V

Correlation Table

| Directive 77/311/EEC | Directive 2006/26/EC | This Directive |
| --- | --- | --- |
| Article 1 | | Article 1 |
| Article 2(1), first subparagraph | | Article 2(1) and (4) |
| Article 2(1), second subparagraph | | — |
| Article 2(2) | | — |
| | Article 5(2) | Article 2(2) |
| | Article 5(3) | Article 2(3) |
| Articles 3, 4 and 5 | | Article 3, 4 and 5 |
| Article 6(1) | | — |
| Article 6(2) | | Article 6 |
| | | Article 7 |
| | | Article 8 |
| Article 7 | | Article 9 |
| Annex I | | Annex I |
| Annex II | | Annex II |
| Annex III | | Annex III |
| — | | Annex IV |
| — | | Annex V |

Directive 77/311/EEC

Directive 2006/26/EC

This Directive

Article 1

Article 1

Article 2(1), first subparagraph

Article 2(1) and (4)

Article 2(1), second subparagraph

—

Article 2(2)

—

Article 5(2)

Article 2(2)

Article 5(3)

Article 2(3)

Articles 3, 4 and 5

Article 3, 4 and 5

Article 6(1)

—

Article 6(2)

Article 6

Article 7

Article 8

Article 7

Article 9

Annex I

Annex I

Annex II

Annex II

Annex III

Annex III

—

Annex IV

—

Annex V

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/29 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/29

---

DIRECTIVE 2009/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 13 July 2009

on passenger hand-holds on two-wheel motor vehicles

(Codified version)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

| (1) | Council Directive 93/32/EEC of 14 June 1993 on passenger hand-holds on two-wheel motor vehicles (3) has been substantially amended (4). In the interests of clarity and rationality the said Directive should be codified. |
| --- | --- |

(1)

Council Directive 93/32/EEC of 14 June 1993 on passenger hand-holds on two-wheel motor vehicles (3) has been substantially amended (4). In the interests of clarity and rationality the said Directive should be codified.

| (2) | Directive 93/32/EEC is one of the separate Directives of the EC type-approval system provided for in Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles as replaced by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (5) and lays down technical prescriptions concerning the design and construction of two-wheel motor vehicles as regards their passenger hand-holds. These technical prescriptions concern the approximation of the laws of the Member States to allow for the EC type-approval procedure provided for in Directive 2002/24/EC to be applied in respect of each type of vehicle. Consequently, the provisions laid down in Directive 2002/24/EC relating to vehicle systems, components and separate technical units apply to this Directive. |
| --- | --- |

(2)

Directive 93/32/EEC is one of the separate Directives of the EC type-approval system provided for in Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles as replaced by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (5) and lays down technical prescriptions concerning the design and construction of two-wheel motor vehicles as regards their passenger hand-holds. These technical prescriptions concern the approximation of the laws of the Member States to allow for the EC type-approval procedure provided for in Directive 2002/24/EC to be applied in respect of each type of vehicle. Consequently, the provisions laid down in Directive 2002/24/EC relating to vehicle systems, components and separate technical units apply to this Directive.

| (3) | Since the objective of this Directive, namely the granting of EC component type-approval in respect of passenger hand-holds for a type of two-wheel motor vehicle, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. |
| --- | --- |

(3)

Since the objective of this Directive, namely the granting of EC component type-approval in respect of passenger hand-holds for a type of two-wheel motor vehicle, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

| (4) | This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives set out in Annex II, Part B, |
| --- | --- |

(4)

This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives set out in Annex II, Part B,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

This Directive shall apply to passenger hand-holds of all types of two-wheel motor vehicles as referred to in Article 1 of Directive 2002/24/EC.

Article 2

The procedure for the granting of EC component type-approval in respect of passenger hand-holds for a type of two-wheel motor vehicle and the conditions governing the free movement of such vehicles shall be as laid down in Chapters II and III of Directive 2002/24/EC.

Article 3

The amendments necessary to adapt to technical progress the requirements of Annex I shall be adopted in accordance with the procedure referred to in Article 18(2) of Directive 2002/24/EC.

Article 4

1.   Member States shall not, on grounds relating to passenger hand-holds:

| — | refuse, in respect of a type of two-wheel vehicle or a type of passenger hand-hold, to grant EC type-approval, |
| --- | --- |

—

refuse, in respect of a type of two-wheel vehicle or a type of passenger hand-hold, to grant EC type-approval,

| — | prohibit the registration, sale or entry into service of two-wheel motor vehicles or the sale or entry into service of passenger hand-holds, |
| --- | --- |

—

prohibit the registration, sale or entry into service of two-wheel motor vehicles or the sale or entry into service of passenger hand-holds,

if the passenger hand-holds comply with the requirements of this Directive.

2.   Member States shall refuse to grant EC type-approval for any type of two-wheel motor vehicle on grounds relating to passenger hand-holds or any type of passenger handhold, if the requirements of this Directive are not fulfilled.

3.   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 5

Directive 93/32/EEC, as amended by the Directive listed in Annex II, Part A, is repealed without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives set out in Annex II, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 6

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

It shall apply from 1 January 2010.

Article 7

This Directive is addressed to the Member States.

Done at Brussels, 13 July 2009.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

E. ERLANDSSON

---

(1)  OJ C 234, 30.9.2003, p. 19.

1

(2)  Opinion of the European Parliament of 25 September 2007 (OJ C 219 E, 28.8.2008, p. 65) and Council Decision of 7 July 2009.

2

(3)  OJ L 188, 29.7.1993, p. 28.

3

(4)  See Annex II, Part A.

4

(5)  OJ L 124, 9.5.2002, p. 1.

5

---

ANNEX I

1.   GENERAL REQUIREMENTS

Where provision is made for carriage of a passenger, the vehicle must be fitted with a passenger hand-hold system, which must take the form of a strap or a hand-grip or hand-grips.

1.1.   Strap

The strap must be fitted to the seat or to other parts connected to the frame in such a way that it may easily be used by the passenger. The strap and its attachment must be designed in such a way that they withstand, without snapping, a vertical traction force of 2 000 N applied statically to the centre of the surface of the strap at a maximum pressure of 2 Mpa.

1.2.   Hand-grip

If a hand-grip is used it must be close to the saddle and symmetrical to the median longitudinal plane of the vehicle.

This hand-grip must be designed in such a way that it is able to withstand, without snapping, a vertical traction force of 2 000 N applied statically to the centre of the surface of the hand-grip at a maximum pressure of 2 MPa.

If two hand-grips are used they must be fitted one on each side in a symmetrical manner.

These hand-grips must be designed in such a way that each is able to withstand, without snapping, a vertical traction force of 1 000 N applied statically to the centre of the surface of the hand-grip at a maximum pressure of 1 MPa.

Appendix 1

Information document in respect of passenger hand-holds for a type of two-wheel motor vehicle

(to be attached to the application for EC component type-approval if this is submitted separately from the application for EC vehicle type-approval)

Order No (assigned by the applicant): ...

The application for EC component type-approval in respect of passenger hand-holds for a two-wheel motor vehicle must contain the information set out under the following points in Annex II to Directive 2002/24/EC:

| — | Part 1, Section A, points:






  — | 0.1, |
| --- | --- | --- |

—

Part 1, Section A, points:

—

0.1,

| — | 0.2, |
| --- | --- |

—

0.2,

| — | 0.4 to 0.6. |
| --- | --- |

—

0.4 to 0.6.

| — | Part 1, Section B, points:






  — | 1.4 to 1.4.2. |
| --- | --- | --- |

—

Part 1, Section B, points:

—

1.4 to 1.4.2.

Appendix 2

Name of administration

EC Component type-approval certificate in respect of restraint devices for passengers for a type of two-wheel motor vehicle

MODEL

Report No ... by technical service ... date ...

EC Component type-approval No: ... Extension No: ...

| 1. | Trade mark or name of vehicle: ... |
| --- | --- |

1.

Trade mark or name of vehicle: ...

| 2. | Type of vehicle: ... |
| --- | --- |

2.

Type of vehicle: ...

| 3. | Name and address of manufacturer: ...
  ... |
| --- | --- |

3.

Name and address of manufacturer: ...

...

| 4. | Name and address of manufacturer’s representative (if any): ...
  ... |
| --- | --- |

4.

Name and address of manufacturer’s representative (if any): ...

...

| 5. | Date vehicle submitted for test: ... |
| --- | --- |

5.

Date vehicle submitted for test: ...

| 6. | EC Component type-approval granted/refused (1) |
| --- | --- |

6.

EC Component type-approval granted/refused (1)

| 7. | Place: ... |
| --- | --- |

7.

Place: ...

| 8. | Date: ... |
| --- | --- |

8.

Date: ...

| 9. | Signature: ... |
| --- | --- |

9.

Signature: ...

---

(1)  Delete as appropriate.

---

ANNEX II

PART A

Repealed Directive with its amendment

(referred to in Article 5)

| Council Directive 93/32/EEC | (OJ L 188, 29.7.1993, p. 28). |
| --- | --- |
| Commission Directive 1999/24/EC | (OJ L 104, 21.4.1999, p. 16). |

Council Directive 93/32/EEC

(OJ L 188, 29.7.1993, p. 28).

Commission Directive 1999/24/EC

(OJ L 104, 21.4.1999, p. 16).

PART B

List of the time-limits for transposition into national law and application

(referred to in Article 5)

| Directive | Time-limit for transposition | Date of application |
| --- | --- | --- |
| 93/32/EEC | 14 December 1994 | 14 June 1995 (1) |
| 1999/24/EC | 31 December 1999 | 1 January 2000 (2) |

Directive

Time-limit for transposition

Date of application

93/32/EEC

14 December 1994

14 June 1995 (1)

1999/24/EC

31 December 1999

1 January 2000 (2)

---

(1)  In conformity with the third subparagraph of Article 4(1) of Directive 93/32/EEC:

‘From the date mentioned in the first subparagraph Member States may not, for reasons connected with the passenger hand-holds, prohibit the initial entry into service of vehicles which conform to this Directive.’

The said date is 14 December 1994; see the first subparagraph of Article 4(1) of Directive 93/32/EEC.

(2)  In conformity with Article 2 of Directive 1999/24/EC:

2

‘1.   With effect from 1 January 2000, Member States shall not, on grounds relating to passenger hand-holds:

| — | refuse, in respect of a type of two-wheel vehicle or a type of passenger hand-hold, to grant EC type-approval, |
| --- | --- |

—

refuse, in respect of a type of two-wheel vehicle or a type of passenger hand-hold, to grant EC type-approval,

| — | prohibit the registration, sale or entry into service of two-wheel motor vehicles or the sale or entry into service of passenger hand-holds, |
| --- | --- |

—

prohibit the registration, sale or entry into service of two-wheel motor vehicles or the sale or entry into service of passenger hand-holds,

if the passenger hand-holds comply with the requirements of Council Directive 93/32/EEC, as amended by this Directive.

2.   With effect from 1 July 2000, Member States shall refuse to grant EC type-approval for any type of two-wheel motor vehicle on grounds relating to passenger hand-holds or any type of passenger handhold, if the requirements of Directive 93/32/EEC, as amended by this Directive, are not fulfilled.’

---

ANNEX III

Correlation table

| Directive 93/32/EEC | Directive 1999/24/EC | This Directive |
| --- | --- | --- |
| Articles 1, 2 and 3 | | Articles 1, 2 and 3 |
| Article 4(1) | | — |
| | Article 2(1) | Article 4(1) |
| | Article 2(2) | Article 4(2) |
| Article 4(2) | | Article 4(3) |
| — | | Article 5 |
| — | | Article 6 |
| Article 5 | | Article 7 |
| Annex | | Annex I |
| Appendix 1 | | Appendix 1 |
| Appendix 2 | | Appendix 2 |
| — | | Annex II |
| — | | Annex III |

Directive 93/32/EEC

Directive 1999/24/EC

This Directive

Articles 1, 2 and 3

Articles 1, 2 and 3

Article 4(1)

—

Article 2(1)

Article 4(1)

Article 2(2)

Article 4(2)

Article 4(2)

Article 4(3)

—

Article 5

—

Article 6

Article 5

Article 7

Annex

Annex I

Appendix 1

Appendix 1

Appendix 2

Appendix 2

—

Annex II

—

Annex III

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/36 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/36

---

COMMISSION DIRECTIVE 2009/90/EC

of 31 July 2009

laying down, pursuant to Directive 2000/60/EC of the European Parliament and of the Council, technical specifications for chemical analysis and monitoring of water status

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (1), and in particular Article 8(3) thereof,

Whereas:

| (1) | The quality and comparability of analytical results generated by laboratories appointed by competent authorities of the Member States to perform water chemical monitoring pursuant to Article 8 of Directive 2000/60/EC should be ensured. The EN ISO/IEC-17025 standard on general requirements for the competence of testing and calibration laboratories provides appropriate international standards for the validation of the methods of analysis used. |
| --- | --- |

(1)

The quality and comparability of analytical results generated by laboratories appointed by competent authorities of the Member States to perform water chemical monitoring pursuant to Article 8 of Directive 2000/60/EC should be ensured. The EN ISO/IEC-17025 standard on general requirements for the competence of testing and calibration laboratories provides appropriate international standards for the validation of the methods of analysis used.

| (2) | In order to fulfil validation requirements, all methods of analysis applied by Member States for the purposes of chemical monitoring programmes of water status should meet certain minimum performance criteria, including rules on the uncertainty of measurements and on the limit of quantification of the methods. To ensure comparability of chemical monitoring results, the limit of quantification should be determined in accordance with a commonly agreed definition. |
| --- | --- |

(2)

In order to fulfil validation requirements, all methods of analysis applied by Member States for the purposes of chemical monitoring programmes of water status should meet certain minimum performance criteria, including rules on the uncertainty of measurements and on the limit of quantification of the methods. To ensure comparability of chemical monitoring results, the limit of quantification should be determined in accordance with a commonly agreed definition.

| (3) | Where there are no methods which comply with the minimum performance criteria, monitoring should be based on best available techniques not entailing excessive costs. |
| --- | --- |

(3)

Where there are no methods which comply with the minimum performance criteria, monitoring should be based on best available techniques not entailing excessive costs.

| (4) | The calculation of mean values should take account of measurement results that are below the limit of quantification of methods of analysis. Rules to be used in this respect should be provided. |
| --- | --- |

(4)

The calculation of mean values should take account of measurement results that are below the limit of quantification of methods of analysis. Rules to be used in this respect should be provided.

| (5) | Technical operations to ensure the quality and comparability of analytical results should follow quality management system practices accepted at international level. For that purpose, the practices set out in EN ISO/IEC-17025 are appropriate. It is appropriate to ensure that laboratories performing chemical analysis demonstrate their competence through the participation in internationally or nationally recognised proficiency testing programmes and through the use of available reference materials. In view of harmonising practices at the Community level, the organisation of proficiency testing programmes should be based on relevant international standards. To that end, ISO/IEC guide 43-1 on proficiency testing by interlaboratory comparisons — Part 1: Development and operation of proficiency testing schemes provides an appropriate guide. The results of those programmes should be evaluated on the basis of the internationally recognised scoring systems. In this regard, ISO-13528 on statistical methods for use in proficiency testing by interlaboratory comparisons provides appropriate standards. |
| --- | --- |

(5)

Technical operations to ensure the quality and comparability of analytical results should follow quality management system practices accepted at international level. For that purpose, the practices set out in EN ISO/IEC-17025 are appropriate. It is appropriate to ensure that laboratories performing chemical analysis demonstrate their competence through the participation in internationally or nationally recognised proficiency testing programmes and through the use of available reference materials. In view of harmonising practices at the Community level, the organisation of proficiency testing programmes should be based on relevant international standards. To that end, ISO/IEC guide 43-1 on proficiency testing by interlaboratory comparisons — Part 1: Development and operation of proficiency testing schemes provides an appropriate guide. The results of those programmes should be evaluated on the basis of the internationally recognised scoring systems. In this regard, ISO-13528 on statistical methods for use in proficiency testing by interlaboratory comparisons provides appropriate standards.

| (6) | The Committee referred to in Article 21(1) of Directive 2000/60/EC was consulted on 15 May 2008 and delivered a positive opinion on the draft Commission Directive laying down, pursuant to Directive 2000/60/EC, technical specifications for chemical analysis and monitoring of water status. On 6 June 2008 the Commission submitted the said draft for scrutiny by the European Parliament and the Council. The European Parliament did not oppose the draft measures within the set deadline. The Council opposed the adoption by the Commission indicating that the proposed measures exceeded the implementing powers provided for in Directive 2000/60/EC. As a consequence, the Commission did not adopt the draft measures and submitted an amended draft of the concerned Directive to the Committee referred to in Article 21(1) of Directive 2000/60/EC. The Committee was consulted on the said draft by written procedure launched on 28 January 2009 and delivered a positive opinion. |
| --- | --- |

(6)

The Committee referred to in Article 21(1) of Directive 2000/60/EC was consulted on 15 May 2008 and delivered a positive opinion on the draft Commission Directive laying down, pursuant to Directive 2000/60/EC, technical specifications for chemical analysis and monitoring of water status. On 6 June 2008 the Commission submitted the said draft for scrutiny by the European Parliament and the Council. The European Parliament did not oppose the draft measures within the set deadline. The Council opposed the adoption by the Commission indicating that the proposed measures exceeded the implementing powers provided for in Directive 2000/60/EC. As a consequence, the Commission did not adopt the draft measures and submitted an amended draft of the concerned Directive to the Committee referred to in Article 21(1) of Directive 2000/60/EC. The Committee was consulted on the said draft by written procedure launched on 28 January 2009 and delivered a positive opinion.

| (7) | The measures provided for in this Directive are in accordance with the opinion of the Committee referred to in Article 21(1) of Directive 2000/60/EC, |
| --- | --- |

(7)

The measures provided for in this Directive are in accordance with the opinion of the Committee referred to in Article 21(1) of Directive 2000/60/EC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Subject matter

This Directive lays down technical specifications for chemical analysis and monitoring of water status in accordance with Article 8(3) of Directive 2000/60/EC. It establishes minimum performance criteria for methods of analysis to be applied by Member States when monitoring water status, sediment and biota, as well as rules for demonstrating the quality of analytical results.

Article 2

Definitions

For the purpose of this Directive, the following definitions shall apply:

| 1. | ‘limit of detection’ means the output signal or concentration value above which it can be affirmed, with a stated level of confidence that a sample is different from a blank sample containing no determinand of interest; |
| --- | --- |

1.

‘limit of detection’ means the output signal or concentration value above which it can be affirmed, with a stated level of confidence that a sample is different from a blank sample containing no determinand of interest;

| 2. | ‘limit of quantification’ means a stated multiple of the limit of detection at a concentration of the determinand that can reasonably be determined with an acceptable level of accuracy and precision. The limit of quantification can be calculated using an appropriate standard or sample, and may be obtained from the lowest calibration point on the calibration curve, excluding the blank; |
| --- | --- |

2.

‘limit of quantification’ means a stated multiple of the limit of detection at a concentration of the determinand that can reasonably be determined with an acceptable level of accuracy and precision. The limit of quantification can be calculated using an appropriate standard or sample, and may be obtained from the lowest calibration point on the calibration curve, excluding the blank;

| 3. | ‘uncertainty of measurement’ means a non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used. |
| --- | --- |

3.

‘uncertainty of measurement’ means a non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used.

Article 3

Methods of analysis

Member States shall ensure that all methods of analysis, including laboratory, field and on-line methods, used for the purposes of chemical monitoring programmes carried out under Directive 2000/60/EC are validated and documented in accordance with EN ISO/IEC-17025 standard or other equivalent standards accepted at international level.

Article 4

Minimum performance criteria for methods of analysis

1.   Member States shall ensure that the minimum performance criteria for all methods of analysis applied are based on an uncertainty of measurement of 50 % or below (k = 2) estimated at the level of relevant environmental quality standards and a limit of quantification equal or below a value of 30 % of the relevant environmental quality standards.

2.   In the absence of relevant environmental quality standard for a given parameter, or in the absence of method of analysis meeting the minimum performance criteria set out in paragraph 1, Member States shall ensure that monitoring is carried out using best available techniques not entailing excessive costs.

Article 5

Calculation of mean values

1.   Where the amounts of physico-chemical or chemical measurands in a given sample are below the limit of quantification, the measurement results shall be set to half of the value of the limit of quantification concerned for the calculation of mean values.

2.   Where a calculated mean value of the measurement results referred to paragraph 1 is below the limits of quantification, the value shall be referred to as ‘less than limit of quantification’.

3.   Paragraph 1 shall not apply to measurands that are total sums of a given group of physico-chemical parameters or chemical measurands, including their relevant metabolites, degradation and reaction products. In those cases, results below the limit of quantification of the individual substances shall be set to zero.

Article 6

Quality assurance and control

1.   Member States shall ensure that laboratories or parties contracted by laboratories apply quality management system practices in accordance with EN ISO/IEC-17025 or other equivalent standards accepted at international level.

2.   Member States shall ensure that laboratories or parties contracted by laboratories demonstrate their competences in analysing relevant physico-chemical or chemical measurands by:

| (a) | participation in proficiency testing programmes covering the methods of analysis referred to in Article 3 of this Directive of measurands at levels of concentrations that are representative of chemical monitoring programmes carried out under Directive 2000/60/EC, and |
| --- | --- |

(a)

participation in proficiency testing programmes covering the methods of analysis referred to in Article 3 of this Directive of measurands at levels of concentrations that are representative of chemical monitoring programmes carried out under Directive 2000/60/EC, and

| (b) | analysis of available reference materials that are representative of collected samples which contain appropriate levels of concentrations in relation to relevant environmental quality standards referred to in Article 4(1). |
| --- | --- |

(b)

analysis of available reference materials that are representative of collected samples which contain appropriate levels of concentrations in relation to relevant environmental quality standards referred to in Article 4(1).

3.   The proficiency testing programmes referred to in paragraph 2(a) shall be organised by accredited organisations or internationally or nationally recognised organisations which meet the requirements of ISO/IEC guide 43-1 or of other equivalent standards accepted at international level.

The results of participation in those programmes shall be evaluated on the basis of the scoring systems set out in ISO/IEC guide 43-1 or in the ISO-13528 standard or in other equivalent standards accepted at international level.

Article 7

Transposition

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive at the latest two years after its entry into force. They shall forthwith communicate to the Commission the text of those provisions.

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 8

Entry into force

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

Article 9

Addressees

This Directive is addressed to the Member States.

Done at Brussels, 31 July 2009.

For the Commission

Stavros DIMAS

Member of the Commission

---

(1)  OJ L 327, 22.12.2000, p. 1.

1

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| 1.8.2009 | EN | Official Journal of the European Union | L 201/39 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/39

---

COMMISSION DIRECTIVE 2009/91/EC

of 31 July 2009

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 disodium tetraborate. |
| --- | --- |

(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 disodium tetraborate.

| (2) | Pursuant to Regulation (EC) No 1451/2007, disodium tetraborate 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 Directive 98/8/EC. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, disodium tetraborate 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 Directive 98/8/EC.

| (3) | The Netherlands was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 7 July 2006 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 7 July 2006 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 20 February 2009, 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 20 February 2009, in an assessment report.

| (5) | It appears from the examinations made that biocidal products used as wood preservatives and containing disodium tetraborate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include disodium tetraborate in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing disodium tetraborate can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from the examinations made that biocidal products used as wood preservatives and containing disodium tetraborate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include disodium tetraborate in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing disodium tetraborate can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

| (6) | However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood exposed to weathering. Therefore, authorisations for these uses should not be granted unless data have been submitted in order to demonstrate that the products can be used without unacceptable risks to the environment. |
| --- | --- |

(6)

However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood exposed to weathering. Therefore, authorisations for these uses should not be granted unless data have been submitted in order to demonstrate that the products can be used without unacceptable risks to the environment.

| (7) | Not all potential uses have been evaluated at the Community level. It is therefore appropriate that Member States assess those risks to the compartments and populations that have not been representatively addressed in the Community level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks to acceptable levels. |
| --- | --- |

(7)

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

| (8) | In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing disodium tetraborate and used as wood preservatives. In particular, appropriate measures should be taken to protect the soil and aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Products should also be used with appropriate protective equipment if the risk identified for professional and industrial users cannot be reduced by other means. |
| --- | --- |

(8)

In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing disodium tetraborate and used as wood preservatives. In particular, appropriate measures should be taken to protect the soil and aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Products should also be used with appropriate protective equipment if the risk identified for professional and industrial users cannot be reduced by other means.

| (9) | It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance disodium tetraborate 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 the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance disodium tetraborate 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 in order to permit Member States and the 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 in order to permit Member States and the 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, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing disodium tetraborate to ensure that they comply with 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, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing disodium tetraborate to ensure that they comply with 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

1.   Member States shall adopt and publish, by 31 August 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 September 2011.

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, 31 July 2009.

For the Commission

Stavros DIMAS

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

The following entry ‘No 24’ is inserted in Annex I to Directive 98/8/EC:

| 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) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘24 | disodium tetraborate | disodium tetraborate
  EC No: 215-540-4
  CAS No (anhydrous): 1330-43-4
  CAS No (pentahydrate): 12267-73-1
  CAS No (decahydrate): 1303-96-4 | 990 g/kg | 1 September 2011 | 31 August 2013 | 31 August 2021 | 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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.
  When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.
  Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.
  Member States shall ensure that authorisations are subject to the following conditions:






  1. | Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/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)

‘24

disodium tetraborate

disodium tetraborate

EC No: 215-540-4

CAS No (anhydrous): 1330-43-4

CAS No (pentahydrate): 12267-73-1

CAS No (decahydrate): 1303-96-4

990 g/kg

1 September 2011

31 August 2013

31 August 2021

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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

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

1.

Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

| 2. | In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.’ |
| --- | --- |

2.

In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must 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

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| 1.8.2009 | EN | Official Journal of the European Union | L 201/43 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/43

---

COMMISSION DIRECTIVE 2009/92/EC

of 31 July 2009

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 bromadiolone. |
| --- | --- |

(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 bromadiolone.

| (2) | Pursuant to Regulation (EC) No 1451/2007, bromadiolone has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, bromadiolone has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.

| (3) | Sweden was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 30 June 2006 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Sweden was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 30 June 2006 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 30 May 2008, 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 30 May 2008, in an assessment report.

| (5) | It appears from the examinations made that biocidal products used as rodenticides and containing bromadiolone may be expected not to present a risk to humans except for accidental incidents with children. Regarding non-target animals and the environment a risk has been identified. However, the target rodents are vermin and thus constitute a danger to public health. Moreover, it has not yet been established that adequate alternatives to bromadiolone exist, which are both equally effective and less damaging to the environment. It is, therefore, with view of points 63 and 96 of Annex VI to Directive 98/8/EC, justified to include bromadiolone in Annex I for a limited period, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing bromadiolone can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from the examinations made that biocidal products used as rodenticides and containing bromadiolone may be expected not to present a risk to humans except for accidental incidents with children. Regarding non-target animals and the environment a risk has been identified. However, the target rodents are vermin and thus constitute a danger to public health. Moreover, it has not yet been established that adequate alternatives to bromadiolone exist, which are both equally effective and less damaging to the environment. It is, therefore, with view of points 63 and 96 of Annex VI to Directive 98/8/EC, justified to include bromadiolone in Annex I for a limited period, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing bromadiolone can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

| (6) | In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing bromadiolone and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals as well as the long-term effects of the substance on the environment. |
| --- | --- |

(6)

In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing bromadiolone and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals as well as the long-term effects of the substance on the environment.

| (7) | Because of the identified risks and its characteristics, which render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate bromadiolone should be included in Annex I for five years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed. |
| --- | --- |

(7)

Because of the identified risks and its characteristics, which render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate bromadiolone should be included in Annex I for five years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.

| (8) | It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance bromadiolone and also to facilitate the proper operation of the biocidal products market in general. |
| --- | --- |

(8)

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

| (9) | A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the 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. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the 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) | After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing bromadiolone to ensure that they comply with Directive 98/8/EC. |
| --- | --- |

(10)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing bromadiolone to ensure that they comply with Directive 98/8/EC.

| (11) | Directive 98/8/EC should therefore be amended accordingly. |
| --- | --- |

(11)

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

| (12) | The Standing Committee on Biocidal Products was consulted on 30 May 2008 and delivered a positive opinion on the draft Commission Directive amending Annex I of Directive 98/8/EC to include bromadiolone as an active substance. On 11 June 2008 the Commission submitted the said draft for scrutiny by the European Parliament and the Council. The European Parliament did not oppose the draft measures within the set deadline. The Council opposed the adoption by the Commission indicating that the proposed measures exceeded the implementing powers provided for in Directive 98/8/EC. As a consequence, the Commission did not adopt the draft measures and submitted an amended draft of the concerned Directive to the Standing Committee on Biocidal Products. The Standing Committee was consulted on the said draft on 20 February 2009. |
| --- | --- |

(12)

The Standing Committee on Biocidal Products was consulted on 30 May 2008 and delivered a positive opinion on the draft Commission Directive amending Annex I of Directive 98/8/EC to include bromadiolone as an active substance. On 11 June 2008 the Commission submitted the said draft for scrutiny by the European Parliament and the Council. The European Parliament did not oppose the draft measures within the set deadline. The Council opposed the adoption by the Commission indicating that the proposed measures exceeded the implementing powers provided for in Directive 98/8/EC. As a consequence, the Commission did not adopt the draft measures and submitted an amended draft of the concerned Directive to the Standing Committee on Biocidal Products. The Standing Committee was consulted on the said draft on 20 February 2009.

| (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

1.   Member States shall adopt and publish, by 30 June 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 July 2011.

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, 31 July 2009.

For the Commission

Stavros DIMAS

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

The following entry ‘No 17’ is inserted in Annex I to Directive 98/8/EC:

| 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) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘17 | bromadiolone | 3-[3-(4’-Bromo[1,1’-biphenyl]-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-1-benzopyran-2-one
  EC No: 249-205-9
  CAS No: 28772-56-7 | 969 g/kg | 1 July 2011 | 30 June 2013 | 30 June 2016 | 14 | In view of the fact that the active substance characteristics render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.
  Member States shall ensure that authorisations are subject to the following conditions:






  1. | The nominal concentration of the active substance in the products shall not exceed 50 mg/kg and only ready-for-use products shall be authorised. |

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)

‘17

bromadiolone

3-[3-(4’-Bromo[1,1’-biphenyl]-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-1-benzopyran-2-one

EC No: 249-205-9

CAS No: 28772-56-7

969 g/kg

1 July 2011

30 June 2013

30 June 2016

14

In view of the fact that the active substance characteristics render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.

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

1.

The nominal concentration of the active substance in the products shall not exceed 50 mg/kg and only ready-for-use products shall be authorised.

| 2. | Products shall contain an aversive agent and, where appropriate, a dye. |
| --- | --- |

2.

Products shall contain an aversive agent and, where appropriate, a dye.

| 3. | Products shall not be used as tracking powder. |
| --- | --- |

3.

Products shall not be used as tracking powder.

| 4. | Primary as well as secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures. These include, amongst others, the restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.’ |
| --- | --- |

4.

Primary as well as secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures. These include, amongst others, the restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.’

---

(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

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/46 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/46

---

COMMISSION DIRECTIVE 2009/93/EC

of 31 July 2009

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 alphachloralose. |
| --- | --- |

(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 alphachloralose.

| (2) | Pursuant to Regulation (EC) No 1451/2007, alphachloralose has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, alphachloralose has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.

| (3) | Portugal was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 14 November 2006 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Portugal was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 14 November 2006 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 30 May 2008, 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 30 May 2008, in an assessment report.

| (5) | It appears from the examinations made that biocidal products used as rodenticides and containing alphachloralose may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include alphachloralose in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing alphachloralose can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from the examinations made that biocidal products used as rodenticides and containing alphachloralose may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include alphachloralose in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing alphachloralose can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

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

(6)

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

| (7) | In the light of the conclusions of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing alphachloralose and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals as well as the long-term effects of the substance on the environment. |
| --- | --- |

(7)

In the light of the conclusions of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing alphachloralose and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals as well as the long-term effects of the substance on the environment.

| (8) | It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance alphachloralose and also to facilitate the proper operation of the biocidal products market in general. |
| --- | --- |

(8)

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

| (9) | A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the 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. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the 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) | After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing alphachloralose to ensure that they comply with Directive 98/8/EC. |
| --- | --- |

(10)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing alphachloralose to ensure that they comply with Directive 98/8/EC.

| (11) | Directive 98/8/EC should therefore be amended accordingly. |
| --- | --- |

(11)

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

| (12) | The Standing Committee on Biocidal Products was consulted on 30 May 2008 and delivered a positive opinion on the draft Commission Directive amending Annex I to Directive 98/8/EC to include alphachloralose as an active substance. On 11 June 2008 the Commission submitted the said draft for scrutiny by the European Parliament and the Council. The European Parliament did not oppose the draft measures within the set deadline. The Council opposed the adoption by the Commission indicating that the proposed measures exceeded the implementing powers provided for in Directive 1998/8/EC. As a consequence, the Commission did not adopt the draft measures and submitted an amended draft of the concerned Directive to the Standing Committee on Biocidal Products. The Standing Committee was consulted on the said draft on 20 February 2009. |
| --- | --- |

(12)

The Standing Committee on Biocidal Products was consulted on 30 May 2008 and delivered a positive opinion on the draft Commission Directive amending Annex I to Directive 98/8/EC to include alphachloralose as an active substance. On 11 June 2008 the Commission submitted the said draft for scrutiny by the European Parliament and the Council. The European Parliament did not oppose the draft measures within the set deadline. The Council opposed the adoption by the Commission indicating that the proposed measures exceeded the implementing powers provided for in Directive 1998/8/EC. As a consequence, the Commission did not adopt the draft measures and submitted an amended draft of the concerned Directive to the Standing Committee on Biocidal Products. The Standing Committee was consulted on the said draft on 20 February 2009.

| (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

1.   Member States shall adopt and publish, by 30 June 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 July 2011.

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, 31 July 2009.

For the Commission

Stavros DIMAS

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

The following entry ‘No 15’ is inserted in Annex I to Directive 98/8/EC:

| 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) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘15 | alphachloralose | (R)-1,2-O-(2.2,2-Trichloroethylidene)-α-D-glucofuranose
  EC No: 240-016-7
  CAS No: 15879-93-3 | 825 g/kg | 1 July 2011 | 30 June 2013 | 30 June 2021 | 14 | 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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.
  When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.
  Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.
  In particular, products cannot be authorised for outdoor use unless data is submitted to demonstrate 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. | The nominal concentration of the active substance in the products shall not exceed 40 g/kg. |

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)

‘15

alphachloralose

(R)-1,2-O-(2.2,2-Trichloroethylidene)-α-D-glucofuranose

EC No: 240-016-7

CAS No: 15879-93-3

825 g/kg

1 July 2011

30 June 2013

30 June 2021

14

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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

In particular, products cannot be authorised for outdoor use unless data is submitted to demonstrate 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.

The nominal concentration of the active substance in the products shall not exceed 40 g/kg.

| 2. | Products shall contain an aversive agent and a dye. |
| --- | --- |

2.

Products shall contain an aversive agent and a dye.

| 3. | Only products for use in tamper resistant and securely closed bait boxes shall be authorised.’ |
| --- | --- |

3.

Only products for use in tamper resistant and securely closed bait boxes shall be authorised.’

---

(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

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/50 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/50

---

COMMISSION DIRECTIVE 2009/94/EC

of 31 July 2009

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 boric acid. |
| --- | --- |

(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 boric acid.

| (2) | Pursuant to Regulation (EC) No 1451/2007, boric acid 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 Directive 98/8/EC. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, boric acid 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 Directive 98/8/EC.

| (3) | The Netherlands was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 7 July 2006 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 7 July 2006 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 20 February 2009, 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 20 February 2009, in an assessment report.

| (5) | It appears from the examinations made that biocidal products used as wood preservatives and containing boric acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include boric acid in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing boric acid can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from the examinations made that biocidal products used as wood preservatives and containing boric acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include boric acid in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing boric acid can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

| (6) | However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood exposed to weathering. Therefore, authorisations for these uses should not be granted unless data have been submitted in order to demonstrate that the products can be used without unacceptable risks to the environment. |
| --- | --- |

(6)

However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood exposed to weathering. Therefore, authorisations for these uses should not be granted unless data have been submitted in order to demonstrate that the products can be used without unacceptable risks to the environment.

| (7) | Not all potential uses have been evaluated at the Community level. It is therefore appropriate that Member States assess those risks to the compartments and populations that have not been representatively addressed in the Community level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks to acceptable levels. |
| --- | --- |

(7)

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

| (8) | In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing boric acid and used as wood preservatives. In particular, appropriate measures should be taken to protect the soil and aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Products should also be used with appropriate protective equipment if the risk identified for professional and industrial users cannot be reduced by other means. |
| --- | --- |

(8)

In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing boric acid and used as wood preservatives. In particular, appropriate measures should be taken to protect the soil and aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Products should also be used with appropriate protective equipment if the risk identified for professional and industrial users cannot be reduced by other means.

| (9) | It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance boric acid 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 the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance boric acid 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 in order to permit Member States and the 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 in order to permit Member States and the 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, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing boric acid to ensure that they comply with 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, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing boric acid to ensure that they comply with 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

1.   Member States shall adopt and publish, by 31 August 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 September 2011.

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, 31 July 2009.

For the Commission

Stavros DIMAS

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

The following entry ‘No 22’ is inserted in Annex I to Directive 98/8/EC:

| 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) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘22 | boric acid | boric acid
  EC No: 233-139-2
  CAS No: 10043-35-3 | 990 g/kg | 1 September 2011 | 31 August 2013 | 31 August 2021 | 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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.
  When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.
  Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.
  Member States shall ensure that authorisations are subject to the following conditions:






  1. | Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/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)

‘22

boric acid

boric acid

EC No: 233-139-2

CAS No: 10043-35-3

990 g/kg

1 September 2011

31 August 2013

31 August 2021

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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

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

1.

Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

| 2. | In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.’ |
| --- | --- |

2.

In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must 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

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/54 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/54

---

COMMISSION DIRECTIVE 2009/95/EC

of 31 July 2009

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 aluminium phosphide. |
| --- | --- |

(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 aluminium phosphide.

| (2) | Pursuant to Regulation (EC) No 1451/2007, aluminium phosphide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, aluminium phosphide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.

| (3) | Germany was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 19 July 2006 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 19 July 2006 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 30 May 2008, 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 30 May 2008, in an assessment report.

| (5) | It appears from the examinations made that biocidal products used as rodenticides and containing aluminium phosphide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include aluminium phosphide in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing aluminium phosphide can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from the examinations made that biocidal products used as rodenticides and containing aluminium phosphide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include aluminium phosphide in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing aluminium phosphide can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

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

(6)

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

| (7) | In the light of the conclusions of the assessment report, it is appropriate to require that products containing aluminium phosphide and used as rodenticides be authorised only for use by trained professionals in accordance with Article 10(2)(i)(e) of Directive 98/8/EC, and that specific risk mitigation measures are applied at product authorisation level to such products. Such measures should be aimed at limiting the risk of exposure of users and of non-target animals to aluminium phosphide to an acceptable level. |
| --- | --- |

(7)

In the light of the conclusions of the assessment report, it is appropriate to require that products containing aluminium phosphide and used as rodenticides be authorised only for use by trained professionals in accordance with Article 10(2)(i)(e) of Directive 98/8/EC, and that specific risk mitigation measures are applied at product authorisation level to such products. Such measures should be aimed at limiting the risk of exposure of users and of non-target animals to aluminium phosphide to an acceptable level.

| (8) | It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance aluminium phosphide and also to facilitate the proper operation of the biocidal products market in general. |
| --- | --- |

(8)

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

| (9) | A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the 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. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the 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) | After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing aluminium phosphide to ensure that they comply with Directive 98/8/EC. |
| --- | --- |

(10)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing aluminium phosphide to ensure that they comply with Directive 98/8/EC.

| (11) | Directive 98/8/EC should therefore be amended accordingly. |
| --- | --- |

(11)

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

| (12) | The Standing Committee on Biocidal Products was consulted on 30 May 2008 and delivered a positive opinion on the draft Commission Directive amending Annex I of Directive 98/8/EC to include aluminium phosphide as an active substance. On 11 June 2008 the Commission submitted the said draft for scrutiny by the European Parliament and the Council. The European Parliament did not oppose the draft measures within the set deadline. The Council opposed the adoption by the Commission indicating that the proposed measures exceeded the implementing powers provided for in Directive 98/8/EC. As a consequence, the Commission did not adopt the draft measures and submitted an amended draft of the concerned Directive to the Standing Committee on Biocidal Products. The Standing Committee was consulted on the said draft on 20 February 2009. |
| --- | --- |

(12)

The Standing Committee on Biocidal Products was consulted on 30 May 2008 and delivered a positive opinion on the draft Commission Directive amending Annex I of Directive 98/8/EC to include aluminium phosphide as an active substance. On 11 June 2008 the Commission submitted the said draft for scrutiny by the European Parliament and the Council. The European Parliament did not oppose the draft measures within the set deadline. The Council opposed the adoption by the Commission indicating that the proposed measures exceeded the implementing powers provided for in Directive 98/8/EC. As a consequence, the Commission did not adopt the draft measures and submitted an amended draft of the concerned Directive to the Standing Committee on Biocidal Products. The Standing Committee was consulted on the said draft on 20 February 2009.

| (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

1.   Member States shall adopt and publish, by 31 August 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 September 2011.

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, 31 July 2009.

For the Commission

Stavros DIMAS

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

The following entry ‘No 20’ is inserted in Annex I to Directive 98/8/EC:

| 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) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘20 | aluminium phosphide releasing phosphine | aluminium phosphide
  EC No: 244-088-0
  CAS No: 20859-73-8 | 830 g/kg | 1 September 2011 | 31 August 2013 | 31 August 2021 | 14 | 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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.
  When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.
  Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels. In particular, products cannot be authorised for indoor use unless data is submitted to demonstrate 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. | Products shall only be sold to and used by specifically trained professionals. |

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)

‘20

aluminium phosphide releasing phosphine

aluminium phosphide

EC No: 244-088-0

CAS No: 20859-73-8

830 g/kg

1 September 2011

31 August 2013

31 August 2021

14

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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels. In particular, products cannot be authorised for indoor use unless data is submitted to demonstrate 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.

Products shall only be sold to and used by specifically trained professionals.

| 2. | In view of the risks identified for operators, appropriate risk mitigation measures must be applied. These include, amongst others, the use of appropriate personal protective equipment, the use of applicators and the presentation of the product in a form designed to reduce operator exposure to an acceptable level. |
| --- | --- |

2.

In view of the risks identified for operators, appropriate risk mitigation measures must be applied. These include, amongst others, the use of appropriate personal protective equipment, the use of applicators and the presentation of the product in a form designed to reduce operator exposure to an acceptable level.

| 3. | In view of the risks identified for terrestrial non-target species, appropriate risk reduction measures must be applied. These include, amongst others, the non-treatment of areas where other burrowing mammals than the target species are present.’ |
| --- | --- |

3.

In view of the risks identified for terrestrial non-target species, appropriate risk reduction measures must be applied. These include, amongst others, the non-treatment of areas where other burrowing mammals than the target species are present.’

---

(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

---

| 1.8.2009 | EN | Official Journal of the European Union | L 201/58 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/58

---

COMMISSION DIRECTIVE 2009/96/EC

of 31 July 2009

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 disodium octaborate tetrahydrate. |
| --- | --- |

(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 disodium octaborate tetrahydrate.

| (2) | Pursuant to Regulation (EC) No 1451/2007, disodium octaborate tetrahydrate 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 Directive 98/8/EC. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, disodium octaborate tetrahydrate 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 Directive 98/8/EC.

| (3) | The Netherlands was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 7 July 2006 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 7 July 2006 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 20 February 2009, 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 20 February 2009, in an assessment report.

| (5) | It appears from the examinations made that biocidal products used as wood preservatives and containing disodium octaborate tetrahydrate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include disodium octaborate tetrahydrate in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing disodium octaborate tetrahydrate can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from the examinations made that biocidal products used as wood preservatives and containing disodium octaborate tetrahydrate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include disodium octaborate tetrahydrate in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing disodium octaborate tetrahydrate can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

| (6) | However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood exposed to weathering. Therefore, authorisations for these uses should not be granted unless data have been submitted in order to demonstrate that the products can be used without unacceptable risks to the environment. |
| --- | --- |

(6)

However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood exposed to weathering. Therefore, authorisations for these uses should not be granted unless data have been submitted in order to demonstrate that the products can be used without unacceptable risks to the environment.

| (7) | Not all potential uses have been evaluated at the Community level. It is therefore appropriate that Member States assess those risks to the compartments and populations that have not been representatively addressed in the Community level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks to acceptable levels. |
| --- | --- |

(7)

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

| (8) | In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing disodium octaborate tetrahydrate. In particular, appropriate measures should be taken to protect the soil and aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Products should also be used with appropriate protective equipment if the risk identified for professional and industrial users cannot be reduced by other means. |
| --- | --- |

(8)

In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing disodium octaborate tetrahydrate. In particular, appropriate measures should be taken to protect the soil and aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Products should also be used with appropriate protective equipment if the risk identified for professional and industrial users cannot be reduced by other means.

| (9) | It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance disodium octaborate tetrahydrate 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 the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance disodium octaborate tetrahydrate 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 in order to permit Member States and the 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 in order to permit Member States and the 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, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing disodium octaborate tetrahydrate to ensure that they comply with 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, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing disodium octaborate tetrahydrate to ensure that they comply with 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

1.   Member States shall adopt and publish, by 31 August 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 September 2011.

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, 31 July 2009.

For the Commission

Stavros DIMAS

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

The following entry ‘No 25’ is inserted in Annex I to Directive 98/8/EC:

| 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) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘25 | disodium octaborate tetrahydrate | disodium octaborate tetrahydrate
  EC No: 234-541-0
  CAS No: 12280-03-4 | 975 g/kg | 1 September 2011 | 31 August 2013 | 31 August 2021 | 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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.
  When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.
  Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.
  Member States shall ensure that authorisations are subject to the following conditions:






  1. | Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/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)

‘25

disodium octaborate tetrahydrate

disodium octaborate tetrahydrate

EC No: 234-541-0

CAS No: 12280-03-4

975 g/kg

1 September 2011

31 August 2013

31 August 2021

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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.

Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.

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

1.

Products authorised for industrial and professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

| 2. | In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.’ |
| --- | --- |

2.

In view of the risks identified for the soil and aquatic compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. In particular, labels and/or safety-data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter and/or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.’

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(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

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II Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory

DECISIONS

Council

| 1.8.2009 | EN | Official Journal of the European Union | L 201/62 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/62

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COUNCIL DECISION

of 27 July 2009

appointing one Hungarian member of the European Economic and Social Committee

(2009/583/EC, Euratom)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 259 thereof,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 167 thereof,

Having regard to Decision 2006/524/EC, Euratom (1),

Having regard to the proposal of the Hungarian Government,

Having regard to the opinion of the Commission,

Whereas a member’s seat on the European Economic and Social Committee has become vacant following the death of Mr István GARAI,

HAS DECIDED AS FOLLOWS:

Article 1

Mr József NAGY, Various Interest Group (GROUP III), is hereby appointed as a member of the European Economic and Social Committee for the remainder of the current term of office, which runs until 20 September 2010.

Article 2

This Decision shall take effect on the day of its adoption.

Done at Brussels, 27 July 2009.

For the Council

The President

C. BILDT

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(1)  OJ L 207, 28.7.2006, p. 30.

1

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Commission

| 1.8.2009 | EN | Official Journal of the European Union | L 201/63 |
| --- | --- | --- | --- |

1.8.2009

EN

Official Journal of the European Union

L 201/63

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COMMISSION DECISION

of 31 July 2009

establishing the High Level Steering Group on SafeSeaNet

(Notified under document C(2009) 5924)

(Text with EEA relevance)

(2009/584/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system (1), and in particular point 2.2 of Annex III thereof,

Whereas:

| (1) | The Commission is responsible for the management and development at policy level of the central SafeSeaNet system and for the oversight of the SafeSeaNet system, in cooperation with Member States. |
| --- | --- |

(1)

The Commission is responsible for the management and development at policy level of the central SafeSeaNet system and for the oversight of the SafeSeaNet system, in cooperation with Member States.

| (2) | Point 2.2 of Annex III to Directive 2002/59/EC provides that the Commission shall establish a High-Level Steering Group to assist in the management of the SafeSeaNet system. |
| --- | --- |

(2)

Point 2.2 of Annex III to Directive 2002/59/EC provides that the Commission shall establish a High-Level Steering Group to assist in the management of the SafeSeaNet system.

| (3) | Therefore the High-Level Steering Group should be set up and its tasks and its structure defined. |
| --- | --- |

(3)

Therefore the High-Level Steering Group should be set up and its tasks and its structure defined.

| (4) | The High-Level Steering Group should be made up of representatives of the Member States and of the Commission. |
| --- | --- |

(4)

The High-Level Steering Group should be made up of representatives of the Member States and of the Commission.

| (5) | The European Maritime Safety Agency (EMSA) is responsible for the technical implementation of the SafeSeaNet system, in cooperation with the Member States and the Commission, in accordance with Regulation (EC) No 1406/2002 of the European Parliament and of the Council (2); it should therefore be closely involved in the work of the High-Level Steering Group. |
| --- | --- |

(5)

The European Maritime Safety Agency (EMSA) is responsible for the technical implementation of the SafeSeaNet system, in cooperation with the Member States and the Commission, in accordance with Regulation (EC) No 1406/2002 of the European Parliament and of the Council (2); it should therefore be closely involved in the work of the High-Level Steering Group.

| (6) | It appears also necessary to address strategic issues related to the future developments of the SafeSeaNet system, taking into account in particular the objectives of the integrated maritime policy of the European Union and the 2018 maritime transport policy objectives as set out in the Communication of the Commission on the strategic goals and recommendations for the EU’s maritime transport policy until 2018 (3), |
| --- | --- |

(6)

It appears also necessary to address strategic issues related to the future developments of the SafeSeaNet system, taking into account in particular the objectives of the integrated maritime policy of the European Union and the 2018 maritime transport policy objectives as set out in the Communication of the Commission on the strategic goals and recommendations for the EU’s maritime transport policy until 2018 (3),

HAS ADOPTED THIS DECISION:

Article 1

The High Level Steering Group on SafeSeaNet

The High Level Steering Group on SafeSeaNet hereinafter referred to as ‘the group’ is hereby set up.

Article 2

Tasks

The Commission may consult the group on any matter relating to the current and future developments of SafeSeaNet, including its contribution to the maritime surveillance from a holistic perspective.

The group’s tasks shall be:

| (a) | to make recommendations to improve the effectiveness and security of SafeSeaNet; |
| --- | --- |

(a)

to make recommendations to improve the effectiveness and security of SafeSeaNet;

| (b) | to provide appropriate guidance for the development of SafeSeaNet; |
| --- | --- |

(b)

to provide appropriate guidance for the development of SafeSeaNet;

| (c) | to assist the Commission in reviewing the performance of SafeSeaNet; |
| --- | --- |

(c)

to assist the Commission in reviewing the performance of SafeSeaNet;

| (d) | to approve the interface and functionalities control document referred to in point 2.3 of Annex III of Directive 2002/59/EC, and any amendments thereto. |
| --- | --- |

(d)

to approve the interface and functionalities control document referred to in point 2.3 of Annex III of Directive 2002/59/EC, and any amendments thereto.

Article 3

Membership-Appointment

1.   The group shall be composed of one representative per Member State and of one representative of the Commission.

2.   Member States shall designate their representatives, and their alternates, to the group for a 3-year term, which could be renewed. They shall be senior officials.

3.   The members of the Group to be appointed by the Commission shall be senior officials.

4.   A representative of the European Maritime Safety Agency (EMSA) shall attend the group meetings as observer. The EMSA shall be represented at a high level.

5.   The representatives of the members of the European Economic Area may attend group meetings as observers.

6.   The members shall remain in office until such time as they are replaced or their term of office ends.

7.   Members who are no longer able to contribute effectively to the group’s deliberations or who resign may be replaced.

Article 4

Operation

1.   The group shall be chaired by a representative of the Commission.

2.   In agreement with the Commission, sub-groups may be set up to examine specific questions under terms of reference established by the group. Such sub-groups shall be dissolved as soon as their mandates are fulfilled.

3.   The Commission’s representative chairing the group may ask experts with specific competence on a subject on the agenda to participate in the group’s or sub-group’s discussion if this is useful and/or necessary.

4.   Information obtained by participating in the deliberations of a group or sub-group shall not be divulged if, in the opinion of the Commission, that information relates to confidential matters.

5.   The group and its sub-groups shall normally meet on Commission premises in accordance with the procedures and schedule established by it. The Commission shall provide the Secretariat of the group.

6.   The group shall adopt its rules of procedure on the basis of the standard rules of procedure adopted by the Commission.

7.   The Commission may publish any résumé, conclusion, or partial conclusion or working document of the group.

Article 5

Meeting expenses

The Commission shall reimburse travel and, where appropriate, subsistence expenses for members, experts and observers in connection with the group’s activities in accordance with the Commission's rules on the compensation of experts.

The members shall not be remunerated for the services they render.

Meeting expenses are reimbursed within the limits of the annual budget allocated to the group by the responsible Commission services.

Article 6

Entry into force

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 31 July 2009.

For the Commission

Antonio TAJANI

Vice-President

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(1)  OJ L 208, 5.8.2002, p. 10.

1

(2)  OJ L 208, 5.8.2002, p. 1.

2

(3)  COM(2009) 8 final.

3

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| 1.8.2009 | EN | Official Journal of the European Union | L 201/65 |
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1.8.2009

EN

Official Journal of the European Union

L 201/65

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COMMISSION DECISION

of 31 July 2009

amending Decision 2008/965/EC on financial aid from the Community for the year 2009 for certain Community reference laboratories in the field of animal health and live animals

(Notified under document C(2009) 5947)

(Only the English text is authentic)

(2009/585/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field (1), and in particular Article 31(2) thereof,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (2), and in particular Article 32(7) thereof,

Whereas:

| (1) | Pursuant to Article 31(1) of Decision 2009/470/EC Community reference laboratories in the field of animal health and live animals may be granted Community aid. |
| --- | --- |

(1)

Pursuant to Article 31(1) of Decision 2009/470/EC Community reference laboratories in the field of animal health and live animals may be granted Community aid.

| (2) | Commission Decision 2008/965/EC (3) granted Community financial assistance up to a maximum of EUR 400 000 at the rate of 100 % of the eligible costs as defined in Commission Regulation (EC) No 1754/2006 of 28 November 2006 laying down detailed rules for the granting of Community financial assistance to Community reference laboratories for feed and food and the animal health sector (4) to be incurred by the Veterinary Laboratories Agency (VLA), New Haw, Weybridge, United Kingdom, the Community Reference Laboratory (CRL) for avian influenza, for the work programme to be implemented in the period from 1 January to 31 December 2009. |
| --- | --- |

(2)

Commission Decision 2008/965/EC (3) granted Community financial assistance up to a maximum of EUR 400 000 at the rate of 100 % of the eligible costs as defined in Commission Regulation (EC) No 1754/2006 of 28 November 2006 laying down detailed rules for the granting of Community financial assistance to Community reference laboratories for feed and food and the animal health sector (4) to be incurred by the Veterinary Laboratories Agency (VLA), New Haw, Weybridge, United Kingdom, the Community Reference Laboratory (CRL) for avian influenza, for the work programme to be implemented in the period from 1 January to 31 December 2009.

| (3) | The approved work programme of the CRL for avian influenza foresees that, in the light of the occurrence of influenza in birds and other animals, it is necessary to keep under review the possible zoonotic impact arising from the risk of these influenza viruses. |
| --- | --- |

(3)

The approved work programme of the CRL for avian influenza foresees that, in the light of the occurrence of influenza in birds and other animals, it is necessary to keep under review the possible zoonotic impact arising from the risk of these influenza viruses.

| (4) | The novel A/H1N1 influenza virus recently reported in humans in Mexico, USA and then elsewhere in the world contains genetic material of pig, bird and human influenza viruses but it appears to be distinct from other H1N1 viruses known to occur in pigs. The finding of the novel A/H1N1 influenza virus in a swine herd in Canada is the first reported possible case of human-to-animal transmission of this particular new virus subtype. However, the importance of these findings is still to be fully understood and assessed by the scientific community once sufficient scientific data are made available. |
| --- | --- |

(4)

The novel A/H1N1 influenza virus recently reported in humans in Mexico, USA and then elsewhere in the world contains genetic material of pig, bird and human influenza viruses but it appears to be distinct from other H1N1 viruses known to occur in pigs. The finding of the novel A/H1N1 influenza virus in a swine herd in Canada is the first reported possible case of human-to-animal transmission of this particular new virus subtype. However, the importance of these findings is still to be fully understood and assessed by the scientific community once sufficient scientific data are made available.

| (5) | The investigation of infection dynamics, pathogenesis, host susceptibility and transmissibility of the current novel A/H1N1 influenza virus in different animal species, and in particular in pigs is essential for providing the necessary scientific evidence for a veterinary risk assessment. A key output from the study will be the development of a ‘toolkit’ of reagents and materials for laboratory diagnosis. |
| --- | --- |

(5)

The investigation of infection dynamics, pathogenesis, host susceptibility and transmissibility of the current novel A/H1N1 influenza virus in different animal species, and in particular in pigs is essential for providing the necessary scientific evidence for a veterinary risk assessment. A key output from the study will be the development of a ‘toolkit’ of reagents and materials for laboratory diagnosis.

| (6) | These investigations should be incorporated into the 2009 annual work programme of the CRL for avian influenza which has already developed models for studying infection parameters and performed some testing with influenza viruses from a variety of sources. Complementary investigations will utilise pigs, and, through a combination of multi-factorial measurements will aim at providing evidence for susceptibility and potential consequences of infection of pigs with the novel A/H1N1 influenza virus. All experiments (both on animals and in laboratory) will be carried under strict respect of biosafety and biocontainment conditions already applied at the CRL for avian influenza. |
| --- | --- |

(6)

These investigations should be incorporated into the 2009 annual work programme of the CRL for avian influenza which has already developed models for studying infection parameters and performed some testing with influenza viruses from a variety of sources. Complementary investigations will utilise pigs, and, through a combination of multi-factorial measurements will aim at providing evidence for susceptibility and potential consequences of infection of pigs with the novel A/H1N1 influenza virus. All experiments (both on animals and in laboratory) will be carried under strict respect of biosafety and biocontainment conditions already applied at the CRL for avian influenza.

| (7) | Regulation (EC) No 1754/2006 provides that the financial assistance from the Community is to be granted if the approved work programmes are efficiently carried out and the beneficiaries supply all the necessary information within certain time limits. |
| --- | --- |

(7)

Regulation (EC) No 1754/2006 provides that the financial assistance from the Community is to be granted if the approved work programmes are efficiently carried out and the beneficiaries supply all the necessary information within certain time limits.

| (8) | The Commission has assessed the amended complementary work programme and corresponding amended budget estimates submitted by the CRL for avian influenza. |
| --- | --- |

(8)

The Commission has assessed the amended complementary work programme and corresponding amended budget estimates submitted by the CRL for avian influenza.

| (9) | Accordingly, an additional Community financial assistance should be granted to the CRL for avian influenza to carry out the complementary investigations on the novel A/H1N1 influenza virus. |
| --- | --- |

(9)

Accordingly, an additional Community financial assistance should be granted to the CRL for avian influenza to carry out the complementary investigations on the novel A/H1N1 influenza virus.

| (10) | In accordance with Article 3(2)(a) of Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (5), animal disease eradication and control programmes (veterinary measures) shall be financed from the European Agricultural Guarantee Fund (EAGF). Furthermore, Article 13, second paragraph of that Regulation foresees that in duly justified exceptional cases, for measures and programmes covered by Council Decision 90/424/EEC (6), expenditure relating to administrative and personnel costs incurred by Member States and beneficiaries of aid from the EAGF shall be borne by the Fund and in this case the expenditure proposed qualifies as justified. For financial control purposes, Articles 9, 36 and 37 of Regulation (EC) No 1290/2005 are to apply. |
| --- | --- |

(10)

In accordance with Article 3(2)(a) of Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (5), animal disease eradication and control programmes (veterinary measures) shall be financed from the European Agricultural Guarantee Fund (EAGF). Furthermore, Article 13, second paragraph of that Regulation foresees that in duly justified exceptional cases, for measures and programmes covered by Council Decision 90/424/EEC (6), expenditure relating to administrative and personnel costs incurred by Member States and beneficiaries of aid from the EAGF shall be borne by the Fund and in this case the expenditure proposed qualifies as justified. For financial control purposes, Articles 9, 36 and 37 of Regulation (EC) No 1290/2005 are to apply.

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

(11)

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

HAS ADOPTED THIS DECISION:

Article 1

In the second paragraph of Article 13 of Decision 2008/965/EC ‘EUR 400 000’ is replaced by ‘EUR 530 000’.

Article 2

This Decision is addressed to Veterinary Laboratories Agency (VLA) Weybridge, New Haw, Addlestone, Surrey, KT15 3NB, United Kingdom; Mr Ian Brown, tel. +44 1932 35 73 39.

Done at Brussels, 31 July 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

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(1)  OJ L 155, 18.6.2009, p. 30.

1

(2)  OJ L 165, 30.4.2004, p. 1.

2

(3)  OJ L 344, 20.12.2008, p. 112.

3

(4)  OJ L 331, 29.11.2006, p. 8.

4

(5)  OJ L 209, 11.8.2005, p. 1.

5

(6)  OJ L 224, 18.8.1990, p. 19.

6

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