# Official Journal L 34/7 Fe

| | ISSN 1725-2555 |
| --- | --- |
| Official Journal
  of the European Union | L 34 |
| | |
| English edition | Legislation | Volume 497 February 2006 |

ISSN 1725-2555

Official Journal

of the European Union

L 34

English edition

Legislation

Volume 497 February 2006

---

| Contents | | I   Acts whose publication is obligatory | page |
| --- | --- | --- | --- |
| | | Commission Regulation (EC) No 203/2006 of 6 February 2006 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | * | Commission Regulation (EC) No 204/2006 of 6 February 2006 adapting Council Regulation (EEC) No 571/88 and amending Commission Decision 2000/115/EC with a view to the organisation of Community surveys on the structure of agricultural holdings in 2007 | 3 |
| | * | Commission Regulation (EC) No 205/2006 of 6 February 2006 amending Annexes I and II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards toltrazuril, diethylene glycol monoethyl ether and polyoxyethylene sorbitan monooleate (
  1
  ) | 21 |
| | * | Commission Directive 2006/14/EC of 6 February 2006 amending Annex IV to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community | 24 |

Contents

I   Acts whose publication is obligatory

page

Commission Regulation (EC) No 203/2006 of 6 February 2006 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

*

Commission Regulation (EC) No 204/2006 of 6 February 2006 adapting Council Regulation (EEC) No 571/88 and amending Commission Decision 2000/115/EC with a view to the organisation of Community surveys on the structure of agricultural holdings in 2007

3

*

Commission Regulation (EC) No 205/2006 of 6 February 2006 amending Annexes I and II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards toltrazuril, diethylene glycol monoethyl ether and polyoxyethylene sorbitan monooleate (
  1
  )

1

21

*

Commission Directive 2006/14/EC of 6 February 2006 amending Annex IV to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

24

| | | II   Acts whose publication is not obligatory |
| --- | --- | --- |
| | | Commission |
| | * | Commission Decision of 13 January 2006 authorising the placing on the market of foods and food ingredients derived from genetically modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document number C(2005) 5939) | 26 |
| | * | Commission Decision of 13 January 2006 authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document number C(2005) 5940) | 29 |
| | * | Commission Decision of 31 January 2006 amending Decision 2001/844/EC, ECSC, Euratom | 32 |

II   Acts whose publication is not obligatory

Commission

*

Commission Decision of 13 January 2006 authorising the placing on the market of foods and food ingredients derived from genetically modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document number C(2005) 5939)

(notified under document number C(2005) 5939)

26

*

Commission Decision of 13 January 2006 authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document number C(2005) 5940)

(notified under document number C(2005) 5940)

29

*

Commission Decision of 31 January 2006 amending Decision 2001/844/EC, ECSC, Euratom

32

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

---

(1)   Text with EEA relevance

1

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

EN

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

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

---

I Acts whose publication is obligatory

| 7.2.2006 | EN | Official Journal of the European Union | L 34/1 |
| --- | --- | --- | --- |

7.2.2006

EN

Official Journal of the European Union

L 34/1

---

COMMISSION REGULATION (EC) No 203/2006

of 6 February 2006

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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Commission Regulation (EC) No 3223/94 of 21 December 1994 on detailed rules for the application of the import arrangements for fruit and vegetables (1), and in particular Article 4(1) thereof,

Whereas:

| (1) | Regulation (EC) No 3223/94 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 the Annex thereto. |
| --- | --- |

(1)

Regulation (EC) No 3223/94 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 the Annex thereto.

| (2) | In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation, |
| --- | --- |

(2)

In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 4 of Regulation (EC) No 3223/94 shall be fixed as indicated in the Annex hereto.

Article 2

This Regulation shall enter into force on 7 February 2006.

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

Done at Brussels, 6 February 2006.

For the Commission

J. L. DEMARTY

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 337, 24.12.1994, p. 66. Regulation as last amended by Regulation (EC) No 386/2005 (OJ L 62, 9.3.2005, p. 3).

1

---

ANNEX

to Commission Regulation of 6 February 2006 establishing the 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 | 052 | 91,2 |
| 204 | 50,2 |
| 212 | 139,7 |
| 624 | 111,0 |
| 999 | 98,0 |
| 0707 00 05 | 052 | 125,0 |
| 204 | 101,8 |
| 628 | 167,7 |
| 999 | 131,5 |
| 0709 10 00 | 220 | 63,9 |
| 999 | 63,9 |
| 0709 90 70 | 052 | 170,8 |
| 204 | 109,6 |
| 999 | 140,2 |
| 0805 10 20 | 052 | 50,2 |
| 204 | 58,2 |
| 212 | 43,1 |
| 220 | 49,8 |
| 448 | 47,8 |
| 624 | 61,3 |
| 999 | 51,7 |
| 0805 20 10 | 204 | 93,6 |
| 999 | 93,6 |
| 0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90 | 052 | 62,9 |
| 204 | 111,4 |
| 400 | 79,6 |
| 464 | 145,9 |
| 624 | 75,6 |
| 662 | 45,3 |
| 999 | 86,8 |
| 0805 50 10 | 052 | 46,3 |
| 999 | 46,3 |
| 0808 10 80 | 400 | 127,1 |
| 404 | 98,4 |
| 720 | 75,1 |
| 999 | 100,2 |
| 0808 20 50 | 388 | 92,3 |
| 400 | 78,0 |
| 528 | 111,0 |
| 720 | 58,1 |
| 999 | 84,9 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

052

91,2

204

50,2

212

139,7

624

111,0

999

98,0

0707 00 05

052

125,0

204

101,8

628

167,7

999

131,5

0709 10 00

220

63,9

999

63,9

0709 90 70

052

170,8

204

109,6

999

140,2

0805 10 20

052

50,2

204

58,2

212

43,1

220

49,8

448

47,8

624

61,3

999

51,7

0805 20 10

204

93,6

999

93,6

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

052

62,9

204

111,4

400

79,6

464

145,9

624

75,6

662

45,3

999

86,8

0805 50 10

052

46,3

999

46,3

0808 10 80

400

127,1

404

98,4

720

75,1

999

100,2

0808 20 50

388

92,3

400

78,0

528

111,0

720

58,1

999

84,9

---

(1)  Country nomenclature as fixed by Commission Regulation (EC) No 750/2005 (OJ L 126, 19.5.2005, p. 12). Code ‘
  999
  ’ stands for ‘of other origin’.

---

| 7.2.2006 | EN | Official Journal of the European Union | L 34/3 |
| --- | --- | --- | --- |

7.2.2006

EN

Official Journal of the European Union

L 34/3

---

COMMISSION REGULATION (EC) No 204/2006

of 6 February 2006

adapting Council Regulation (EEC) No 571/88 and amending Commission Decision 2000/115/EC with a view to the organisation of Community surveys on the structure of agricultural holdings in 2007

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to the Council Regulation (EEC) No 571/88 of 29 February 1988 on the organisation of Community surveys on the structure of agricultural holdings (1), and in particular Articles 5 and 8 thereof,

Whereas:

| (1) | The list of characteristics set out in Annex I to Regulation (EEC) No 571/88 has to be adapted in order to follow the evolution of the agricultural sector and of the common agricultural policy. |
| --- | --- |

(1)

The list of characteristics set out in Annex I to Regulation (EEC) No 571/88 has to be adapted in order to follow the evolution of the agricultural sector and of the common agricultural policy.

| (2) | In certain Member States, the results from the Community survey on the structure of agricultural holdings carried out in 2003 have shown that some characteristics are insignificant, and that others have gained in importance. |
| --- | --- |

(2)

In certain Member States, the results from the Community survey on the structure of agricultural holdings carried out in 2003 have shown that some characteristics are insignificant, and that others have gained in importance.

| (3) | Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers and amending Regulations (EEC) No 2019/93, (EC) No 1452/2001, (EC) No 1453/2001, (EC) No 1454/2001, (EC) 1868/94, (EC) No 1251/1999, (EC) No 1254/1999, (EC) No 1673/2000, (EEC) No 2358/71 and (EC) No 2529/2001 (2) introduces the maintenance of land in good agricultural and environmental condition as an agricultural activity, which makes the revision of various definitions necessary. |
| --- | --- |

(3)

Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers and amending Regulations (EEC) No 2019/93, (EC) No 1452/2001, (EC) No 1453/2001, (EC) No 1454/2001, (EC) 1868/94, (EC) No 1251/1999, (EC) No 1254/1999, (EC) No 1673/2000, (EEC) No 2358/71 and (EC) No 2529/2001 (2) introduces the maintenance of land in good agricultural and environmental condition as an agricultural activity, which makes the revision of various definitions necessary.

| (4) | Both Regulation (EEC) No 571/88 itself and the decision laying down the definitions and explanations relating to that Regulation, namely Commission Decision 2000/115/EC (3) should therefore be amended accordingly. |
| --- | --- |

(4)

Both Regulation (EEC) No 571/88 itself and the decision laying down the definitions and explanations relating to that Regulation, namely Commission Decision 2000/115/EC (3) should therefore be amended accordingly.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Agricultural Statistics established by Council Decision 72/279/EEC (4), |
| --- | --- |

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Agricultural Statistics established by Council Decision 72/279/EEC (4),

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EEC) No 571/88 is replaced by Annex I to this Regulation.

Article 2

Annex I to Decision 2000/115/EC is amended as shown in Annex II to this Regulation.

Article 3

This Regulation shall enter into force on the 20th 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 2006.

For the Commission

Joaquín ALMUNIA

Member of the Commission

---

(1)  
  OJ L 56, 2.3.1988, p. 1. Regulation as last amended by Commission Regulation (EC) No 2139/2004 (OJ L 369, 16.12.2004, p. 26).

1

(2)  
  OJ L 270, 21.10.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 2183/2005 (OJ L 347, 30.12.2005, p. 56).

2

(3)  
  OJ L 38, 12.2.2000, p. 1. Decision as last amended by Regulation (EC) No 2139/2004.

3

(4)  
  OJ L 179, 7.8.1972, p. 1.

4

---

ANNEX I

‘ANNEX I

LIST OF CHARACTERISTICS FOR 2007 (*1)

Explanatory notes:

| — | The characteristics marked with the letters “NE” in the Annex are deemed not to exist or to be close to zero in the respective Member States. |
| --- | --- |

—

The characteristics marked with the letters “NE” in the Annex are deemed not to exist or to be close to zero in the respective Member States.

| — | The characteristics marked with the letters “NS” are deemed to be non-significant in the respective Member States. |
| --- | --- |

—

The characteristics marked with the letters “NS” are deemed to be non-significant in the respective Member States.

| | | BE | CZ | DK | DE | EE | EL | ES | FR | IE | IT | CY | LV | LT | LU | HU | MT | NL | AT | PL | PT | SI | SK | FI | SE | UK |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| A.   Geographical situation of the holding |
| 1. | Survey district |

BE

CZ

DK

DE

EE

EL

ES

FR

IE

IT

CY

LV

LT

LU

HU

MT

NL

AT

PL

PT

SI

SK

FI

SE

UK

Geographical situation of the holding

1.

Survey district

code

| (a) | Municipality or sub-survey district (1) |
| --- | --- |

(a)

Municipality or sub-survey district (1)

code

| 2. | Less-favoured area (1) |
| --- | --- |

2.

Less-favoured area (1)

yes/no

NE

| (a) | Mountain area (1) |
| --- | --- |

(a)

Mountain area (1)

yes/no

NE

NE

NE

NE

NE

| 3. | Agricultural areas with environmental restrictions |
| --- | --- |

3.

Agricultural areas with environmental restrictions

yes/no

NE

NE

NE

NE

Legal personality and management of the holding (on the day of the survey)

Is the legal and economic responsibility of the holding assumed by:

| (a) | a natural person who is a sole holder, where the holding is independent? |
| --- | --- |

(a)

a natural person who is a sole holder, where the holding is independent?

yes/no

| (b) | one or more natural persons who is/are a partner, where the holding is a group holding? (2) |
| --- | --- |

(b)

one or more natural persons who is/are a partner, where the holding is a group holding? (2)

yes/no

NS

NS

NS

NS

NS

NS

NS

NS

NS

NS

NS

NE

NS

NS

| (c) | a legal person? |
| --- | --- |

(c)

a legal person?

yes/no

| 2. | If the answer to question B/1 (a) is “yes”, is the person (the holder) also the manager? |
| --- | --- |

2.

If the answer to question B/1 (a) is “yes”, is the person (the holder) also the manager?

yes/no

| (a) | If the answer to question B/2 is “no”, is the manager a member of the holder’s family? |
| --- | --- |

(a)

If the answer to question B/2 is “no”, is the manager a member of the holder’s family?

yes/no

| (b) | If the answer to question B/2 a) is “yes”, is the manager the spouse of the holder? |
| --- | --- |

(b)

If the answer to question B/2 a) is “yes”, is the manager the spouse of the holder?

yes/no

NS

NS

Type of tenure (in relation to the holder) and farming system

Agricultural area utilised:

| 1. | For owner farming |
| --- | --- |

1.

For owner farming

ha/a

| 2. | For tenant farming |
| --- | --- |

2.

For tenant farming

ha/a

| 3. | For share farming or other modes |
| --- | --- |

3.

For share farming or other modes

ha/a

NE

NS

NS

NS

NE

NE

NE

NS

Farming system and practises:

| (a) | The utilised agricultural area of the holding on which organic farming production methods are applied according to European Community rules |
| --- | --- |

(a)

The utilised agricultural area of the holding on which organic farming production methods are applied according to European Community rules

ha/a

NS

NE

| (d) | The utilised agricultural area of the holding that are under conversion to organic farming production methods |
| --- | --- |

(d)

The utilised agricultural area of the holding that are under conversion to organic farming production methods

ha/a

NS

NE

| (e) | Is the holding applying organic production methods also to the animal production? |
| --- | --- |

(e)

Is the holding applying organic production methods also to the animal production?

totally, partly, not at all

NS

NE

Destination of the holding’s production:

| (a) | Does the household of the holder consume more than 50 % of the final production (in value terms) of the holding? |
| --- | --- |

(a)

Does the household of the holder consume more than 50 % of the final production (in value terms) of the holding?

yes/no

NS

NS

NE

NS

NS

NS

NE

NS

NS

NS

NE

| (b) | Do the direct sales to consumers account for more than 50 % of the total sales? |
| --- | --- |

(b)

Do the direct sales to consumers account for more than 50 % of the total sales?

yes/no

NS

NS

NS

NS

NS

NS

NS

NS

NS

NS

Arable land

Cereals for the production of grain (including seed):

| 1. | Common wheat and spelt |
| --- | --- |

1.

Common wheat and spelt

ha/a

NE

| 2. | Durum wheat |
| --- | --- |

2.

Durum wheat

ha/a

NE

NS

NE

NE

NE

NE

NE

NE

NE

NE

NE

NS

NE

NE

NS

| 3. | Rye |
| --- | --- |

3.

Rye

ha/a

NS

NS

NE

| 4. | Barley |
| --- | --- |

4.

Barley

ha/a

NE

| 5. | Oats |
| --- | --- |

5.

Oats

ha/a

NE

| 6. | Grain maize |
| --- | --- |

6.

Grain maize

ha/a

NE

NE

NE

NS

NE

NE

NE

NE

NS

| 7. | Rice |
| --- | --- |

7.

Rice

ha/a

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

| 8. | Other cereals for the production of grain |
| --- | --- |

8.

Other cereals for the production of grain

ha/a

NE

| 9. | Protein crops for the production of grain (including seed and mixtures of cereals and pulses) |
| --- | --- |

9.

Protein crops for the production of grain (including seed and mixtures of cereals and pulses)

ha/a

NE

of which:

| (e) | peas, field beans and sweet lupines |
| --- | --- |

(e)

peas, field beans and sweet lupines

ha/a

NE

| (f) | lentils, chick peas and vetches |
| --- | --- |

(f)

lentils, chick peas and vetches

ha/a

NS

NS

NS

NS

NS

NS

NE

NS

NS

NS

NE

NS

| (g) | other protein crops harvested dry |
| --- | --- |

(g)

other protein crops harvested dry

ha/a

NS

NS

NS

NS

NS

NS

NS

NE

NS

NS

NS

NS

NE

| 10. | Potatoes (including early potatoes and seed potatoes) |
| --- | --- |

10.

Potatoes (including early potatoes and seed potatoes)

ha/a

| 11. | Sugar beet (excluding seeds) |
| --- | --- |

11.

Sugar beet (excluding seeds)

ha/a

NE

NE

NE

| 12. | Fodder roots and brassicas (excluding seeds) |
| --- | --- |

12.

Fodder roots and brassicas (excluding seeds)

ha/a

NE

NS

NS

Industrial plants:

| 23. | Tobacco |
| --- | --- |

23.

Tobacco

ha/a

NE

NE

NE

NE

NE

NE

NE

NE

NS

NE

NE

NE

NE

| 24. | Hops |
| --- | --- |

24.

Hops

ha/a

NE

NE

NS

NE

NE

NS

NE

NS

NE

NE

NS

NS

NE

NE

| 25. | Cotton |
| --- | --- |

25.

Cotton

ha/a

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NS

NE

NE

NE

NE

NE

| 26. | Rape and turnip rape |
| --- | --- |

26.

Rape and turnip rape

ha/a

NE

NE

NE

NS

| 27. | Sunflower |
| --- | --- |

27.

Sunflower

ha/a

NS

NS

NE

NE

NS

NE

NE

NE

NE

NS

NS

NE

NS

| 28. | Soya |
| --- | --- |

28.

Soya

ha/a

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NS

NS

NE

NE

NS

| 29. | Linseed (oil flax) |
| --- | --- |

29.

Linseed (oil flax)

ha/a

NS

NS

NS

NS

NE

NE

NS

NE

NS

NS

NS

| 30. | Other oil seed crops |
| --- | --- |

30.

Other oil seed crops

ha/a

NS

NS

NE

NS

NE

NE

NE

NS

NS

NS

NS

| 31. | Flax |
| --- | --- |

31.

Flax

ha/a

NS

NE

NS

NE

NS

NS

NE

NS

NS

NS

NS

| 32. | Hemp |
| --- | --- |

32.

Hemp

ha/a

NS

NS

NS

NE

NS

NE

NE

NS

NE

NS

NE

NS

NS

NS

NS

NS

| 33. | Other textile crops |
| --- | --- |

33.

Other textile crops

ha/a

NE

NE

NE

NE

NE

NE

NE

NS

NE

NE

NE

NE

NS

NE

NE

NS

NE

NS

| 34. | Aromatic plants, medicinal and culinary plants |
| --- | --- |

34.

Aromatic plants, medicinal and culinary plants

ha/a

NS

NE

NE

NS

NS

NS

| 35. | Industrial plants, not mentioned elsewhere |
| --- | --- |

35.

Industrial plants, not mentioned elsewhere

ha/a

NS

NS

NS

NS

NE

NS

NS

NS

Fresh vegetables, melons, strawberries:

| 14. | Outdoor or under low (not accessible) protective cover |
| --- | --- |

14.

Outdoor or under low (not accessible) protective cover

ha/a

of which:

| (a) | open field |
| --- | --- |

(a)

open field

ha/a

NE

NS

| (b) | market gardening |
| --- | --- |

(b)

market gardening

ha/a

NE

| 15. | Under glass or other (accessible) protective cover |
| --- | --- |

15.

Under glass or other (accessible) protective cover

ha/a

Flowers and ornamental plants (excluding nurseries):

| 16. | Outdoor or under low (not accessible) protective cover |
| --- | --- |

16.

Outdoor or under low (not accessible) protective cover

ha/a

NS

NS

| 17. | Under glass or other (accessible) protective cover |
| --- | --- |

17.

Under glass or other (accessible) protective cover

ha/a

Forage plants:

| (a) | temporary grass |
| --- | --- |

(a)

temporary grass

ha/a

NE

| (b) | other green fodder |
| --- | --- |

(b)

other green fodder

ha/a

of which:

| (i) | green maize (maize for silage) |
| --- | --- |

(i)

green maize (maize for silage)

ha/a

NE

NS

NS

| (iii) | other forage plants |
| --- | --- |

(iii)

other forage plants

ha/a

NS

| 19. | Arable land seeds and seedlings (excluding cereals, dried vegetables, potatoes and oil-seed plants) |
| --- | --- |

19.

Arable land seeds and seedlings (excluding cereals, dried vegetables, potatoes and oil-seed plants)

ha/a

NS

NE

NE

| 20. | Other arable land crops |
| --- | --- |

20.

Other arable land crops

ha/a

NS

NS

NE

| 21. | Fallow land without any subsidies |
| --- | --- |

21.

Fallow land without any subsidies

ha/a

NE

| 22. | Fallow land subject to the payment of subsidies, with no economic use |
| --- | --- |

22.

Fallow land subject to the payment of subsidies, with no economic use

ha/a

| E. | Kitchen gardens |
| --- | --- |

E.

ha/a

NS

NS

NS

NS

NS

NS

NS

| F. | Permanent grassland and meadow |
| --- | --- |

F.

ha/a

NE

| 1. | Pasture and meadow, excluding rough grazing |
| --- | --- |

1.

Pasture and meadow, excluding rough grazing

ha/a

NE

| 2. | Rough grazing |
| --- | --- |

2.

Rough grazing

ha/a

NE

NE

NE

NE

NE

NE

| 3. | Permanent grassland and meadows no longer used for production purposes and eligible for the payment of subsidies |
| --- | --- |

3.

Permanent grassland and meadows no longer used for production purposes and eligible for the payment of subsidies

ha/a

Permanent crops

| 1. | Fruit and berry plantations |
| --- | --- |

1.

Fruit and berry plantations

ha/a

| (a) | fresh fruit and berry species of temperate climate zones (3) |
| --- | --- |

(a)

fresh fruit and berry species of temperate climate zones (3)

ha/a

| (b) | fruit and berry species of subtropical climate zones |
| --- | --- |

(b)

fruit and berry species of subtropical climate zones

ha/a

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

| (c) | nuts |
| --- | --- |

(c)

nuts

ha/a

NS

NS

NE

NS

NE

NE

NE

NE

NE

NE

NS

NS

NS

NE

NE

NS

| 2. | Citrus plantations |
| --- | --- |

2.

Citrus plantations

ha/a

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NS

NE

NE

NE

NE

| 3. | Olive plantations |
| --- | --- |

3.

Olive plantations

ha/a

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

| (a) | normally producing table olives |
| --- | --- |

(a)

normally producing table olives

ha/a

NE

NE

NE

NE

NE

NS

NE

NE

NE

NE

NE

NE

NE

NE

NS

NE

NE

NE

NE

| (b) | normally producing olives for oil production |
| --- | --- |

(b)

normally producing olives for oil production

ha/a

NE

NE

NE

NE

NE

NS

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

NE

| 4. | Vineyards |
| --- | --- |

4.

Vineyards

ha/a

NS

NE

NE

NE

NE

NE

NS

NS

NE

NE

of which normally producing:

| (a) | quality wine |
| --- | --- |

(a)

quality wine

ha/a

NS

NE

NE

NE

NE

NE

NE

NS

NS

NE

NE

NE

| (b) | other wines |
| --- | --- |

(b)

other wines

ha/a

NS

NE

NE

NS

NE

NE

NE

NE

NE

NS

NE

NS

NE

NE

| (c) | table grapes |
| --- | --- |

(c)

table grapes

ha/a

NS

NE

NS

NE

NE

NE

NE

NE

NS

NS

NS

NS

NE

NE

NE

| (d) | raisins |
| --- | --- |

(d)

raisins

ha/a

NS

NE

NE

NE

NE

NE

NE

NS

NE

NE

NE

NE

NE

NE

NE

NS

NS

NE

NE

NE

NE

NE

| 5. | Nurseries |
| --- | --- |

5.

Nurseries

ha/a

| 6. | Other permanent crops |
| --- | --- |

6.

Other permanent crops

ha/a

NE

NE

NS

NS

NS

NS

NE

NE

NS

NE

NS

NE

NE

NS

| 7. | Permanent crops under glass |
| --- | --- |

7.

Permanent crops under glass

ha/a

NS

NE

NE

NS

NS

NS

NE

NE

NS

NS

NE

NS

NS

NE

NE

NE

NE

NE

Other land

| 1. | Unutilised agricultural land (agricultural land which is no longer farmed, for economic, social or other reasons, and which is not used in the crop rotation system) |
| --- | --- |

1.

Unutilised agricultural land (agricultural land which is no longer farmed, for economic, social or other reasons, and which is not used in the crop rotation system)

ha/a

| 2. | Wooded area |
| --- | --- |

2.

Wooded area

ha/a

NE

| 3. | Other land (land occupied by buildings, farmyards, tracks, ponds, quarries, infertile land, rock, etc.) |
| --- | --- |

3.

Other land (land occupied by buildings, farmyards, tracks, ponds, quarries, infertile land, rock, etc.)

ha/a

Mushrooms, irrigation, areas no longer used for production purposes, subject to the payment of subsidies, and areas subject to set-aside incentive schemes

| 2. | Mushrooms |
| --- | --- |

2.

Mushrooms

ha/a

NS

NS

NE

NS

NS

NS

Irrigated area

| (a) | total irrigable area |
| --- | --- |

(a)

total irrigable area

ha/a

NS

NS

NS

NS

NS

NE

| (b) | cultivated area irrigated |
| --- | --- |

(b)

cultivated area irrigated

ha/a

NS

NS

NS

NS

NS

NE

NS

| 8. | Areas no longer used for production purposes, subject to the payment of subsidies, and area subject to set-aside incentive schemes, broken down by: |
| --- | --- |

8.

Areas no longer used for production purposes, subject to the payment of subsidies, and area subject to set-aside incentive schemes, broken down by:

ha/a

| (a) | areas no longer used for production purposes, subject to the payment of subsidies (already recorded under D/22 and F/3) |
| --- | --- |

(a)

areas no longer used for production purposes, subject to the payment of subsidies (already recorded under D/22 and F/3)

ha/a

| (b) | areas used for the production of agricultural raw material for non-food purposes (e.g. rape, trees, bushes, etc., including lentils, chick peas and vetches; already recorded under D and G) |
| --- | --- |

(b)

areas used for the production of agricultural raw material for non-food purposes (e.g. rape, trees, bushes, etc., including lentils, chick peas and vetches; already recorded under D and G)

ha/a

NE

NE

| (c) | areas converted into permanent pasture and meadow (already recorded under F/1 and F/2) (4) |
| --- | --- |

(c)

areas converted into permanent pasture and meadow (already recorded under F/1 and F/2) (4)

ha/a

NS

NE

NE

NE

NE

| (d) | former agricultural areas converted into wooded area or being prepared for afforestation (already recorded under H/2) (4) |
| --- | --- |

(d)

former agricultural areas converted into wooded area or being prepared for afforestation (already recorded under H/2) (4)

ha/a

NS

NE

NS

| (e) | other areas (already recorded under H/1 and H/3) (4) |
| --- | --- |

(e)

other areas (already recorded under H/1 and H/3) (4)

ha/a

NS

NE

Livestock (on the reference day of the survey)

| 1. | Equidae |
| --- | --- |

1.

Equidae

number of heads

Bovine animals:

| 2. | Bovine animals, under one year old, male and female |
| --- | --- |

2.

Bovine animals, under one year old, male and female

number of heads

| 3. | Male bovine animals, one but less than two years old |
| --- | --- |

3.

Male bovine animals, one but less than two years old

number of heads

| 4. | Female bovine animals, one but less than two years old |
| --- | --- |

4.

Female bovine animals, one but less than two years old

number of heads

| 5. | Male bovine animals, two years old and over |
| --- | --- |

5.

Male bovine animals, two years old and over

number of heads

| 6. | Heifers, two years old and over |
| --- | --- |

6.

Heifers, two years old and over

number of heads

| 7. | Dairy cows |
| --- | --- |

7.

Dairy cows

number of heads

| 8. | Other cows |
| --- | --- |

8.

Other cows

number of heads

Sheep and goats:

| 9. | Sheep (all ages) |
| --- | --- |

9.

Sheep (all ages)

number of heads

| (a) | sheep, breeding females |
| --- | --- |

(a)

sheep, breeding females

number of heads

| (b) | other sheep |
| --- | --- |

(b)

other sheep

number of heads

| 10. | Goats (all ages) |
| --- | --- |

10.

Goats (all ages)

number of heads

NS

NS

NS

| (a) | goats, breeding females |
| --- | --- |

(a)

goats, breeding females

number of heads

NS

NS

NS

| (b) | other goats |
| --- | --- |

(b)

other goats

number of heads

NS

NS

NS

Pigs:

| 11. | Piglets having a live weight of under 20 kilograms |
| --- | --- |

11.

Piglets having a live weight of under 20 kilograms

number of heads

| 12. | Breeding sows weighing 50 kilograms and over |
| --- | --- |

12.

Breeding sows weighing 50 kilograms and over

number of heads

| 13. | Other pigs |
| --- | --- |

13.

Other pigs

number of heads

Poultry:

| 14. | Broilers |
| --- | --- |

14.

Broilers

number of heads

| 15. | Laying hens |
| --- | --- |

15.

Laying hens

number of heads

| 16. | Other poultry |
| --- | --- |

16.

Other poultry

number of heads

of which:

| (a) | turkeys |
| --- | --- |

(a)

turkeys

number of heads

NS

| (b) | ducks |
| --- | --- |

(b)

ducks

number of heads

NS

NS

NS

| (c) | geese |
| --- | --- |

(c)

geese

number of heads

NS

NS

NS

NE

NS

| (d) | other poultry, not mentioned elsewhere |
| --- | --- |

(d)

other poultry, not mentioned elsewhere

number of heads

NS

NS

NS

NS

| 17. | Rabbits, breeding females |
| --- | --- |

17.

Rabbits, breeding females

number of heads

NS

NS

NS

NS

NS

NE

NE

NS

| 18. | Bees |
| --- | --- |

18.

Bees

number of hives

NS

NS

NS

NS

NS

NS

NS

NS

NS

| 19. | Livestock not mentioned elsewhere |
| --- | --- |

19.

Livestock not mentioned elsewhere

yes/no

NS

NS

NS

NS

NS

NS

Farm labour force (in the 12 months preceding the day of the survey)

Statistical information is collected for each person, working on the holding, belonging to the following farm labour force categories in a way allowing multiple crossing with each other and/or with any other survey characteristics.

| 1. | Holders |
| --- | --- |

1.

Holders

In this category are found:

| — | natural persons:







  — | sole holders of independent holdings (all persons who have answered “yes” to question B/1(a)) |
| --- | --- | --- |

—

natural persons:

—

sole holders of independent holdings (all persons who have answered “yes” to question B/1(a))

| — | the partner on group holdings that has been identified as being the holder |
| --- | --- |

—

the partner on group holdings that has been identified as being the holder

| — | legal persons |
| --- | --- |

—

legal persons

The following information is recorded for each natural person mentioned above:

| — | the gender, |
| --- | --- |

—

the gender,

| — | the age according to the following age classes: |
| --- | --- |

—

the age according to the following age classes:

from school leaving age to < 25 years, 25-34, 35-44, 45-54, 55-64, 65 and over,

| — | the farm work on the holding (apart from housework) according to the classification: |
| --- | --- |

—

the farm work on the holding (apart from housework) according to the classification:

0 %, > 0 - < 25 %, 25 - < 50 %, 50 - < 75 %, 75 - < 100 %, 100 % (full-time) of annual time worked by a full-time farm worker.

| 1. (a) | Managers |
| --- | --- |

1. (a)

Managers

In this category are found:

| — | The managers on independent holdings, including spouses and other members of the holders’ families who are also manager; that is where the answer is “yes” to either B/2(a) or B/2(b). |
| --- | --- |

—

The managers on independent holdings, including spouses and other members of the holders’ families who are also manager; that is where the answer is “yes” to either B/2(a) or B/2(b).

| — | The partners on group holdings who have been identified as managers. |
| --- | --- |

—

The partners on group holdings who have been identified as managers.

| — | The managers on holdings where the holder is a legal person. |
| --- | --- |

—

The managers on holdings where the holder is a legal person.

(The managers who are at the same time sole holders or partners identified as being the holder of a group holding are recorded only once, that is, as a holder in category L/1).

The following information is recorded for each person mentioned above:

| — | the gender, |
| --- | --- |

—

the gender,

| — | the age according to the following age classes: |
| --- | --- |

—

the age according to the following age classes:

from school leaving age to < 25 years, 25-34, 35-44, 45-54, 55-64, 65 and over,

| — | the farm work on the holding (apart from housework) according to the classification: |
| --- | --- |

—

the farm work on the holding (apart from housework) according to the classification:

> 0 - < 25 %, 25 - < 50 %, 50 - < 75 %, 75 - < 100 %, 100 % (full-time) of annual time worked by a full-time farm worker.

| 2. | Spouses of holders |
| --- | --- |

2.

Spouses of holders

In this category are found the spouses of sole holders (the answer to question B/1(a) is “yes”) who are not included in L/1, nor included in L/1(a) (they are not managers: the answer to question B/2(b) is “no”)

The following information is recorded for each person mentioned above:

| — | the gender, |
| --- | --- |

—

the gender,

| — | the age according to the following age classes: |
| --- | --- |

—

the age according to the following age classes:

from school leaving age to < 25 years, 25-34, 35-44, 45-54, 55-64, 65 and over,

| — | the farm work on the holding (apart from housework) according to the classification: |
| --- | --- |

—

the farm work on the holding (apart from housework) according to the classification:

0 %, > 0 - < 25 %, 25 - < 50 %, 50 - < 75 %, 75 - < 100 %, 100 % (full-time) of annual time worked by a full-time farm worker.

| 3. (a) | Other members of sole holders’ families carrying out farm work for the holding: male (excluding persons in categories L/1, L/1(a) and L/2) |
| --- | --- |

3. (a)

Other members of sole holders’ families carrying out farm work for the holding: male (excluding persons in categories L/1, L/1(a) and L/2)

| 3. (b) | Other members of sole holders’ families carrying out farm work for the holding: female (excluding persons in categories L/1, L/1(a) and L/2) |
| --- | --- |

3. (b)

Other members of sole holders’ families carrying out farm work for the holding: female (excluding persons in categories L/1, L/1(a) and L/2)

The following information on the number of persons on the holding corresponding to the following classes is to be recorded for each person of the categories mentioned above:

| — | the farm work on the holding (apart from housework) according to the classification: |
| --- | --- |

—

the farm work on the holding (apart from housework) according to the classification:

> 0 - < 25 %, 25 - < 50 %, 50 - < 75 %, 75 - < 100 %, 100 % (full-time) of annual time worked by a full-time farm worker.

| 4. (a) | Non-family labour regularly employed: male (excluding persons in categories L/1, L/1(a), L/2 and L/3) |
| --- | --- |

4. (a)

Non-family labour regularly employed: male (excluding persons in categories L/1, L/1(a), L/2 and L/3)

| 4. (b) | Non-family labour regularly employed: female (excluding persons in categories L/1, L/1(a), L/2 and L/3) |
| --- | --- |

4. (b)

Non-family labour regularly employed: female (excluding persons in categories L/1, L/1(a), L/2 and L/3)

The following information on the number of persons on the holding corresponding to the following classes is to be recorded for each of the categories mentioned above:

| — | the farm work on the holding (apart from housework) according to the classification: |
| --- | --- |

—

the farm work on the holding (apart from housework) according to the classification:

> 0 - < 25 %, 25 - < 50 %, 50 - < 75 %, 75 - < 100 %, 100 % (full-time) of annual time worked by a full-time farm worker.

| 5. + 6. | Non-family labour employed on a non-regular basis: male and female |
| --- | --- |

5. + 6.

Non-family labour employed on a non-regular basis: male and female

Number of working days

| 7. | Does the holder who is also the manager have any other gainful activities? |
| --- | --- |

7.

Does the holder who is also the manager have any other gainful activities?

| — | as his/her major occupation? |
| --- | --- |

—

as his/her major occupation?

yes/no

| — | as a subsidiary occupation? |
| --- | --- |

—

as a subsidiary occupation?

yes/no

| 8. | Does the sole holder’s spouse have any other gainful activity: |
| --- | --- |

8.

Does the sole holder’s spouse have any other gainful activity:

| — | as his/her major occupation? |
| --- | --- |

—

as his/her major occupation?

yes/no

| — | as a subsidiary occupation? |
| --- | --- |

—

as a subsidiary occupation?

yes/no

| 9. | Does any other member of the sole holder’s family engaged in the farm work of the holding have any other gainful activity? If “yes”, how many have other gainful activities: |
| --- | --- |

9.

Does any other member of the sole holder’s family engaged in the farm work of the holding have any other gainful activity? If “yes”, how many have other gainful activities:

| — | as his/her major occupation? |
| --- | --- |

—

as his/her major occupation?

number of persons

| — | as a subsidiary occupation? |
| --- | --- |

—

as a subsidiary occupation?

number of persons

| 10. | Total number of equivalent full-time working days of farm work during the 12 months preceding the day of the survey, not included under L/1 to L/6, undertaken on the holding by persons not employed directly by the holding (e.g. contractors’ employees) (5) |
| --- | --- |

10.

Total number of equivalent full-time working days of farm work during the 12 months preceding the day of the survey, not included under L/1 to L/6, undertaken on the holding by persons not employed directly by the holding (e.g. contractors’ employees) (5)

number of days

NE

NS

NS

Rural development

Other gainful activities on the holding (other than agriculture), directly related to the holding:

| (a) | tourism, accommodation and other leisure activities |
| --- | --- |

(a)

tourism, accommodation and other leisure activities

yes/no

NS

NE

| (b) | handicraft |
| --- | --- |

(b)

handicraft

yes/no

NS

NE

NS

| (c) | processing of farm products |
| --- | --- |

(c)

processing of farm products

yes/no

| (d) | wood processing (e.g. sawing, etc.) |
| --- | --- |

(d)

wood processing (e.g. sawing, etc.)

yes/no

NS

NE

NE

NS

| (e) | aqua culture |
| --- | --- |

(e)

aqua culture

yes/no

NS

NE

| (f) | renewable energy production (wind energy, straw burning, etc.) |
| --- | --- |

(f)

renewable energy production (wind energy, straw burning, etc.)

yes/no

NS

NS

NE

| (g) | contractual work (using equipment of the holding) |
| --- | --- |

(g)

contractual work (using equipment of the holding)

yes/no

| (h) | other |
| --- | --- |

(h)

other

yes/no

NE

---

(*1)  Note to the reader: The numbering of the characteristics is a consequence of the long history of the Farm Structure Surveys and cannot be changed without repercussion on comparability between surveys.

*1

(1)  The provision of information on less-favoured area (A2) and mountain area (A2a) is optional in case the municipality code (A1a) is sent for each holding. In case the municipality code (A1a) is not provided for the holding, the information on less-favoured area (A2) and mountain area (A2a) is obligatory.

1

(2)  Voluntary information.

2

(3)  Belgium, the Netherlands and Austria may include item G/1(c) “nuts” under this heading.

3

(4)  Germany may merge headings 8(c), 8(d) and 8(e).

4

(5)  Optional for Member States that are able to provide an overall estimate for this characteristic at regional level.’

5

---

ANNEX II

AMENDMENTS TO ANNEX I TO DECISION 2000/115/EC

1.

‘AGRICULTURAL HOLDING

| I. | A single unit both technically and economically, which has single management and which produces agricultural products or maintains its land which is no longer used for production purposes in good agricultural and environmental condition, in line with Council Regulation (EC) No 1782/2003 (*1). The holding may also provide other supplementary (non-agricultural) products and services. |
| --- | --- |

I.

(*1)  
  OJ L 270, 21.10.2003, p. 1.’
  "

2.

| ‘1.4. | With the 2003 CAP reform, “Maintaining the land in good agricultural and environmental condition” was introduced as an agricultural activity (Article 2 of Regulation (EC) No 1782/2003). Besides this activity, farmers do not have to have any other agricultural activity in order to have access to the single payment scheme.’ |
| --- | --- |

‘1.4.

3.

‘Gifts to family and relatives without remuneration should be considered as household consumption. Final production as referred to under this characteristic follows the definition of final output used in the agricultural accounts (i.e. agricultural products used as input for other production, such as forage for animal production, are not included in final output).

The 50 % should of course not be considered as an exact threshold, but just as an order of magnitude.’

4.

| 4.1. | the third paragraph of the explanatory notes to paragraph D is replaced by the following:

  ‘Arable land comprises crop categories D/1 to D/20, D/23 to D/35, fallow land without any subsidies (D/21) and fallow land subject to the payment of subsidies, with no economic use (D/22).’, |
| --- | --- |

4.1.

the third paragraph of the explanatory notes to paragraph D is replaced by the following:

‘Arable land comprises crop categories D/1 to D/20, D/23 to D/35, fallow land without any subsidies (D/21) and fallow land subject to the payment of subsidies, with no economic use (D/22).’,

| 4.2. | the title of subparagraph D/22 is replaced by the following:
  ‘D/22   Fallow land subject to the payment of subsidies, with no economic use’, |
| --- | --- |

4.2.

the title of subparagraph D/22 is replaced by the following:

‘D/22   Fallow land subject to the payment of subsidies, with no economic use’,

| 4.3. | the definition of subparagraph D/22 is replaced by the following:






  ‘I. | Areas no longer used for production purposes for which the holding is entitled to financial aid. This includes areas which, in line with Regulation (EC) No 1782/2003 (or, where applicable, the most recent legislation), are no longer used for production purposes, are maintained in good agricultural and environmental condition, and are eligible for the single payment or for the payment of set-aside entitlements. If there are similar national schemes, these areas are also included under this characteristic.
  Areas taken out of production for more than five years, under schemes which do not require the maintenance in good agricultural and environmental condition, should be recorded under H/1 + H/3.’ |
| --- | --- | --- |

4.3.

the definition of subparagraph D/22 is replaced by the following:

‘I.

Areas taken out of production for more than five years, under schemes which do not require the maintenance in good agricultural and environmental condition, should be recorded under H/1 + H/3.’

5.

‘F/3   Permanent grassland and meadows no longer used for production purposes and eligible for the payment of subsidies

| I. | Areas of permanent grassland and meadows no longer used for production purposes, which, in line with Regulation (EC) No 1782/2003 (or, where applicable, the most recent legislation), are maintained in good agricultural and environmental condition and are eligible for the single payment.’ |
| --- | --- |

I.

6.

| 6.1. | the title of paragraph I is replaced by the following:
  ‘I.   MUSHROOMS, IRRIGATION, AREAS NO LONGER USED FOR PRODUCTION PURPOSES, SUBJECT TO THE PAYMENT OF SUBSIDIES, AND AREAS SUBJECT TO SET-ASIDE INCENTIVE SCHEMES’, |
| --- | --- |

6.1.

the title of paragraph I is replaced by the following:

‘I.   MUSHROOMS, IRRIGATION, AREAS NO LONGER USED FOR PRODUCTION PURPOSES, SUBJECT TO THE PAYMENT OF SUBSIDIES, AND AREAS SUBJECT TO SET-ASIDE INCENTIVE SCHEMES’,

| 6.2. | the title of subparagraph I/8 is replaced by the following:
  ‘I/8   Areas no longer used for production purposes, subject to the payment of subsidies, and area subject to set-aside incentive schemes, broken down by:’, |
| --- | --- |

6.2.

the title of subparagraph I/8 is replaced by the following:

‘I/8   Areas no longer used for production purposes, subject to the payment of subsidies, and area subject to set-aside incentive schemes, broken down by:’,

| 6.3. | in subparagraph I/8, points (a) and (b) are replaced by the following:






  ‘(a) | areas no longer used for production purposes, subject to the payment of subsidies (already recorded under D/22 and F/3) |
| --- | --- | --- |

6.3.

in subparagraph I/8, points (a) and (b) are replaced by the following:

‘(a)

areas no longer used for production purposes, subject to the payment of subsidies (already recorded under D/22 and F/3)

| (b) | areas used for the production of agricultural raw material for non-food purposes (e.g. rape, trees, bushes, etc., including lentils, chick peas and vetches; already recorded under D and G)’, |
| --- | --- |

(b)

areas used for the production of agricultural raw material for non-food purposes (e.g. rape, trees, bushes, etc., including lentils, chick peas and vetches; already recorded under D and G)’,

| 6.4. | the definition of subparagraph I/8 is replaced by the following:






  ‘I. | Areas no longer used for production purposes for which the holding is entitled to financial aid. This includes areas which, in line with Regulation (EC) No 1782/2003 (or, where applicable, the most recent legislation), are no longer used for production purposes, are maintained in good agricultural and environmental condition, and are eligible for the single payment or for the payment of set-aside entitlements. If there are similar national schemes, these areas are also included under this characteristic.’ |
| --- | --- | --- |

6.4.

the definition of subparagraph I/8 is replaced by the following:

‘I.

---

(*1)  
  OJ L 270, 21.10.2003, p. 1.’
  ’

*1

---

| 7.2.2006 | EN | Official Journal of the European Union | L 34/21 |
| --- | --- | --- | --- |

7.2.2006

EN

Official Journal of the European Union

L 34/21

---

COMMISSION REGULATION (EC) No 205/2006

of 6 February 2006

amending Annexes I and II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards toltrazuril, diethylene glycol monoethyl ether and polyoxyethylene sorbitan monooleate

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (1), and in particular Articles 2 and 3 thereof,

Having regard to the opinions of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,

Whereas:

| (1) | All pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90. |
| --- | --- |

(1)

All pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90.

| (2) | The substance toltrazuril is included in Annex I to Regulation (EEC) No 2377/90 for chicken and turkey for muscle, skin and fat, liver and kidney, excluding animals from which eggs are produced for human consumption, and for porcine, for muscle, skin and fat, liver and kidney. Toltrazuril is also included in Annex III to that Regulation for bovine species for muscle, fat, liver and kidney, excluding animals from which milk is produced for human consumption, awaiting completion of scientific studies. Those studies have now been completed and toltrazuril should therefore be extended in Annex I to Regulation (EEC) No 2377/90 to include bovines. The entry should also be extended to all mammalian food-producing species for muscle, fat, liver and kidney, excluding animals from which milk is produced for human consumption and to poultry for muscle, skin and fat, liver and kidney excluding animals from which eggs are produced for human consumption. |
| --- | --- |

(2)

The substance toltrazuril is included in Annex I to Regulation (EEC) No 2377/90 for chicken and turkey for muscle, skin and fat, liver and kidney, excluding animals from which eggs are produced for human consumption, and for porcine, for muscle, skin and fat, liver and kidney. Toltrazuril is also included in Annex III to that Regulation for bovine species for muscle, fat, liver and kidney, excluding animals from which milk is produced for human consumption, awaiting completion of scientific studies. Those studies have now been completed and toltrazuril should therefore be extended in Annex I to Regulation (EEC) No 2377/90 to include bovines. The entry should also be extended to all mammalian food-producing species for muscle, fat, liver and kidney, excluding animals from which milk is produced for human consumption and to poultry for muscle, skin and fat, liver and kidney excluding animals from which eggs are produced for human consumption.

| (3) | The substance diethylene glycol monoethyl ether is included in Annex II for bovine and porcine species. The entry for diethylene glycol monoethyl ether should be extended to include all ruminants. |
| --- | --- |

(3)

The substance diethylene glycol monoethyl ether is included in Annex II for bovine and porcine species. The entry for diethylene glycol monoethyl ether should be extended to include all ruminants.

| (4) | The substance polysorbate 80 is included in Annex II to Regulation (EEC) No 2377/90 for all food-producing species. That entry should be replaced by the general name polyoxyethylene sorbitan monooleate, covering both polysorbate 80 and polysorbate 81 for all food-producing species. |
| --- | --- |

(4)

The substance polysorbate 80 is included in Annex II to Regulation (EEC) No 2377/90 for all food-producing species. That entry should be replaced by the general name polyoxyethylene sorbitan monooleate, covering both polysorbate 80 and polysorbate 81 for all food-producing species.

| (5) | Regulation (EEC) No 2377/90 should therefore be amended accordingly. |
| --- | --- |

(5)

Regulation (EEC) No 2377/90 should therefore be amended accordingly.

| (6) | An adequate period should be allowed before the applicability of this Regulation in order to enable Member States to make any adjustment which may be necessary in the light of this Regulation to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (2) to take account of the provisions of this Regulation. |
| --- | --- |

(6)

An adequate period should be allowed before the applicability of this Regulation in order to enable Member States to make any adjustment which may be necessary in the light of this Regulation to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (2) to take account of the provisions of this Regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and II to Regulation (EEC) No 2377/90 are 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.

It shall apply from 8 April 2006.

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

Done at Brussels, 6 February 2006.

For the Commission

Günter VERHEUGEN

Vice-President

---

(1)  
  OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 6/2006 (OJ L 3, 6.1.2006, p. 3).

1

(2)  
  OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).

2

---

ANNEX

A.   The following substance is inserted in Annex I to Regulation (EEC) No 2377/90:

2.   Antiparasitic agents

2.4.   Agents acting against protozoa

2.4.1.   Triazinetrione derivatives

| Pharmacologically active substance(s) | Marker residue | Animal species | MRLs | Target tissues |
| --- | --- | --- | --- | --- |
| ‘Toltrazuril | Toltrazuril sulfone | All mammalian food producing species (1) | 100  μg/kg | Muscle |
| 150  μg/kg | Fat (2) |
| 500  μg/kg | Liver |
| 250  μg/kg | Kidney |
| Poultry (3) | 100  μg/kg | Muscle |
| 200  μg/kg | Skin + fat |
| 600  μg/kg | Liver |
| 400  μg/kg | Kidney |

Pharmacologically active substance(s)

Marker residue

Animal species

MRLs

Target tissues

‘Toltrazuril

Toltrazuril sulfone

All mammalian food producing species (1)

100  μg/kg

Muscle

150  μg/kg

Fat (2)

500  μg/kg

Liver

250  μg/kg

Kidney

Poultry (3)

100  μg/kg

Muscle

200  μg/kg

Skin + fat

600  μg/kg

Liver

400  μg/kg

Kidney

B.   The following substances are inserted in Annex II to Regulation (EEC) No 2377/90:

2.   Organic compounds

| Pharmacologically active substance(s) | Animal species |
| --- | --- |
| ‘Diethylene glycol monoethyl ether | All ruminants and porcine’ |

Pharmacologically active substance(s)

Animal species

‘Diethylene glycol monoethyl ether

All ruminants and porcine’

3.   Substances generally recognised as safe

| Pharmacologically active substance(s) | Animal species |
| --- | --- |
| ‘Polyoxyethylene sorbitan monooleate | All food producing species’ |

Pharmacologically active substance(s)

Animal species

‘Polyoxyethylene sorbitan monooleate

All food producing species’

---

(1)  Not for use in animals from which milk is produced for human consumption.

1

(2)  For porcine species this MRL relates to “skin and fat in natural proportions”.

2

(3)  Not for use in animals from which eggs are produced for human consumption.’

3

---

| 7.2.2006 | EN | Official Journal of the European Union | L 34/24 |
| --- | --- | --- | --- |

7.2.2006

EN

Official Journal of the European Union

L 34/24

---

COMMISSION DIRECTIVE 2006/14/EC

of 6 February 2006

amending Annex IV to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular point (d) of the second paragraph of Article 14 thereof,

Whereas:

| (1) | The FAO International Standard for Phytosanitary Measures (ISPM) No 15 on ‘Guidelines for regulating wood packaging material in international trade’ was adopted in March 2002 by the Fourth Interim Commission on Phytosanitary Measures (ICPM). The relevant provisions of Directive 2000/29/EC were brought in line with those Guidelines by Commission Directive 2004/102/EC of 5 October 2004 amending Annexes II, III, IV and V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (2). |
| --- | --- |

(1)

The FAO International Standard for Phytosanitary Measures (ISPM) No 15 on ‘Guidelines for regulating wood packaging material in international trade’ was adopted in March 2002 by the Fourth Interim Commission on Phytosanitary Measures (ICPM). The relevant provisions of Directive 2000/29/EC were brought in line with those Guidelines by Commission Directive 2004/102/EC of 5 October 2004 amending Annexes II, III, IV and V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (2).

| (2) | In addition to the measures approved under ISPM 15, Directive 2004/102/EC includes a requirement that imported wood packaging material be made from debarked round wood. ISPM No 15 made this an option subject to technical justification. The application of that requirement was postponed until 1 March 2006 by Council Directive 2005/15/EC of 28 February 2005 amending Annex IV to Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (3). |
| --- | --- |

(2)

In addition to the measures approved under ISPM 15, Directive 2004/102/EC includes a requirement that imported wood packaging material be made from debarked round wood. ISPM No 15 made this an option subject to technical justification. The application of that requirement was postponed until 1 March 2006 by Council Directive 2005/15/EC of 28 February 2005 amending Annex IV to Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (3).

| (3) | The Community has requested that ISPM No 15 be reviewed at international level to include a requirement addressing the Community’s concern about the presence of bark on such wood packaging material in international trade. |
| --- | --- |

(3)

The Community has requested that ISPM No 15 be reviewed at international level to include a requirement addressing the Community’s concern about the presence of bark on such wood packaging material in international trade.

| (4) | While the procedure for the review of ISPM No 15 is under way and pending the results of that review, the application of the Community requirement that wood packaging material imported from third countries be made from debarked round wood should be postponed temporarily. |
| --- | --- |

(4)

While the procedure for the review of ISPM No 15 is under way and pending the results of that review, the application of the Community requirement that wood packaging material imported from third countries be made from debarked round wood should be postponed temporarily.

| (5) | Directive 2000/29/EC should therefore be amended accordingly. |
| --- | --- |

(5)

Directive 2000/29/EC should therefore be amended accordingly.

| (6) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, |
| --- | --- |

(6)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 2000/29/EC is amended as follows:

| 1. | In Annex IV, Part A, section I, point 2, the last paragraph at the end of the right hand column is replaced by the following:

  ‘The first indent, requiring wood packaging material to be made from debarked round wood, shall only apply from 1 January 2009. This paragraph shall be reviewed by 1 September 2007.’ |
| --- | --- |

1.

In Annex IV, Part A, section I, point 2, the last paragraph at the end of the right hand column is replaced by the following:

‘The first indent, requiring wood packaging material to be made from debarked round wood, shall only apply from 1 January 2009. This paragraph shall be reviewed by 1 September 2007.’

| 2. | In Annex IV, Part A, section I, point 8, the last paragraph at the end of the right hand column is replaced by the following:

  ‘The first line of point (a), requiring wood packaging material to be made from debarked round wood, shall only apply from 1 January 2009. This paragraph shall be reviewed by 1 September 2007.’ |
| --- | --- |

2.

In Annex IV, Part A, section I, point 8, the last paragraph at the end of the right hand column is replaced by the following:

‘The first line of point (a), requiring wood packaging material to be made from debarked round wood, shall only apply from 1 January 2009. This paragraph shall be reviewed by 1 September 2007.’

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2006 at the latest.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 6 February 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  
  OJ L 169, 10.7.2000, p. 1. Directive as last amended by Commission Directive 2005/77/EC (OJ L 296, 12.11.2005, p. 17).

1

(2)  
  OJ L 309, 6.10.2004, p. 9.

2

(3)  
  OJ L 56, 2.3.2005, p. 12.

3

---

II Acts whose publication is not obligatory

Commission

| 7.2.2006 | EN | Official Journal of the European Union | L 34/26 |
| --- | --- | --- | --- |

7.2.2006

EN

Official Journal of the European Union

L 34/26

---

COMMISSION DECISION

of 13 January 2006

authorising the placing on the market of foods and food ingredients derived from genetically modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2005) 5939)

(Only the French and Dutch texts are authentic)

(2006/68/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

| (1) | On 15 July 2002, Monsanto submitted to the competent authorities of Germany a request, in accordance with Article 4 of the Regulation, for placing on the market foods and food ingredients derived from genetically modified maize line MON 863 (hereinafter referred to as MON 863 maize) as novel foods or novel food ingredients, in accordance with Regulation (EC) No 258/97. |
| --- | --- |

(1)

On 15 July 2002, Monsanto submitted to the competent authorities of Germany a request, in accordance with Article 4 of the Regulation, for placing on the market foods and food ingredients derived from genetically modified maize line MON 863 (hereinafter referred to as MON 863 maize) as novel foods or novel food ingredients, in accordance with Regulation (EC) No 258/97.

| (2) | In its initial assessment report of 8 April 2003, Germany’s competent food assessment body came to the conclusion that an additional assessment was required because of the presence of an antibiotic resistance marker gene (nptII) used in the product concerned. |
| --- | --- |

(2)

In its initial assessment report of 8 April 2003, Germany’s competent food assessment body came to the conclusion that an additional assessment was required because of the presence of an antibiotic resistance marker gene (nptII) used in the product concerned.

| (3) | The Commission forwarded the initial assessment report to all Member States on 3 June 2003 with additional comments raised by the Member States. |
| --- | --- |

(3)

The Commission forwarded the initial assessment report to all Member States on 3 June 2003 with additional comments raised by the Member States.

| (4) | On 9 December 2003 the Commission requested a scientific opinion from the European Food Safety Authority (EFSA) in accordance with Article 11 of the Regulation. On 2 April 2004 the EFSA delivered its opinion that from the point of view of consumer health, MON 863 maize and derived products are as safe as grain and derived products from conventional maize lines (2). In delivering its opinion the EFSA addressed all specific questions and concerns raised by the Member States. |
| --- | --- |

(4)

On 9 December 2003 the Commission requested a scientific opinion from the European Food Safety Authority (EFSA) in accordance with Article 11 of the Regulation. On 2 April 2004 the EFSA delivered its opinion that from the point of view of consumer health, MON 863 maize and derived products are as safe as grain and derived products from conventional maize lines (2). In delivering its opinion the EFSA addressed all specific questions and concerns raised by the Member States.

| (5) | Article 46(1) of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (3) provides that requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97, notwithstanding Article 38 of Regulation (EC) No 1829/2003, in cases where the additional assessment report required in accordance with Article 6(3) or 6(4) of Regulation (EC) No 258/97 has been transmitted to the Commission before the date of application of Regulation (EC) No 1829/2003. |
| --- | --- |

(5)

Article 46(1) of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (3) provides that requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97, notwithstanding Article 38 of Regulation (EC) No 1829/2003, in cases where the additional assessment report required in accordance with Article 6(3) or 6(4) of Regulation (EC) No 258/97 has been transmitted to the Commission before the date of application of Regulation (EC) No 1829/2003.

| (6) | The Joint Research Centre of the European Commission (JRC), in collaboration with the European Network of GMO Laboratories (ENGL), has validated a method for detection of MON 863 maize. The JRC has carried out a full validation study (ring-trial) following internationally accepted guidelines to test the performance of a quantitative event-specific method to detect and quantify the MON 863 transformation event in maize. The materials needed in the study had been provided by Monsanto. The JRC has considered that the method performance was appropriate for its purpose, taken into account the performance criteria proposed by the ENGL for methods submitted for regulatory compliance as well as the current scientific understanding about satisfactory method performance. Both the method and the results of the validation have been made publicly available. |
| --- | --- |

(6)

The Joint Research Centre of the European Commission (JRC), in collaboration with the European Network of GMO Laboratories (ENGL), has validated a method for detection of MON 863 maize. The JRC has carried out a full validation study (ring-trial) following internationally accepted guidelines to test the performance of a quantitative event-specific method to detect and quantify the MON 863 transformation event in maize. The materials needed in the study had been provided by Monsanto. The JRC has considered that the method performance was appropriate for its purpose, taken into account the performance criteria proposed by the ENGL for methods submitted for regulatory compliance as well as the current scientific understanding about satisfactory method performance. Both the method and the results of the validation have been made publicly available.

| (7) | Reference material for MON 863 maize has been produced by the JRC. |
| --- | --- |

(7)

Reference material for MON 863 maize has been produced by the JRC.

| (8) | Food and food ingredients from MON 863 maize should be labelled in accordance with the provisions of Regulation (EC) No 1829/2003 and should be subject to the traceability requirements laid down in Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (4). |
| --- | --- |

(8)

Food and food ingredients from MON 863 maize should be labelled in accordance with the provisions of Regulation (EC) No 1829/2003 and should be subject to the traceability requirements laid down in Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (4).

| (9) | In accordance with Commission Regulation (EC) No 65/2004 (5), a unique identifier has been assigned to the product for the purposes of Regulation (EC) No 1830/2003. |
| --- | --- |

(9)

In accordance with Commission Regulation (EC) No 65/2004 (5), a unique identifier has been assigned to the product for the purposes of Regulation (EC) No 1830/2003.

| (10) | Information, contained in the Annex, on the identification of foods and food ingredients derived from MON 863 maize, including the validated detection method and the reference material, should be retrievable from the Register referred to in Article 28 of Regulation (EC) No 1829/2003. |
| --- | --- |

(10)

Information, contained in the Annex, on the identification of foods and food ingredients derived from MON 863 maize, including the validated detection method and the reference material, should be retrievable from the Register referred to in Article 28 of Regulation (EC) No 1829/2003.

| (11) | On the basis of the information available, it is established that MON 863 maize complies with criteria laid down in Regulation (EC) No 258/97. |
| --- | --- |

(11)

On the basis of the information available, it is established that MON 863 maize complies with criteria laid down in Regulation (EC) No 258/97.

| (12) | The Standing Committee on the Food Chain and Animal Health has not given an opinion; the Commission has therefore submitted a proposal to the Council on 26 July 2005 in accordance with Article 5(4) of the Council Decision 1999/468/EC (6), the Council being required to act within three months. |
| --- | --- |

(12)

The Standing Committee on the Food Chain and Animal Health has not given an opinion; the Commission has therefore submitted a proposal to the Council on 26 July 2005 in accordance with Article 5(4) of the Council Decision 1999/468/EC (6), the Council being required to act within three months.

| (13) | However, the Council has not acted within the required time limit; a Decision should now be adopted by the Commission, |
| --- | --- |

(13)

However, the Council has not acted within the required time limit; a Decision should now be adopted by the Commission,

HAS ADOPTED THIS DECISION:

Article 1

Foods and food ingredients derived from genetically modified maize line MON 863 (hereinafter referred to as the products), as designated and specified in the Annex, may be placed on the Community market as novel foods or novel food ingredients.

Article 2

The products shall be labelled as ‘genetically modified maize’ or ‘produced from genetically modified maize’ in accordance with the labelling requirements laid down in Article 13 of Regulation (EC) No 1829/2003.

Article 3

The products and the information included in the Annex shall be entered in the Community Register of genetically modified food and feed.

Article 4

This Decision is addressed to Monsanto Europe SA, Belgium, representing Monsanto Company, USA. It shall be valid for a period of 10 years.

Done at Brussels, 13 January 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  
  OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

1

(2)  EFSA Journal (2004) 50, 1-25; http://www.efsa.eu.int/science/gmo/gmo_opinions/383/opinion_gmo_07_en1.pdf

2

(3)  
  OJ L 268, 18.10.2003, p. 1.

3

(4)  
  OJ L 268, 18.10.2003, p. 24.

4

(5)  
  OJ L 10, 16.1.2004, p. 5.

5

(6)  
  OJ L 184, 17.7.1999, p. 23.

6

---

ANNEX

INFORMATION TO BE ENTERED IN THE COMMUNITY REGISTER OF GENETICALLY MODIFIED FOOD AND FEED

1.   Applicant and authorisation holder:

| Name | : | Monsanto Europe SA |
| --- | --- | --- |
| Address | : | Avenue de Tervuren 270-272, B-1150 Brussels, Belgium |

Name

:

Monsanto Europe SA

Address

:

Avenue de Tervuren 270-272, B-1150 Brussels, Belgium

On behalf of Monsanto Company, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, USA.

2.   Designation and specification of the products: Foods and food ingredients derived from genetically modified maize (Zea maize L.) line MON 863 with increased protection to insects and from all its crosses with traditionally bred maize lines. MON 863 maize contains two cassettes:

| (a) | cassette 1:
  A modified cry3Bb1 gene derived from Bacillus thuringiensis subsp. kumamotoensis, which confers resistance to the corn rootworm Diabrotica spp., under the regulation of the 4AS1 promoter derived from Cauliflower Mosaic Virus, the wtCAB translation enhancer from wheat (Triticum aestivum), the transcription enhancer ract1 intron from the actin 1 gene of rice (Oryza sativa) and terminator sequences tahsp 17 3’ from wheat; |
| --- | --- |

(a)

cassette 1:

A modified cry3Bb1 gene derived from Bacillus thuringiensis subsp. kumamotoensis, which confers resistance to the corn rootworm Diabrotica spp., under the regulation of the 4AS1 promoter derived from Cauliflower Mosaic Virus, the wtCAB translation enhancer from wheat (Triticum aestivum), the transcription enhancer ract1 intron from the actin 1 gene of rice (Oryza sativa) and terminator sequences tahsp 17 3’ from wheat;

| (b) | cassette 2:
  The nptII gene from E. coli, which confers resistance to aminoglycosides comprising kanamycin and neomycin, under the regulation of the 35S Cauliflower Mosaic Virus promoter, and the NOS 3’ terminator sequences from Agrobacterium tumefaciens as well as the non-functional, truncated ble gene from E. coli. |
| --- | --- |

(b)

cassette 2:

The nptII gene from E. coli, which confers resistance to aminoglycosides comprising kanamycin and neomycin, under the regulation of the 35S Cauliflower Mosaic Virus promoter, and the NOS 3’ terminator sequences from Agrobacterium tumefaciens as well as the non-functional, truncated ble gene from E. coli.

3.   Labelling: ‘Genetically modified maize’ or ‘produced from genetically modified maize’.

4.   Method for detection:

| — | Event-specific real-time quantitative PCR based method for genetically modified maize line MON 863. |
| --- | --- |

—

Event-specific real-time quantitative PCR based method for genetically modified maize line MON 863.

| — | Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL), published at http://gmo-crl.jrc.it/statusofdoss.htm |
| --- | --- |

—

Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL), published at http://gmo-crl.jrc.it/statusofdoss.htm

| — | Reference material: IRMM-416 produced by the Joint Research Centre (JRC) of the European Commission. |
| --- | --- |

—

Reference material: IRMM-416 produced by the Joint Research Centre (JRC) of the European Commission.

5.   Unique identifier: MON-ØØ863-5

6.   Information required under Annex II to the Cartagena Protocol: Not applicable.

7.   Conditions or restrictions for the placing on the market of the product: Not applicable.

8.   Post market monitoring requirements: Not applicable.

---

| 7.2.2006 | EN | Official Journal of the European Union | L 34/29 |
| --- | --- | --- | --- |

7.2.2006

EN

Official Journal of the European Union

L 34/29

---

COMMISSION DECISION

of 13 January 2006

authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2005) 5940)

(Only the French and Dutch texts are authentic)

(2006/69/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

| (1) | On 24 July 1998, Monsanto submitted to the competent authorities of the Netherlands a request, in accordance with Article 4 of Regulation (EC) No 258/97, for placing on the market foods and food ingredients derived from genetically modified maize line GA21 as novel foods or novel food ingredients. |
| --- | --- |

(1)

On 24 July 1998, Monsanto submitted to the competent authorities of the Netherlands a request, in accordance with Article 4 of Regulation (EC) No 258/97, for placing on the market foods and food ingredients derived from genetically modified maize line GA21 as novel foods or novel food ingredients.

| (2) | In its initial assessment report of 21 December 1999, the Netherlands’ competent food assessment body came to the conclusion that GA21 maize and foodstuffs and food ingredients made from it are as safe to eat as maize and maize products that have not been genetically modified. |
| --- | --- |

(2)

In its initial assessment report of 21 December 1999, the Netherlands’ competent food assessment body came to the conclusion that GA21 maize and foodstuffs and food ingredients made from it are as safe to eat as maize and maize products that have not been genetically modified.

| (3) | The Commission forwarded the initial assessment report to all Member States on 18 February 2000. Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97, reasoned objections to the marketing of the product were raised in accordance with that provision. |
| --- | --- |

(3)

The Commission forwarded the initial assessment report to all Member States on 18 February 2000. Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97, reasoned objections to the marketing of the product were raised in accordance with that provision.

| (4) | On 18 May 2000, the Commission requested an opinion from the Scientific Committee on Foods (SCF) in accordance with Article 11 of Regulation (EC) No 258/97. On 27 February 2002 the SCF delivered its opinion that from the point of view of consumer health, GA21 maize and derived products are as safe as grain and derived products from conventional maize lines (2). In delivering its opinion the SCF considered all specific questions and concerns raised by the Member States. |
| --- | --- |

(4)

On 18 May 2000, the Commission requested an opinion from the Scientific Committee on Foods (SCF) in accordance with Article 11 of Regulation (EC) No 258/97. On 27 February 2002 the SCF delivered its opinion that from the point of view of consumer health, GA21 maize and derived products are as safe as grain and derived products from conventional maize lines (2). In delivering its opinion the SCF considered all specific questions and concerns raised by the Member States.

| (5) | On 24 April 2002, Monsanto asked to limit the request to food and food ingredients produced from genetically modified maize line GA21. |
| --- | --- |

(5)

On 24 April 2002, Monsanto asked to limit the request to food and food ingredients produced from genetically modified maize line GA21.

| (6) | With respect to the use of the product as or in feed, Monsanto submitted, on 12 December 1997, a notification under Part C of Council Directive 90/220/EEC (3). The opinion adopted on 22 September 2000 by the Scientific Committee on Plants concluded that there is no evidence to indicate that the placing on the market of GA21 maize for this use is likely to cause any adverse effects on human health and the environment. However, the application was withdrawn for commercial reasons. |
| --- | --- |

(6)

With respect to the use of the product as or in feed, Monsanto submitted, on 12 December 1997, a notification under Part C of Council Directive 90/220/EEC (3). The opinion adopted on 22 September 2000 by the Scientific Committee on Plants concluded that there is no evidence to indicate that the placing on the market of GA21 maize for this use is likely to cause any adverse effects on human health and the environment. However, the application was withdrawn for commercial reasons.

| (7) | Article 46(1) of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (4) provides that requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97, notwithstanding Article 38 of Regulation (EC) No 1829/2003, in cases where the additional assessment report required in accordance with Article 6(3) or 6(4) of Regulation (EC) No 258/97 has been transmitted to the Commission before the date of application of Regulation (EC) No 1829/2003. |
| --- | --- |

(7)

Article 46(1) of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (4) provides that requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97, notwithstanding Article 38 of Regulation (EC) No 1829/2003, in cases where the additional assessment report required in accordance with Article 6(3) or 6(4) of Regulation (EC) No 258/97 has been transmitted to the Commission before the date of application of Regulation (EC) No 1829/2003.

| (8) | The Joint Research Centre of the European Commission (JRC) in collaboration with the European Network of GMO Laboratories (ENGL), has validated a method for detection of GA21 maize. The JRC has carried out a full validation study (ring-trial) following internationally accepted guidelines to test the performance of a quantitative event-specific method to detect and quantify the GA21 transformation event in maize. The materials needed in the study had been provided by Monsanto. The JRC has considered that the method performance was appropriate for its aimed purpose, taken into account the performance criteria proposed by the ENGL for methods submitted for regulatory compliance as well as the current scientific understanding about satisfactory method performance. Both the method and the results of the validation have been published by the JRC. |
| --- | --- |

(8)

The Joint Research Centre of the European Commission (JRC) in collaboration with the European Network of GMO Laboratories (ENGL), has validated a method for detection of GA21 maize. The JRC has carried out a full validation study (ring-trial) following internationally accepted guidelines to test the performance of a quantitative event-specific method to detect and quantify the GA21 transformation event in maize. The materials needed in the study had been provided by Monsanto. The JRC has considered that the method performance was appropriate for its aimed purpose, taken into account the performance criteria proposed by the ENGL for methods submitted for regulatory compliance as well as the current scientific understanding about satisfactory method performance. Both the method and the results of the validation have been published by the JRC.

| (9) | Reference material for GA21 maize has been produced by the JRC. |
| --- | --- |

(9)

Reference material for GA21 maize has been produced by the JRC.

| (10) | Food and food ingredients from GA21 maize should be labelled in accordance with the provisions of Regulation (EC) No 1829/2003 and should be subject to the traceability requirements laid down in Regulation (EC) No 1830/2003 of the European Parliament and the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (5). |
| --- | --- |

(10)

Food and food ingredients from GA21 maize should be labelled in accordance with the provisions of Regulation (EC) No 1829/2003 and should be subject to the traceability requirements laid down in Regulation (EC) No 1830/2003 of the European Parliament and the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (5).

| (11) | In accordance with Commission Regulation (EC) No 65/2004 (6), a unique identifier has been assigned to the product for the purposes of Regulation (EC) No 1830/2003. |
| --- | --- |

(11)

In accordance with Commission Regulation (EC) No 65/2004 (6), a unique identifier has been assigned to the product for the purposes of Regulation (EC) No 1830/2003.

| (12) | Information, contained in the Annex, on the identification of foods and food ingredients produced from GA21 maize, including the validated detection method and the reference material, should be retrievable from the Register referred to in Article 28 of Regulation (EC) No 1829/2003. |
| --- | --- |

(12)

Information, contained in the Annex, on the identification of foods and food ingredients produced from GA21 maize, including the validated detection method and the reference material, should be retrievable from the Register referred to in Article 28 of Regulation (EC) No 1829/2003.

| (13) | The Standing Committee on the Food Chain and Animal Health has not given an opinion; the Commission has therefore submitted a proposal to the Council on 29 July 2005 in accordance with Article 5(4) of the Council Decision 1999/468/EC (7), the Council being required to act within three months. |
| --- | --- |

(13)

The Standing Committee on the Food Chain and Animal Health has not given an opinion; the Commission has therefore submitted a proposal to the Council on 29 July 2005 in accordance with Article 5(4) of the Council Decision 1999/468/EC (7), the Council being required to act within three months.

| (14) | However, the Council has not acted within the required time-limit; a Decision should now be adopted by the Commission, |
| --- | --- |

(14)

However, the Council has not acted within the required time-limit; a Decision should now be adopted by the Commission,

HAS ADOPTED THIS DECISION:

Article 1

Foods and food ingredients produced from genetically modified maize line GA21 (hereinafter referred to as the products), as designated and specified in the Annex, may be placed on the Community market as novel foods or novel food ingredients.

Article 2

The products shall be labelled as ‘genetically modified maize’ or ‘produced from genetically modified maize’ in accordance with the labelling requirements laid down in Article 13 of Regulation (EC) No 1829/2003.

Article 3

The products and the information included in the Annex shall be entered in the Community Register of genetically modified food and feed.

Article 4

This Decision is addressed to Monsanto Europe SA, Belgium, representing Monsanto Company, USA. It shall be valid for a period of 10 years.

Done at Brussels, 13 January 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10. 2003, p. 1).

1

(2)  http://europa.eu.int/comm/food/fs/sc/scf/index_en.html

2

(3)  
  OJ L 117, 8.5.1990 p. 15. Directive repealed by Directive 2001/18/EC of the European Parliament and of the Council (OJ L 106, 17.4.2001, p. 1).

3

(4)  
  OJ L 268, 18.10.2003, p. 1.

4

(5)  
  OJ L 268, 18.10.2003, p. 24.

5

(6)  
  OJ L 10, 16.1.2004, p. 5.

6

(7)  
  OJ L 184, 17.7.1999, p. 23.

7

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ANNEX

INFORMATION TO BE ENTERED IN THE COMMUNITY REGISTER OF GENETICALLY MODIFIED FOOD AND FEED

1.   Applicant and authorisation holder:

| Name | : | Monsanto Europe SA. |
| --- | --- | --- |
| Address | : | Avenue de Tervuren 270-272, B-1150 Brussels, Belgium. |

Name

:

Monsanto Europe SA.

Address

:

Avenue de Tervuren 270-272, B-1150 Brussels, Belgium.

On behalf of Monsanto Company, 800 N. Lindbergh Boulevard, St Louis, Missouri 63167, USA.

2.   Designation and specification of the products: Foods and food ingredients produced from genetically modified maize (Zea mays L.) line GA21 with increased tolerance to the herbicide glyphosate and from all its crosses with traditionally bred maize lines. GA21 maize contains the modified 5-enolpyruvylshikimate-3-phosphate synthase (mEPSPS) coding sequence under the regulation of the rice actin 1 promoter (r-act) and an optimised transit peptide (OPT) sequence based on chloroplast transit peptide sequences from Helianthus annuus and the RuBisCo gene from Zea mays L.

3.   Labelling: ‘Genetically modified maize’ or ‘produced from genetically modified maize’.

4.   Method for detection:

| — | Event specific real-time quantitative PCR based method for genetically modified maize line GA21, |
| --- | --- |

—

Event specific real-time quantitative PCR based method for genetically modified maize line GA21,

| — | Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL), published at http://gmo-crl.jrc.it/statusofdoss.htm |
| --- | --- |

—

Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL), published at http://gmo-crl.jrc.it/statusofdoss.htm

| — | Reference Material: IRMM-414 produced by the Joint Research Centre (JRC) of the European Commission. |
| --- | --- |

—

Reference Material: IRMM-414 produced by the Joint Research Centre (JRC) of the European Commission.

5.   Unique identifier: MON-ØØØ21-9.

6.   Information required under Annex II to the Cartagena Protocol: Not applicable.

7.   Conditions or restrictions for the placing on the market of the product: Not applicable.

8.   Post market monitoring requirements: Not applicable.

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| 7.2.2006 | EN | Official Journal of the European Union | L 34/32 |
| --- | --- | --- | --- |

7.2.2006

EN

Official Journal of the European Union

L 34/32

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COMMISSION DECISION

of 31 January 2006

amending Decision 2001/844/EC, ECSC, Euratom

(2006/70/EC, Euratom)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community, and in particular Article 218(2) thereof,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 131 thereof,

Having regard to the Treaty on European Union, and in particular Articles 21(1) and 41(1) thereof,

Whereas:

| (1) | The Commission’s provisions on security are contained in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure (1). |
| --- | --- |

(1)

The Commission’s provisions on security are contained in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure (1).

| (2) | The Commission has decided on a number of changes in the assignment of responsibilities and in the designation of departments and services. |
| --- | --- |

(2)

The Commission has decided on a number of changes in the assignment of responsibilities and in the designation of departments and services.

| (3) | Definitions in the Annex to Decision 2001/844/EC, ECSC, Euratom should be in line with the relevant provisions in the text. |
| --- | --- |

(3)

Definitions in the Annex to Decision 2001/844/EC, ECSC, Euratom should be in line with the relevant provisions in the text.

| (4) | The text of the rules on security should be amended accordingly, |
| --- | --- |

(4)

The text of the rules on security should be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The Rules on security as set out in the Annex to Decision 2001/844/EC, ECSC, Euratom are amended as follows:

| 1. | in Section 4.2(e) ‘President of the Commission’ is replaced by ‘Director of the Commission Security Directorate’; |
| --- | --- |

1.

in Section 4.2(e) ‘President of the Commission’ is replaced by ‘Director of the Commission Security Directorate’;

| 2. | Section 13 is replaced by the following text:
  ‘13.   THE COMMISSION SECURITY BOARD
  A Commission Security Board shall be set up. It shall consist of the Director-General for Administration and Personnel, who shall have the chair, a Member of the Cabinet of the Commissioner responsible for security matters, a Member of the Cabinet of the President, the Deputy Secretary-General who chairs the Commission crisis management group, the Directors-General of the Legal Service, External Relations, Justice, Freedom and Security, the Joint Research Centre, Informatics and the Internal Audit Service and the Director of the Commission Security Directorate, or their representatives. Other Commission officials may be invited. Its remit is to assess security measures within the Commission and to make recommendations in this domain to the Member of the Commission responsible for security matters.’; |
| --- | --- |

2.

Section 13 is replaced by the following text:

‘13.   THE COMMISSION SECURITY BOARD

A Commission Security Board shall be set up. It shall consist of the Director-General for Administration and Personnel, who shall have the chair, a Member of the Cabinet of the Commissioner responsible for security matters, a Member of the Cabinet of the President, the Deputy Secretary-General who chairs the Commission crisis management group, the Directors-General of the Legal Service, External Relations, Justice, Freedom and Security, the Joint Research Centre, Informatics and the Internal Audit Service and the Director of the Commission Security Directorate, or their representatives. Other Commission officials may be invited. Its remit is to assess security measures within the Commission and to make recommendations in this domain to the Member of the Commission responsible for security matters.’;

| 3. | in Appendix 2, ‘President’ is replaced by ‘Member of the Commission responsible for security matters’; |
| --- | --- |

3.

in Appendix 2, ‘President’ is replaced by ‘Member of the Commission responsible for security matters’;

| 4. | in point 10(c) of Appendix 4, ‘President’ is replaced by ‘Director of the Commission Security Directorate’; |
| --- | --- |

4.

in point 10(c) of Appendix 4, ‘President’ is replaced by ‘Director of the Commission Security Directorate’;

| 5. | in point 7 of Appendix 5, ‘President’ is replaced by ‘Member of the Commission responsible for security matters’; |
| --- | --- |

5.

in point 7 of Appendix 5, ‘President’ is replaced by ‘Member of the Commission responsible for security matters’;

| 6. | throughout the text of the rules on security and its Appendices:






  (a) | ‘Commission Security Office’ and ‘Commission Security Service’ are replaced by: ‘Commission Security Directorate’; |
| --- | --- | --- |

6.

throughout the text of the rules on security and its Appendices:

(a)

‘Commission Security Office’ and ‘Commission Security Service’ are replaced by: ‘Commission Security Directorate’;

| (b) | ‘Head of the Commission Security Office’ is replaced by ‘Director of the Commission Security Directorate’; |
| --- | --- |

(b)

‘Head of the Commission Security Office’ is replaced by ‘Director of the Commission Security Directorate’;

| 7. | a new recital is added after recital 7 of the Annex, reading: ‘These provisions are without prejudice to Article 286 of the Treaty and to Regulation (EC) 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data.’ |
| --- | --- |

7.

a new recital is added after recital 7 of the Annex, reading: ‘These provisions are without prejudice to Article 286 of the Treaty and to Regulation (EC) 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data.’

Article 2

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

Done at Brussels, 31 January 2006.

For the Commission

Siim KALLAS

Vice-President

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(1)  
  OJ L 317, 3.12.2001, p. 1. Decision as last amended by Decision 2005/94/EC, Euratom (OJ L 31, 4.2.2005, p. 66).

1

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