# Official Journal L 252/2014

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 252 |
| | |
| English edition | Legislation | Volume 5726 August 2014 |

ISSN 1977-0677

Official Journal

of the European Union

L 252

English edition

Legislation

Volume 5726 August 2014

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) No 920/2014 of 21 August 2014 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff | 1 |
| | * | Commission Implementing Regulation (EU) No 921/2014 of 25 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance tebuconazole (
  1
  ) | 3 |
| | * | Commission Implementing Regulation (EU) No 922/2014 of 25 August 2014 approving the active substance metaflumizone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (
  1
  ) | 6 |
| | * | Commission Regulation (EU) No 923/2014 of 25 August 2014 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of aluminium lakes of riboflavins (E 101) and cochineal, carminic acid, carmines (E 120) in certain food categories and Annex to Regulation (EU) No 231/2012 as regards the specifications for riboflavins (E 101) (
  1
  ) | 11 |
| | | Commission Implementing Regulation (EU) No 924/2014 of 25 August 2014 establishing the standard import values for determining the entry price of certain fruit and vegetables | 18 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) No 920/2014 of 21 August 2014 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff

1

*

Commission Implementing Regulation (EU) No 921/2014 of 25 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance tebuconazole (
  1
  )

1

3

*

Commission Implementing Regulation (EU) No 922/2014 of 25 August 2014 approving the active substance metaflumizone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (
  1
  )

1

6

*

Commission Regulation (EU) No 923/2014 of 25 August 2014 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of aluminium lakes of riboflavins (E 101) and cochineal, carminic acid, carmines (E 120) in certain food categories and Annex to Regulation (EU) No 231/2012 as regards the specifications for riboflavins (E 101) (
  1
  )

1

11

Commission Implementing Regulation (EU) No 924/2014 of 25 August 2014 establishing the standard import values for determining the entry price of certain fruit and vegetables

18

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| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

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

EN

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

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

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II Non-legislative acts

REGULATIONS

| 26.8.2014 | EN | Official Journal of the European Union | L 252/1 |
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26.8.2014

EN

Official Journal of the European Union

L 252/1

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COMMISSION IMPLEMENTING REGULATION (EU) No 920/2014

of 21 August 2014

amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (1), and in particular Article 9(1)(a) thereof,

Whereas:

| (1) | Regulation (EEC) No 2658/87 established a nomenclature of goods (hereinafter referred to as the ‘Combined Nomenclature’), which is set out in Annex I to that Regulation. |
| --- | --- |

(1)

Regulation (EEC) No 2658/87 established a nomenclature of goods (hereinafter referred to as the ‘Combined Nomenclature’), which is set out in Annex I to that Regulation.

| (2) | The classification of pieces of fish meat as fillets or other fish meat in heading 0304 of the Combined Nomenclature depends on whether such pieces can be identified as having been obtained from fish fillets. |
| --- | --- |

(2)

The classification of pieces of fish meat as fillets or other fish meat in heading 0304 of the Combined Nomenclature depends on whether such pieces can be identified as having been obtained from fish fillets.

| (3) | The term ‘loins’ is used as a synonym for fillets of big fish in the Combined Nomenclature. Since heading 1604 of the Combined Nomenclature, covering prepared or preserved fish, makes already reference to ‘fillets known as loins’ such a reference should also be introduced in Chapter 3 of the Combined Nomenclature, covering fish. |
| --- | --- |

(3)

The term ‘loins’ is used as a synonym for fillets of big fish in the Combined Nomenclature. Since heading 1604 of the Combined Nomenclature, covering prepared or preserved fish, makes already reference to ‘fillets known as loins’ such a reference should also be introduced in Chapter 3 of the Combined Nomenclature, covering fish.

| (4) | Taking into account the anatomy of big fish such as tuna (of the genus Thunnus), swordfish (Xiphias gladius), marlin, sailfish and spearfish (of the family Istiophoridae), as well as oceanic sharks (Hexanchus griseus; Cetorhinus maximus; family Alopiidae; Rhincodon typus; family Carcharhinidae; family Sphyrnidae; family Isuridae), a maximum of four relatively large fish fillets per fish can be obtained (from the right and left side as well as from the upper and lower side). |
| --- | --- |

(4)

Taking into account the anatomy of big fish such as tuna (of the genus Thunnus), swordfish (Xiphias gladius), marlin, sailfish and spearfish (of the family Istiophoridae), as well as oceanic sharks (Hexanchus griseus; Cetorhinus maximus; family Alopiidae; Rhincodon typus; family Carcharhinidae; family Sphyrnidae; family Isuridae), a maximum of four relatively large fish fillets per fish can be obtained (from the right and left side as well as from the upper and lower side).

| (5) | In order to ensure a consistent application of the Combined Nomenclature, the classification of fish fillets referred to as ‘loins’ (whether or not cut into pieces) obtained from big fish, under heading 0304, should be clarified. |
| --- | --- |

(5)

In order to ensure a consistent application of the Combined Nomenclature, the classification of fish fillets referred to as ‘loins’ (whether or not cut into pieces) obtained from big fish, under heading 0304, should be clarified.

| (6) | An Additional Note should therefore be inserted in Chapter 3 of Part Two of the Combined Nomenclature to ensure its uniform interpretation throughout the Union. |
| --- | --- |

(6)

An Additional Note should therefore be inserted in Chapter 3 of Part Two of the Combined Nomenclature to ensure its uniform interpretation throughout the Union.

| (7) | Annex I to Regulation (EEC) No 2658/87 should therefore be amended accordingly. |
| --- | --- |

(7)

Annex I to Regulation (EEC) No 2658/87 should therefore be amended accordingly.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee, |
| --- | --- |

(8)

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

HAS ADOPTED THIS REGULATION:

Article 1

In Chapter 3 of Part Two of the Combined Nomenclature set out in Annex I to Regulation (EEC) No 2658/87 the following Additional note 2 is added:

| ‘2. | For the purposes of the CN subheadings referred to in the third subparagraph, the term “fillets” includes “loins”, i.e. the strips of meat constituting the upper or lower, right or left, side of a fish insofar as the head, guts, fins (dorsal, anal, caudal, ventral, pectoral) and bones (spinal column or main backbone, ventral or costal bones, branchial bone or stapes, etc.) have been removed.
  The classification of such products as fillets is unaffected by cutting them into pieces, provided that these pieces can be identified as having been obtained from fillets.
  The provisions of the first two subparagraphs apply to the following fish:






  (a) | tuna (of the genus Thunnus) of CN subheadings 0304 49 90 and 0304 87 00, |
| --- | --- | --- |

‘2.

For the purposes of the CN subheadings referred to in the third subparagraph, the term “fillets” includes “loins”, i.e. the strips of meat constituting the upper or lower, right or left, side of a fish insofar as the head, guts, fins (dorsal, anal, caudal, ventral, pectoral) and bones (spinal column or main backbone, ventral or costal bones, branchial bone or stapes, etc.) have been removed.

The classification of such products as fillets is unaffected by cutting them into pieces, provided that these pieces can be identified as having been obtained from fillets.

The provisions of the first two subparagraphs apply to the following fish:

(a)

tuna (of the genus Thunnus) of CN subheadings 0304 49 90 and 0304 87 00,

| (b) | swordfish (Xiphias gladius) of CN subheadings 0304 45 00 and 0304 84 00, |
| --- | --- |

(b)

swordfish (Xiphias gladius) of CN subheadings 0304 45 00 and 0304 84 00,

| (c) | marlin, sailfish and spearfish (of the family Istiophoridae) of CN subheadings 0304 49 90 and 0304 89 90, |
| --- | --- |

(c)

marlin, sailfish and spearfish (of the family Istiophoridae) of CN subheadings 0304 49 90 and 0304 89 90,

| (d) | oceanic sharks (Hexanchus griseus; Cetorhinus maximus; family Alopiidae; Rhincodon typus; family Carcharhinidae; family Sphyrnidae; family Isuridae) of CN subheadings 0304 49 90 and 0304 89 59.’ |
| --- | --- |

(d)

oceanic sharks (Hexanchus griseus; Cetorhinus maximus; family Alopiidae; Rhincodon typus; family Carcharhinidae; family Sphyrnidae; family Isuridae) of CN subheadings 0304 49 90 and 0304 89 59.’

Article 2

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

Official Journal of the European Union

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

Done at Brussels, 21 August 2014.

For the Commission,

On behalf of the President,

Karel DE GUCHT

Member of the Commission

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(1)  OJ L 256, 7.9.1987, p. 1.

1

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| 26.8.2014 | EN | Official Journal of the European Union | L 252/3 |
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26.8.2014

EN

Official Journal of the European Union

L 252/3

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COMMISSION IMPLEMENTING REGULATION (EU) No 921/2014

of 25 August 2014

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance tebuconazole

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2)(c) thereof,

Whereas:

| (1) | Commission Directive 2008/125/EC (2) included tebuconazole as active substance in Annex I to Council Directive 91/414/EEC (3) for use as a fungicide, under the condition that the Member States concerned ensure that the notifiers at whose request tebuconazole was included in that Annex provides further confirmatory information in the form of studies on the risk for birds and mammals. |
| --- | --- |

(1)

Commission Directive 2008/125/EC (2) included tebuconazole as active substance in Annex I to Council Directive 91/414/EEC (3) for use as a fungicide, under the condition that the Member States concerned ensure that the notifiers at whose request tebuconazole was included in that Annex provides further confirmatory information in the form of studies on the risk for birds and mammals.

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
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(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | On 8 April 2010 one of the notifiers at whose request tebuconazole was included in Annex I to Directive 91/414/EEC, submitted an application for an amendment to the conditions of approval of the active substance tebuconazole to allow uses as a plant growth regulator to be authorised without restriction. That application was accompanied by information relating to the requested additional supported use as plant growth regulator in oilseed rape. It was submitted to Denmark, which had been designated rapporteur Member State by Commission Regulation No. 1490/2002 (5). |
| --- | --- |

(3)

On 8 April 2010 one of the notifiers at whose request tebuconazole was included in Annex I to Directive 91/414/EEC, submitted an application for an amendment to the conditions of approval of the active substance tebuconazole to allow uses as a plant growth regulator to be authorised without restriction. That application was accompanied by information relating to the requested additional supported use as plant growth regulator in oilseed rape. It was submitted to Denmark, which had been designated rapporteur Member State by Commission Regulation No. 1490/2002 (5).

| (4) | Denmark assessed the information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 23 July 2012. |
| --- | --- |

(4)

Denmark assessed the information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 23 July 2012.

| (5) | The Commission consulted the Authority which presented its opinion on the risk assessment of tebuconazole on 9 December 2013 (6). The draft assessment report, the addendum and the opinion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised within the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 in the format of the Commission review report for tebuconazole. |
| --- | --- |

(5)

The Commission consulted the Authority which presented its opinion on the risk assessment of tebuconazole on 9 December 2013 (6). The draft assessment report, the addendum and the opinion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised within the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 in the format of the Commission review report for tebuconazole.

| (6) | The Commission invited the notifier to submit its comments on the review report for tebuconazole. |
| --- | --- |

(6)

The Commission invited the notifier to submit its comments on the review report for tebuconazole.

| (7) | The Commission has come to the conclusion that allowing uses as a plant growth regulator to be authorised without restriction does not cause any risks in addition to those already taken into account in the approval of tebuconazole and in the Commission review report for that substance. |
| --- | --- |

(7)

The Commission has come to the conclusion that allowing uses as a plant growth regulator to be authorised without restriction does not cause any risks in addition to those already taken into account in the approval of tebuconazole and in the Commission review report for that substance.

| (8) | It is appropriate to extend the approval of tebuconazole to cover uses as a plant growth regulator without restriction. However, in order to take into account the remaining uncertainty on the potential for groundwater exposure of the metabolite 1,2,4-triazole for the representative spray uses on cereals, as a barley seed treatment and on grapes, Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole. |
| --- | --- |

(8)

It is appropriate to extend the approval of tebuconazole to cover uses as a plant growth regulator without restriction. However, in order to take into account the remaining uncertainty on the potential for groundwater exposure of the metabolite 1,2,4-triazole for the representative spray uses on cereals, as a barley seed treatment and on grapes, Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole.

| (9) | In January 2014, Denmark finalized the evaluation of the confirmatory information as regards the risk to birds and mammals. The Standing Committee on Plants, Animals, Food and Feed agrees that, on the basis of the current outcome, the risk to birds and mammals is acceptable. Therefore, the conclusions of the original risk assessment are not substantially affected by the evaluation of the submitted confirmatory data. No further review by the Authority has been considered necessary. |
| --- | --- |

(9)

In January 2014, Denmark finalized the evaluation of the confirmatory information as regards the risk to birds and mammals. The Standing Committee on Plants, Animals, Food and Feed agrees that, on the basis of the current outcome, the risk to birds and mammals is acceptable. Therefore, the conclusions of the original risk assessment are not substantially affected by the evaluation of the submitted confirmatory data. No further review by the Authority has been considered necessary.

| (10) | The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(10)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Amendment to Regulation (EC) No 540/2011

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

Entry into force

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

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

Done at Brussels, 25 August 2014.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  Commission Directive 2008/125/EC of 19 December 2008 amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (OJ L 344, 20.12.2008, p. 78).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

4

(5)  Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000 (OJ L 224, 21.8.2002, p. 23).

5

(6)  EFSA (European Food Safety Authority), 2013. Conclusion on the peer review of the pesticide risk assessment of the active substance tebuconazole. EFSA Journal 2014;12(1):3485, 98 pp. doi:10.2903/j.efsa.2014.3485.

6

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ANNEX

The column ‘Specific provisions’ of row 268, tebuconazole, of Part A of the Annex to Implementing Regulation (EU) No 540/2011, is replaced by the following:

‘PART A

Only uses as fungicide and plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

| — | the dietary exposure of consumers to the tebuconazole (triazole) metabolites; |
| --- | --- |

—

the dietary exposure of consumers to the tebuconazole (triazole) metabolites;

| — | the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole; |
| --- | --- |

—

the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole;

| — | the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; |
| --- | --- |

—

the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

| — | the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. |
| --- | --- |

—

the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.’

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| 26.8.2014 | EN | Official Journal of the European Union | L 252/6 |
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26.8.2014

EN

Official Journal of the European Union

L 252/6

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COMMISSION IMPLEMENTING REGULATION (EU) No 922/2014

of 25 August 2014

approving the active substance metaflumizone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,

Whereas:

| (1) | In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For metaflumizone the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/517/EC (3). |
| --- | --- |

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For metaflumizone the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/517/EC (3).

| (2) | In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 29 March 2005 an application from BASF SE. for the inclusion of the active substance metaflumizone in Annex I to Directive 91/414/EEC. Decision 2006/517/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. |
| --- | --- |

(2)

In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 29 March 2005 an application from BASF SE. for the inclusion of the active substance metaflumizone in Annex I to Directive 91/414/EEC. Decision 2006/517/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

| (3) | For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 29 March 2005. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 5 July 2011. The evaluation of the additional data by the United Kingdom was submitted in the format of an updated draft assessment report on 8 June 2012. |
| --- | --- |

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 29 March 2005. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 5 July 2011. The evaluation of the additional data by the United Kingdom was submitted in the format of an updated draft assessment report on 8 June 2012.

| (4) | The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance metaflumizone (5) on 13 September 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised within the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 in the format of the Commission review report for metaflumizone. |
| --- | --- |

(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance metaflumizone (5) on 13 September 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised within the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 in the format of the Commission review report for metaflumizone.

| (5) | It has appeared from the various examinations made that plant protection products containing metaflumizone may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve metaflumizone. |
| --- | --- |

(5)

It has appeared from the various examinations made that plant protection products containing metaflumizone may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve metaflumizone.

| (6) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information. |
| --- | --- |

(6)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

| (7) | A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval. |
| --- | --- |

(7)

A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

| (8) | Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing metaflumizone. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles. |
| --- | --- |

(8)

Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing metaflumizone. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

| (9) | The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances. |
| --- | --- |

(9)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

| (10) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (7) should be amended accordingly. |
| --- | --- |

(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (7) should be amended accordingly.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Approval of active substance

The active substance metaflumizone, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Re-evaluation of plant protection products

1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing metaflumizone as an active substance by 30 June 2015.

By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing metaflumizone as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.

Following that determination Member States shall:

| (a) | in the case of a product containing metaflumizone as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2016 at the latest; or |
| --- | --- |

(a)

in the case of a product containing metaflumizone as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2016 at the latest; or

| (b) | in the case of a product containing metaflumizone as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest. |
| --- | --- |

(b)

in the case of a product containing metaflumizone as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

Article 3

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 4

Entry into force and date of application

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

It shall apply from 1 January 2015.

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

Done at Brussels, 25 August 2014.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

2

(3)  Commission Decision 2006/517/EC of 19 July 2006 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of metaflumizone in Annex I to Council Directive 91/414/EEC (OJ L 201, 25.7.2006, p. 34).

3

(4)  Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).

4

(5)  EFSA Journal 2013;11(10):3373. Available online: www.efsa.europa.eu

5

(6)  Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10).

6

(7)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

7

---

ANNEX I

| Common name, identification numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Metaflumizone
  CAS No 139968-49-3
  CIPAC No 779 | (EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide | ≥ 945 g/kg
  (90-100 % E-isomer
  10-0 % Z-isomer)
  The following relevant impurities shall not exceed a certain threshold: | Hydrazine ≤ 1 mg/kg |

Common name, identification numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Metaflumizone

CAS No 139968-49-3

CIPAC No 779

(EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide

≥ 945 g/kg

(90-100 % E-isomer

10-0 % Z-isomer)

The following relevant impurities shall not exceed a certain threshold:

Hydrazine ≤ 1 mg/kg

| | 4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kg |
| --- | --- |

4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kg

| | Toluene ≤ 2 g/kg |
| --- | --- |

Toluene ≤ 2 g/kg

1 January 2015

31 December 2024

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metaflumizone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| (a) | the risk to fish and sediment dwelling organisms; |
| --- | --- |

(a)

the risk to fish and sediment dwelling organisms;

| (b) | the risk to snail- or earthworm-eating birds. |
| --- | --- |

(b)

the risk to snail- or earthworm-eating birds.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

| (1) | the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification; |
| --- | --- |

(1)

the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification;

| (2) | information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains. |
| --- | --- |

(2)

information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 June 2015 and under (2) by 31 December 2016.

---

(1)  Further details on identity and specification of active substance are provided in the review report.

---

ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

| Number | Common name, identification numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘78 | Metaflumizone
  CAS No 139968-49-3
  CIPAC No 779 | (EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide | ≥ 945 g/kg
  (90-100 % E-isomer
  10-0 % Z-isomer)
  The following relevant impurities shall not exceed a certain threshold: | Hydrazine ≤ 1 mg/kg |

Number

Common name, identification numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘78

Metaflumizone

CAS No 139968-49-3

CIPAC No 779

(EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide

≥ 945 g/kg

(90-100 % E-isomer

10-0 % Z-isomer)

The following relevant impurities shall not exceed a certain threshold:

Hydrazine ≤ 1 mg/kg

| | 4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kg |
| --- | --- |

4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kg

| | Toluene ≤ 2 g/kg |
| --- | --- |

Toluene ≤ 2 g/kg

1 January 2015

31 December 2024

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metaflumizone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| (a) | the risk to fish and sediment dwelling organisms; |
| --- | --- |

(a)

the risk to fish and sediment dwelling organisms;

| (b) | the risk to snail- or earthworm-eating birds. |
| --- | --- |

(b)

the risk to snail- or earthworm-eating birds.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

| (1) | the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification; |
| --- | --- |

(1)

the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification;

| (2) | information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains. |
| --- | --- |

(2)

information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 June 2015 and under (2) by 31 December 2016.’

---

(1)  Further details on identity and specification of active substance are provided in the review report.

1

---

| 26.8.2014 | EN | Official Journal of the European Union | L 252/11 |
| --- | --- | --- | --- |

26.8.2014

EN

Official Journal of the European Union

L 252/11

---

COMMISSION REGULATION (EU) No 923/2014

of 25 August 2014

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of aluminium lakes of riboflavins (E 101) and cochineal, carminic acid, carmines (E 120) in certain food categories and Annex to Regulation (EU) No 231/2012 as regards the specifications for riboflavins (E 101)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) and Article 14,

Whereas:

| (1) | Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use. |
| --- | --- |

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

| (2) | Commission Regulation (EU) No 231/2012 (2) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008. |
| --- | --- |

(2)

Commission Regulation (EU) No 231/2012 (2) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.

| (3) | The Union list of food additives and the specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council either on the initiative of the Commission or following an application (3). |
| --- | --- |

(3)

The Union list of food additives and the specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council either on the initiative of the Commission or following an application (3).

| (4) | The European Food Safety Authority (hereinafter: ‘the Authority’), in its opinion of 22 May 2008 (4) recommended to lower the tolerable weekly intake (TWI) for aluminium to 1 mg/kg body weight/week. In addition, the Authority considered that the revised TWI was generally exceeded for high consumers, especially children, in a significant part of the Union. In order to ensure that the revised TWI is not exceeded, the conditions of use and the use levels for food additives containing aluminium, including aluminium lakes were amended by Commission Regulation (EU) No 380/2012 (5). |
| --- | --- |

(4)

The European Food Safety Authority (hereinafter: ‘the Authority’), in its opinion of 22 May 2008 (4) recommended to lower the tolerable weekly intake (TWI) for aluminium to 1 mg/kg body weight/week. In addition, the Authority considered that the revised TWI was generally exceeded for high consumers, especially children, in a significant part of the Union. In order to ensure that the revised TWI is not exceeded, the conditions of use and the use levels for food additives containing aluminium, including aluminium lakes were amended by Commission Regulation (EU) No 380/2012 (5).

| (5) | Regulation (EU) No 380/2012 provides that aluminium lakes prepared from all colours listed in Table 1 of Part B of Annex II to Regulation (EC) No 1333/2008 are authorised until 31 July 2014. From 1 August 2014 only aluminium lakes prepared from the colours listed in Table 3 of Part A of Annex II to Regulation (EC) No 1333/2008 are authorised and only in those food categories where provisions on maximum limits on aluminium coming from lakes are explicitly stated in Part E of that Annex. |
| --- | --- |

(5)

Regulation (EU) No 380/2012 provides that aluminium lakes prepared from all colours listed in Table 1 of Part B of Annex II to Regulation (EC) No 1333/2008 are authorised until 31 July 2014. From 1 August 2014 only aluminium lakes prepared from the colours listed in Table 3 of Part A of Annex II to Regulation (EC) No 1333/2008 are authorised and only in those food categories where provisions on maximum limits on aluminium coming from lakes are explicitly stated in Part E of that Annex.

| (6) | Applications for authorisation of the use of aluminium lakes of riboflavins (E 101) and the extension of use of aluminium lakes of cochineal, carminic acid, carmines (E 120) were submitted in the course of 2013 and have been made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. While considering the applications a special attention was paid to a possible exposure to aluminium in order not to undermine Regulation (EU) No 380/2012. |
| --- | --- |

(6)

Applications for authorisation of the use of aluminium lakes of riboflavins (E 101) and the extension of use of aluminium lakes of cochineal, carminic acid, carmines (E 120) were submitted in the course of 2013 and have been made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. While considering the applications a special attention was paid to a possible exposure to aluminium in order not to undermine Regulation (EU) No 380/2012.

| (7) | In aluminium lakes of colours the dye is rendered insoluble and functions differently to its dye equivalent (e.g. improved light, pH and heat stability, preventing colour bleed and providing a different colour shade to dye colours) making the lake form suitable for certain specific technical applications. |
| --- | --- |

(7)

In aluminium lakes of colours the dye is rendered insoluble and functions differently to its dye equivalent (e.g. improved light, pH and heat stability, preventing colour bleed and providing a different colour shade to dye colours) making the lake form suitable for certain specific technical applications.

| (8) | The authorisation of aluminium lakes of riboflavins provides an alternative to aluminium lakes of other yellow colours in foods in which the use of aluminium lakes is authorised. The use levels requested for aluminium lakes of cochineal, carminic acid, carmines are low and the extension of use is either to niche products or to products which are not consumed by children. A higher use level for pasteurised fish roe is needed due to the heat treatment to guarantee a stable colour during the shelf life of the product. It is not expected that the authorisation of aluminium lakes of riboflavins and the extension of use of aluminium lakes of cochineal, carminic acid, carmines would have a significant impact on the total exposure to aluminium. |
| --- | --- |

(8)

The authorisation of aluminium lakes of riboflavins provides an alternative to aluminium lakes of other yellow colours in foods in which the use of aluminium lakes is authorised. The use levels requested for aluminium lakes of cochineal, carminic acid, carmines are low and the extension of use is either to niche products or to products which are not consumed by children. A higher use level for pasteurised fish roe is needed due to the heat treatment to guarantee a stable colour during the shelf life of the product. It is not expected that the authorisation of aluminium lakes of riboflavins and the extension of use of aluminium lakes of cochineal, carminic acid, carmines would have a significant impact on the total exposure to aluminium.

| (9) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where such update is not liable to have an effect on human health. Since the authorisation of aluminium lakes of riboflavins and the extensions of use of aluminium lakes of cochineal, carminic acid, carmines constitute updates of that list which are not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. |
| --- | --- |

(9)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where such update is not liable to have an effect on human health. Since the authorisation of aluminium lakes of riboflavins and the extensions of use of aluminium lakes of cochineal, carminic acid, carmines constitute updates of that list which are not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority.

| (10) | Annex to Regulation (EU) No 231/2012 stipulates that a colour may be used in the form of aluminium lakes only where explicitly stated. Therefore, the authorisation of aluminium lakes of riboflavins (E 101) requires modification of the specifications for that food additive provided in the Annex to Regulation (EU) No 231/2012 with regard to use of aluminium lakes of colours. |
| --- | --- |

(10)

Annex to Regulation (EU) No 231/2012 stipulates that a colour may be used in the form of aluminium lakes only where explicitly stated. Therefore, the authorisation of aluminium lakes of riboflavins (E 101) requires modification of the specifications for that food additive provided in the Annex to Regulation (EU) No 231/2012 with regard to use of aluminium lakes of colours.

| (11) | Therefore, Annex II to Regulation (EC) No 1333/2008 and Annex to Regulation (EU) No 231/2012 should be amended accordingly. |
| --- | --- |

(11)

Therefore, Annex II to Regulation (EC) No 1333/2008 and Annex to Regulation (EU) No 231/2012 should be amended accordingly.

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

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.

Article 2

Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.

Article 3

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

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

Done at Brussels, 25 August 2014.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 354, 31.12.2008, p. 16.

1

(2)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

2

(3)  Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).

3

(4)  Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC) on Safety of aluminium from dietary intake, (The EFSA Journal (2008) 754, p. 1).

4

The EFSA Journal

(5)  Commission Regulation (EU) No 380/2012 of 3 May 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the conditions of use and the use levels for aluminium-containing food additives (OJ L 119, 4.5.2012, p. 14).

5

---

ANNEX I

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

| (1) | In Part A, in Table 3 the following entry is inserted after the entry for food additive E 100:






  ‘E 101 | Riboflavins’ |
| --- | --- | --- |

(1)

In Part A, in Table 3 the following entry is inserted after the entry for food additive E 100:

‘E 101

Riboflavins’

| (2) | Part E is amended as follows:






  (a) | in category 01.7.2 Ripened cheese:






  (i) | the entry concerning the food additive E 120 is replaced by the following: | ‘E 120 | Cochineal, Carminic acid, Carmines | 125 | (83) | only red marbled cheese’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |

(2)

Part E is amended as follows:

(a)

in category 01.7.2 Ripened cheese:

(i)

the entry concerning the food additive E 120 is replaced by the following:

‘E 120

Cochineal, Carminic acid, Carmines

125

(83)

only red marbled cheese’

| (ii) | the following footnote is added: | | ‘(83): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 3,2 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’ |
| --- | --- | --- | --- | --- |

(ii)

the following footnote is added:

‘(83):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 3,2 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’

| (b) | in category 08.2 Meat preparations as defined by Regulation (EC) No 853/2004:






  (i) | the entry concerning the food additive E 120 is replaced by the following: | ‘E 120 | Cochineal, Carminic acid, Carmines | 100 | (66) | only breakfast sausages with a minimum cereal content of 6 %, burger meat with a minimum vegetable and/or cereal content of 4 % mixed within the meat (in these products, the meat is minced in such a way so that the muscle and fat tissue are completely dispersed, so that fibre makes an emulsion with the fat, giving those products their typical appearance), merguez type products, salsicha fresca, mici, butifarra fresca, longaniza fresca, chorizo fresco, cevapcici and pljeskavice’ |
| --- | --- | --- | --- | --- | --- | --- | --- |

(b)

in category 08.2 Meat preparations as defined by Regulation (EC) No 853/2004:

(i)

the entry concerning the food additive E 120 is replaced by the following:

‘E 120

Cochineal, Carminic acid, Carmines

100

(66)

only breakfast sausages with a minimum cereal content of 6 %, burger meat with a minimum vegetable and/or cereal content of 4 % mixed within the meat (in these products, the meat is minced in such a way so that the muscle and fat tissue are completely dispersed, so that fibre makes an emulsion with the fat, giving those products their typical appearance), merguez type products, salsicha fresca, mici, butifarra fresca, longaniza fresca, chorizo fresco, cevapcici and pljeskavice’

| (ii) | the following footnote is added: | | ‘(66): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’ |
| --- | --- | --- | --- | --- |

(ii)

the following footnote is added:

‘(66):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’

| (c) | in category 09.2 Processed fish and fishery products including molluscs and crustaceans:






  (i) | the entry concerning Group III is replaced by the following: | ‘Group III | Colours with combined maximum limit | 500 | (84) | only surimi and similar products and salmon substitutes’ |
| --- | --- | --- | --- | --- | --- | --- | --- |

(c)

in category 09.2 Processed fish and fishery products including molluscs and crustaceans:

(i)

the entry concerning Group III is replaced by the following:

‘Group III

Colours with combined maximum limit

500

(84)

only surimi and similar products and salmon substitutes’

| (ii) | the first entry concerning the food additive E 120 is replaced by the following: | ‘E 120 | Cochineal, Carminic acid, Carmines | 100 | (35) (85) | only fish paste and crustacean paste’ |
| --- | --- | --- | --- | --- | --- | --- |

(ii)

the first entry concerning the food additive E 120 is replaced by the following:

‘E 120

Cochineal, Carminic acid, Carmines

100

(35) (85)

only fish paste and crustacean paste’

| (iii) | the following footnotes are added: | | ‘(84): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 4 mg/kg. As a derogation to this rule, the maximum limit only for salmon substitutes shall be 5,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013. |
| --- | --- | --- | --- | --- |

(iii)

the following footnotes are added:

‘(84):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 4 mg/kg. As a derogation to this rule, the maximum limit only for salmon substitutes shall be 5,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.

| (85): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 2 mg/kg only in fish paste. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’ |
| --- | --- |

(85):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 2 mg/kg only in fish paste. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’

| (d) | in category 09.3 Fish roe:






  (i) | the entry concerning Group III is replaced by the following: | ‘Group III | Colours with combined maximum limit | 300 | (86) | except Sturgeons' eggs (Caviar)’ |
| --- | --- | --- | --- | --- | --- | --- | --- |

(d)

in category 09.3 Fish roe:

(i)

the entry concerning Group III is replaced by the following:

‘Group III

Colours with combined maximum limit

300

(86)

except Sturgeons' eggs (Caviar)’

| (ii) | the following footnote is added: | | ‘(86): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 3 mg/kg. As a derogation to this rule, the maximum limit only for pasteurised products shall be 50 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’ |
| --- | --- | --- | --- | --- |

(ii)

the following footnote is added:

‘(86):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 3 mg/kg. As a derogation to this rule, the maximum limit only for pasteurised products shall be 50 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’

| (e) | in category 14.2.6 Spirit drinks as defined in Regulation (EC) No 110/2008:






  (i) | the entry concerning Group III is replaced by the following: | ‘Group III | Colours with combined maximum limit | 200 | (87) | except: spirit drinks as defined in Article 5(1) and sales denominations listed in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 and spirits (preceded by the name of the fruit) obtained by maceration and distillation, Geist (with the name of the fruit or the raw material used), London Gin, Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà’ |
| --- | --- | --- | --- | --- | --- | --- | --- |

(e)

in category 14.2.6 Spirit drinks as defined in Regulation (EC) No 110/2008:

(i)

the entry concerning Group III is replaced by the following:

‘Group III

Colours with combined maximum limit

200

(87)

except: spirit drinks as defined in Article 5(1) and sales denominations listed in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 and spirits (preceded by the name of the fruit) obtained by maceration and distillation, Geist (with the name of the fruit or the raw material used), London Gin, Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà’

| (ii) | the following footnote is added: | | ‘(87): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’ |
| --- | --- | --- | --- | --- |

(ii)

the following footnote is added:

‘(87):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’

| (f) | in category 14.2.7.1 Aromatised wines:






  (i) | the entry concerning the additive E 120 is replaced by the following: | ‘E 120 | Cochineal, Carminic acid, Carmines | 100 | (26) (27) (87) | only americano, bitter vino’ |
| --- | --- | --- | --- | --- | --- | --- | --- |

(f)

in category 14.2.7.1 Aromatised wines:

(i)

the entry concerning the additive E 120 is replaced by the following:

‘E 120

Cochineal, Carminic acid, Carmines

100

(26) (27) (87)

only americano, bitter vino’

| (ii) | the following footnote is added: | | ‘(87): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’ |
| --- | --- | --- | --- | --- |

(ii)

the following footnote is added:

‘(87):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’

| (g) | in category 14.2.7.2 Aromatised wine-based drinks:






  (i) | the entry concerning the additive E 120 is replaced by the following: | ‘E 120 | Cochineal, Carminic acid, Carmines | 100 | (28) (87) | only bitter soda’ |
| --- | --- | --- | --- | --- | --- | --- | --- |

(g)

in category 14.2.7.2 Aromatised wine-based drinks:

(i)

the entry concerning the additive E 120 is replaced by the following:

‘E 120

Cochineal, Carminic acid, Carmines

100

(28) (87)

only bitter soda’

| (ii) | the following footnote is added: | | ‘(87): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’ |
| --- | --- | --- | --- | --- |

(ii)

the following footnote is added:

‘(87):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’

| (h) | in category 14.2.7.3 Aromatised wine-product cocktails:






  (i) | the entry concerning Group III is replaced by the following: | ‘Group III | Colours with combined maximum limit | 200 | (87)’ | |
| --- | --- | --- | --- | --- | --- | --- | --- |

(h)

in category 14.2.7.3 Aromatised wine-product cocktails:

(i)

the entry concerning Group III is replaced by the following:

‘Group III

Colours with combined maximum limit

200

(87)’

| (ii) | the following footnote is added: | | ‘(87): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’ |
| --- | --- | --- | --- | --- |

(ii)

the following footnote is added:

‘(87):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’

| (i) | In category 14.2.8 Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol:






  (i) | the entry concerning Group III is replaced by the following: | ‘Group III | Colours with combined maximum limit | 200 | (87) | only alcoholic drinks with less than 15 % of alcohol and nalewka na winie owocowym, aromatyzowana nalewka na winie owocowym, nalewka na winie z soku winogronowego, aromatyzowana nalewka na winie z soku winogronowego, napój winny owocowy lub miodowy, aromatyzowany napój winny owocowy lub miodowy, wino owocowe niskoalkoholowe and aromatyzowane wino owocowe niskoalkoholowe’ |
| --- | --- | --- | --- | --- | --- | --- | --- |

(i)

In category 14.2.8 Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol:

(i)

the entry concerning Group III is replaced by the following:

‘Group III

Colours with combined maximum limit

200

(87)

only alcoholic drinks with less than 15 % of alcohol and nalewka na winie owocowym, aromatyzowana nalewka na winie owocowym, nalewka na winie z soku winogronowego, aromatyzowana nalewka na winie z soku winogronowego, napój winny owocowy lub miodowy, aromatyzowany napój winny owocowy lub miodowy, wino owocowe niskoalkoholowe and aromatyzowane wino owocowe niskoalkoholowe’

| (ii) | the following footnote is added: | | ‘(87): | Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’ |
| --- | --- | --- | --- | --- |

(ii)

the following footnote is added:

‘(87):

Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.’

---

ANNEX II

Annex to Regulation (EU) No 231/2012 is amended as follows:

| (1) | The following sentence is inserted at the end of the entry for additive E 101 (i) RIBOFLAVIN:
  ‘Aluminium lakes of this colour may be used.’ |
| --- | --- |

(1)

The following sentence is inserted at the end of the entry for additive E 101 (i) RIBOFLAVIN:

‘Aluminium lakes of this colour may be used.’

| (2) | The following sentence is inserted at the end of the entry for additive E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE:
  ‘Aluminium lakes of this colour may be used.’ |
| --- | --- |

(2)

The following sentence is inserted at the end of the entry for additive E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE:

‘Aluminium lakes of this colour may be used.’

---

| 26.8.2014 | EN | Official Journal of the European Union | L 252/18 |
| --- | --- | --- | --- |

26.8.2014

EN

Official Journal of the European Union

L 252/18

---

COMMISSION IMPLEMENTING REGULATION (EU) No 924/2014

of 25 August 2014

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

THE EUROPEAN COMMISSION,

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

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

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

Whereas:

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

(1)

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

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

Done at Brussels, 25 August 2014.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

---

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

1

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

2

---

ANNEX

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

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0707 00 05 | TR | 81,4 |
| ZZ | 81,4 |
| 0709 93 10 | TR | 105,1 |
| ZZ | 105,1 |
| 0805 50 10 | AR | 174,9 |
| TR | 83,0 |
| UY | 161,7 |
| ZA | 185,3 |
| ZZ | 151,2 |
| 0806 10 10 | BR | 181,8 |
| CL | 73,7 |
| EG | 200,2 |
| MA | 170,3 |
| TR | 133,7 |
| ZA | 315,5 |
| ZZ | 179,2 |
| 0808 10 80 | AR | 83,7 |
| BR | 64,4 |
| CL | 93,8 |
| CN | 120,5 |
| NZ | 125,0 |
| PE | 21,0 |
| US | 131,3 |
| ZA | 87,8 |
| ZZ | 90,9 |
| 0808 30 90 | AR | 40,6 |
| CL | 77,3 |
| TR | 124,4 |
| ZA | 62,6 |
| ZZ | 76,2 |
| 0809 30 | MK | 68,0 |
| TR | 121,2 |
| ZZ | 94,6 |
| 0809 40 05 | BA | 36,8 |
| ZA | 206,3 |
| ZZ | 121,6 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0707 00 05

TR

81,4

ZZ

81,4

0709 93 10

TR

105,1

ZZ

105,1

0805 50 10

AR

174,9

TR

83,0

UY

161,7

ZA

185,3

ZZ

151,2

0806 10 10

BR

181,8

CL

73,7

EG

200,2

MA

170,3

TR

133,7

ZA

315,5

ZZ

179,2

0808 10 80

AR

83,7

BR

64,4

CL

93,8

CN

120,5

NZ

125,0

PE

21,0

US

131,3

ZA

87,8

ZZ

90,9

0808 30 90

AR

40,6

CL

77,3

TR

124,4

ZA

62,6

ZZ

76,2

0809 30

MK

68,0

TR

121,2

ZZ

94,6

0809 40 05

BA

36,8

ZA

206,3

ZZ

121,6

---

(1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.

---