# Official Journal L 72/2013

| | ISSN 1977-0677
  doi:10.3000/19770677.L_2013.072.eng |
| --- | --- |
| Official Journal
  of the European Union | L 72 |
| | |
| English edition | Legislation | Volume 5615 March 2013 |

ISSN 1977-0677

doi:10.3000/19770677.L_2013.072.eng

Official Journal

of the European Union

L 72

English edition

Legislation

Volume 5615 March 2013

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) No 222/2013 of 6 March 2013 entering a name in the register of protected designations of origin and protected geographical indications (Spargel aus Franken/Fränkischer Spargel/Franken-Spargel (PGI)) | 1 |
| | * | Commission Implementing Regulation (EU) No 223/2013 of 6 March 2013 entering a name in the register of protected designations of origin and protected geographical indications (Mela Rossa Cuneo (PGI)) | 3 |
| | * | Commission Implementing Regulation (EU) No 224/2013 of 6 March 2013 entering a name in the register of protected designations of origin and protected geographical indications (Kitkan viisas (PDO)) | 5 |
| | * | Commission Implementing Regulation (EU) No 225/2013 of 6 March 2013 entering a name in the register of protected designations of origin and protected geographical indications (Ficodindia di San Cono (PDO)) | 7 |
| | | Commission Implementing Regulation (EU) No 226/2013 of 14 March 2013 establishing the standard import values for determining the entry price of certain fruit and vegetables | 9 |
| | | DECISIONS |
| | | 2013/129/EU |
| | * | Council Decision of 7 March 2013 on subjecting 4-methylamphetamine to control measures | 11 |
| | | 2013/130/EU |
| | * | Commission Implementing Decision of 13 March 2013 rejecting a restriction of the authorisation of a biocidal product containing indoxacarb notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
  (notified under document C(2013) 1366) | 13 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) No 222/2013 of 6 March 2013 entering a name in the register of protected designations of origin and protected geographical indications (Spargel aus Franken/Fränkischer Spargel/Franken-Spargel (PGI))

1

*

Commission Implementing Regulation (EU) No 223/2013 of 6 March 2013 entering a name in the register of protected designations of origin and protected geographical indications (Mela Rossa Cuneo (PGI))

3

*

Commission Implementing Regulation (EU) No 224/2013 of 6 March 2013 entering a name in the register of protected designations of origin and protected geographical indications (Kitkan viisas (PDO))

5

*

Commission Implementing Regulation (EU) No 225/2013 of 6 March 2013 entering a name in the register of protected designations of origin and protected geographical indications (Ficodindia di San Cono (PDO))

7

Commission Implementing Regulation (EU) No 226/2013 of 14 March 2013 establishing the standard import values for determining the entry price of certain fruit and vegetables

9

DECISIONS

2013/129/EU

*

Council Decision of 7 March 2013 on subjecting 4-methylamphetamine to control measures

11

2013/130/EU

*

Commission Implementing Decision of 13 March 2013 rejecting a restriction of the authorisation of a biocidal product containing indoxacarb notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
  (notified under document C(2013) 1366)

(notified under document C(2013) 1366)

13

| 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

| 15.3.2013 | EN | Official Journal of the European Union | L 72/1 |
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15.3.2013

EN

Official Journal of the European Union

L 72/1

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COMMISSION IMPLEMENTING REGULATION (EU) No 222/2013

of 6 March 2013

entering a name in the register of protected designations of origin and protected geographical indications (Spargel aus Franken/Fränkischer Spargel/Franken-Spargel (PGI))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2). |
| --- | --- |

(1)

Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

| (2) | Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Germany’s application to register the name ‘Spargel aus Franken’ or ‘Fränkischer Spargel’ or ‘Franken-Spargel’ was published in the Official Journal of the European Union (3). |
| --- | --- |

(2)

Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Germany’s application to register the name ‘Spargel aus Franken’ or ‘Fränkischer Spargel’ or ‘Franken-Spargel’ was published in the Official Journal of the European Union (3).

| (3) | As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register, |
| --- | --- |

(3)

As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby entered in the register.

Article 2

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

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

Done at Brussels, 6 March 2013.

For the Commission, On behalf of the President,

Dacian CIOLOȘ

Member of the Commission

---

(1)  
  OJ L 343, 14.12.2012, p. 1.

1

(2)  
  OJ L 93, 31.3.2006, p. 12.

2

(3)  
  OJ C 125, 28.4.2012, p. 13.

3

---

ANNEX

Agricultural products intended for human consumption listed in Annex I to the Treaty:

Class 1.6.   Fruit, vegetables and cereals, fresh or processed

GERMANY

Spargel aus Franken/Fränkischer Spargel/Franken-Spargel (PGI)

---

| 15.3.2013 | EN | Official Journal of the European Union | L 72/3 |
| --- | --- | --- | --- |

15.3.2013

EN

Official Journal of the European Union

L 72/3

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COMMISSION IMPLEMENTING REGULATION (EU) No 223/2013

of 6 March 2013

entering a name in the register of protected designations of origin and protected geographical indications (Mela Rossa Cuneo (PGI))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2). |
| --- | --- |

(1)

Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

| (2) | Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Mela Rossa Cuneo’ was published in the Official Journal of the European Union (3). |
| --- | --- |

(2)

Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Mela Rossa Cuneo’ was published in the Official Journal of the European Union (3).

| (3) | As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register, |
| --- | --- |

(3)

As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby entered in the register.

Article 2

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

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

Done at Brussels, 6 March 2013.

For the Commission, On behalf of the President,

Dacian CIOLOȘ

Member of the Commission

---

(1)  
  OJ L 343, 14.12.2012, p. 1.

1

(2)  
  OJ L 93, 31.3.2006, p. 12.

2

(3)  
  OJ C 140, 16.5.2012, p. 4.

3

---

ANNEX

Agricultural products intended for human consumption listed in Annex I to the Treaty:

Class 1.6.   Fruit, vegetables and cereals, fresh or processed

ITALY

Mela Rossa Cuneo (PGI)

---

| 15.3.2013 | EN | Official Journal of the European Union | L 72/5 |
| --- | --- | --- | --- |

15.3.2013

EN

Official Journal of the European Union

L 72/5

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COMMISSION IMPLEMENTING REGULATION (EU) No 224/2013

of 6 March 2013

entering a name in the register of protected designations of origin and protected geographical indications (Kitkan viisas (PDO))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2). |
| --- | --- |

(1)

Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

| (2) | Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Finland’s application to register the name ‘Kitkan viisas’ was published in the Official Journal of the European Union (3). |
| --- | --- |

(2)

Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Finland’s application to register the name ‘Kitkan viisas’ was published in the Official Journal of the European Union (3).

| (3) | As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register, |
| --- | --- |

(3)

As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby entered in the register.

Article 2

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

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

Done at Brussels, 6 March 2013.

For the Commission, On behalf of the President,

Dacian CIOLOȘ

Member of the Commission

---

(1)  
  OJ L 343, 14.12.2012, p. 1.

1

(2)  
  OJ L 93, 31.3.2006, p. 12.

2

(3)  
  OJ C 136, 11.5.2012, p. 13.

3

---

ANNEX

Agricultural products intended for human consumption listed in Annex I to the Treaty:

Class 1.7.   Fresh fish, molluscs and crustaceans and products derived therefrom

FINLAND

Kitkan viisas (PDO)

---

| 15.3.2013 | EN | Official Journal of the European Union | L 72/7 |
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15.3.2013

EN

Official Journal of the European Union

L 72/7

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COMMISSION IMPLEMENTING REGULATION (EU) No 225/2013

of 6 March 2013

entering a name in the register of protected designations of origin and protected geographical indications (Ficodindia di San Cono (PDO))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2). |
| --- | --- |

(1)

Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

| (2) | Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Ficodindia di San Cono’ was published in the Official Journal of the European Union (3). |
| --- | --- |

(2)

Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Ficodindia di San Cono’ was published in the Official Journal of the European Union (3).

| (3) | As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register, |
| --- | --- |

(3)

As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby entered in the register.

Article 2

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

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

Done at Brussels, 6 March 2013.

For the Commission, On behalf of the President,

Dacian CIOLOȘ

Member of the Commission

---

(1)  
  OJ L 343, 14.12.2012, p. 1.

1

(2)  
  OJ L 93, 31.3.2006, p. 12.

2

(3)  
  OJ C 150, 26.5.2012, p. 9.

3

---

ANNEX

Agricultural products intended for human consumption listed in Annex I to the Treaty:

Class 1.6.   Fruit, vegetables and cereals, fresh or processed

ITALY

Ficodindia di San Cono (PDO)

---

| 15.3.2013 | EN | Official Journal of the European Union | L 72/9 |
| --- | --- | --- | --- |

15.3.2013

EN

Official Journal of the European Union

L 72/9

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COMMISSION IMPLEMENTING REGULATION (EU) No 226/2013

of 14 March 2013

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, 14 March 2013.

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

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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 | IL | 107,2 |
| MA | 73,9 |
| TN | 92,1 |
| TR | 109,3 |
| ZZ | 95,6 |
| 0707 00 05 | MA | 167,3 |
| TR | 167,9 |
| ZZ | 167,6 |
| 0709 91 00 | EG | 82,2 |
| ZZ | 82,2 |
| 0709 93 10 | MA | 46,9 |
| TR | 104,0 |
| ZZ | 75,5 |
| 0805 10 20 | EG | 57,8 |
| IL | 72,0 |
| MA | 61,2 |
| TN | 62,2 |
| TR | 73,6 |
| ZZ | 65,4 |
| 0805 50 10 | TR | 92,9 |
| ZZ | 92,9 |
| 0808 10 80 | AR | 116,3 |
| BR | 89,4 |
| CL | 139,6 |
| CN | 93,7 |
| MK | 29,8 |
| US | 185,0 |
| ZZ | 109,0 |
| 0808 30 90 | AR | 112,4 |
| BR | 113,7 |
| CL | 148,0 |
| CN | 91,6 |
| TR | 171,6 |
| ZA | 108,9 |
| ZZ | 124,4 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

IL

107,2

MA

73,9

TN

92,1

TR

109,3

ZZ

95,6

0707 00 05

MA

167,3

TR

167,9

ZZ

167,6

0709 91 00

EG

82,2

ZZ

82,2

0709 93 10

MA

46,9

TR

104,0

ZZ

75,5

0805 10 20

EG

57,8

IL

72,0

MA

61,2

TN

62,2

TR

73,6

ZZ

65,4

0805 50 10

TR

92,9

ZZ

92,9

0808 10 80

AR

116,3

BR

89,4

CL

139,6

CN

93,7

MK

29,8

US

185,0

ZZ

109,0

0808 30 90

AR

112,4

BR

113,7

CL

148,0

CN

91,6

TR

171,6

ZA

108,9

ZZ

124,4

---

(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

| 15.3.2013 | EN | Official Journal of the European Union | L 72/11 |
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15.3.2013

EN

Official Journal of the European Union

L 72/11

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COUNCIL DECISION

of 7 March 2013

on subjecting 4-methylamphetamine to control measures

(2013/129/EU)

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances (1), and in particular Article 8(3) thereof,

Having regard to the initiative of the European Commission,

Whereas:

| (1) | A risk assessment report on 4-methylamphetamine was drawn up on the basis of Article 6 of Decision 2005/387/JHA by a special session of the extended Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction, and was subsequently received by the Commission on 29 November 2012. |
| --- | --- |

(1)

A risk assessment report on 4-methylamphetamine was drawn up on the basis of Article 6 of Decision 2005/387/JHA by a special session of the extended Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction, and was subsequently received by the Commission on 29 November 2012.

| (2) | 4-methylamphetamine is a synthetic ring-methylated derivative of amphetamine which has predominantly been seized in powder and paste form in samples containing amphetamine and caffeine, but which has also appeared in tablet and liquid form. It has emerged on the illicit amphetamine market where it is sold and used as the controlled drug, amphetamine. There has been one report of the substance being detected in a commercial product sold on the internet. The main chemical precursor for the synthesis of 4-methylamphetamine is 4-methylbenzyl methyl ketone (4-methyl-BMK), which appears to be commercially available on the internet and is not controlled under the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. |
| --- | --- |

(2)

4-methylamphetamine is a synthetic ring-methylated derivative of amphetamine which has predominantly been seized in powder and paste form in samples containing amphetamine and caffeine, but which has also appeared in tablet and liquid form. It has emerged on the illicit amphetamine market where it is sold and used as the controlled drug, amphetamine. There has been one report of the substance being detected in a commercial product sold on the internet. The main chemical precursor for the synthesis of 4-methylamphetamine is 4-methylbenzyl methyl ketone (4-methyl-BMK), which appears to be commercially available on the internet and is not controlled under the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

| (3) | The specific physical effects of 4-methylamphetamine have been rarely reported by users, since users are typically unaware that they have taken the substance. However, the few reports that are available suggest that it has stimulant-type effects. Limited data available relating to humans suggest that the adverse effects of 4-methylamphetamine include hyperthermia, hypertension, anorexia, nausea, perspiration, gastric distress, coughing, vomiting, headache, palpitations, insomnia, paranoia, anxiety and depression. Current data is not sufficient to determine the relative dependence-producing potential of the substance. |
| --- | --- |

(3)

The specific physical effects of 4-methylamphetamine have been rarely reported by users, since users are typically unaware that they have taken the substance. However, the few reports that are available suggest that it has stimulant-type effects. Limited data available relating to humans suggest that the adverse effects of 4-methylamphetamine include hyperthermia, hypertension, anorexia, nausea, perspiration, gastric distress, coughing, vomiting, headache, palpitations, insomnia, paranoia, anxiety and depression. Current data is not sufficient to determine the relative dependence-producing potential of the substance.

| (4) | According to the limited data sources available, the acute toxicity of 4-methylamphetamine is similar to that of other stimulants. Certain evidence suggests that a combination of 4-methylamphetamine with other substances, including amphetamine and caffeine, may result in a higher risk of overall enhanced toxicity. |
| --- | --- |

(4)

According to the limited data sources available, the acute toxicity of 4-methylamphetamine is similar to that of other stimulants. Certain evidence suggests that a combination of 4-methylamphetamine with other substances, including amphetamine and caffeine, may result in a higher risk of overall enhanced toxicity.

| (5) | There have been a total of 21 fatalities registered in four Member States where 4-methylamphetamine alone, or in combination with one or more substances, especially amphetamine, has been detected in post-mortem samples. While it is not possible to determine with certainty from the information available the role of 4-methylamphetamine in those fatalities, in some cases the substance was the predominant drug detected, with levels comparable to those found in certain cases of death caused by the consumption of amphetamine. |
| --- | --- |

(5)

There have been a total of 21 fatalities registered in four Member States where 4-methylamphetamine alone, or in combination with one or more substances, especially amphetamine, has been detected in post-mortem samples. While it is not possible to determine with certainty from the information available the role of 4-methylamphetamine in those fatalities, in some cases the substance was the predominant drug detected, with levels comparable to those found in certain cases of death caused by the consumption of amphetamine.

| (6) | 4-methylamphetamine has been detected in 15 Member States, while one Member State has reported the manufacture of the substance on its territory. Prevalence specific to 4-methylamphetamine is difficult to estimate. There is no information on specific demand for the substance from user groups and it is not commercially marketed through internet shops. |
| --- | --- |

(6)

4-methylamphetamine has been detected in 15 Member States, while one Member State has reported the manufacture of the substance on its territory. Prevalence specific to 4-methylamphetamine is difficult to estimate. There is no information on specific demand for the substance from user groups and it is not commercially marketed through internet shops.

| (7) | The information available suggests that 4-methylamphetamine is produced and distributed by the same organised crime groups that are involved in the manufacture and trafficking of amphetamine. |
| --- | --- |

(7)

The information available suggests that 4-methylamphetamine is produced and distributed by the same organised crime groups that are involved in the manufacture and trafficking of amphetamine.

| (8) | 4-methylamphetamine has no known, established or acknowledged medical value or use in the Union and there is no marketing authorisation for the substance in the Union. Apart from its use as an analytical reference standard and in scientific research, there is no indication that it may be used for any other legitimate purpose. |
| --- | --- |

(8)

4-methylamphetamine has no known, established or acknowledged medical value or use in the Union and there is no marketing authorisation for the substance in the Union. Apart from its use as an analytical reference standard and in scientific research, there is no indication that it may be used for any other legitimate purpose.

| (9) | 4-methylamphetamine is not currently under assessment and has not been under assessment by the United Nations system. Eight Member States control the substance under drug control legislation by virtue of their obligations under the 1971 United Nations Convention on Psychotropic Substances. Two other Member States apply the generic definition of phenethylamine in their national legislation to the product while one Member State controls it under its medicines legislation. |
| --- | --- |

(9)

4-methylamphetamine is not currently under assessment and has not been under assessment by the United Nations system. Eight Member States control the substance under drug control legislation by virtue of their obligations under the 1971 United Nations Convention on Psychotropic Substances. Two other Member States apply the generic definition of phenethylamine in their national legislation to the product while one Member State controls it under its medicines legislation.

| (10) | The risk assessment report reveals that there is limited scientific evidence available on the characteristics and risks of 4-methylamphetamine and points out that further studies are required on the overall health and social risks associated with the substance. However, the evidence available provides sufficient grounds for subjecting 4-methylamphetamine to control measures across the Union. As a result of the health risks it poses, as documented in its detection in several reported fatalities, especially when used in combination with other substances; its strong resemblance in terms of appearance and effects with amphetamine; the fact that users may unknowingly consume the substance and its limited medical value or use, 4-methylamphetamine should be subjected to control measures across the Union. |
| --- | --- |

(10)

The risk assessment report reveals that there is limited scientific evidence available on the characteristics and risks of 4-methylamphetamine and points out that further studies are required on the overall health and social risks associated with the substance. However, the evidence available provides sufficient grounds for subjecting 4-methylamphetamine to control measures across the Union. As a result of the health risks it poses, as documented in its detection in several reported fatalities, especially when used in combination with other substances; its strong resemblance in terms of appearance and effects with amphetamine; the fact that users may unknowingly consume the substance and its limited medical value or use, 4-methylamphetamine should be subjected to control measures across the Union.

| (11) | Since 10 Member States already control 4-methylamphetamine, subjecting it to control measures across the Union may help avoid problems in cross-border law enforcement and judicial cooperation. |
| --- | --- |

(11)

Since 10 Member States already control 4-methylamphetamine, subjecting it to control measures across the Union may help avoid problems in cross-border law enforcement and judicial cooperation.

| (12) | Union-wide control measures may also help prevent 4-methylamphetamine developing as an alternative to amphetamine in the illicit drug markets, |
| --- | --- |

(12)

Union-wide control measures may also help prevent 4-methylamphetamine developing as an alternative to amphetamine in the illicit drug markets,

HAS ADOPTED THIS DECISION:

Article 1

The new psychoactive substance, 4-methylamphetamine, is hereby subjected to control measures across the Union.

Article 2

By 17 March 2014, Member States shall take the necessary measures, in accordance with their national law, to subject 4-methylamphetamine to control measures and criminal penalties, as provided for under their legislation complying with their obligations under the 1971 United Nations Convention on Psychotropic Substances.

Article 3

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

Done at Brussels, 7 March 2013.

For the Council

The President

A. SHATTER

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(1)  
  OJ L 127, 20.5.2005, p. 32.

1

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| 15.3.2013 | EN | Official Journal of the European Union | L 72/13 |
| --- | --- | --- | --- |

15.3.2013

EN

Official Journal of the European Union

L 72/13

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COMMISSION IMPLEMENTING DECISION

of 13 March 2013

rejecting a restriction of the authorisation of a biocidal product containing indoxacarb notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council

(notified under document C(2013) 1366)

(Only the German text is authentic)

(2013/130/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular Article 4(4) thereof,

Whereas:

| (1) | Annex I to Directive 98/8/EC contains the list of active substances approved at Union level for inclusion in biocidal products. Commission Directive 2009/87/EC of 29 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include indoxacarb as an active substance in Annex I thereto (2) added the active substance indoxacarb to products belonging to product-type 18: Insecticides, acaricides and products to control other arthropods, as defined in Annex V to Directive 98/8/EC. |
| --- | --- |

(1)

Annex I to Directive 98/8/EC contains the list of active substances approved at Union level for inclusion in biocidal products. Commission Directive 2009/87/EC of 29 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include indoxacarb as an active substance in Annex I thereto (2) added the active substance indoxacarb to products belonging to product-type 18: Insecticides, acaricides and products to control other arthropods, as defined in Annex V to Directive 98/8/EC.

| (2) | Directive 2009/87/EC requires Member States to assess, for the purpose of granting product authorisation, any relevant use scenarios that have not been representatively addressed at the Union level risk assessment. |
| --- | --- |

(2)

Directive 2009/87/EC requires Member States to assess, for the purpose of granting product authorisation, any relevant use scenarios that have not been representatively addressed at the Union level risk assessment.

| (3) | The company DuPont de Nemours (Deutschland) GmbH (‘the applicant’) submitted an application to the United Kingdom for authorisation of a product containing indoxacarb (‘the contested product’) in accordance with Article 8 of Directive 98/8/EC. The names and reference numbers of the contested product in the Register for Biocidal Products (‘R4BP’) are indicated in the Annex to this Decision. |
| --- | --- |

(3)

The company DuPont de Nemours (Deutschland) GmbH (‘the applicant’) submitted an application to the United Kingdom for authorisation of a product containing indoxacarb (‘the contested product’) in accordance with Article 8 of Directive 98/8/EC. The names and reference numbers of the contested product in the Register for Biocidal Products (‘R4BP’) are indicated in the Annex to this Decision.

| (4) | On 28 October 2011, the United Kingdom authorised the contested product for the control of ants. According to that authorisation, the product may be applied only in and around residential homes, industrial facilities, offices, warehouses, commercial kitchens, hospitals, schools, nursing homes, hotels, buses, trains, aircraft, retail and commercial establishments. That authorisation further provides that the application of the contested product to food or feed areas of food or feed handling establishments may be made only as a crack and crevice treatment. The authorisation set out that the product had to be labelled with the following instruction: ‘Do not apply to areas where food/feed, food utensils or food processing surfaces may come into contact with, or be contaminated by the product’. |
| --- | --- |

(4)

On 28 October 2011, the United Kingdom authorised the contested product for the control of ants. According to that authorisation, the product may be applied only in and around residential homes, industrial facilities, offices, warehouses, commercial kitchens, hospitals, schools, nursing homes, hotels, buses, trains, aircraft, retail and commercial establishments. That authorisation further provides that the application of the contested product to food or feed areas of food or feed handling establishments may be made only as a crack and crevice treatment. The authorisation set out that the product had to be labelled with the following instruction: ‘Do not apply to areas where food/feed, food utensils or food processing surfaces may come into contact with, or be contaminated by the product’.

| (5) | On 21 December 2011, the applicant submitted a complete application to Germany for mutual recognition of the first authorisation in respect of the contested product. |
| --- | --- |

(5)

On 21 December 2011, the applicant submitted a complete application to Germany for mutual recognition of the first authorisation in respect of the contested product.

| (6) | On 23 April 2012, Germany notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisation in accordance with Article 4(4) of Directive 98/8/EC by excluding food protection from the authorised intended uses of the contested product. |
| --- | --- |

(6)

On 23 April 2012, Germany notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisation in accordance with Article 4(4) of Directive 98/8/EC by excluding food protection from the authorised intended uses of the contested product.

| (7) | As justification for the notification, Germany submitted that products used for food protection are covered, for this purpose, by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (3), and are hence excluded from the scope of Directive 98/8/EC if the protected food consists of plants or plant products within the meaning of Article 3(5) and (6) of Regulation (EC) No 1107/2009. |
| --- | --- |

(7)

As justification for the notification, Germany submitted that products used for food protection are covered, for this purpose, by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (3), and are hence excluded from the scope of Directive 98/8/EC if the protected food consists of plants or plant products within the meaning of Article 3(5) and (6) of Regulation (EC) No 1107/2009.

| (8) | The Commission invited the other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within that deadline by the United Kingdom, France and Spain. The notification was also discussed between Commission representatives, representatives of Member States’ Competent Authorities for biocidal products in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 22-23 May 2012, where the applicant was present. |
| --- | --- |

(8)

The Commission invited the other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within that deadline by the United Kingdom, France and Spain. The notification was also discussed between Commission representatives, representatives of Member States’ Competent Authorities for biocidal products in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 22-23 May 2012, where the applicant was present.

| (9) | As it is undisputed that the contested product is covered by the definition of a biocidal product in Article 2(1)(a) of Directive 98/8/EC, it merely should be examined whether the product is nevertheless excluded from the scope of Directive 98/8/EC by virtue of Article 1(2)(r) of that Directive for the purpose of certain uses, in which case those particular uses would require an additional authorisation in accordance with Regulation (EC) No 1107/2009. |
| --- | --- |

(9)

As it is undisputed that the contested product is covered by the definition of a biocidal product in Article 2(1)(a) of Directive 98/8/EC, it merely should be examined whether the product is nevertheless excluded from the scope of Directive 98/8/EC by virtue of Article 1(2)(r) of that Directive for the purpose of certain uses, in which case those particular uses would require an additional authorisation in accordance with Regulation (EC) No 1107/2009.

| (10) | It follows from Article 2(1)(a) of Regulation (EC) No 1107/2009 that that Regulation does not apply to products whose main purpose is considered to be hygiene rather than the protection of plants or plant products. |
| --- | --- |

(10)

It follows from Article 2(1)(a) of Regulation (EC) No 1107/2009 that that Regulation does not apply to products whose main purpose is considered to be hygiene rather than the protection of plants or plant products.

| (11) | The contested product is, inter alia, intended for use as an insecticide against ants in commercial kitchens. One of the intentions of such use can be the protection of plant products as defined in Article 3(6) of Regulation (EC) No 1107/2009, which can include food. |
| --- | --- |

(11)

The contested product is, inter alia, intended for use as an insecticide against ants in commercial kitchens. One of the intentions of such use can be the protection of plant products as defined in Article 3(6) of Regulation (EC) No 1107/2009, which can include food.

| (12) | The contested product is also intended for a large number of other use areas, where it will not serve the purpose of protecting food consisting of plants or plant products. Furthermore, even the application in commercial kitchens cannot be considered as primarily intended for plant product protection: First, the contested product must not be directly applied on food or indirectly come into contact with food through application on empty structures. Second, most products handled in a commercial kitchen are not plant products (4). Third, Member States other than Germany have informed the Commission that the contested product is used in kitchens to comply with the general hygiene requirements according to Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (5) for all stages of production, processing and distribution. |
| --- | --- |

(12)

The contested product is also intended for a large number of other use areas, where it will not serve the purpose of protecting food consisting of plants or plant products. Furthermore, even the application in commercial kitchens cannot be considered as primarily intended for plant product protection: First, the contested product must not be directly applied on food or indirectly come into contact with food through application on empty structures. Second, most products handled in a commercial kitchen are not plant products (4). Third, Member States other than Germany have informed the Commission that the contested product is used in kitchens to comply with the general hygiene requirements according to Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (5) for all stages of production, processing and distribution.

| (13) | As the main purpose of the contested product is hygiene rather than the protection of plants or plant products, the product is not excluded from the scope of Directive 98/8/EC by virtue of Article 1(2)(r) of that Directive for the purpose of its use in commercial kitchens. The Commission therefore considers that the restriction requested by Germany cannot be justified on the grounds put forward. |
| --- | --- |

(13)

As the main purpose of the contested product is hygiene rather than the protection of plants or plant products, the product is not excluded from the scope of Directive 98/8/EC by virtue of Article 1(2)(r) of that Directive for the purpose of its use in commercial kitchens. The Commission therefore considers that the restriction requested by Germany cannot be justified on the grounds put forward.

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

(14)

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

HAS ADOPTED THIS DECISION:

Article 1

The proposal by Germany to restrict the authorisation granted by the United Kingdom on 28 October 2011 of the product mentioned in the Annex, by excluding food protection from the authorised intended uses of the product, is rejected.

Article 2

This Decision is addressed to the Federal Republic of Germany.

Done at Brussels, 13 March 2013.

For the Commission

Janez POTOČNIK

Member of the Commission

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

1

(2)  
  OJ L 198, 30.7.2009, p. 35.

2

(3)  
  OJ L 309, 24.11.2009, p. 1.

3

(4)  See, in this respect, a published guidance document agreed between the Commission services and the competent authorities of Member States for the biocidal products Directive 98/8/EC and for the plant protection products Council Directive 91/414/EEC (OJ L 230, 19.8.1991, p. 1) entitled Borderline between Directive 98/8/EC concerning the placing on the market of Biocidal product and Directive 91/414/EEC concerning the placing on the market of plant protection products, available on the website http://ec.europa.eu/food/plant/protection/evaluation/borderline_en.htm

4

Borderline between Directive 98/8/EC concerning the placing on the market of Biocidal product and Directive 91/414/EEC concerning the placing on the market of plant protection products

(5)  
  OJ L 139, 30.4.2004, p. 1.

5

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ANNEX

Product for which the proposal by Germany, to restrict the authorisation granted in accordance with Article 4 of Directive 98/8/EC, is rejected:

| Product name in the United Kingdom | United Kingdom application reference number in the Register for Biocidal Products | Product name in Germany | German application reference number in the Register for Biocidal Products |
| --- | --- | --- | --- |
| DuPont Advion Ant Gel 0,05 % | 2010/1949/4987/UK/AA/5945 | Advion® Ameisen Gel | 2011/1949/4987/DE/MA/28005 |

Product name in the United Kingdom

United Kingdom application reference number in the Register for Biocidal Products

Product name in Germany

German application reference number in the Register for Biocidal Products

DuPont Advion Ant Gel 0,05 %

2010/1949/4987/UK/AA/5945

Advion® Ameisen Gel

2011/1949/4987/DE/MA/28005

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