# Official Journal L 34/2012

| | ISSN 1977-0677
  doi:10.3000/19770677.L_2012.034.eng |
| --- | --- |
| Official Journal
  of the European Union | L 34 |
| | |
| English edition | Legislation | Volume 557 February 2012 |

ISSN 1977-0677

doi:10.3000/19770677.L_2012.034.eng

Official Journal

of the European Union

L 34

English edition

Legislation

Volume 557 February 2012

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) No 95/2012 of 6 February 2012 amending Regulation (EU) No 1125/2010 as regards the intervention centres for cereals in Germany | 1 |
| | | Commission Implementing Regulation (EU) No 96/2012 of 6 February 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables | 3 |
| | | DECISIONS |
| | | 2012/67/EU |
| | * | Commission Implementing Decision of 3 February 2012 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
  (notified under document C(2012) 514)

   (
  1
  ) | 5 |
| | | 2012/68/EU |
| | * | Commission Implementing Decision of 3 February 2012 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
  (notified under document C(2012) 516)

   (
  1
  ) | 8 |
| | | 2012/69/EU |
| | * | Commission Implementing Decision of 3 February 2012 amending Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the tolerance period for traces of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as of their derived products
  (notified under document C(2012) 518) | 12 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) No 95/2012 of 6 February 2012 amending Regulation (EU) No 1125/2010 as regards the intervention centres for cereals in Germany

1

Commission Implementing Regulation (EU) No 96/2012 of 6 February 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

3

DECISIONS

2012/67/EU

*

Commission Implementing Decision of 3 February 2012 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
  (notified under document C(2012) 514)

   (
  1
  )

(notified under document C(2012) 514)

1

5

2012/68/EU

*

Commission Implementing Decision of 3 February 2012 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
  (notified under document C(2012) 516)

   (
  1
  )

(notified under document C(2012) 516)

1

8

2012/69/EU

*

Commission Implementing Decision of 3 February 2012 amending Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the tolerance period for traces of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as of their derived products
  (notified under document C(2012) 518)

(notified under document C(2012) 518)

12

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

---

(1)   Text with EEA relevance

1

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

EN

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

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

---

II Non-legislative acts

REGULATIONS

| 7.2.2012 | EN | Official Journal of the European Union | L 34/1 |
| --- | --- | --- | --- |

7.2.2012

EN

Official Journal of the European Union

L 34/1

---

COMMISSION IMPLEMENTING REGULATION (EU) No 95/2012

of 6 February 2012

amending Regulation (EU) No 1125/2010 as regards the intervention centres for cereals in Germany

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 41 in conjunction with Article 4 thereof,

Whereas:

| (1) | The Annex to Commission Regulation (EU) No 1125/2010 of 3 December 2010 determining the intervention centres for cereals and amending Regulation (EC) No 1173/2009 (2) designates the intervention centres for cereals. |
| --- | --- |

(1)

The Annex to Commission Regulation (EU) No 1125/2010 of 3 December 2010 determining the intervention centres for cereals and amending Regulation (EC) No 1173/2009 (2) designates the intervention centres for cereals.

| (2) | In accordance with Article 55(1) of Commission Regulation (EU) No 1272/2009 of 11 December 2009 laying down common detailed rules for the implementation of Council Regulation (EC) No 1234/2007 as regards buying-in and selling of agricultural products under public intervention (3), Germany has communicated to the Commission the amended list of its intervention centres for cereals and the list of storage premises attached to those centres which have been approved as fulfilling the minimum standards required by EU legislation (4). |
| --- | --- |

(2)

In accordance with Article 55(1) of Commission Regulation (EU) No 1272/2009 of 11 December 2009 laying down common detailed rules for the implementation of Council Regulation (EC) No 1234/2007 as regards buying-in and selling of agricultural products under public intervention (3), Germany has communicated to the Commission the amended list of its intervention centres for cereals and the list of storage premises attached to those centres which have been approved as fulfilling the minimum standards required by EU legislation (4).

| (3) | Regulation (EU) No 1125/2010 should therefore be amended accordingly, and the list of storage premises attached thereto should be published on the Internet, together with all the information required by the operators concerned by the public intervention. |
| --- | --- |

(3)

Regulation (EU) No 1125/2010 should therefore be amended accordingly, and the list of storage premises attached thereto should be published on the Internet, together with all the information required by the operators concerned by the public intervention.

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

(4)

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

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EU) No 1125/2010 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 6 February 2012.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  
  OJ L 318, 4.12.2010, p. 10.

2

(3)  
  OJ L 349, 29.12.2009, p. 1.

3

(4)  The addresses of the storage premises of the intervention centres are available on the European Commission website CIRCA (http://circa.europa.eu/Public/irc/agri/cereals/library?l=/publicsdomain/cereals/intervention_agencies&vm=detailed&sb=Title).

4

---

ANNEX

In the Annex to Regulation (EU) No 1125/2010, the section entitled ‘GERMANY’ is replaced by the following:

‧GERMANY

Andernach

Aschersleben

Augsburg

Bad Gandersheim

Bad Oldesloe

Beverungen

Brake

Bremen

Büdelsdorf

Bülstringen

Büsum

Buttstädt

Dessau-Roßlau

Drebkau

Ebeleben

Eberswalde

Eilenburg

Emden

Gransee

Halle

Hamburg

Hanau

Heiligenhafen

Hildesheim

Holzminden

Hoya

Itzehoe

Kappeln

Karstädt

Ketzin

Kiel

Krefeld

Kyritz

Lübeck

Lüneburg

Magdeburg

Malchin

Mannheim

Neubrandenburg

Nienburg

Nordhackstedt

Northeim

Ochsenfurt

Pasewalk

Querfurt

Regensburg

Rethem/Aller

Riesa

Rinteln

Rosdorf

Rostock

Salzhemmendorf

Salzwedel

Schwerin

Stralsund

Stuttgart

Torgau

Trebsen

Würzburg

Ziegra-Knobelsdorf‧

---

| 7.2.2012 | EN | Official Journal of the European Union | L 34/3 |
| --- | --- | --- | --- |

7.2.2012

EN

Official Journal of the European Union

L 34/3

---

COMMISSION IMPLEMENTING REGULATION (EU) No 96/2012

of 6 February 2012

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

THE EUROPEAN COMMISSION,

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

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

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

Whereas:

| (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, 6 February 2012.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

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

1

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

2

---

ANNEX

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

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | IL | 156,8 |
| MA | 58,6 |
| TN | 88,0 |
| TR | 118,5 |
| ZZ | 105,5 |
| 0707 00 05 | EG | 217,9 |
| JO | 137,5 |
| TR | 173,9 |
| US | 57,6 |
| ZZ | 146,7 |
| 0709 91 00 | EG | 317,7 |
| ZZ | 317,7 |
| 0709 93 10 | MA | 94,6 |
| TR | 166,7 |
| ZZ | 130,7 |
| 0805 10 20 | EG | 45,2 |
| MA | 51,0 |
| TN | 54,6 |
| TR | 75,7 |
| ZZ | 56,6 |
| 0805 20 10 | IL | 165,6 |
| MA | 82,7 |
| ZZ | 124,2 |
| 0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90 | CN | 60,6 |
| IL | 91,1 |
| JM | 98,5 |
| KR | 94,1 |
| MA | 82,8 |
| PK | 55,0 |
| TR | 68,6 |
| ZZ | 78,7 |
| 0805 50 10 | EG | 69,1 |
| TR | 59,0 |
| ZZ | 64,1 |
| 0808 10 80 | CA | 130,0 |
| CL | 98,4 |
| CN | 91,2 |
| MA | 59,2 |
| US | 147,5 |
| ZZ | 105,3 |
| 0808 30 90 | CL | 216,1 |
| CN | 60,2 |
| US | 121,0 |
| ZA | 89,0 |
| ZZ | 121,6 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

IL

156,8

MA

58,6

TN

88,0

TR

118,5

ZZ

105,5

0707 00 05

EG

217,9

JO

137,5

TR

173,9

US

57,6

ZZ

146,7

0709 91 00

EG

317,7

ZZ

317,7

0709 93 10

MA

94,6

TR

166,7

ZZ

130,7

0805 10 20

EG

45,2

MA

51,0

TN

54,6

TR

75,7

ZZ

56,6

0805 20 10

IL

165,6

MA

82,7

ZZ

124,2

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

CN

60,6

IL

91,1

JM

98,5

KR

94,1

MA

82,8

PK

55,0

TR

68,6

ZZ

78,7

0805 50 10

EG

69,1

TR

59,0

ZZ

64,1

0808 10 80

CA

130,0

CL

98,4

CN

91,2

MA

59,2

US

147,5

ZZ

105,3

0808 30 90

CL

216,1

CN

60,2

US

121,0

ZA

89,0

ZZ

121,6

---

(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’.

---

DECISIONS

| 7.2.2012 | EN | Official Journal of the European Union | L 34/5 |
| --- | --- | --- | --- |

7.2.2012

EN

Official Journal of the European Union

L 34/5

---

COMMISSION IMPLEMENTING DECISION

of 3 February 2012

amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products

(notified under document C(2012) 514)

(Text with EEA relevance)

(2012/67/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular Article 16f thereof,

Having regard to the opinion of the European Medicines Agency, formulated on 15 July 2010 by the Committee for Herbal Medicinal Products,

Whereas:

| (1) | Thymus vulgaris L., Thymus zygis Loefl. ex L. can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive. |
| --- | --- |

(1)

Thymus vulgaris L., Thymus zygis Loefl. ex L. can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive.

| (2) | It is therefore appropriate to include Thymus vulgaris L., Thymus zygis Loefl. ex L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC (2). |
| --- | --- |

(2)

It is therefore appropriate to include Thymus vulgaris L., Thymus zygis Loefl. ex L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC (2).

| (3) | Decision 2008/911/EC should therefore be amended accordingly. |
| --- | --- |

(3)

Decision 2008/911/EC should therefore be amended accordingly.

| (4) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use, |
| --- | --- |

(4)

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

HAS ADOPTED THIS DECISION:

Article 1

Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 3 February 2012.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 311, 28.11.2001, p. 67.

1

(2)  
  OJ L 328, 6.12.2008, p. 42.

2

---

ANNEX

Decision 2008/911/EC is amended as follows:

| (1) | in Annex I, the following substance is inserted after Pimpinella anisum L.:

  ‘
  Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum’; |
| --- | --- |

(1)

in Annex I, the following substance is inserted after Pimpinella anisum L.:

‘
  Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum’;

| (2) | in Annex II, the following is inserted after the entry on Pimpinella anisum L.:

  ‘
  COMMUNITY LIST ENTRY ON THYMUS VULGARIS L., THYMUS ZYGIS LOEFL. EX L., AETHEROLEUM


  Scientific name of the plant


  Thymus vulgaris L., Thymus zygis Loefl. ex L.

  Botanical family

  Lamiaceae

  Herbal preparation(s)

  Essential oil obtained by steam distillation from the fresh flowering aerial parts of Thymus vulgaris L., Thymus zygis Loefl. ex L. or a mixture of both species

  European Pharmacopoeia monograph reference

  01/2008:1374

  Indication(s)

  Traditional herbal medicinal product for the relief of symptoms in coughs and colds.
  The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.

  Type of tradition

  European

  Specified strength

  Please see “Specified posology”


  Specified posology


  Adults and elderly

  Cutaneous use: in liquid and semi-solid dosage forms in concentrations up to 10 %; apply up to 3 times daily.
  Use as bath additive: 0,007-0,025 g per litre.

  Adolescents

  Use as bath additive: 0,007-0,025 g per litre

  Children 6-12 years

  Use as bath additive: 0,0035-0,017 g per litre

  Children 3-6 years

  Use as bath additive: 0,0017-0,0082 g per litre
  One bath every day or every second day.
  The cutaneous use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precaution for use”).
  The use as bath additive in children under 3 years of age is not recommended (see section “Special warnings and precaution for use”).

  Route of administration

  Cutaneous use: apply to the chest and the back.
  Use as a bath additive: recommended temperature of bath: 35-38 °C.

  Duration of use or any restrictions on the duration of use

  Duration of a bath: 10-20 minutes.
  If the symptoms persist longer than 1 week, a doctor or a qualified health care practitioner should be consulted.

  Any other information necessary for the safe use


  Contraindications

  Hypersensitivity to the active substance.

  Use as bath additive:

  Full baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac insufficiency.

  Special warnings and precautions for use


  Cutaneous use:

  Like other essential oils Thyme oil should not be applied to the face particularly in the nasal area of babies and infants under the age of 2 years because of the risk of a laryngospasm.
  When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.
  The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.

  Use as bath additive:

  When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.
  The use in children under 3 years of age is not recommended because medical advice should be sought and due to lack of adequate data.
  In cases of hypertension, a full bath should be used with caution.

  Interactions with other medicinal products and other forms of interaction

  None reported.

  Pregnancy and lactation

  Safety during pregnancy and lactation has not been established.
  In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

  Effects on ability to drive and use machines

  No studies on the effect on the ability to drive and use machines have been performed.

  Undesirable effects

  Hypersensitivity reactions and skin irritation have been observed. The frequency is not known.
  If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

  Overdose

  No case of overdose has been reported.

  Pharmaceutical particulars [If necessary]

  Not applicable.

  Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [If necessary for the safe use of the product]

  Not applicable.’ |
| --- | --- |

(2)

in Annex II, the following is inserted after the entry on Pimpinella anisum L.:

‘
  COMMUNITY LIST ENTRY ON THYMUS VULGARIS L., THYMUS ZYGIS LOEFL. EX L., AETHEROLEUM

Scientific name of the plant

Thymus vulgaris L., Thymus zygis Loefl. ex L.

Botanical family

Lamiaceae

Herbal preparation(s)

Essential oil obtained by steam distillation from the fresh flowering aerial parts of Thymus vulgaris L., Thymus zygis Loefl. ex L. or a mixture of both species

European Pharmacopoeia monograph reference

01/2008:1374

Indication(s)

Traditional herbal medicinal product for the relief of symptoms in coughs and colds.

The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.

Type of tradition

European

Specified strength

Please see “Specified posology”

Specified posology

Adults and elderly

Cutaneous use: in liquid and semi-solid dosage forms in concentrations up to 10 %; apply up to 3 times daily.

Use as bath additive: 0,007-0,025 g per litre.

Adolescents

Use as bath additive: 0,007-0,025 g per litre

Children 6-12 years

Use as bath additive: 0,0035-0,017 g per litre

Children 3-6 years

Use as bath additive: 0,0017-0,0082 g per litre

One bath every day or every second day.

The cutaneous use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precaution for use”).

The use as bath additive in children under 3 years of age is not recommended (see section “Special warnings and precaution for use”).

Route of administration

Cutaneous use: apply to the chest and the back.

Use as a bath additive: recommended temperature of bath: 35-38 °C.

Duration of use or any restrictions on the duration of use

Duration of a bath: 10-20 minutes.

If the symptoms persist longer than 1 week, a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications

Hypersensitivity to the active substance.

Use as bath additive:

Full baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac insufficiency.

Special warnings and precautions for use

Cutaneous use:

Like other essential oils Thyme oil should not be applied to the face particularly in the nasal area of babies and infants under the age of 2 years because of the risk of a laryngospasm.

When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.

The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.

Use as bath additive:

When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.

The use in children under 3 years of age is not recommended because medical advice should be sought and due to lack of adequate data.

In cases of hypertension, a full bath should be used with caution.

Interactions with other medicinal products and other forms of interaction

None reported.

Pregnancy and lactation

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects

Hypersensitivity reactions and skin irritation have been observed. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Overdose

No case of overdose has been reported.

Pharmaceutical particulars [If necessary]

Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [If necessary for the safe use of the product]

Not applicable.’

---

| 7.2.2012 | EN | Official Journal of the European Union | L 34/8 |
| --- | --- | --- | --- |

7.2.2012

EN

Official Journal of the European Union

L 34/8

---

COMMISSION IMPLEMENTING DECISION

of 3 February 2012

amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products

(notified under document C(2012) 516)

(Text with EEA relevance)

(2012/68/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular Article 16f thereof,

Having regard to the opinion of the European Medicines Agency, formulated on 15 July 2010 by the Committee for Herbal Medicinal Products,

Whereas:

| (1) | Vitis vinifera L. can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive. |
| --- | --- |

(1)

Vitis vinifera L. can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive.

| (2) | It is therefore appropriate to include Vitis vinifera L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC (2). |
| --- | --- |

(2)

It is therefore appropriate to include Vitis vinifera L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC (2).

| (3) | Decision 2008/911/EC should therefore be amended accordingly. |
| --- | --- |

(3)

Decision 2008/911/EC should therefore be amended accordingly.

| (4) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use, |
| --- | --- |

(4)

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

HAS ADOPTED THIS DECISION:

Article 1

Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 3 February 2012.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 311, 28.11.2001, p. 67.

1

(2)  
  OJ L 328, 6.12.2008, p. 42.

2

---

ANNEX

Decision 2008/911/EC is amended as follows:

| (1) | in Annex I, the following substance is inserted after Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:

  ‘
  Vitis vinifera L., folium’ |
| --- | --- |

(1)

in Annex I, the following substance is inserted after Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:

‘
  Vitis vinifera L., folium’

| (2) | in Annex II, the following is inserted after the entry on Thymus vulgaris L., Thymus zygis Loefl. ex L.:

  ‘COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM

  Scientific name of the plant


  Vitis vinifera L.

  Botanical family

  Vitaceae

  Herbal substance

  Grapevine leaf (1)


  Common name of herbal substance in all EU official languages | BG (bălgarski): лоза, лист |
| --- | --- | --- |

(2)

in Annex II, the following is inserted after the entry on Thymus vulgaris L., Thymus zygis Loefl. ex L.:

‘COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM

Scientific name of the plant

Vitis vinifera L.

Botanical family

Vitaceae

Herbal substance

Grapevine leaf (1)

Common name of herbal substance in all EU official languages

BG (bălgarski): лоза, лист

| | CS (čeština): Červený list vinné révy |
| --- | --- |

CS (čeština): Červený list vinné révy

| | DA (dansk): Vinblad |
| --- | --- |

DA (dansk): Vinblad

| | DE (Deutsch): Rote Weinrebenblätter |
| --- | --- |

DE (Deutsch): Rote Weinrebenblätter

| | EL (elliniká): Φύλλο Αμπέλου |
| --- | --- |

EL (elliniká): Φύλλο Αμπέλου

| | EN (English): Grapevine leaf |
| --- | --- |

EN (English): Grapevine leaf

| | ES (español): Vid, hoja de |
| --- | --- |

ES (español): Vid, hoja de

| | ET (eesti keel): Viinapuu lehed |
| --- | --- |

ET (eesti keel): Viinapuu lehed

| | FI (suomi): Aitoviiniköynnös, lehti |
| --- | --- |

FI (suomi): Aitoviiniköynnös, lehti

| | FR (français): Feuille de vigne rouge |
| --- | --- |

FR (français): Feuille de vigne rouge

| | HU (magyar): Bortermő szőlő levél |
| --- | --- |

HU (magyar): Bortermő szőlő levél

| | IT (italiano): Vite, foglia |
| --- | --- |

IT (italiano): Vite, foglia

| | LT (lietuvių kalba): Tikrųjų vynmedžių lapai |
| --- | --- |

LT (lietuvių kalba): Tikrųjų vynmedžių lapai

| | LV (latviešu valoda): Īstā vīnkoka lapas |
| --- | --- |

LV (latviešu valoda): Īstā vīnkoka lapas

| | MT (malti): Werqa tad-dielja |
| --- | --- |

MT (malti): Werqa tad-dielja

| | NL (nederlands): Wijnstokblad |
| --- | --- |

NL (nederlands): Wijnstokblad

| | PL (polski): Liść winorośli właściwej |
| --- | --- |

PL (polski): Liść winorośli właściwej

| | PT (português): Folha de videira |
| --- | --- |

PT (português): Folha de videira

| | RO (română): Frunze de viță-de-vie |
| --- | --- |

RO (română): Frunze de viță-de-vie

| | SK (slovenčina): List viniča |
| --- | --- |

SK (slovenčina): List viniča

| | SL (slovenščina): List vinske trte |
| --- | --- |

SL (slovenščina): List vinske trte

| | SV (svenska): Blad från vinranka |
| --- | --- |

SV (svenska): Blad från vinranka

| | IS (íslenska): Vínviðarlauf |
| --- | --- |

IS (íslenska): Vínviðarlauf

| | NO (norsk): Rød vinranke, blad |
| --- | --- |

NO (norsk): Rød vinranke, blad

Herbal preparation(s)

Soft extract (2.5-4:1; extraction solvent water)

European Pharmacopoeia monograph reference

Not applicable

Indication(s)

Traditional herbal medicinal product to relieve symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances.

The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.

Type of tradition

European

Specified strength

Please see “Specified posology”.

Specified posology

Adults and elderly

Soft extract (2.5-4:1; extraction solvent water) in a cream base (10 g contain 282 mg soft extract).

Apply a thin layer on the affected area 1-3 times daily.

The use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precautions for use”).

Route of administration

Cutaneous use.

Duration of use or any restrictions on the duration of use

Adults and elderly

The recommended duration of use is 4 weeks.

If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications

Hypersensitivity to the active substance.

Special warnings and precautions for use

If there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs, cardiac or renal insufficiency, a doctor should be consulted.

The product should not be used on broken skin, around the eyes or on mucous membranes.

In the absence of sufficient safety data, the use in children and adolescents below 18 years of age is not recommended.

Interactions with other medicinal products and other forms of interaction

None reported.

Pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects

Contact allergy and/or hypersensitivity reactions of the skin (itching and erythema, urticaria) have been reported. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Overdose

No case of overdose has been reported.

Pharmaceutical particulars (if necessary)

Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)

Not applicable.

(1)  The material complies with the monograph of the Pharmacopée Française X., 1996.’
  "

---

(1)  The material complies with the monograph of the Pharmacopée Française X., 1996.’
  ’

---

| 7.2.2012 | EN | Official Journal of the European Union | L 34/12 |
| --- | --- | --- | --- |

7.2.2012

EN

Official Journal of the European Union

L 34/12

---

COMMISSION IMPLEMENTING DECISION

of 3 February 2012

amending Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the tolerance period for traces of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as of their derived products

(notified under document C(2012) 518)

(Only the German text is authentic)

(2012/69/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 8(6) and 20(6) thereof,

Whereas:

| (1) | Commission Decisions 2007/305/EC (2), 2007/306/EC (3) and 2007/307/EC (4) set out the rules for the withdrawal from the market of the following genetically modified material (‘the GM material’): Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as their derived products. Those Decisions have been adopted after the notifier of the GM material had indicated to the Commission that it had no intention to submit an application for renewal of the authorisation of that material in accordance with the first subparagraph of Article 8(4), Article 11, Article 20(4) and Article 23 of Regulation (EC) No 1829/2003. |
| --- | --- |

(1)

Commission Decisions 2007/305/EC (2), 2007/306/EC (3) and 2007/307/EC (4) set out the rules for the withdrawal from the market of the following genetically modified material (‘the GM material’): Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as their derived products. Those Decisions have been adopted after the notifier of the GM material had indicated to the Commission that it had no intention to submit an application for renewal of the authorisation of that material in accordance with the first subparagraph of Article 8(4), Article 11, Article 20(4) and Article 23 of Regulation (EC) No 1829/2003.

| (2) | All three Decisions provide for a transitional period of time of 5 years, during which food and feed containing the GM material are allowed to be placed on the market, in accordance with Article 4(2) or Article 16(2) of the Regulation, subject to a number of conditions. The Decisions require in particular that the presence of the GM material in food and feed does not exceed a threshold of 0,9 % and that the presence of this GM material be adventitious or technically unavoidable. The purpose of the transitional period is to take into consideration the fact that minute traces of the GM material can be present in the food and feed chain some time after the notifier has decided to stop selling seeds derived from the GMO, even if the notifier has taken all measures to avoid that presence. |
| --- | --- |

(2)

All three Decisions provide for a transitional period of time of 5 years, during which food and feed containing the GM material are allowed to be placed on the market, in accordance with Article 4(2) or Article 16(2) of the Regulation, subject to a number of conditions. The Decisions require in particular that the presence of the GM material in food and feed does not exceed a threshold of 0,9 % and that the presence of this GM material be adventitious or technically unavoidable. The purpose of the transitional period is to take into consideration the fact that minute traces of the GM material can be present in the food and feed chain some time after the notifier has decided to stop selling seeds derived from the GMO, even if the notifier has taken all measures to avoid that presence.

| (3) | Decisions 2007/305/EC and 2007/306/EC also set out a series of measures that the notifier has to take to ensure the effective withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and their derived products. Similar measures were not considered necessary in Decision 2007/307/EC since the notifier had stopped selling seeds of oilseed rape ACS-BNØØ7-1 after the 2003 planting season and in light of the fact that stocks of products derived from ACS-BNØØ7-1 oilseed rape had been used up before 18 April 2007. However, given that minute traces of ACS-BNØØ7-1 oilseed rape might remain present in food or feed products for a certain period of time it was necessary to adopt Decision 2007/307/EC. |
| --- | --- |

(3)

Decisions 2007/305/EC and 2007/306/EC also set out a series of measures that the notifier has to take to ensure the effective withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and their derived products. Similar measures were not considered necessary in Decision 2007/307/EC since the notifier had stopped selling seeds of oilseed rape ACS-BNØØ7-1 after the 2003 planting season and in light of the fact that stocks of products derived from ACS-BNØØ7-1 oilseed rape had been used up before 18 April 2007. However, given that minute traces of ACS-BNØØ7-1 oilseed rape might remain present in food or feed products for a certain period of time it was necessary to adopt Decision 2007/307/EC.

| (4) | In the absence of experience or concrete data on the time needed to ensure a complete withdrawal from the market of the GM material, the tolerated level of presence of that material and the time needed to ensure total withdrawal from the food and feed chains provided for in Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC were set on the basis of data available at this time and results of testing by stakeholders. |
| --- | --- |

(4)

In the absence of experience or concrete data on the time needed to ensure a complete withdrawal from the market of the GM material, the tolerated level of presence of that material and the time needed to ensure total withdrawal from the food and feed chains provided for in Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC were set on the basis of data available at this time and results of testing by stakeholders.

| (5) | In accordance with the requirements of Decisions 2007/305/EC and 2007/306/EC, the authorisation holder submitted detailed reports in October 2007 and November 2011 on the implementation of discontinuation measures for the above GM oilseed rape events. These reports outline past and current measures which have been implemented by the authorisation holder in accordance with the abovementioned decisions to ensure the removal of this GM material from the market. These include, among others, steps taken to inform commercial operators in the EU of the discontinued status of this GM material, the implementation of a series of measures to ensure the recall and destruction of remaining commercial seed stock, the conclusion of agreements with all third parties involved in the commercialisation of this GM material to ensure that the seed from this GM material is either sent back to the authorisation holder or is effectively destroyed, the actions undertaken to ensure the deregistration of registered varieties of the event concerned from the national seed catalogue and the implementation of an in-house program based on a quality assurance process to avoid the presence of these GM events in breeding and seed production. |
| --- | --- |

(5)

In accordance with the requirements of Decisions 2007/305/EC and 2007/306/EC, the authorisation holder submitted detailed reports in October 2007 and November 2011 on the implementation of discontinuation measures for the above GM oilseed rape events. These reports outline past and current measures which have been implemented by the authorisation holder in accordance with the abovementioned decisions to ensure the removal of this GM material from the market. These include, among others, steps taken to inform commercial operators in the EU of the discontinued status of this GM material, the implementation of a series of measures to ensure the recall and destruction of remaining commercial seed stock, the conclusion of agreements with all third parties involved in the commercialisation of this GM material to ensure that the seed from this GM material is either sent back to the authorisation holder or is effectively destroyed, the actions undertaken to ensure the deregistration of registered varieties of the event concerned from the national seed catalogue and the implementation of an in-house program based on a quality assurance process to avoid the presence of these GM events in breeding and seed production.

| (6) | Recent test results notified by stakeholders to the Commission show that the measures undertaken by the authorisation holder have allowed the removal of nearly all the GM material from the market. However, these results also show that minute traces (< 0,1 %) of the GM material may still be present in the food or feed chain at the end of the transitional period set out in Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC. The presence of remaining traces after the expiry date set out in these decisions, despite the measures undertaken by the notifier, can be explained by the biology of oilseed rape which can remain dormant for long periods as well as by the farm practices which have been employed to harvest the seed and resulting accidental spillage, the level of which was difficult to estimate at the date of adoption of the three abovementioned Decisions. |
| --- | --- |

(6)

Recent test results notified by stakeholders to the Commission show that the measures undertaken by the authorisation holder have allowed the removal of nearly all the GM material from the market. However, these results also show that minute traces (< 0,1 %) of the GM material may still be present in the food or feed chain at the end of the transitional period set out in Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC. The presence of remaining traces after the expiry date set out in these decisions, despite the measures undertaken by the notifier, can be explained by the biology of oilseed rape which can remain dormant for long periods as well as by the farm practices which have been employed to harvest the seed and resulting accidental spillage, the level of which was difficult to estimate at the date of adoption of the three abovementioned Decisions.

| (7) | Against this background it is necessary to extend the current transitional period of time for another 5 years, that is until 31 December 2016. This supplementary transitional period should provide sufficient time to allow the total removal of the GM material from the food and feed chain, taking into account the abovementioned parameters linked to the biology of oilseed rape and the past farming practices used to harvest the crops. |
| --- | --- |

(7)

Against this background it is necessary to extend the current transitional period of time for another 5 years, that is until 31 December 2016. This supplementary transitional period should provide sufficient time to allow the total removal of the GM material from the food and feed chain, taking into account the abovementioned parameters linked to the biology of oilseed rape and the past farming practices used to harvest the crops.

| (8) | In order to further contribute to the removal of oilseed rape ACS-BNØØ7-1 from the food and feed chains, it is also appropriate to provide in Decision 2007/307/EC that the notifier implements an in-house program to avoid the presence of this event in the breeding and seed production process. |
| --- | --- |

(8)

In order to further contribute to the removal of oilseed rape ACS-BNØØ7-1 from the food and feed chains, it is also appropriate to provide in Decision 2007/307/EC that the notifier implements an in-house program to avoid the presence of this event in the breeding and seed production process.

| (9) | By 1 January 2014, the notifier should submit a report to the Commission providing information on the implementation during the additional period of time granted by this decision of the measures set out in the Annex to Decisions 2007/305/EC and 2007/306/EC, as well as in Article 1(1) of Decision 2007/307/EC. |
| --- | --- |

(9)

By 1 January 2014, the notifier should submit a report to the Commission providing information on the implementation during the additional period of time granted by this decision of the measures set out in the Annex to Decisions 2007/305/EC and 2007/306/EC, as well as in Article 1(1) of Decision 2007/307/EC.

| (10) | In view of the very low trace levels which have been reported, it is appropriate to reduce to 0,1 % the level of presence of the GM material that is tolerated in food and feed. |
| --- | --- |

(10)

In view of the very low trace levels which have been reported, it is appropriate to reduce to 0,1 % the level of presence of the GM material that is tolerated in food and feed.

| (11) | Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC should therefore be amended accordingly. |
| --- | --- |

(11)

Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC should therefore be amended accordingly.

| (12) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(12)

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

1.   Decision 2007/305/EC is amended as follows:

| (a) | the second paragraph of Article 1 shall be replaced by the following:
  ‘By 1 January 2014, the notifier shall submit to the Commission a report on the implementation of the measures set out in the Annex.’; |
| --- | --- |

(a)

the second paragraph of Article 1 shall be replaced by the following:

‘By 1 January 2014, the notifier shall submit to the Commission a report on the implementation of the measures set out in the Annex.’;

| (b) | Article 2 shall be replaced by the following:

  ‘Article 2
  The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape in food or feed products notified under Article 8(1)(a) and Article 20(1) of Regulation (EC) No 1829/2003 shall be tolerated until 31 December 2016:






  (a) | provided that this presence is adventitious or technically unavoidable; and |
| --- | --- | --- |

(b)

Article 2 shall be replaced by the following:

‘Article 2

The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape in food or feed products notified under Article 8(1)(a) and Article 20(1) of Regulation (EC) No 1829/2003 shall be tolerated until 31 December 2016:

(a)

provided that this presence is adventitious or technically unavoidable; and

| (b) | in a proportion no higher than 0,1 %.’; |
| --- | --- |

(b)

in a proportion no higher than 0,1 %.’;

2.   Decision 2007/306/EC is amended as follows:

| (a) | the second paragraph of Article 1 shall be replaced by the following:
  ‘By 1 January 2014, the notifier shall submit to the Commission a report on the implementation of the measures set out in the Annex.’; |
| --- | --- |

(a)

the second paragraph of Article 1 shall be replaced by the following:

‘By 1 January 2014, the notifier shall submit to the Commission a report on the implementation of the measures set out in the Annex.’;

| (b) | Article 2 is replaced by the following:

  ‘Article 2
  The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape in food or feed products notified under Article 8(1)(a) and Article 20(1) of the Regulation (EC) No 1829/2003 shall be tolerated until 31 December 2016:






  (a) | provided that this presence is adventitious or technically unavoidable; and |
| --- | --- | --- |

(b)

Article 2 is replaced by the following:

‘Article 2

The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape in food or feed products notified under Article 8(1)(a) and Article 20(1) of the Regulation (EC) No 1829/2003 shall be tolerated until 31 December 2016:

(a)

provided that this presence is adventitious or technically unavoidable; and

| (b) | in a proportion no higher than 0,1 %.’; |
| --- | --- |

(b)

in a proportion no higher than 0,1 %.’;

3.   Article 1 of Decision 2007/307/EC is replaced by the following:

‘Article 1

1.   The notifier shall implement an in-house program to avoid the presence of ACS-BNØØ7-1 oilseed rape in breeding and seed production and shall report to the Commission on the implementation of this measure by 1 January 2014.

3.2.   The presence of material which contains, consists of or is produced from ACS-BNØØ7-1 oilseed rape in food or feed products notified under Article 8(1)(a) and Article 20(1) of the Regulation (EC) No 1829/2003 shall be tolerated until 31 December 2016:

| (a) | provided that this presence is adventitious or technically unavoidable; and |
| --- | --- |

(a)

provided that this presence is adventitious or technically unavoidable; and

| (b) | in a proportion no higher than 0,1 %.’ |
| --- | --- |

(b)

in a proportion no higher than 0,1 %.’

Article 2

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003, regarding ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape, ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape, and ACS-BNØØ7-1 oilseed rape shall be modified in order to take account of this Decision.

Article 3

This Decision is addressed to Bayer CropScience AG, Alfred-Nobel-Str. 50, 40789 Monheim am Rhein, Germany.

Done at Brussels, 3 February 2012.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 268, 18.10.2003, p. 1.

1

(2)  
  OJ L 117, 5.5.2007, p. 17.

2

(3)  
  OJ L 117, 5.5.2007, p. 20.

3

(4)  
  OJ L 117, 5.5.2007, p. 23.

4

---