# Official Journal L 21/2011

| | ISSN 1725-2555
  doi:10.3000/17252555.L_2011.021.eng |
| --- | --- |
| Official Journal
  of the European Union | L 21 |
| | |
| English edition | Legislation | Volume 5425 January 2011 |

ISSN 1725-2555

doi:10.3000/17252555.L_2011.021.eng

Official Journal

of the European Union

L 21

English edition

Legislation

Volume 5425 January 2011

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | | Commission Regulation (EU) No 58/2011 of 24 January 2011 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | | DECISIONS |
| | | 2011/47/EU |
| | * | Commission Decision of 20 January 2011 on a derogation from the rules of origin set out in Council Decision 2001/822/EC as regards sugar from the Netherlands Antilles
  (notified under document C(2011) 140) | 3 |
| | | 2011/48/EU |
| | * | Commission Decision of 24 January 2011 concerning the placing on the market for essential use of biocidal products containing temephos in the French overseas departments
  (notified under document C(2011) 167) | 6 |

Contents

II   Non-legislative acts

page

REGULATIONS

Commission Regulation (EU) No 58/2011 of 24 January 2011 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

DECISIONS

2011/47/EU

*

Commission Decision of 20 January 2011 on a derogation from the rules of origin set out in Council Decision 2001/822/EC as regards sugar from the Netherlands Antilles
  (notified under document C(2011) 140)

(notified under document C(2011) 140)

3

2011/48/EU

*

Commission Decision of 24 January 2011 concerning the placing on the market for essential use of biocidal products containing temephos in the French overseas departments
  (notified under document C(2011) 167)

(notified under document C(2011) 167)

6

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 348, 31.12.2010) | 8 |

Corrigenda

*

Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 348, 31.12.2010)

(OJ L 348, 31.12.2010)

8

| 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.

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II Non-legislative acts

REGULATIONS

| 25.1.2011 | EN | Official Journal of the European Union | L 21/1 |
| --- | --- | --- | --- |

25.1.2011

EN

Official Journal of the European Union

L 21/1

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COMMISSION REGULATION (EU) No 58/2011

of 24 January 2011

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

THE EUROPEAN COMMISSION,

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

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

Having regard to Commission 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 25 January 2011.

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

Done at Brussels, 24 January 2011.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

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

1

(2)  OJ L 350, 31.12.2007, p. 1.

2

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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 | MA | 59,3 |
| TR | 96,7 |
| ZZ | 78,0 |
| 0707 00 05 | JO | 87,5 |
| TR | 119,6 |
| ZZ | 103,6 |
| 0709 90 70 | MA | 44,0 |
| TR | 128,3 |
| ZZ | 86,2 |
| 0709 90 80 | EG | 66,7 |
| ZZ | 66,7 |
| 0805 10 20 | AR | 41,5 |
| BR | 41,5 |
| EG | 58,1 |
| MA | 58,8 |
| TR | 70,5 |
| ZA | 41,5 |
| ZZ | 52,0 |
| 0805 20 10 | MA | 85,0 |
| TR | 79,6 |
| ZZ | 82,3 |
| 0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90 | CN | 69,9 |
| IL | 67,8 |
| JM | 101,1 |
| MA | 103,7 |
| PK | 51,5 |
| TR | 81,4 |
| ZZ | 79,2 |
| 0805 50 10 | AR | 45,3 |
| TR | 56,6 |
| UY | 45,3 |
| ZZ | 49,1 |
| 0808 10 80 | AR | 78,5 |
| CA | 88,5 |
| CL | 81,7 |
| CN | 97,0 |
| MK | 46,1 |
| US | 135,9 |
| ZZ | 88,0 |
| 0808 20 50 | CN | 51,5 |
| US | 126,6 |
| ZA | 104,0 |
| ZZ | 94,0 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MA

59,3

TR

96,7

ZZ

78,0

0707 00 05

JO

87,5

TR

119,6

ZZ

103,6

0709 90 70

MA

44,0

TR

128,3

ZZ

86,2

0709 90 80

EG

66,7

ZZ

66,7

0805 10 20

AR

41,5

BR

41,5

EG

58,1

MA

58,8

TR

70,5

ZA

41,5

ZZ

52,0

0805 20 10

MA

85,0

TR

79,6

ZZ

82,3

0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

CN

69,9

IL

67,8

JM

101,1

MA

103,7

PK

51,5

TR

81,4

ZZ

79,2

0805 50 10

AR

45,3

TR

56,6

UY

45,3

ZZ

49,1

0808 10 80

AR

78,5

CA

88,5

CL

81,7

CN

97,0

MK

46,1

US

135,9

ZZ

88,0

0808 20 50

CN

51,5

US

126,6

ZA

104,0

ZZ

94,0

---

(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’.

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DECISIONS

| 25.1.2011 | EN | Official Journal of the European Union | L 21/3 |
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25.1.2011

EN

Official Journal of the European Union

L 21/3

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COMMISSION DECISION

of 20 January 2011

on a derogation from the rules of origin set out in Council Decision 2001/822/EC as regards sugar from the Netherlands Antilles

(notified under document C(2011) 140)

(2011/47/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Council Decision 2001/822/EC of 27 November 2001 on the association of the overseas countries and territories with the European Community (‘Overseas Association Decision’) (1), and in particular Article 37 of Annex III thereof,

Whereas:

| (1) | Annex III to Decision 2001/822/EC concerns the definition of the concept of ‘originating products’ and methods of administrative cooperation. Article 37 thereof provides that derogations from those rules of origin may be adopted where justified by the development of existing industries or the creation of new industries in a country or territory. |
| --- | --- |

(1)

Annex III to Decision 2001/822/EC concerns the definition of the concept of ‘originating products’ and methods of administrative cooperation. Article 37 thereof provides that derogations from those rules of origin may be adopted where justified by the development of existing industries or the creation of new industries in a country or territory.

| (2) | By Commission Decision 2009/699/EC (2), the request submitted in 2009 for extension of the previous derogation was rejected whereas the requested new derogation was granted for the quantities for which import licences for sugar were allocated to the Netherlands Antilles for 2009 and 2010. |
| --- | --- |

(2)

By Commission Decision 2009/699/EC (2), the request submitted in 2009 for extension of the previous derogation was rejected whereas the requested new derogation was granted for the quantities for which import licences for sugar were allocated to the Netherlands Antilles for 2009 and 2010.

| (3) | According to the quarterly statements of the quantities used under Decision 2009/699/EC forwarded by the Netherlands Antilles to the Commission, the consumption of the derogation granted in respect of 7 000 tonnes for 2010 is currently at around 2 500 tonnes in that year. |
| --- | --- |

(3)

According to the quarterly statements of the quantities used under Decision 2009/699/EC forwarded by the Netherlands Antilles to the Commission, the consumption of the derogation granted in respect of 7 000 tonnes for 2010 is currently at around 2 500 tonnes in that year.

| (4) | On 24 August 2010 the Netherlands requested on behalf of the Netherlands Antilles a new derogation from the rules of origin set out in Annex III to Decision 2001/822/EC for the period from 1 January 2011 until 31 December 2013, date of expiry of Decision 2001/822/EC. On 8 September and 11 October 2010 additional information was provided by the Netherlands Antilles. The request covers a total annual quantity of 7 000 tonnes of sugar products originating in third countries and processed in the Netherlands Antilles for export to the Union. |
| --- | --- |

(4)

On 24 August 2010 the Netherlands requested on behalf of the Netherlands Antilles a new derogation from the rules of origin set out in Annex III to Decision 2001/822/EC for the period from 1 January 2011 until 31 December 2013, date of expiry of Decision 2001/822/EC. On 8 September and 11 October 2010 additional information was provided by the Netherlands Antilles. The request covers a total annual quantity of 7 000 tonnes of sugar products originating in third countries and processed in the Netherlands Antilles for export to the Union.

| (5) | The request for a new derogation aims at allowing the use of raw sugar from third countries to be aromatized, coloured, milled and processed into sugar lumps in the Netherlands Antilles while conferring OCTs (Overseas Countries and Territories) origin. Moreover, the Netherlands Antilles request that for the years 2011, 2012 and 2013 the yearly amount for which ACP/EU-OCTs cumulation may be temporarily allowed by virtue of Article 6 of Annex III to Decision 2001/822/EC would be set at 7 000 tonnes. |
| --- | --- |

(5)

The request for a new derogation aims at allowing the use of raw sugar from third countries to be aromatized, coloured, milled and processed into sugar lumps in the Netherlands Antilles while conferring OCTs (Overseas Countries and Territories) origin. Moreover, the Netherlands Antilles request that for the years 2011, 2012 and 2013 the yearly amount for which ACP/EU-OCTs cumulation may be temporarily allowed by virtue of Article 6 of Annex III to Decision 2001/822/EC would be set at 7 000 tonnes.

| (6) | The request for a new derogation is based on quality requirements stating that ACP sugar in the Caribbean region does not meet the criteria for a production of high quality sugar destined to Union customers, and on availability stating that ACP sugar from the Caribbean is subject to continuous shortfalls due to climatic conditions. Furthermore, ACP States are increasingly exporting their sugar production directly to the United States and the Union. Further, the Union does not produce raw cane sugar which is used for the end product. Therefore it would be justified that the Netherlands Antilles source raw sugar in neighbouring third countries that are not part of the ACP States, the OCTs or the Union. |
| --- | --- |

(6)

The request for a new derogation is based on quality requirements stating that ACP sugar in the Caribbean region does not meet the criteria for a production of high quality sugar destined to Union customers, and on availability stating that ACP sugar from the Caribbean is subject to continuous shortfalls due to climatic conditions. Furthermore, ACP States are increasingly exporting their sugar production directly to the United States and the Union. Further, the Union does not produce raw cane sugar which is used for the end product. Therefore it would be justified that the Netherlands Antilles source raw sugar in neighbouring third countries that are not part of the ACP States, the OCTs or the Union.

| (7) | In its additional information, the Netherlands indicated that the sugar industry in the Netherlands Antilles, which should benefit from the requested derogation, aims to diversify into producing mixtures and ‘biosugar’, which both address distinctively different markets than the sugar products for which the requested derogation is submitted. At the moment diversification is still insufficient and the derogation would be needed to earn the necessary capital for the investments required for further diversification. |
| --- | --- |

(7)

In its additional information, the Netherlands indicated that the sugar industry in the Netherlands Antilles, which should benefit from the requested derogation, aims to diversify into producing mixtures and ‘biosugar’, which both address distinctively different markets than the sugar products for which the requested derogation is submitted. At the moment diversification is still insufficient and the derogation would be needed to earn the necessary capital for the investments required for further diversification.

| (8) | The requested new derogation from the rules of origin set out in Annex III to Decision 2001/822/EC for a quantity of 7 000 tonnes for products falling within CN codes 1701 11 90, 1701 99 10 and 1701 91 00 is justified according to Article 37(1), (3) and (7) of that Annex under certain conditions, which aim at balancing the legitimate interests of the OCTs operators with the objectives of the external dimension of the Union’s common market organisation on sugar. |
| --- | --- |

(8)

The requested new derogation from the rules of origin set out in Annex III to Decision 2001/822/EC for a quantity of 7 000 tonnes for products falling within CN codes 1701 11 90, 1701 99 10 and 1701 91 00 is justified according to Article 37(1), (3) and (7) of that Annex under certain conditions, which aim at balancing the legitimate interests of the OCTs operators with the objectives of the external dimension of the Union’s common market organisation on sugar.

| (9) | It is in favour of the legitimate interests of the Netherlands Antilles that the derogation concerns products which involve actual processing and the value added to the raw sugar is at least 45 % of the value of the finished product. Further, granting the derogation will contribute to the ability of the existing industry to continue its exports to the Union. The requested derogation is expected to generate the required turnover to finance further investments in diversification of products and activities, so that the industry concerned would no longer be required to request derogations of this kind. |
| --- | --- |

(9)

It is in favour of the legitimate interests of the Netherlands Antilles that the derogation concerns products which involve actual processing and the value added to the raw sugar is at least 45 % of the value of the finished product. Further, granting the derogation will contribute to the ability of the existing industry to continue its exports to the Union. The requested derogation is expected to generate the required turnover to finance further investments in diversification of products and activities, so that the industry concerned would no longer be required to request derogations of this kind.

| (10) | Additionally, the rules relating to cumulation of origin do not provide a solution for the sugar industry in the Netherlands Antilles. Article 6(4) of Annex III to Decision 2001/822/EC sets out the periods and the quantitative limits for which cumulation of origin has been temporarily allowed, and which are compatible with the objectives of the Union’s common market organisation whilst taking due account of the legitimate interests of the OCTs operators. These quantities have been progressively reduced and will be finally phased out to zero tonnes on 1 January 2011. |
| --- | --- |

(10)

Additionally, the rules relating to cumulation of origin do not provide a solution for the sugar industry in the Netherlands Antilles. Article 6(4) of Annex III to Decision 2001/822/EC sets out the periods and the quantitative limits for which cumulation of origin has been temporarily allowed, and which are compatible with the objectives of the Union’s common market organisation whilst taking due account of the legitimate interests of the OCTs operators. These quantities have been progressively reduced and will be finally phased out to zero tonnes on 1 January 2011.

| (11) | The phasing out of the ACP/EC-OCTs cumulation with regard to sugar, as provided for in Article 6(4) of Annex III to Decision 2001/822/EC, shows the Union’s intention that specific origin rules are to be more restrictive as regards sugar in order to take due account of the Union’s operators in the sugar market. That principle should be applied for the purpose of determining the quantities for which derogation is granted. The phasing out is also justified in view of the Union’s envisaged negotiation of free trade agreements with Latin American countries, from which sugar may be usually sourced by the Netherlands Antilles. Taking into account the intention of the Netherlands Antilles’ industry to diversify away from the sugar production requiring a derogation as the present one, the amounts for derogation should be phased out over time. |
| --- | --- |

(11)

The phasing out of the ACP/EC-OCTs cumulation with regard to sugar, as provided for in Article 6(4) of Annex III to Decision 2001/822/EC, shows the Union’s intention that specific origin rules are to be more restrictive as regards sugar in order to take due account of the Union’s operators in the sugar market. That principle should be applied for the purpose of determining the quantities for which derogation is granted. The phasing out is also justified in view of the Union’s envisaged negotiation of free trade agreements with Latin American countries, from which sugar may be usually sourced by the Netherlands Antilles. Taking into account the intention of the Netherlands Antilles’ industry to diversify away from the sugar production requiring a derogation as the present one, the amounts for derogation should be phased out over time.

| (12) | Given the low utilisation of the quantities, provided for in the past derogations, it is appropriate to provide for the double amount of the current utilisation as an initial quantity, which respects the ability of the existing industry to continue its exports to the Union. In line with the envisaged phasing out, the amounts should be reduced progressively over the requested period. Such a phasing out should allow, at the same time, to generate the required turnover to finance further investments in the Netherlands Antilles and to give an incentive for the sugar industry concerned there to promote the intended diversification. |
| --- | --- |

(12)

Given the low utilisation of the quantities, provided for in the past derogations, it is appropriate to provide for the double amount of the current utilisation as an initial quantity, which respects the ability of the existing industry to continue its exports to the Union. In line with the envisaged phasing out, the amounts should be reduced progressively over the requested period. Such a phasing out should allow, at the same time, to generate the required turnover to finance further investments in the Netherlands Antilles and to give an incentive for the sugar industry concerned there to promote the intended diversification.

| (13) | Consequently, subject to compliance with certain conditions relating to quantities, surveillance and duration, the derogation should be granted for 5 000 tonnes for 2011, 3 000 tonnes for 2012 and 1 500 tonnes for 2013. |
| --- | --- |

(13)

Consequently, subject to compliance with certain conditions relating to quantities, surveillance and duration, the derogation should be granted for 5 000 tonnes for 2011, 3 000 tonnes for 2012 and 1 500 tonnes for 2013.

| (14) | Subject to these conditions the derogation is not such as to cause serious injury to an economic sector or an established industry in the Union. |
| --- | --- |

(14)

Subject to these conditions the derogation is not such as to cause serious injury to an economic sector or an established industry in the Union.

| (15) | Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Common Customs Code (3) lays down rules for the management of tariff quotas. Those rules should be applied mutatis mutandis to the management of the quantity in respect of which the derogation in question is granted. |
| --- | --- |

(15)

Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Common Customs Code (3) lays down rules for the management of tariff quotas. Those rules should be applied mutatis mutandis to the management of the quantity in respect of which the derogation in question is granted.

| (16) | Since the current derogation expires on 31 December 2010, and a new derogation is requested for a period starting on 1 January 2011 until 31 December 2013, the requested derogation should apply from 1 January 2011 for that period. |
| --- | --- |

(16)

Since the current derogation expires on 31 December 2010, and a new derogation is requested for a period starting on 1 January 2011 until 31 December 2013, the requested derogation should apply from 1 January 2011 for that period.

| (17) | The measures provided for in this Decision are in accordance with the opinion of the Customs Code Committee, |
| --- | --- |

(17)

The measures provided for in this Decision are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS DECISION:

Article 1

By way of derogation from Annex III to Decision 2001/822/EC, sugar products processed in the Netherlands Antilles falling within CN codes 1701 11 90, 1701 99 10 and 1701 91 00 shall be regarded as originating in the Netherlands Antilles where they are obtained from non-originating sugar, in accordance with the terms set out in Articles 2, 3 and 4 of this Decision.

Article 2

The derogation provided for in Article 1 shall apply to the products and the quantities set out in the Annex which are declared for free circulation into the Union from the Netherlands Antilles during the period from 1 January 2011 to 31 December 2013.

Article 3

Articles 308a, 308b and 308c of Regulation (EEC) No 2454/93 relating to the management of tariff quotas shall apply mutatis mutandis to the management of the quantity referred to in the Annex hereto.

Article 4

The customs authorities of the Netherlands Antilles shall take the necessary measures to carry out quantitative checks on exports of the products referred to in Article 2.

All the movement certificates EUR.1 they issue in relation to those products shall bear a reference to this Decision.

The competent authorities of the Netherlands Antilles shall forward to the Commission a quarterly statement of the quantities in respect of which EUR.1 movement certificates have been issued pursuant to this Decision and the serial numbers of those certificates.

Article 5

Box 7 of EUR.1 movement certificates issued under this Decision shall contain one of the following entries:

| — | ‘Derogation – Decision 2011/47/EU’, |
| --- | --- |

—

‘Derogation – Decision 2011/47/EU’,

| — | ‘Dérogation – Décision 2011/47/UE’. |
| --- | --- |

—

‘Dérogation – Décision 2011/47/UE’.

Article 6

This Decision shall apply from 1 January 2011 until 31 December 2013.

Article 7

This Decision is addressed to the Member States.

Done at Brussels, 20 January 2011.

For the Commission

Algirdas ŠEMETA

Member of the Commission

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(1)  OJ L 314, 30.11.2001, p. 1.

1

(2)  OJ L 239, 10.9.2009, p. 55.

2

(3)  OJ L 253, 11.10.1993, p. 1.

3

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ANNEX

| Order No | CN code | Description of goods | Period | Quantities
  (in tonnes) |
| --- | --- | --- | --- | --- |
| 09.7910 | 1701 11 90
  1701 99 10
  1701 91 00 | Sugar products | 1.1.2011 to 31.12.2011 | 5 000 |
| 1.1.2012 to 31.12.2012 | 3 000 |
| 1.1.2013 to 31.12.2013 | 1 500 |

Order No

CN code

Description of goods

Period

Quantities

(in tonnes)

09.7910

1701 11 90

1701 99 10

1701 91 00

Sugar products

1.1.2011 to 31.12.2011

5 000

1.1.2012 to 31.12.2012

3 000

1.1.2013 to 31.12.2013

1 500

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| 25.1.2011 | EN | Official Journal of the European Union | L 21/6 |
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25.1.2011

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COMMISSION DECISION

of 24 January 2011

concerning the placing on the market for essential use of biocidal products containing temephos in the French overseas departments

(notified under document C(2011) 167)

(Only the French text is authentic)

(2011/48/EU)

THE EUROPEAN COMMISSION,

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

Having regard to 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 (1) and in particular Article 5(3) thereof,

Whereas:

| (1) | The first subparagraph of Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (2) provides that the Commission shall commence a 14-year work programme for the systematic examination of all active substances already on the market on 14 May 2000 (hereinafter referred to as ‘the review programme’). |
| --- | --- |

(1)

The first subparagraph of Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (2) provides that the Commission shall commence a 14-year work programme for the systematic examination of all active substances already on the market on 14 May 2000 (hereinafter referred to as ‘the review programme’).

| (2) | Temephos was identified as available on the market before 14 May 2000 as an active substance of biocidal products for purposes other than those referred to in Article 2(2)(c) and (d) of Directive 98/8/EC. No dossier was submitted in support of the inclusion of temephos in Annex I, IA or IB to that Directive within the prescribed deadline. |
| --- | --- |

(2)

Temephos was identified as available on the market before 14 May 2000 as an active substance of biocidal products for purposes other than those referred to in Article 2(2)(c) and (d) of Directive 98/8/EC. No dossier was submitted in support of the inclusion of temephos in Annex I, IA or IB to that Directive within the prescribed deadline.

| (3) | In accordance with the first subparagraph of Article 4(2) of Commission Regulation (EC) No 2032/2003 (3), Member States had to cancel existing authorisations or registrations for biocidal products containing temephos with effect from 1 September 2006. Pursuant to Article 4(1) of Regulation (EC) No 1451/2007, biocidal products containing temephos shall no longer be placed on the market. |
| --- | --- |

(3)

In accordance with the first subparagraph of Article 4(2) of Commission Regulation (EC) No 2032/2003 (3), Member States had to cancel existing authorisations or registrations for biocidal products containing temephos with effect from 1 September 2006. Pursuant to Article 4(1) of Regulation (EC) No 1451/2007, biocidal products containing temephos shall no longer be placed on the market.

| (4) | Article 5 of Regulation (EC) No 1451/2007 lays down the conditions under which Member States may apply to the Commission for derogation from the provision laid down in Article 4(1) of that Regulation and the conditions for granting such derogation. |
| --- | --- |

(4)

Article 5 of Regulation (EC) No 1451/2007 lays down the conditions under which Member States may apply to the Commission for derogation from the provision laid down in Article 4(1) of that Regulation and the conditions for granting such derogation.

| (5) | By Commission Decision 2007/226/EC (4), the Commission granted such derogation for biocidal products containing temephos used for vector mosquito control in the French overseas departments until 14 May 2009. By Commission Decision 2009/395/EC (5), the derogation was prolonged until 14 May 2010. On 4 March 2010, France submitted a report to the Commission relating to the use of temephos. |
| --- | --- |

(5)

By Commission Decision 2007/226/EC (4), the Commission granted such derogation for biocidal products containing temephos used for vector mosquito control in the French overseas departments until 14 May 2009. By Commission Decision 2009/395/EC (5), the derogation was prolonged until 14 May 2010. On 4 March 2010, France submitted a report to the Commission relating to the use of temephos.

| (6) | France has submitted an application to the Commission for extension of the derogation until 14 May 2014. The application contains information relating to recent important outbreaks of mosquito-spread epidemics in the French overseas departments. It explains the need for a range of insecticides to combat the epidemics and details the actions taken to substitute temephos, as well as the ongoing research on alternative methods subsidised by the French authorities. The Commission made the French application publicly available by electronic means on 1 August 2010 for a 60-day public consultation. No objection against the derogation sought was expressed during this period. |
| --- | --- |

(6)

France has submitted an application to the Commission for extension of the derogation until 14 May 2014. The application contains information relating to recent important outbreaks of mosquito-spread epidemics in the French overseas departments. It explains the need for a range of insecticides to combat the epidemics and details the actions taken to substitute temephos, as well as the ongoing research on alternative methods subsidised by the French authorities. The Commission made the French application publicly available by electronic means on 1 August 2010 for a 60-day public consultation. No objection against the derogation sought was expressed during this period.

| (7) | Given the magnitude of the outbreaks of mosquito-spread diseases in the French overseas departments, it is appropriate to allow the continued use of temephos. A further extension of the phase-out period for this substance is, therefore, necessary. The extension should take effect when the previous derogation ended, |
| --- | --- |

(7)

Given the magnitude of the outbreaks of mosquito-spread diseases in the French overseas departments, it is appropriate to allow the continued use of temephos. A further extension of the phase-out period for this substance is, therefore, necessary. The extension should take effect when the previous derogation ended,

HAS ADOPTED THIS DECISION:

Article 1

By way of derogation from Article 4(1) of Regulation (EC) No 1451/2007, France may allow the placing on the market of biocidal products containing Temephos (EC No 222-191-1; CAS No 3383-96-8), for vector mosquito control in the French overseas departments until 14 May 2014.

Article 2

1.   When allowing the placing on the market of biocidal products containing temephos in accordance with Article 1, France shall ensure that the following conditions are complied with:

| (a) | continued use is only possible under the conditions that biocidal products containing temephos are approved for the intended essential use; |
| --- | --- |

(a)

continued use is only possible under the conditions that biocidal products containing temephos are approved for the intended essential use;

| (b) | the continued use is only accepted so far as it has no unacceptable effect on human or animal health or on the environment; |
| --- | --- |

(b)

the continued use is only accepted so far as it has no unacceptable effect on human or animal health or on the environment;

| (c) | all appropriate risk reduction measures are imposed when granting approval; |
| --- | --- |

(c)

all appropriate risk reduction measures are imposed when granting approval;

| (d) | such biocidal products remaining on the market after 1 September 2006 are relabelled in order to match the restricted use conditions; |
| --- | --- |

(d)

such biocidal products remaining on the market after 1 September 2006 are relabelled in order to match the restricted use conditions;

| (e) | where appropriate, alternatives for such uses are being sought by the holders of the approvals or by France. |
| --- | --- |

(e)

where appropriate, alternatives for such uses are being sought by the holders of the approvals or by France.

2.   France shall inform the Commission annually on the application of paragraph 1 and in particular on the actions taken pursuant to point (e) of that paragraph.

Article 3

This Decision is addressed to the French Republic.

Article 4

This Decision shall take effect from 15 May 2010.

Done at Brussels, 24 January 2011.

For the Commission

Janez POTOČNIK

Member of the Commission

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

1

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

2

(3)  OJ L 307, 24.11.2003, p. 1.

3

(4)  OJ L 97, 12.4.2007, p. 47.

4

(5)  OJ L 124, 20.5.2009, p. 65.

5

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Corrigenda

| 25.1.2011 | EN | Official Journal of the European Union | L 21/8 |
| --- | --- | --- | --- |

25.1.2011

EN

Official Journal of the European Union

L 21/8

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Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use

(
  Official Journal of the European Union L 348 of 31 December 2010
  )

On page 98, Article 2(1), introductory wording:

for:

‘21 July 2011’,

read:

‘21 July 2012’;

on page 98, Article 2(1)(b):

for:

| ‘b) | the expiry of a period of 3 years starting from 21 July 2011’, |
| --- | --- |

‘b)

the expiry of a period of 3 years starting from 21 July 2011’,

read:

| ‘b) | 21 July 2015’; |
| --- | --- |

‘b)

21 July 2015’;

on page 98, Article 2(2):

for:

‘21 July 2011’,

read:

‘21 July 2012’.

---