# Official Journal L 94/2015

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 94 |
| | |
| English edition | Legislation | Volume 5810 April 2015 |

ISSN 1977-0677

Official Journal

of the European Union

L 94

English edition

Legislation

Volume 5810 April 2015

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | | Commission Implementing Regulation (EU) 2015/572 of 9 April 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | | DIRECTIVES |
| | * | Commission Delegated Directive (EU) 2015/573 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices (
  1
  ) | 4 |
| | * | Commission Delegated Directive (EU) 2015/574 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for mercury in intravascular ultrasound imaging systems (
  1
  ) | 6 |

Contents

II   Non-legislative acts

page

REGULATIONS

Commission Implementing Regulation (EU) 2015/572 of 9 April 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

DIRECTIVES

*

Commission Delegated Directive (EU) 2015/573 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices (
  1
  )

1

4

*

Commission Delegated Directive (EU) 2015/574 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for mercury in intravascular ultrasound imaging systems (
  1
  )

1

6

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Commission Regulation (EU) 2015/552 of 7 April 2015 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 1,3-dichloropropene, bifenox, dimethenamid-P, prohexadione, tolylfluanid and trifluralin in or on certain products ( OJ L 92, 8.4.2015 ) | 8 |

Corrigenda

*

Corrigendum to Commission Regulation (EU) 2015/552 of 7 April 2015 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 1,3-dichloropropene, bifenox, dimethenamid-P, prohexadione, tolylfluanid and trifluralin in or on certain products ( OJ L 92, 8.4.2015 )

( OJ L 92, 8.4.2015 )

8

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

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(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.

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II Non-legislative acts

REGULATIONS

| 10.4.2015 | EN | Official Journal of the European Union | L 94/1 |
| --- | --- | --- | --- |

10.4.2015

EN

Official Journal of the European Union

L 94/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/572

of 9 April 2015

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 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),

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

Whereas:

| (1) | Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
| --- | --- |

(1)

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

| (2) | The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

This Regulation shall enter into force on the day 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, 9 April 2015.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

---

(1)  OJ L 347, 20.12.2013, p. 671.

1

(2)  OJ L 157, 15.6.2011, 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 | AL | 102,3 |
| MA | 100,3 |
| TR | 122,2 |
| ZZ | 108,3 |
| 0707 00 05 | MA | 39,8 |
| MK | 97,3 |
| TR | 140,4 |
| ZZ | 92,5 |
| 0709 93 10 | MA | 83,5 |
| TR | 166,5 |
| ZZ | 125,0 |
| 0805 10 20 | CL | 64,9 |
| EG | 47,4 |
| IL | 75,6 |
| MA | 58,6 |
| TN | 63,2 |
| TR | 70,0 |
| ZZ | 63,3 |
| 0805 50 10 | TR | 45,7 |
| ZZ | 45,7 |
| 0808 10 80 | BR | 93,7 |
| CL | 94,0 |
| MK | 28,2 |
| US | 253,0 |
| ZA | 125,7 |
| ZZ | 118,9 |
| 0808 30 90 | AR | 116,6 |
| CL | 147,4 |
| CN | 106,3 |
| ZA | 157,3 |
| ZZ | 131,9 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

AL

102,3

MA

100,3

TR

122,2

ZZ

108,3

0707 00 05

MA

39,8

MK

97,3

TR

140,4

ZZ

92,5

0709 93 10

MA

83,5

TR

166,5

ZZ

125,0

0805 10 20

CL

64,9

EG

47,4

IL

75,6

MA

58,6

TN

63,2

TR

70,0

ZZ

63,3

0805 50 10

TR

45,7

ZZ

45,7

0808 10 80

BR

93,7

CL

94,0

MK

28,2

US

253,0

ZA

125,7

ZZ

118,9

0808 30 90

AR

116,6

CL

147,4

CN

106,3

ZA

157,3

ZZ

131,9

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(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.

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DIRECTIVES

| 10.4.2015 | EN | Official Journal of the European Union | L 94/4 |
| --- | --- | --- | --- |

10.4.2015

EN

Official Journal of the European Union

L 94/4

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COMMISSION DELEGATED DIRECTIVE (EU) 2015/573

of 30 January 2015

amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,

Whereas:

| (1) | Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market. |
| --- | --- |

(1)

Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.

| (2) | Blood, body fluid and body gas analysers serve as a critical analytical instrument in many diagnostic and therapeutic procedures. Lead is required as a stabiliser in the processing of the PVC for the sensor cards. Although research of substitutes is ongoing, a suitable alternative is not yet available. The performance of tested alternatives both to lead in PVC and to PVC itself does not meet the specific technical requirements. |
| --- | --- |

(2)

Blood, body fluid and body gas analysers serve as a critical analytical instrument in many diagnostic and therapeutic procedures. Lead is required as a stabiliser in the processing of the PVC for the sensor cards. Although research of substitutes is ongoing, a suitable alternative is not yet available. The performance of tested alternatives both to lead in PVC and to PVC itself does not meet the specific technical requirements.

| (3) | Both the substitution of lead in PVC sensor cards for in-vitro diagnostic medical devices for blood, body fluid and body gas analysis and the elimination of lead via substitution of PVC in these applications are technically impracticable. |
| --- | --- |

(3)

Both the substitution of lead in PVC sensor cards for in-vitro diagnostic medical devices for blood, body fluid and body gas analysis and the elimination of lead via substitution of PVC in these applications are technically impracticable.

| (4) | The use of lead in PVC sensors for blood, body fluid and body gas analysis used in in-vitro diagnostic medical devices should therefore be exempted until 31 December 2018. In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation. |
| --- | --- |

(4)

The use of lead in PVC sensors for blood, body fluid and body gas analysis used in in-vitro diagnostic medical devices should therefore be exempted until 31 December 2018. In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation.

| (5) | Directive 2011/65/EU should therefore be amended accordingly, |
| --- | --- |

(5)

Directive 2011/65/EU should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the last day of the ninth month after entry into force at the latest. 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 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 30 January 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 174, 1.7.2011, p. 88.

1

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ANNEX

In Annex IV to Directive 2011/65/EU, the following point 41 is added:

| ‘41. | Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases.
  Expires on 31 December 2018.’ |
| --- | --- |

‘41.

Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases.

Expires on 31 December 2018.’

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| 10.4.2015 | EN | Official Journal of the European Union | L 94/6 |
| --- | --- | --- | --- |

10.4.2015

EN

Official Journal of the European Union

L 94/6

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COMMISSION DELEGATED DIRECTIVE (EU) 2015/574

of 30 January 2015

amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for mercury in intravascular ultrasound imaging systems

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,

Whereas:

| (1) | Directive 2011/65/EU prohibits the use of mercury in electrical and electronic equipment placed on the market. |
| --- | --- |

(1)

Directive 2011/65/EU prohibits the use of mercury in electrical and electronic equipment placed on the market.

| (2) | Mercury is used in electric rotating connectors in medical devices for intravascular ultrasound imaging. Substitution of mercury or of the specific component would shorten product life or impair performance significantly. |
| --- | --- |

(2)

Mercury is used in electric rotating connectors in medical devices for intravascular ultrasound imaging. Substitution of mercury or of the specific component would shorten product life or impair performance significantly.

| (3) | Both the substitution of mercury in the connector and the elimination of mercury via substitution of the connector or the device are technically impracticable or have negative overall impacts due to an impact on patients' health. |
| --- | --- |

(3)

Both the substitution of mercury in the connector and the elimination of mercury via substitution of the connector or the device are technically impracticable or have negative overall impacts due to an impact on patients' health.

| (4) | The use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency modes of operation (> 50 MHz) should therefore be exempted until 30 June 2019. In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation. |
| --- | --- |

(4)

The use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency modes of operation (> 50 MHz) should therefore be exempted until 30 June 2019. In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation.

| (5) | Directive 2011/65/EU should therefore be amended accordingly, |
| --- | --- |

(5)

Directive 2011/65/EU should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the last day of the ninth month after entry into force at the latest. 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 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 30 January 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 174, 1.7.2011, p. 88.

1

---

ANNEX

In Annex IV to Directive 2011/65/EU, the following point 42 is added:

| ‘42. | Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.
  Expires on 30 June 2019.’ |
| --- | --- |

‘42.

Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.

Expires on 30 June 2019.’

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Corrigenda

| 10.4.2015 | EN | Official Journal of the European Union | L 94/8 |
| --- | --- | --- | --- |

10.4.2015

EN

Official Journal of the European Union

L 94/8

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Corrigendum to Commission Regulation (EU) 2015/552 of 7 April 2015 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 1,3-dichloropropene, bifenox, dimethenamid-P, prohexadione, tolylfluanid and trifluralin in or on certain products

(
  Official Journal of the European Union L 92 of 8 April 2015
  )

On page 22, Article 2:

for:

‘Article 2

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were lawfully produced before 28 April 2015.’

read:

‘Article 2

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were lawfully produced before 28 October 2015.’

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