# Official Journal L 279/2013

| | ISSN 1977-0677
  doi:10.3000/19770677.L_2013.279.eng |
| --- | --- |
| Official Journal
  of the European Union | L 279 |
| | |
| English edition | Legislation | Volume 5619 October 2013 |

ISSN 1977-0677

doi:10.3000/19770677.L_2013.279.eng

Official Journal

of the European Union

L 279

English edition

Legislation

Volume 5619 October 2013

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Information on the entry into force of the Fisheries Partnership Agreement between the Gabonese Republic and the European Community | 1 |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) No 1002/2013 of 12 July 2013 amending Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories with regard to the list of exempted entities (
  1
  ) | 2 |
| | * | Commission Delegated Regulation (EU) No 1003/2013 of 12 July 2013 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to fees charged by the European Securities and Markets Authority to trade repositories (
  1
  ) | 4 |
| | * | Commission Regulation (EU) No 1004/2013 of 15 October 2013 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 8-hydroxyquinoline, cyproconazole, cyprodinil, fluopyram, nicotine, pendimethalin, penthiopyrad and trifloxystrobin in or on certain products (
  1
  ) | 10 |
| | * | Commission Implementing Regulation (EU) No 1005/2013 of 17 October 2013 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [Emmental français est-central (PGI)] | 57 |
| | * | Commission Implementing Regulation (EU) No 1006/2013 of 18 October 2013 concerning the authorisation of L-cystine as a feed additive for all animal species (
  1
  ) | 59 |
| | * | Commission Implementing Regulation (EU) No 1007/2013 of 18 October 2013 adding to the 2013/14 fishing quotas of anchovy in the Bay of Biscay the quantities withheld by France and Spain in the fishing season 2012/13 pursuant to Article 4(2) of Council Regulation (EC) No 847/96 | 61 |
| | | Commission Implementing Regulation (EU) No 1008/2013 of 18 October 2013 establishing the standard import values for determining the entry price of certain fruit and vegetables | 63 |
| | | Commission Implementing Regulation (EU) No 1009/2013 of 18 October 2013 fixing the allocation coefficient to be applied to applications for import licences for olive oil lodged from 14 to 15 October 2013 under the Tunisian tariff quota and suspending the issue of import licences for the month of October 2013 | 65 |
| | | DECISIONS |
| | | 2013/511/CFSP |
| | * | Political and Security Committee Decision EUPOL RD Congo/1/2013 of 8 October 2013 extending the mandate of the Head of Mission of the European Union police mission undertaken in the framework of reform of the security sector (SSR) and its interface with the system of justice in the Democratic Republic of the Congo (EUPOL RD Congo) | 66 |
| | | 2013/512/EU |
| | * | Commission Implementing Decision of 17 October 2013 concerning a financial contribution by the Union to certain Member States to support voluntary surveillance studies on honeybee colony losses for the season 2013–2014
  (notified under document C(2013) 6742) | 67 |
| | | ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS |
| | | 2013/513/EU |
| | * | Decision No 1/2013 of the EU-Monaco Joint Committee established under the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco of 12 July 2013 amending the Annex to the Agreement | 73 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Information on the entry into force of the Fisheries Partnership Agreement between the Gabonese Republic and the European Community

1

REGULATIONS

*

Commission Delegated Regulation (EU) No 1002/2013 of 12 July 2013 amending Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories with regard to the list of exempted entities (
  1
  )

1

2

*

Commission Delegated Regulation (EU) No 1003/2013 of 12 July 2013 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to fees charged by the European Securities and Markets Authority to trade repositories (
  1
  )

1

4

*

Commission Regulation (EU) No 1004/2013 of 15 October 2013 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 8-hydroxyquinoline, cyproconazole, cyprodinil, fluopyram, nicotine, pendimethalin, penthiopyrad and trifloxystrobin in or on certain products (
  1
  )

1

10

*

Commission Implementing Regulation (EU) No 1005/2013 of 17 October 2013 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [Emmental français est-central (PGI)]

57

*

Commission Implementing Regulation (EU) No 1006/2013 of 18 October 2013 concerning the authorisation of L-cystine as a feed additive for all animal species (
  1
  )

1

59

*

Commission Implementing Regulation (EU) No 1007/2013 of 18 October 2013 adding to the 2013/14 fishing quotas of anchovy in the Bay of Biscay the quantities withheld by France and Spain in the fishing season 2012/13 pursuant to Article 4(2) of Council Regulation (EC) No 847/96

61

Commission Implementing Regulation (EU) No 1008/2013 of 18 October 2013 establishing the standard import values for determining the entry price of certain fruit and vegetables

63

Commission Implementing Regulation (EU) No 1009/2013 of 18 October 2013 fixing the allocation coefficient to be applied to applications for import licences for olive oil lodged from 14 to 15 October 2013 under the Tunisian tariff quota and suspending the issue of import licences for the month of October 2013

65

DECISIONS

2013/511/CFSP

*

Political and Security Committee Decision EUPOL RD Congo/1/2013 of 8 October 2013 extending the mandate of the Head of Mission of the European Union police mission undertaken in the framework of reform of the security sector (SSR) and its interface with the system of justice in the Democratic Republic of the Congo (EUPOL RD Congo)

66

2013/512/EU

*

Commission Implementing Decision of 17 October 2013 concerning a financial contribution by the Union to certain Member States to support voluntary surveillance studies on honeybee colony losses for the season 2013–2014
  (notified under document C(2013) 6742)

(notified under document C(2013) 6742)

67

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

2013/513/EU

*

Decision No 1/2013 of the EU-Monaco Joint Committee established under the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco of 12 July 2013 amending the Annex to the Agreement

73

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

---

(1)   Text with EEA relevance

1

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

EN

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

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

---

II Non-legislative acts

INTERNATIONAL AGREEMENTS

| 19.10.2013 | EN | Official Journal of the European Union | L 279/1 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/1

---

Information on the entry into force of the Fisheries Partnership Agreement between the Gabonese Republic and the European Community

The European Union and the Gabonese Republic signed, on 6 June 2007, in Brussels, a Fisheries Partnership Agreement between the Gabonese Republic and the European Community (1).

The European Community notified on that same day that it had completed the necessary internal procedures to conclude the agreement. The Gabonese Republic notified on 11 June 2007.

The Protocol accordingly entered into force on 11 June 2007 pursuant to Article 17 thereof.

---

(1)  OJ L 109, 26.4.2007, p. 3.

---

REGULATIONS

| 19.10.2013 | EN | Official Journal of the European Union | L 279/2 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/2

---

COMMISSION DELEGATED REGULATION (EU) No 1002/2013

of 12 July 2013

amending Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories with regard to the list of exempted entities

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (1), and in particular Article 1(6) thereof,

Whereas:

| (1) | The Commission has assessed the international treatment of public bodies charged with or intervening in the management of public debt and central banks and presented its conclusions to the European Parliament and the Council (2). In particular, the Commission has conducted a comparative analysis of the treatment of such public bodies and central banks in the legal orders of a significant number of third countries, as well as of the risk-management standards applicable to the derivative transactions entered into by those bodies and by central banks in those jurisdictions. |
| --- | --- |

(1)

The Commission has assessed the international treatment of public bodies charged with or intervening in the management of public debt and central banks and presented its conclusions to the European Parliament and the Council (2). In particular, the Commission has conducted a comparative analysis of the treatment of such public bodies and central banks in the legal orders of a significant number of third countries, as well as of the risk-management standards applicable to the derivative transactions entered into by those bodies and by central banks in those jurisdictions.

| (2) | Following this analysis, the Commission concluded that central banks and public bodies charged with or intervening in the management of public debt should be exempted from the clearing and reporting obligation applicable to over-the-counter (OTC) derivatives pursuant to the rules on OTC derivatives introduced in Japan and the United States of America. |
| --- | --- |

(2)

Following this analysis, the Commission concluded that central banks and public bodies charged with or intervening in the management of public debt should be exempted from the clearing and reporting obligation applicable to over-the-counter (OTC) derivatives pursuant to the rules on OTC derivatives introduced in Japan and the United States of America.

| (3) | Adding central banks and public bodies charged with or intervening in the management of the public debt from Japan and from the United States of America to the list of exempted entities referred to in Regulation (EU) No 648/2012 should promote neutral market conditions in the application of OTC derivatives reforms with regard to transactions with central banks across those jurisdictions and contribute to greater international coherence and consistency. |
| --- | --- |

(3)

Adding central banks and public bodies charged with or intervening in the management of the public debt from Japan and from the United States of America to the list of exempted entities referred to in Regulation (EU) No 648/2012 should promote neutral market conditions in the application of OTC derivatives reforms with regard to transactions with central banks across those jurisdictions and contribute to greater international coherence and consistency.

| (4) | The exercise of monetary responsibilities and the management of sovereign debt have a combined impact on the functioning of interest rate markets and should be coordinated to ensure that these two functions are performed efficiently. As Regulation (EU) No 648/2012 excludes from its scope Union central banks and other Union public bodies managing debt so as not to impede their ability to perform tasks of common interest, the application of different rules to such functions when they are exercised by third-country entities would be detrimental to their effectiveness. In order to ensure that third country central banks and other public bodies charged with or intervening in the management of the public debt continue to be in a position to perform their tasks adequately, third-country public bodies charged with or intervening in the management of the public debt should also be exempted from Regulation (EU) No 648/2012, |
| --- | --- |

(4)

The exercise of monetary responsibilities and the management of sovereign debt have a combined impact on the functioning of interest rate markets and should be coordinated to ensure that these two functions are performed efficiently. As Regulation (EU) No 648/2012 excludes from its scope Union central banks and other Union public bodies managing debt so as not to impede their ability to perform tasks of common interest, the application of different rules to such functions when they are exercised by third-country entities would be detrimental to their effectiveness. In order to ensure that third country central banks and other public bodies charged with or intervening in the management of the public debt continue to be in a position to perform their tasks adequately, third-country public bodies charged with or intervening in the management of the public debt should also be exempted from Regulation (EU) No 648/2012,

HAS ADOPTED THIS REGULATION:

Article 1

In Article 1(4) of Regulation (EU) No 648/2012, the following point (c) is added:

| ‘(c) | the central banks and public bodies charged with or intervening in the management of the public debt in the following countries:






  (i) | Japan; |
| --- | --- | --- |

‘(c)

the central banks and public bodies charged with or intervening in the management of the public debt in the following countries:

(i)

Japan;

| (ii) | United States of America.’. |
| --- | --- |

(ii)

United States of America.’.

Article 2

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

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

Done at Brussels, 12 July 2013.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 201, 27.7.2012, p. 1.

1

(2)  COM(2013) 158 final.

2

---

| 19.10.2013 | EN | Official Journal of the European Union | L 279/4 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/4

---

COMMISSION DELEGATED REGULATION (EU) No 1003/2013

of 12 July 2013

supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to fees charged by the European Securities and Markets Authority to trade repositories

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (1), and in particular Article 72(3) thereof,

Whereas:

| (1) | Article 62 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (2) provides that the revenues of the European Securities and Markets Authority (ESMA) consist of fees paid to ESMA in the cases specified in Union legislation, together with contributions from national public authorities and a subsidy from the Union. |
| --- | --- |

(1)

Article 62 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (2) provides that the revenues of the European Securities and Markets Authority (ESMA) consist of fees paid to ESMA in the cases specified in Union legislation, together with contributions from national public authorities and a subsidy from the Union.

| (2) | A registration fee should be charged to trade repositories established in the Union to reflect ESMA’s costs for processing the application for registration. The costs associated with assessing the application increase where a trade repository intends to cover at least three derivative classes or to offer ancillary services. Therefore, the registration fee should be calculated with regard to these two objective criteria. |
| --- | --- |

(2)

A registration fee should be charged to trade repositories established in the Union to reflect ESMA’s costs for processing the application for registration. The costs associated with assessing the application increase where a trade repository intends to cover at least three derivative classes or to offer ancillary services. Therefore, the registration fee should be calculated with regard to these two objective criteria.

| (3) | The provision of ancillary services and of reporting services in more than three derivative classes are also expected to have a direct impact on the future turnover of the trade repository. Therefore, for the purpose of charging registration fees, trade repositories should be classified into three different categories of expected total turnover (high, medium and low expected total turnover), to which different registration fees should apply, depending on whether they intend to provide ancillary services or reporting services in more than three derivative classes, or both. |
| --- | --- |

(3)

The provision of ancillary services and of reporting services in more than three derivative classes are also expected to have a direct impact on the future turnover of the trade repository. Therefore, for the purpose of charging registration fees, trade repositories should be classified into three different categories of expected total turnover (high, medium and low expected total turnover), to which different registration fees should apply, depending on whether they intend to provide ancillary services or reporting services in more than three derivative classes, or both.

| (4) | If, after registration, a trade repository starts offering ancillary services or starts operating in more than three derivative classes, thereby falling into an upper category in terms of expected total turnover, the trade repository should pay the difference between the registration fee initially paid and the registration fee corresponding to the new category of expected total turnover in which it falls. |
| --- | --- |

(4)

If, after registration, a trade repository starts offering ancillary services or starts operating in more than three derivative classes, thereby falling into an upper category in terms of expected total turnover, the trade repository should pay the difference between the registration fee initially paid and the registration fee corresponding to the new category of expected total turnover in which it falls.

| (5) | In order to discourage unfounded applications, registration fees should not be reimbursed if an applicant withdraws its application during the registration process, nor if registration is refused. |
| --- | --- |

(5)

In order to discourage unfounded applications, registration fees should not be reimbursed if an applicant withdraws its application during the registration process, nor if registration is refused.

| (6) | To ensure an efficient use of ESMA’s budget and, at the same time, alleviate the financial burden on Member States and the Union, it is necessary to ensure that trade repositories pay at least all the costs related to their supervision. Fees should be set at a level such as to avoid a significant accumulation of deficit or surplus for activities related to trade repositories. If significant deficits or surplus become recurrent, the Commission should revise the level of the fees and charges. |
| --- | --- |

(6)

To ensure an efficient use of ESMA’s budget and, at the same time, alleviate the financial burden on Member States and the Union, it is necessary to ensure that trade repositories pay at least all the costs related to their supervision. Fees should be set at a level such as to avoid a significant accumulation of deficit or surplus for activities related to trade repositories. If significant deficits or surplus become recurrent, the Commission should revise the level of the fees and charges.

| (7) | In order to ensure a fair and clear allocation of fees which, at the same time, reflects the actual administrative effort devoted to each supervised entity, the supervisory fee should be calculated on the basis of the turnover generated by a trade repository’s core activities. The supervisory fees charged to a trade repository should be proportionate to the activity of that individual trade repository compared to the total activity of all registered and supervised trade repositories within a given financial year. However, given that there are some fixed administrative costs for the supervision of trade repositories, a minimum supervisory fee should be established. |
| --- | --- |

(7)

In order to ensure a fair and clear allocation of fees which, at the same time, reflects the actual administrative effort devoted to each supervised entity, the supervisory fee should be calculated on the basis of the turnover generated by a trade repository’s core activities. The supervisory fees charged to a trade repository should be proportionate to the activity of that individual trade repository compared to the total activity of all registered and supervised trade repositories within a given financial year. However, given that there are some fixed administrative costs for the supervision of trade repositories, a minimum supervisory fee should be established.

| (8) | As only limited data will be available regarding the activity of a trade repository in the year in which it is registered, the initial annual supervisory fee should be calculated on the basis of the registration fee and the supervisory effort ESMA has put into supervising that trade repository that year. |
| --- | --- |

(8)

As only limited data will be available regarding the activity of a trade repository in the year in which it is registered, the initial annual supervisory fee should be calculated on the basis of the registration fee and the supervisory effort ESMA has put into supervising that trade repository that year.

| (9) | Trade repositories are relatively new entities that provide new regulated financial services and therefore a reliable measure of their turnover does not yet exist. Nonetheless, in order to estimate the trade repositories’ turnover, several indicators should be taken into account, in particular the trade repositories’ core financial revenues generated from centrally collecting and maintaining records of derivatives, excluding any revenues arising from ancillary services, the number of trades reported for a certain period and the number of trades outstanding at the end of each period. In the first year of operation of the trade repository, the supervisory fee should correspond to the supervisory effort carried out by ESMA for its supervision since the date of registration until the end of the year, on the basis of registration fees determined according to the expected total turnover level. |
| --- | --- |

(9)

Trade repositories are relatively new entities that provide new regulated financial services and therefore a reliable measure of their turnover does not yet exist. Nonetheless, in order to estimate the trade repositories’ turnover, several indicators should be taken into account, in particular the trade repositories’ core financial revenues generated from centrally collecting and maintaining records of derivatives, excluding any revenues arising from ancillary services, the number of trades reported for a certain period and the number of trades outstanding at the end of each period. In the first year of operation of the trade repository, the supervisory fee should correspond to the supervisory effort carried out by ESMA for its supervision since the date of registration until the end of the year, on the basis of registration fees determined according to the expected total turnover level.

| (10) | Trade repositories registered in 2013 will not start providing reporting services before the end of 2013 and their level of activity in 2013 is likely to be almost non-existent. Therefore, their annual supervisory fee for 2014 should be calculated on the basis of their applicable turnover during the first half of 2014. |
| --- | --- |

(10)

Trade repositories registered in 2013 will not start providing reporting services before the end of 2013 and their level of activity in 2013 is likely to be almost non-existent. Therefore, their annual supervisory fee for 2014 should be calculated on the basis of their applicable turnover during the first half of 2014.

| (11) | In view of the nascent stage of the trade repositories industry and possible future developments, the method of calculating the turnover of trade repositories should be reviewed if necessary. The Commission should assess the appropriateness of the methodology for the calculation of turnover set out in this Regulation within four years of the entry into force of this Regulation. |
| --- | --- |

(11)

In view of the nascent stage of the trade repositories industry and possible future developments, the method of calculating the turnover of trade repositories should be reviewed if necessary. The Commission should assess the appropriateness of the methodology for the calculation of turnover set out in this Regulation within four years of the entry into force of this Regulation.

| (12) | Rules should be provided for fees to be charged to third country trade repositories that apply for recognition in the Union pursuant to the relevant provisions of Regulation (EU) No 648/2012, in order to cover recognition and annual supervisory administrative costs. In this regard, ESMA’s costs are based on the necessary expenditure relating to the recognition of such third country trade repositories pursuant to Article 77(2) of that Regulation, the conclusion of cooperation arrangements with the competent authorities of the third country where the applicant trade repository is registered pursuant to Article 75(3) of that Regulation, and the supervision of recognised trade repositories. The costs associated with the conclusion of cooperation arrangements will be shared among the trade repositories recognised from the same third country. |
| --- | --- |

(12)

Rules should be provided for fees to be charged to third country trade repositories that apply for recognition in the Union pursuant to the relevant provisions of Regulation (EU) No 648/2012, in order to cover recognition and annual supervisory administrative costs. In this regard, ESMA’s costs are based on the necessary expenditure relating to the recognition of such third country trade repositories pursuant to Article 77(2) of that Regulation, the conclusion of cooperation arrangements with the competent authorities of the third country where the applicant trade repository is registered pursuant to Article 75(3) of that Regulation, and the supervision of recognised trade repositories. The costs associated with the conclusion of cooperation arrangements will be shared among the trade repositories recognised from the same third country.

| (13) | The supervisory functions exercised by ESMA in respect of recognised third country trade repositories mainly relate to the implementation of cooperation arrangements, including the effective exchange of data between relevant authorities. The cost of providing those functions should be covered by supervisory fees charged to recognised trade repositories. As those costs will be much lower than the costs incurred by ESMA for providing direct supervision of registered trade repositories in the Union, the supervisory fees for recognised trade repositories should be significantly lower than the minimum supervisory fee charged to registered trade repositories directly supervised by ESMA. |
| --- | --- |

(13)

The supervisory functions exercised by ESMA in respect of recognised third country trade repositories mainly relate to the implementation of cooperation arrangements, including the effective exchange of data between relevant authorities. The cost of providing those functions should be covered by supervisory fees charged to recognised trade repositories. As those costs will be much lower than the costs incurred by ESMA for providing direct supervision of registered trade repositories in the Union, the supervisory fees for recognised trade repositories should be significantly lower than the minimum supervisory fee charged to registered trade repositories directly supervised by ESMA.

| (14) | In view of possible future developments, it is appropriate that the methodology for the calculation of the applicable turnover, as well as the level of registration, recognition and supervision fees be reviewed and updated when necessary. |
| --- | --- |

(14)

In view of possible future developments, it is appropriate that the methodology for the calculation of the applicable turnover, as well as the level of registration, recognition and supervision fees be reviewed and updated when necessary.

| (15) | National competent authorities incur costs when carrying out work pursuant to Regulation (EU) No 648/2012 and, in particular as a result of any delegation of tasks in accordance with Article 74 of Regulation (EU) No 648/2012. The fees charged by ESMA to trade repositories should also cover those costs. In order to avoid competent authorities incurring a loss or profit from carrying out delegated tasks or from assisting ESMA, ESMA should reimburse only the actual costs incurred by that national competent authority. |
| --- | --- |

(15)

National competent authorities incur costs when carrying out work pursuant to Regulation (EU) No 648/2012 and, in particular as a result of any delegation of tasks in accordance with Article 74 of Regulation (EU) No 648/2012. The fees charged by ESMA to trade repositories should also cover those costs. In order to avoid competent authorities incurring a loss or profit from carrying out delegated tasks or from assisting ESMA, ESMA should reimburse only the actual costs incurred by that national competent authority.

| (16) | This Regulation should form the basis for ESMA’s right to charge fees to trade repositories. In order to immediately facilitate effective and efficient supervisory and enforcement activity, it should enter into force on the third day following that of its publication, |
| --- | --- |

(16)

This Regulation should form the basis for ESMA’s right to charge fees to trade repositories. In order to immediately facilitate effective and efficient supervisory and enforcement activity, it should enter into force on the third day following that of its publication,

HAS ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Regulation lays down rules on the fees that the European Securities and Markets Authority (ESMA) shall charge trade repositories for their registration, supervision and recognition.

Article 2

Recovery of supervisory costs in full

The fees charged to trade repositories shall cover:

| (a) | all costs relating to the registration and supervision of trade repositories by ESMA in accordance with Regulation (EU) No 648/2012, including those costs resulting from the recognition of trade repositories; |
| --- | --- |

(a)

all costs relating to the registration and supervision of trade repositories by ESMA in accordance with Regulation (EU) No 648/2012, including those costs resulting from the recognition of trade repositories;

| (b) | all costs for the reimbursement of competent authorities that have carried out work pursuant to Regulation (EU) No 648/2012, in particular as a result of any delegation of tasks in accordance with Article 74 of Regulation (EU) No 648/2012. |
| --- | --- |

(b)

all costs for the reimbursement of competent authorities that have carried out work pursuant to Regulation (EU) No 648/2012, in particular as a result of any delegation of tasks in accordance with Article 74 of Regulation (EU) No 648/2012.

Article 3

Applicable turnover

1.   The applicable turnover of a trade repository for a given financial year (n) shall be the sum of one third of each of the following:

| (a) | the revenues generated from the core functions of centrally collecting and maintaining records of derivatives of the trade repository on the basis of the audited accounts of the previous year (n-1), divided by the total revenues generated from the core functions of centrally collecting and maintaining records of derivatives of all registered trade repositories during the previous year (n-1); |
| --- | --- |

(a)

the revenues generated from the core functions of centrally collecting and maintaining records of derivatives of the trade repository on the basis of the audited accounts of the previous year (n-1), divided by the total revenues generated from the core functions of centrally collecting and maintaining records of derivatives of all registered trade repositories during the previous year (n-1);

| (b) | the number of trades reported to the trade repository during the previous year (n-1), divided by the total number of trades reported to all registered trade repositories during the previous year (n-1); |
| --- | --- |

(b)

the number of trades reported to the trade repository during the previous year (n-1), divided by the total number of trades reported to all registered trade repositories during the previous year (n-1);

| (c) | the number of recorded outstanding trades on 31 December of the previous year (n-1), divided by the total number of recorded outstanding trades on 31 December of the previous year (n-1) in all registered trade repositories. |
| --- | --- |

(c)

the number of recorded outstanding trades on 31 December of the previous year (n-1), divided by the total number of recorded outstanding trades on 31 December of the previous year (n-1) in all registered trade repositories.

The applicable turnover of a given trade repository (‘TRi’ in the formula below) as referred to in the first subparagraph shall be calculated as follows:

Formula

2.   Where the trade repository did not operate during the full year (n-1), the applicable turnover shall be estimated according to the formula set out in paragraph 1 by extrapolating for the trade repository, and for each of the elements referred to in points (a), (b) and (c) of paragraph 1, the values calculated for the number of months during which the trade repository operated in year (n-1) to the whole year (n-1).

Article 4

Adjustment of fees

1.   Fees charged to trade repositories shall be set at a level such as to avoid a significant accumulation of deficit or surplus.

Where there is a recurrent significant surplus or deficit, the Commission shall revise the level of fees.

2.   Where the fees charged to trade repositories in year (n) are insufficient to cover ESMA’s total necessary expenditure for registration, supervision and recognition of trade repositories, ESMA shall increase in year (n+1) the supervisory fees to be charged to the trade repositories that were registered during the full year (n) and are still registered in year (n+1) by the necessary amount.

3.   The adjustment of fees for deficits covered by paragraph 2 shall be calculated for each individual trade repository in proportion to its applicable turnover in year (n).

CHAPTER II

FEES

Article 5

Types of fees

1.   Trade repositories established in the Union that apply for registration in accordance with Article 55(1) of Regulation (EU) No 648/2012 shall be charged the following types of fees:

| (a) | registration fees according to Article 6; |
| --- | --- |

(a)

registration fees according to Article 6;

| (b) | annual supervisory fees according to Article 7. |
| --- | --- |

(b)

annual supervisory fees according to Article 7.

2.   Trade repositories established in third countries that apply for recognition in accordance with Article 77(1) of Regulation (EU) No 648/2012 shall be charged the following types of fees:

| (a) | recognition fees according to Article 8(1); |
| --- | --- |

(a)

recognition fees according to Article 8(1);

| (b) | annual supervisory fees for recognised trade repositories according to Article 8(2). |
| --- | --- |

(b)

annual supervisory fees for recognised trade repositories according to Article 8(2).

Article 6

Registration fee

1.   The registration fee to be paid by individual applicant trade repositories shall be calculated according to the supervisory effort necessary for the assessment and examination of the application, as well as the expected total turnover of the trade repository as specified in paragraphs 2 to 6.

2.   For the calculation of the registration fee, the following activities shall be taken into consideration:

| (a) | the provision by the trade repository of ancillary services such as trade confirmation, trade matching, credit event servicing, portfolio confirmation or portfolio compression services; |
| --- | --- |

(a)

the provision by the trade repository of ancillary services such as trade confirmation, trade matching, credit event servicing, portfolio confirmation or portfolio compression services;

| (b) | the provision of repository services in three or more classes of derivatives by the trade repository. |
| --- | --- |

(b)

the provision of repository services in three or more classes of derivatives by the trade repository.

3.   For the purposes of paragraph 2, a trade repository shall be deemed to offer ancillary services in any of the following situations:

| (a) | where it provides direct ancillary services; |
| --- | --- |

(a)

where it provides direct ancillary services;

| (b) | where an entity belonging to the same group as the trade repository provides indirect ancillary services; |
| --- | --- |

(b)

where an entity belonging to the same group as the trade repository provides indirect ancillary services;

| (c) | where an entity with which the trade repository has concluded an agreement in the context of the trading or post-trading chain or business line to cooperate in the provision of services provides the ancillary services. |
| --- | --- |

(c)

where an entity with which the trade repository has concluded an agreement in the context of the trading or post-trading chain or business line to cooperate in the provision of services provides the ancillary services.

4.   Where a trade repository does not engage in either of the activities set out in paragraph 2, the trade repository concerned is deemed to have a low expected total turnover and shall pay a registration fee of EUR 45 000.

5.   Where a trade repository engages in one of the two activities set out in paragraph 2, the trade repository is deemed to have a medium expected total turnover and shall pay a registration fee of EUR 65 000.

6.   Where a trade repository engages in both activities set out in paragraph 2, the trade repository is deemed to have a high expected total turnover and shall pay a registration fee of EUR 100 000.

7.   In case of a material change in the provision of services, as a consequence of which the trade repository owes a higher registration fee pursuant to paragraphs 4, 5 and 6 than the registration fee paid initially, the trade repository shall be charged the difference between the initially paid registration fee and the higher applicable registration fee resulting from that material change.

Article 7

Annual supervisory fee for registered trade repositories

1.   A registered trade repository shall be charged an annual supervisory fee.

2.   The total annual supervisory fee for a given financial year (n) shall be calculated as follows:

| (a) | the basis for the calculation of the total annual supervisory fee for a given financial year (n) shall be the estimate of expenditure relating to the supervision of trade repositories as included in the ESMA’s budget for that year, set out and approved in accordance with Article 63 of Regulation (EU) No 1095/2010; |
| --- | --- |

(a)

the basis for the calculation of the total annual supervisory fee for a given financial year (n) shall be the estimate of expenditure relating to the supervision of trade repositories as included in the ESMA’s budget for that year, set out and approved in accordance with Article 63 of Regulation (EU) No 1095/2010;

| (b) | the total annual supervisory fee for a given financial year (n) shall be calculated by deducting the following from the estimate of expenditure according to point (a):






  (i) | the total registration fees paid by trade repositories in accordance with Article 6 in a given financial year (n) and the additional registration fees paid in a given financial year (n) by already registered trade repositories in case a material change to their registration takes place as referred to in Article 6(7); |
| --- | --- | --- |

(b)

the total annual supervisory fee for a given financial year (n) shall be calculated by deducting the following from the estimate of expenditure according to point (a):

(i)

the total registration fees paid by trade repositories in accordance with Article 6 in a given financial year (n) and the additional registration fees paid in a given financial year (n) by already registered trade repositories in case a material change to their registration takes place as referred to in Article 6(7);

| (ii) | the total recognition fees paid by third country trade repositories in accordance with Article 8 that given financial year (n); |
| --- | --- |

(ii)

the total recognition fees paid by third country trade repositories in accordance with Article 8 that given financial year (n);

| (iii) | the initial supervisory fee to be paid by trade repositories in a given financial year (n) pursuant to paragraph 4; |
| --- | --- |

(iii)

the initial supervisory fee to be paid by trade repositories in a given financial year (n) pursuant to paragraph 4;

| (c) | a registered trade repository shall pay an annual supervisory fee resulting from dividing the total annual supervisory fee calculated pursuant to point (b) between all trade repositories registered in year n-1, in proportion to the ratio of the trade repository’s applicable turnover to the total applicable turnover of all registered trade repositories calculated pursuant to Article 3(1), and adjusted pursuant to paragraphs 2 and 3 of Article 4. |
| --- | --- |

(c)

a registered trade repository shall pay an annual supervisory fee resulting from dividing the total annual supervisory fee calculated pursuant to point (b) between all trade repositories registered in year n-1, in proportion to the ratio of the trade repository’s applicable turnover to the total applicable turnover of all registered trade repositories calculated pursuant to Article 3(1), and adjusted pursuant to paragraphs 2 and 3 of Article 4.

3.   In no case shall the trade repository pay an annual supervisory fee of less than EUR 30 000.

4.   By way of derogation from paragraphs 2 and 3, a registered trade repository shall pay, in the year of its registration, an initial supervisory fee equal to the lower of the following:

| (a) | the registration fee due in accordance with Article 6; |
| --- | --- |

(a)

the registration fee due in accordance with Article 6;

| (b) | the registration fee due in accordance with Article 6 multiplied by the ratio between the working days from its date of registration until the end of the year and 60 working days. |
| --- | --- |

(b)

the registration fee due in accordance with Article 6 multiplied by the ratio between the working days from its date of registration until the end of the year and 60 working days.

This calculation shall be made as follows:

Formula

Formula

Article 8

Fee for recognition of third country trade repositories

1.   A trade repository applying for recognition shall pay an application fee calculated as the sum of the following:

| (a) | EUR 20 000; |
| --- | --- |

(a)

EUR 20 000;

| (b) | the amount resulting from dividing EUR 35 000 among the total number of trade repositories from the same third country that are either recognised by ESMA, or that have applied for recognition but have not been yet recognised. |
| --- | --- |

(b)

the amount resulting from dividing EUR 35 000 among the total number of trade repositories from the same third country that are either recognised by ESMA, or that have applied for recognition but have not been yet recognised.

2.   A trade repository recognised in accordance with Article 77(1) of Regulation (EU) No 648/2012 shall pay an annual supervisory fee of EUR 5 000.

CHAPTER III

PAYMENT AND REIMBURSEMENT CONDITIONS

Article 9

General payment modalities

1.   All fees shall be payable in euro. They shall be paid as specified in Articles 10, 11 and 12.

2.   Any late payments shall incur a daily penalty equal to 0,1 % of the amount due.

Article 10

Payment of registration fees

1.   The registration fee referred to in Article 6 shall be paid in full at the time the trade repository applies for registration.

2.   Registration fees shall not be reimbursed if a trade repository withdraws its application for registration before ESMA adopts the reasoned decision to register or refuse registration, or if registration is refused.

Article 11

Payment of annual supervisory fees

1.   The annual supervisory fee referred to in Article 7 for a given financial year shall be paid in two instalments.

The first instalment shall be due on 28 February of that year and shall amount to two thirds of the estimated annual supervisory fee. If the applicable turnover calculated pursuant to Article 3 is not yet available at that time, the calculation on the turnover shall be based on the last applicable turnover available pursuant to Article 3.

The second instalment shall be due on 31 August. The amount of the second instalment shall be the annual supervisory fee calculated according to Article 7 reduced by the amount of the first instalment.

2.   ESMA shall send the invoices for the instalments to the trade repositories at least 30 days before the respective payment date.

Article 12

Payment of recognition fees

1.   The recognition fees referred to in Article 8(1) shall be payable in full at the time the trade repository applies for recognition. They shall not be reimbursed.

2.   Each time a new application for recognition of a third country trade repository is made, ESMA shall recalculate the amount referred to in Article 8(1)(b).

ESMA shall reimburse equally among the trade repositories already recognised from the same third country the difference between the amount charged pursuant to Article 8(1)(b) and the amount resulting from the recalculation. That difference shall be reimbursed either through direct payment or through reduction of the fees charged the subsequent year.

3.   The annual supervisory fee for a recognised trade repository shall be due by the end of February each financial year. ESMA shall send a payment invoice to a recognised trade repository at least 30 days before that date.

Article 13

Reimbursement of competent authorities

1.   Only ESMA shall charge fees to trade repositories for their registration, supervision and recognition.

2.   ESMA shall reimburse a competent authority for the actual costs incurred as a result of carrying out tasks pursuant to Regulation (EU) No 648/2012 and, in particular as a result of any delegation of tasks in accordance with Article 74 of Regulation (EU) No 648/2012.

CHAPTER IV

TRANSITIONAL AND FINAL PROVISIONS

Article 14

Fees in 2013

1.   Trade repositories which apply for registration in 2013 shall pay the registration fee referred to in Article 6 in full 30 days after the entry into force of this Regulation or at the date of submission of the application for registration, whichever is the later.

2.   Trade repositories registered in 2013 shall pay for 2013, an initial annual supervisory fee calculated in accordance with Article 7(4) in full 60 days after the entry into force of this Regulation or 30 days after the adoption of the decision on registration, whichever is the later.

3.   Third country trade repositories which apply for recognition in 2013 shall pay the recognition fee referred to in Article 8(1) in full 30 days after the entry into force of this Regulation or at the date of submission of the application, whichever is the later.

4.   Third country trade repositories recognised in 2013 shall pay, for 2013, an annual supervisory fee calculated in accordance with Article 8(3) in full 60 days after the entry into force of this Regulation or 30 days after the adoption of the decision on recognition, whichever is the later.

Article 15

Annual supervisory fee for 2014 for trade repositories registered in 2013

1.   Trade repositories registered in 2013 shall be charged an annual supervisory fee for 2014 calculated according to Article 7 on the basis of their applicable turnover during the period from 1 January 2014 to 30 June 2014, as set out in paragraph 2 of this Article.

2.   For the purposes of calculating supervisory fees for 2014 for trade repositories registered in 2013 pursuant to Article 7, the applicable turnover of a trade repository shall be the sum of one third of each of the following:

| (a) | the revenues generated from the core functions of centrally collecting and maintaining records of derivatives of the trade repository during the period from 1 January 2014 to 30 June 2014, divided by the total revenues generated from the core functions of centrally collecting and maintaining records of derivatives of all registered trade repositories during the period from 1 January 2014 to 30 June 2014; |
| --- | --- |

(a)

the revenues generated from the core functions of centrally collecting and maintaining records of derivatives of the trade repository during the period from 1 January 2014 to 30 June 2014, divided by the total revenues generated from the core functions of centrally collecting and maintaining records of derivatives of all registered trade repositories during the period from 1 January 2014 to 30 June 2014;

| (b) | the number of trades reported to the trade repository during the period from 1 January 2014 to 30 June 2014, divided by the total number of trades reported to all registered trade repositories during the period from 1 January 2014 to 30 June 2014; |
| --- | --- |

(b)

the number of trades reported to the trade repository during the period from 1 January 2014 to 30 June 2014, divided by the total number of trades reported to all registered trade repositories during the period from 1 January 2014 to 30 June 2014;

| (c) | the number of recorded outstanding trades on 30 June 2014, divided by the total number of recorded outstanding trades on 30 June 2014 in all registered trade repositories. |
| --- | --- |

(c)

the number of recorded outstanding trades on 30 June 2014, divided by the total number of recorded outstanding trades on 30 June 2014 in all registered trade repositories.

3.   The annual supervisory fee for 2014 for trade repositories registered in 2013 shall be paid in two instalments.

The first instalment shall be due on 28 February 2014 and shall correspond to the registration fee paid by the trade repository in 2013 pursuant to Article 6.

The second instalment shall be due on 31 August. The amount of the second instalment shall be the annual supervisory fee calculated according to paragraphs 1 and 2 reduced by the amount of the first instalment.

Where the amount paid by a trade repository in the first instalment is higher than the annual supervisory fee calculated according to paragraphs 1 and 2, ESMA shall reimburse the trade repository the difference between the amount paid in the first instalment and the annual supervisory fee calculated according to paragraphs 1 and 2.

4.   ESMA shall send the invoices for the instalments of the annual supervisory fee for 2014 to the trade repositories registered in 2013 at least 30 days before the payment date.

5.   When the audited accounts for 2014 become available, trade repositories registered in 2013 shall report to ESMA any change in the indicators referred to in points (a), (b) or (c) of paragraph 2 used for the calculation of the applicable turnover according to paragraph 2, stemming from the difference between the final data and the provisional data used for the calculation.

Trade repositories will be charged the difference between the annual supervisory fee for 2014 actually paid and the annual supervisory fee for 2014 to be paid as a consequence of any change to the indicators referred to in points (a), (b) or (c) of paragraph 2 used for the calculation of the applicable turnover according to paragraph 2.

ESMA shall send the invoice for any additional payment to be made by a trade repository as a consequence of a change in any of the indicators referred to in points (a), (b) or (c) of paragraph 2 used for the calculation of the applicable turnover according to paragraph 2, at least 30 days before the respective payment date.

Article 16

Entry into force

This Regulation shall enter into force on the third 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 the Member States.

Done at Brussels, 12 July 2013.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 201, 27.7.2012, p. 1.

1

(2)  OJ L 331, 15.12.2010, p. 84.

2

---

| 19.10.2013 | EN | Official Journal of the European Union | L 279/10 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/10

---

COMMISSION REGULATION (EU) No 1004/2013

of 15 October 2013

amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 8-hydroxyquinoline, cyproconazole, cyprodinil, fluopyram, nicotine, pendimethalin, penthiopyrad and trifloxystrobin in or on certain products

(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a) thereof,

Whereas:

| (1) | For pendimethalin and trifloxystrobin maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For cyproconazole, cyprodinil, fluopyram, nicotine and penthiopyrad MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For 8-hydroxyquinoline, no specific MRLs were set in Annex II and III nor was the substance included in Annex IV to Regulation (EC) No 396/2005, so the default value of 0.01 mg/kg applies. |
| --- | --- |

(1)

For pendimethalin and trifloxystrobin maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For cyproconazole, cyprodinil, fluopyram, nicotine and penthiopyrad MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For 8-hydroxyquinoline, no specific MRLs were set in Annex II and III nor was the substance included in Annex IV to Regulation (EC) No 396/2005, so the default value of 0.01 mg/kg applies.

| (2) | In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance 8-hydroxyquinoline on tomatoes, an application was made in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRL. |
| --- | --- |

(2)

In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance 8-hydroxyquinoline on tomatoes, an application was made in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRL.

| (3) | As regards cyproconazole, such an application was made for mustard seed and gold of pleasure. As regards cyprodinil, such an application was made for radishes and cucurbits (inedible peel). As regards pendimethalin, such an application was made for salsify, celeriac, swedes, turnips, celery and herbal infusions (roots). As regards trifloxystrobin, such an application was made for beans (with pods). |
| --- | --- |

(3)

As regards cyproconazole, such an application was made for mustard seed and gold of pleasure. As regards cyprodinil, such an application was made for radishes and cucurbits (inedible peel). As regards pendimethalin, such an application was made for salsify, celeriac, swedes, turnips, celery and herbal infusions (roots). As regards trifloxystrobin, such an application was made for beans (with pods).

| (4) | In accordance with Article 8 of Regulation (EC) No 396/2005 these applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. |
| --- | --- |

(4)

In accordance with Article 8 of Regulation (EC) No 396/2005 these applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.

| (5) | The European Food Safety Authority, hereinafter "the Authority", assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave reasoned opinions on the proposed MRLs (2). It forwarded these opinions to the Commission and the Member States and made them available to the public. |
| --- | --- |

(5)

The European Food Safety Authority, hereinafter "the Authority", assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave reasoned opinions on the proposed MRLs (2). It forwarded these opinions to the Commission and the Member States and made them available to the public.

| (6) | The Authority concluded in its reasoned opinions that, as regards the use of cyproconazole on mustard seed and gold of pleasure, the submitted data are sufficient to set new MRLs for the northern EU use only. As regards the use of pendimethalin on celeriac, swedes, turnips and celery, the Authority concluded that the submitted data are not sufficient to set new MRLs. |
| --- | --- |

(6)

The Authority concluded in its reasoned opinions that, as regards the use of cyproconazole on mustard seed and gold of pleasure, the submitted data are sufficient to set new MRLs for the northern EU use only. As regards the use of pendimethalin on celeriac, swedes, turnips and celery, the Authority concluded that the submitted data are not sufficient to set new MRLs.

| (7) | As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short-term exposure due to high consumption of the relevant crops and products showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. |
| --- | --- |

(7)

As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short-term exposure due to high consumption of the relevant crops and products showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded.

| (8) | As regards penthiopyrad the applicant submitted further data confirming that the metabolism of penthiopyrad in genetically modified crop is comparable to the one occuring in its conventional counterpart. To avoid trade barriers for the importation of sunflower seed, rape seed, soya bean and cotton seed higher MRLs are necessary. The new MRLs for those products should therefore be set in Part A of Annex III to Regulation (EC) No 396/2005. |
| --- | --- |

(8)

As regards penthiopyrad the applicant submitted further data confirming that the metabolism of penthiopyrad in genetically modified crop is comparable to the one occuring in its conventional counterpart. To avoid trade barriers for the importation of sunflower seed, rape seed, soya bean and cotton seed higher MRLs are necessary. The new MRLs for those products should therefore be set in Part A of Annex III to Regulation (EC) No 396/2005.

| (9) | As regards fluopyram, by Regulation (EU) No 270/2012 (3) provisional MRLs were set for several products until 31 December 2013, pending the submission of further residue data. Such data were submitted to Germany, the evaluating Member State for that substance, on 17 December 2012. In order to provide the necessary time for the evaluating Member State to evaluate those data and prepare an evaluation report, for the Authority to evaluate that report and for the Commission to take its decision, it is appropriate to extend the validity of these MRLs until two years from the publication of this Regulation. |
| --- | --- |

(9)

As regards fluopyram, by Regulation (EU) No 270/2012 (3) provisional MRLs were set for several products until 31 December 2013, pending the submission of further residue data. Such data were submitted to Germany, the evaluating Member State for that substance, on 17 December 2012. In order to provide the necessary time for the evaluating Member State to evaluate those data and prepare an evaluation report, for the Authority to evaluate that report and for the Commission to take its decision, it is appropriate to extend the validity of these MRLs until two years from the publication of this Regulation.

| (10) | As regards nicotine, by Regulation (EU) No 812/2011 (4) provisional MRLs were set for tea, herbal infusions, spices, rose hips and fresh herbs until 14 August 2013, pending the submission and evaluation of new data and information on the natural occurrence or formation of nicotine in the concerned products. The Commission was informed of a research project which is being carried out to investigate on the sources of nicotine resulting in those crops. In view of the expected duration of the study and in order to provide the necessary time for the Commission to take its decision, it is appropriate to extend the validity of these MRLs until three years from the publication of this Regulation. |
| --- | --- |

(10)

As regards nicotine, by Regulation (EU) No 812/2011 (4) provisional MRLs were set for tea, herbal infusions, spices, rose hips and fresh herbs until 14 August 2013, pending the submission and evaluation of new data and information on the natural occurrence or formation of nicotine in the concerned products. The Commission was informed of a research project which is being carried out to investigate on the sources of nicotine resulting in those crops. In view of the expected duration of the study and in order to provide the necessary time for the Commission to take its decision, it is appropriate to extend the validity of these MRLs until three years from the publication of this Regulation.

| (11) | Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the relevant requirements of Article 14(2) of Regulation (EC) No 396/2005. |
| --- | --- |

(11)

Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the relevant requirements of Article 14(2) of Regulation (EC) No 396/2005.

| (12) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(12)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (13) | In the interest of legal certainty, the provisions concerning nicotine should apply from 15 August 2013. |
| --- | --- |

(13)

In the interest of legal certainty, the provisions concerning nicotine should apply from 15 August 2013.

| (14) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(14)

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

Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

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

It shall, however, apply from 15 August 2013 for nicotine in rose hips of code number 0154050, fresh herbs of code number 0256000, tea of code number 0610000, herbal infusions of code number 0630000 and spices of code number 0800000.

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

Done at Brussels, 15 October 2013.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 70, 16.3.2005, p. 1.

1

(2)  EFSA scientific reports available online: http://www.efsa.europa.eu:

2

Reasoned opinion on the modification of the existing MRL for 8-hydroxyquinoline in tomatoes. EFSA Journal 2013;11(5):3224 [20 pp.]. doi:10.2903/j.efsa.2013.3224.

Reasoned opinion on the modification of the existing MRLs for cyproconazole in mustard seed and gold of pleasure. EFSA Journal 2013;11(4):3194 [26 pp.]. doi:10.2903/j.efsa.2013.3194.

Reasoned opinion on the modification of the existing MRLs for cyprodinil in radishes and cucurbits inedible peel. EFSA Journal 2013;11(4):3184 [24 pp.]. doi:10.2903/j.efsa.2013.3184.

Reasoned opinion on the modification of the existing MRLs for pendimethalin in various crops. EFSA Journal 2013;11(5):3217 [27 pp.]. doi:10.2903/j.efsa.2013.3217.

Reasoned opinion on the modification of the existing MRL for trifloxystrobin in beans with pods. EFSA Journal 2013;11(4):3199 [24 pp.]. doi:10.2903/j.efsa.2013.3199.

(3)  OJ L 89, 27.3.2012, p. 5.

3

(4)  OJ L 208, 13.8.2011, p. 1.

4

---

ANNEX

Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:

| (1) | In Annex II, the columns for pendimethalin and trifloxystrobin are replaced by the following:
  ‘Pesticide residues and maximum residue levels (mg/kg)









  Code number | Groups and examples of individual products to which the MRLs apply (1) | Pendimethalin (F) | Trifloxystrobin (F) (R) |
| --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) |
| 0100000 | 1. | FRUIT FRESH OR FROZEN NUTS |

(1)

In Annex II, the columns for pendimethalin and trifloxystrobin are replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply (1)

Pendimethalin (F)

Trifloxystrobin (F) (R)

(1)

(2)

(3)

(4)

0100000

1.

0,05 (2)

0110000

| (i) | Citrus fruit |
| --- | --- |

(i)

0,3

0110010

Grapefruit (Shaddocks, pomelos, sweeties, tangelo (except mineola), ugli and other hybrids)

0110020

Oranges (Bergamot, bitter orange, chinotto and other hybrids)

0110030

Lemons (Citron, lemon, Buddha’s hand (Citrus medica var. sarcodactylis))

0110040

Limes

0110050

Mandarins (Clementine, tangerine, mineola and other hybrids tangor (Citrus reticulata x sinensis))

0110990

Others

0120000

| (ii) | Tree nuts |
| --- | --- |

(ii)

0,02 (2)

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts (Filbert)

0120070

Macadamia

0120080

Pecans

0120090

Pine nuts

0120100

Pistachios

0120110

Walnuts

0120990

Others

0130000

| (iii) | Pome fruit |
| --- | --- |

(iii)

0,5

0130010

Apples (Crab apple)

0130020

Pears (Oriental pear)

0130030

Quinces

0130040

Medlar

(3)

(3)

0130050

Loquat

(3)

(3)

0130990

Others

0140000

| (iv) | Stone fruit |
| --- | --- |

(iv)

0140010

Apricots

1

0140020

Cherries (Sweet cherries, sour cherries)

1

0140030

Peaches (Nectarines and similar hybrids)

1

0140040

Plums (Damson, greengage, mirabelle, sloe, red date/Chinese date/Chinese jujube (Ziziphus zizyphus))

0,2

0140990

Others

0,02 (2)

0150000

| (v) | Berries & small fruit |
| --- | --- |

(v)

0151000

| (a) | Table and wine grapes |
| --- | --- |

(a)

5

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | Strawberries |
| --- | --- |

(b)

0,5

0153000

| (c) | Cane fruit |
| --- | --- |

(c)

0,02 (2)

0153010

Blackberries

0153020

Dewberries (Loganberries, tayberries, boysenberries, cloudberries and other Rubus hybrids)

0153030

Raspberries (Wineberries, arctic bramble/raspberry, (Rubus arcticus), nectar raspberries (Rubus arcticus x Rubus idaeus))

0153990

Others

0154000

| (d) | Other small fruit & berries |
| --- | --- |

(d)

0154010

Blueberries (Bilberries)

2

0154020

Cranberries (Cowberries/red bilberries (V. vitis-idaea))

0,02 (2)

0154030

Currants (red, black and white)

1

0154040

Gooseberries (Including hybrids with other Ribes species)

1

0154050

Rose hips

(3)

(3)

0154060

Mulberries (Arbutus berry)

(3)

(3)

0154070

Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta))

(3)

(3)

0154080

Elderberries (Black chokeberry/appleberry, mountain ash, buckthorn/sea sallowthorn, hawthorn, serviceberries, and other treeberries)

(3)

(3)

0154990

Others

0,02 (2)

0160000

| (vi) | Miscellaneous fruit |
| --- | --- |

(vi)

0161000

| (a) | Edible peel |
| --- | --- |

(a)

0161010

Dates

0,02 (2)

0161020

Figs

0,02 (2)

0161030

Table olives

0,3

0161040

Kumquats (Marumi kumquats, nagami kumquats, limequats (Citrus aurantifolia x Fortunella spp.))

0,02 (2)

0161050

Carambola (Bilimbi)

(3)

(3)

0161060

Persimmon

(3)

(3)

0161070

Jambolan (java plum) (Java apple/water apple, pomerac, rose apple, Brazilean cherry, Surinam cherry/grumichama (Eugenia uniflora))

(3)

(3)

0161990

Others

0,02 (2)

0162000

| (b) | Inedible peel, small |
| --- | --- |

(b)

0162010

Kiwi

0,02 (2)

0162020

Lychee (Litchi) (Pulasan, rambutan/hairy litchi, longan, mangosteen, langsat, salak)

0,02 (2)

0162030

Passion fruit

4

0162040

Prickly pear (cactus fruit)

(3)

(3)

0162050

Star apple

(3)

(3)

0162060

American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel/yellow sapote, mammey sapote)

(3)

(3)

0162990

Others

0,02 (2)

0163000

| (c) | Inedible peel, large |
| --- | --- |

(c)

0163010

Avocados

0,02 (2)

0163020

Bananas (Dwarf banana, plantain, apple banana)

0,05

0163030

Mangoes

0,5

0163040

Papaya

1

0163050

Pomegranate

0,02 (2)

0163060

Cherimoya (Custard apple, sugar apple/sweetsop, ilama (Annona diversifolia) and other medium sized Annonaceae fruits)

(3)

(3)

0163070

Guava (Red pitaya/dragon fruit (Hylocereus undatus))

(3)

(3)

0163080

Pineapples

0,02 (2)

0163090

Bread fruit (Jackfruit)

(3)

(3)

0163100

Durian

(3)

(3)

0163110

Soursop (guanabana)

(3)

(3)

0163990

Others

0,02 (2)

0200000

| 2. | VEGETABLES FRESH OR FROZEN |
| --- | --- |

2.

0210000

| (i) | Root and tuber vegetables |
| --- | --- |

(i)

0211000

| (a) | Potatoes |
| --- | --- |

(a)

0,05 (2)

0,02 (2)

0212000

| (b) | Tropical root and tuber vegetables |
| --- | --- |

(b)

0,05 (2)

0,02 (2)

0212010

Cassava (Dasheen, eddoe/Japanese taro, tannia)

0212020

Sweet potatoes

0212030

Yams (Potato bean/yam bean, Mexican yam bean)

0212040

Arrowroot

(3)

(3)

0212990

Others

0213000

| (c) | Other root and tuber vegetables except sugar beet |
| --- | --- |

(c)

0213010

Beetroot

0,05 (2)

0,02 (2)

0213020

Carrots

0,2

0,05

0213030

Celeriac

0,1

0,02 (2)

0213040

Horseradish (Angelica roots, lovage roots, gentiana roots)

0,2

0,02 (2)

0213050

Jerusalem artichokes (Crosne)

0,05 (2)

0,02 (2)

0213060

Parsnips

0,2

0,04

0213070

Parsley root

0,2

0,04

0213080

Radishes (Black radish, Japanese radish, small radish and similar varieties, tiger nut (Cyperus esculentus))

0,05 (2)

0,02 (2)

0213090

Salsify (Scorzonera, Spanish salsify/Spanish oysterplant, edible burdock)

0,2

0,04

0213100

Swedes

0,05 (2)

0,04

0213110

Turnips

0,05 (2)

0,04

0213990

Others

0,05 (2)

0,02 (2)

0220000

| (ii) | Bulb vegetables |
| --- | --- |

(ii)

0,05 (2)

0220010

Garlic

0,02 (2)

0220020

Onions (Other bulb onions, silverskin onions)

0,02 (2)

0220030

Shallots

0,02 (2)

0220040

Spring onions and welsh onions (Other green onions and similar varieties)

0,1

0220990

Others

0,02 (2)

0230000

| (iii) | Fruiting vegetables |
| --- | --- |

(iii)

0,05 (2)

0231000

| (a) | Solanacea |
| --- | --- |

(a)

0231010

Tomatoes (Cherry tomatoes, Physalis spp., gojiberry, wolfberry (Lycium barbarum and L. chinense), tree tomato)

0,5

0231020

Peppers (Chilli peppers)

0,3

0231030

Aubergines (egg plants) (Pepino, antroewa/white eggplant (S. macrocarpon))

0,3

0231040

Okra (lady’s fingers)

0,02 (2)

0231990

Others

0,02 (2)

0232000

| (b) | Cucurbits — edible peel |
| --- | --- |

(b)

0,2

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes (Summer squash, marrow (patisson), lauki (Lagenaria siceraria), chayote, sopropo/bitter melon, snake gourd, angled luffa/teroi)

0232990

Others

0233000

| (c) | Cucurbits-inedible peel |
| --- | --- |

(c)

0233010

Melons (Kiwano)

0,3

0233020

Pumpkins (Winter squash, marrow (late variety))

0,2

0233030

Watermelons

0,2

0233990

Others

0,02 (2)

0234000

| (d) | Sweet corn (Baby corn) |
| --- | --- |

(d)

0,02 (2)

0239000

| (e) | Other fruiting vegetables |
| --- | --- |

(e)

0,02 (2)

0240000

| (iv) | Brassica vegetables |
| --- | --- |

(iv)

0241000

| (a) | Flowering brassica |
| --- | --- |

(a)

0,05 (2)

0241010

Broccoli (Calabrese, Broccoli raab, Chinese broccoli)

0,05

0241020

Cauliflower

0,05

0241990

Others

0,02 (2)

0242000

| (b) | Head brassica |
| --- | --- |

(b)

0,05 (2)

0242010

Brussels sprouts

0,5

0242020

Head cabbage (Pointed head cabbage, red cabbage, savoy cabbage, white cabbage)

0,3

0242990

Others

0,02 (2)

0243000

| (c) | Leafy brassica |
| --- | --- |

(c)

0,5

3

0243010

Chinese cabbage (Indian or Chinese) mustard, pak choi, Chinese flat cabbage/ai goo choi, choi sum, Peking cabbage/pe-tsai

0243020

Kale (Borecole/curly kale, collards, Portuguese Kale, Portuguese cabbage, cow cabbage)

0243990

Others

0244000

| (d) | Kohlrabi |
| --- | --- |

(d)

0,3

0,5

0250000

| (v) | Leaf vegetables & fresh herbs |
| --- | --- |

(v)

0251000

| (a) | Lettuce and other salad plants including Brassicacea |
| --- | --- |

(a)

0,05 (2)

0251010

Lamb’s lettuce (Italian corn salad)

0,02 (2)

0251020

Lettuce (Head lettuce, lollo rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce)

10

0251030

Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curly leaf endive, sugar loaf (C. endivia var. crispum/C. intybus var. foliosum), dandelion greens)

10

0251040

Cress (Mung bean sprouts, alfalfa sprouts)

0,02 (2)

0251050

Land cress

(3)

(3)

0251060

Rocket, Rucola (Wild rocket (Diplotaxis spp.))

0,02 (2)

0251070

Red mustard

(3)

(3)

0251080

Leaves and sprouts of Brassica spp, including turnip greens (Mizuna, leaves of peas and radish and other babyleaf crops, including brassica crops (crops harvested up to 8 true leaf stage), kohlrabi leaves)

0,02 (2)

0251990

Others

0,02 (2)

0252000

| (b) | Spinach & similar (leaves) |
| --- | --- |

(b)

0,05 (2)

0,02 (2)

0252010

Spinach (New Zealand spinach, amaranthus spinach (pak-khom, tampara), tajer leaves, bitterblad/bitawiri)

0252020

Purslane (Winter purslane/miner’s lettuce, garden purslane, common purslane, sorrel, glassworth, agretti (Salsola soda))

(3)

(3)

0252030

Beet leaves (chard) (Leaves of beetroot)

0252990

Others

0253000

| (c) | Vine leaves (grape leaves) (Malabar nightshade, banana leaves, climbing wattle (Acacia pennata)) |
| --- | --- |

(c)

(3)

(3)

0254000

| (d) | Water cress (Morning glory/Chinese convolvulus/water convolvulus/water spinach/kangkung (Ipomea aquatica), water clover, water mimosa) |
| --- | --- |

(d)

0,05 (2)

0,02 (2)

0255000

| (e) | Witloof |
| --- | --- |

(e)

0,05 (2)

0,02 (2)

0256000

| (f) | Herbs |
| --- | --- |

(f)

10

0256010

Chervil

0,6

0256020

Chives

0,6

0256030

Celery leaves (Fennel leaves, coriander leaves, dill leaves, caraway leaves, lovage, angelica, sweet cisely and other Apiacea leaves, culantro/stinking/long coriander/stink weed (Eryngium foetidum))

0,6

0256040

Parsley (leaves of root parsley)

2

0256050

Sage (Winter savory, summer savory, Borago officinalis leaves)

(3)

(3)

0256060

Rosemary

(3)

(3)

0256070

Thyme (Marjoram, oregano)

(3)

(3)

0256080

Basil (Balm leaves, mint, peppermint, holy basil, sweet basil, hairy basil, edible flowers (marigold flower and others), pennywort, wild betel leaf, curry leaves)

(3)

(3)

0256090

Bay leaves (laurel) (Lemon grass)

(3)

(3)

0256100

Tarragon (Hyssop)

(3)

(3)

0256990

Others

0,6

0260000

| (vi) | Legume vegetables (fresh) |
| --- | --- |

(vi)

0,2

0260010

Beans (with pods) (Green bean/French beans/snap beans, scarlet runner bean, slicing bean, yard long beans, guar beans, soya beans)

1

0260020

Beans (without pods) (Broad beans, flageolets, jack bean, lima bean, cowpea)

0,02 (2)

0260030

Peas (with pods) (Mangetout/sugar peas/snow peas)

0,02 (2)

0260040

Peas (without pods) (Garden pea, green pea, chickpea)

0,02 (2)

0260050

Lentils

0,02 (2)

0260990

Others

0,02 (2)

0270000

| (vii) | Stem vegetables (fresh) |
| --- | --- |

(vii)

0270010

Asparagus

0,05 (2)

0,02 (2)

0270020

Cardoons (Borago officinalis stems)

0,05 (2)

0,02 (2)

0270030

Celery

0,1

1

0270040

Fennel

0,05 (2)

0,02 (2)

0270050

Globe artichokes (Banana flower)

0,05 (2)

0,2

0270060

Leek

0,05 (2)

0,2

0270070

Rhubarb

0,05 (2)

0,02 (2)

0270080

Bamboo shoots

(3)

(3)

0270090

Palm hearts

(3)

(3)

0270990

Others

0,05 (2)

0,02 (2)

0280000

| (viii) | Fungi |
| --- | --- |

(viii)

0,05 (2)

0,02 (2)

0280010

Cultivated fungi (Common mushroom, oyster mushroom, shiitake, fungus mycelium (vegetative parts))

0280020

Wild fungi (Chanterelle, truffle, morel, cep)

0280990

Others

0290000

| (ix) | Sea weeds |
| --- | --- |

(ix)

(3)

(3)

0300000

| 3. | PULSES, DRY |
| --- | --- |

3.

0,2

0,02 (2)

0300010

Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)

0300020

Lentils

0300030

Peas (Chickpeas, field peas, chickling vetch)

0300040

Lupins

0300990

Others

0400000

| 4. | OILSEEDS AND OILFRUITS |
| --- | --- |

4.

0401000

| (i) | Oilseeds |
| --- | --- |

(i)

0,1 (2)

0,05 (2)

0401010

Linseed

0401020

Peanuts

0401030

Poppy seed

0401040

Sesame seed

0401050

Sunflower seed

0401060

Rape seed (Bird rapeseed, turnip rape)

0401070

Soya bean

0401080

Mustard seed

0401090

Cotton seed

0401100

Pumpkin seeds (Other seeds of Cucurbitaceae)

0401110

Safflower

(3)

(3)

0401120

Borage (Purple viper’s bugloss/Canary flower (Echium plantagineum), Corn Gromwell (Buglossoides arvensis))

(3)

(3)

0401130

Gold of pleasure

(3)

(3)

0401140

Hempseed

0401150

Castor bean

(3)

(3)

0401990

Others

0402000

| (ii) | Oilfruits |
| --- | --- |

(ii)

0402010

Olives for oil production

0,05 (2)

0,3

0402020

Palm nuts (palmoil kernels)

(3)

(3)

0402030

Palmfruit

(3)

(3)

0402040

Kapok

(3)

(3)

0402990

Others

0,1 (2)

0,05 (2)

0500000

| 5. | CEREALS |
| --- | --- |

5.

0,05 (2)

0500010

Barley

0,3

0500020

Buckwheat (Amaranthus, quinoa)

0,02 (2)

0500030

Maize

0,02 (2)

0500040

Millet (Foxtail millet, teff, finger millet, pearl millet)

0,02 (2)

0500050

Oats

0,02 (2)

0500060

Rice (Indian/wild rice (Zizania aquatica))

0,02 (2)

0500070

Rye

0,05

0500080

Sorghum

0,02 (2)

0500090

Wheat (Spelt, triticale)

0,05

0500990

Others (Canary grass seeds (Phalaris canariensis))

0,02 (2)

0600000

| 6. | TEA, COFFEE, HERBAL INFUSIONS AND COCOA |
| --- | --- |

6.

0,05 (2)

0610000

| (i) | Tea |
| --- | --- |

(i)

0,1 (2)

0620000

| (ii) | Coffee beans |
| --- | --- |

(ii)

(3)

(3)

0630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

(3)

(3)

0631000

| (a) | Flowers |
| --- | --- |

(a)

(3)

(3)

0631010

Camomille flowers

(3)

(3)

0631020

Hybiscus flowers

(3)

(3)

0631030

Rose petals

(3)

(3)

0631040

Jasmine flowers (Elderflowers (Sambucus nigra))

(3)

(3)

0631050

Lime (linden)

(3)

(3)

0631990

Others

(3)

(3)

0632000

| (b) | Leaves |
| --- | --- |

(b)

(3)

(3)

0632010

Strawberry leaves

(3)

(3)

0632020

Rooibos leaves (Ginkgo leaves)

(3)

(3)

0632030

Maté

(3)

(3)

0632990

Others

(3)

(3)

0633000

| (c) | Roots |
| --- | --- |

(c)

(3)

(3)

0633010

Valerian root

(3)

(3)

0633020

Ginseng root

(3)

(3)

0633990

Others

(3)

(3)

0639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

(3)

(3)

0640000

| (iv) | Cocoabeans (fermented or dried) |
| --- | --- |

(iv)

(3)

(3)

0650000

| (v) | Carob (st johns bread) |
| --- | --- |

(v)

(3)

(3)

0700000

| 7. | HOPS (dried) |
| --- | --- |

7.

0,1 (2)

30

0800000

| 8. | SPICES |
| --- | --- |

8.

(3)

(3)

0810000

| (i) | Seeds |
| --- | --- |

(i)

(3)

(3)

0810010

Anise

(3)

(3)

0810020

Black caraway

(3)

(3)

0810030

Celery seed (Lovage seed)

(3)

(3)

0810040

Coriander seed

(3)

(3)

0810050

Cumin seed

(3)

(3)

0810060

Dill seed

(3)

(3)

0810070

Fennel seed

(3)

(3)

0810080

Fenugreek

(3)

(3)

0810090

Nutmeg

(3)

(3)

0810990

Others

(3)

(3)

0820000

| (ii) | Fruits and berries |
| --- | --- |

(ii)

(3)

(3)

0820010

Allspice

(3)

(3)

0820020

Sichuan pepper (Anise pepper, Japan pepper)

(3)

(3)

0820030

Caraway

(3)

(3)

0820040

Cardamom

(3)

(3)

0820050

Juniper berries

(3)

(3)

0820060

Pepper, black, green and white (Long pepper, pink pepper)

(3)

(3)

0820070

Vanilla pods

(3)

(3)

0820080

Tamarind

(3)

(3)

0820990

Others

(3)

(3)

0830000

| (iii) | Bark |
| --- | --- |

(iii)

(3)

(3)

0830010

Cinnamon (Cassia)

(3)

(3)

0830990

Others

(3)

(3)

0840000

| (iv) | Roots or rhizome |
| --- | --- |

(iv)

(3)

(3)

0840010

Liquorice

(3)

(3)

0840020

Ginger

(3)

(3)

0840030

Turmeric (Curcuma)

(3)

(3)

0840040

Horseradish

(3)

(3)

0840990

Others

(3)

(3)

0850000

| (v) | Buds |
| --- | --- |

(v)

(3)

(3)

0850010

Cloves

(3)

(3)

0850020

Capers

(3)

(3)

0850990

Others

(3)

(3)

0860000

| (vi) | Flower stigma |
| --- | --- |

(vi)

(3)

(3)

0860010

Saffron

(3)

(3)

0860990

Others

(3)

(3)

0870000

| (vii) | Aril |
| --- | --- |

(vii)

(3)

(3)

0870010

Mace

(3)

(3)

0870990

Others

(3)

(3)

0900000

| 9. | SUGAR PLANTS |
| --- | --- |

9.

(3)

(3)

0900010

Sugar beet (root)

(3)

(3)

0900020

Sugar cane

(3)

(3)

0900030

Chicory roots

(3)

(3)

0900990

Others

(3)

(3)

1000000

| 10. | PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS |
| --- | --- |

10.

0,05 (2)

1010000

| (i) | Tissue |
| --- | --- |

(i)

0,04 (2)

1011000

| (a) | Swine |
| --- | --- |

(a)

1011010

Muscle

1011020

Fat

1011030

Liver

1011040

Kidney

1011050

Edible offal

1011990

Others

1012000

| (b) | Bovine |
| --- | --- |

(b)

1012010

Muscle

1012020

Fat

1012030

Liver

1012040

Kidney

1012050

Edible offal

1012990

Others

1013000

| (c) | Sheep |
| --- | --- |

(c)

1013010

Muscle

1013020

Fat

1013030

Liver

1013040

Kidney

1013050

Edible offal

1013990

Others

1014000

| (d) | Goat |
| --- | --- |

(d)

1014010

Muscle

1014020

Fat

1014030

Liver

1014040

Kidney

1014050

Edible offal

1014990

Others

1015000

| (e) | Horses, asses, mules or hinnies |
| --- | --- |

(e)

(3)

(3)

1015010

Muscle

(3)

(3)

1015020

Fat

(3)

(3)

1015030

Liver

(3)

(3)

1015040

Kidney

(3)

(3)

1015050

Edible offal

(3)

(3)

1015990

Others

(3)

(3)

1016000

| (f) | Poultry -chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon |
| --- | --- |

(f)

1016010

Muscle

1016020

Fat

1016030

Liver

1016040

Kidney

1016050

Edible offal

1016990

Others

1017000

| (g) | Other farm animals (Rabbit, kangaroo, deer) |
| --- | --- |

(g)

(3)

(3)

1017010

Muscle

(3)

(3)

1017020

Fat

(3)

(3)

1017030

Liver

(3)

(3)

1017040

Kidney

(3)

(3)

1017050

Edible offal

(3)

(3)

1017990

Others

(3)

(3)

1020000

| (ii) | Milk |
| --- | --- |

(ii)

0,02 (2)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others

1030000

| (iii) | Bird eggs |
| --- | --- |

(iii)

0,04 (2)

1030010

Chicken

1030020

Duck

(3)

(3)

1030030

Goose

(3)

(3)

1030040

Quail

(3)

(3)

1030990

Others

(3)

(3)

1040000

| (iv) | Honey (Royal jelly, pollen, honey comb with honey (comb honey)) |
| --- | --- |

(iv)

(3)

(3)

1050000

| (v) | Amphibians and reptiles (Frog legs, crocodiles) |
| --- | --- |

(v)

(3)

(3)

1060000

| (vi) | Snails |
| --- | --- |

(vi)

(3)

(3)

1070000

| (vii) | Other terrestrial animal products (Wild game) |
| --- | --- |

(vii)

(3)

(3)

(F)= Fat soluble

| (R) | = | The residue definition differs for the following combinations pesticide-code number:
  Trifloxystrobin- code 1000000: the sum of trifloxystrobin and its metabolite (E, E)-methoxyimino- {2-[1-(3-trifluoromethyl-phenyl)-ethylideneamino-oxymethyl]-phenyl}-acetic acid (CGA 321113)’ |
| --- | --- | --- |

(R)

=

The residue definition differs for the following combinations pesticide-code number:

Trifloxystrobin- code 1000000: the sum of trifloxystrobin and its metabolite (E, E)-methoxyimino- {2-[1-(3-trifluoromethyl-phenyl)-ethylideneamino-oxymethyl]-phenyl}-acetic acid (CGA 321113)’

| (2) | Part A of Annex III is amended as follows:






  (a) | The columns for cyproconazole, cyprodinil, fluopyram, nicotine and penthiopyrad are replaced by the following:
  ‘Pesticide residues and maximum residue levels (mg/kg)












  Code number | Groups and examples of individual products to which the MRLs apply (4) | Cyproconazole (F) | Cyprodinil (F) (R) | Fluopyram (R) | Nicotine | Penthiopyrad |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) |
| 0100000 | 1. | FRUIT FRESH OR FROZEN NUTS |

(2)

Part A of Annex III is amended as follows:

(a)

The columns for cyproconazole, cyprodinil, fluopyram, nicotine and penthiopyrad are replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply (4)

Cyproconazole (F)

Cyprodinil (F) (R)

Fluopyram (R)

Nicotine

Penthiopyrad

(1)

(2)

(3)

(4)

(5)

(6)

(7)

0100000

1.

0110000

| (i) | Citrus fruit |
| --- | --- |

(i)

0,05 (5)

0,05 (5)

0,01 (5)

0,01 (5)

0110010

Grapefruit (Shaddocks, pomelos, sweeties, tangelo (except mineola), ugli and other hybrids)

0110020

Oranges (Bergamot, bitter orange, chinotto and other hybrids)

0110030

Lemons (Citron, lemon, Buddha’s hand (Citrus medica var. sarcodactylis))

0110040

Limes

0110050

Mandarins (Clementine, tangerine, mineola and other hybrids tangor (Citrus reticulata x sinensis))

0110990

Others

0120000

| (ii) | Tree nuts |
| --- | --- |

(ii)

0,05 (5)

0,05 (5)

0120010

Almonds

0,05

0,05

0120020

Brazil nuts

0,05

0,05

0120030

Cashew nuts

0,05

0,05

0120040

Chestnuts

0,05

0,05

0120050

Coconuts

0,01 (5)

0,01 (5)

0120060

Hazelnuts (Filbert)

0,05

0,05

0120070

Macadamia

0,05

0,05

0120080

Pecans

0,05

0,05

0120090

Pine nuts

0,05

0,01 (5)

0120100

Pistachios

0,05

0,05

0120110

Walnuts

0,05

0,05

0120990

Others

0,05

0,05

0130000

| (iii) | Pome fruit |
| --- | --- |

(iii)

0,1

1

0,5

0130010

Apples (Crab apple)

0,6

0130020

Pears (Oriental pear)

0,5

0130030

Quinces

0,5

0130040

Medlar

0,5

0130050

Loquat

0,5

0130990

Others

0,5

0140000

| (iv) | Stone fruit |
| --- | --- |

(iv)

0140010

Apricots

0,1

2

0,7

0,01 (5)

0140020

Cherries (Sweet cherries, sour cherries)

0,1

1

1,5

4

0140030

Peaches (Nectarines and similar hybrids)

0,1

2

0,7

2

0140040

Plums (Damson, greengage, mirabelle, sloe, red date/Chinese date/Chinese jujube (Ziziphus zizyphus))

0,05 (5)

2

0,01 (5)

1,5

0140990

Others

0,05 (5)

0,5

0,01 (5)

0,01 (5)

0150000

| (v) | Berries & small fruit |
| --- | --- |

(v)

0151000

| (a) | Table and wine grapes |
| --- | --- |

(a)

0,2

5

1,5

0,01 (5)

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | Strawberries |
| --- | --- |

(b)

0,05 (5)

5

2

3

0153000

| (c) | Cane fruit |
| --- | --- |

(c)

0,05 (5)

0,01 (5)

0,01 (5)

0153010

Blackberries

10

0153020

Dewberries (Loganberries, tayberries, boysenberries, cloudberries and other Rubus hybrids)

0,05 (5)

0153030

Raspberries (Wineberries, arctic bramble/raspberry, (Rubus arcticus), nectar raspberries (Rubus arcticus x Rubus idaeus))

10

0153990

Others

0,05 (5)

0154000

| (d) | Other small fruit & berries |
| --- | --- |

(d)

0,05 (5)

0,01 (5)

0,01 (5)

0154010

Blueberries (Bilberries)

5

0154020

Cranberries (Cowberries/red bilberries (V. vitis-idaea))

2

0154030

Currants (red, black and white)

5

0154040

Gooseberries (Including hybrids with other Ribes species)

5

0154050

Rose hips

2

0,3 (+)

0154060

Mulberries (Arbutus berry)

2

0154070

Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta))

2

0154080

Elderberries (Black chokeberry/appleberry, mountain ash, buckthorn/sea sallowthorn, hawthorn, serviceberries, and other treeberries)

2

0154990

Others

2

0160000

| (vi) | Miscellaneous fruit |
| --- | --- |

(vi)

0,05 (5)

0,05 (5)

0,01 (5)

0161000

| (a) | Edible peel |
| --- | --- |

(a)

0,01 (5)

0161010

Dates

0161020

Figs

0161030

Table olives

0161040

Kumquats (Marumi kumquats, nagami kumquats, limequats (Citrus aurantifolia x Fortunella spp.))

0161050

Carambola (Bilimbi)

0161060

Persimmon

0161070

Jambolan (java plum) (Java apple/water apple, pomerac, rose apple, Brazilean cherry, Surinam cherry/grumichama (Eugenia uniflora))

0161990

Others

0162000

| (b) | Inedible peel, small |
| --- | --- |

(b)

0,01 (5)

0162010

Kiwi

0162020

Lychee (Litchi) (Pulasan, rambutan/hairy litchi, longan, mangosteen, langsat, salak)

0162030

Passion fruit

0162040

Prickly pear (cactus fruit)

0162050

Star apple

0162060

American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel/yellow sapote, mammey sapote)

0162990

Others

0163000

| (c) | Inedible peel, large |
| --- | --- |

(c)

0163010

Avocados

0,01 (5)

0163020

Bananas (Dwarf banana, plantain, apple banana)

0,6

0163030

Mangoes

0,01 (5)

0163040

Papaya

0,01 (5)

0163050

Pomegranate

0,01 (5)

0163060

Cherimoya (Custard apple, sugar apple/sweetsop, ilama (Annona diversifolia) and other medium sized Annonaceae fruits)

0,01 (5)

0163070

Guava (Red pitaya/dragon fruit (Hylocereus undatus))

0,01 (5)

0163080

Pineapples

0,01 (5)

0163090

Bread fruit (Jackfruit)

0,01 (5)

0163100

Durian

0,01 (5)

0163110

Soursop (guanabana)

0,01 (5)

0163990

Others

0,01 (5)

0200000

| 2. | VEGETABLES FRESH OR FROZEN |
| --- | --- |

2.

0210000

| (i) | Root and tuber vegetables |
| --- | --- |

(i)

0,05 (5)

0211000

| (a) | Potatoes |
| --- | --- |

(a)

0,05 (5)

0,1

0,04

0212000

| (b) | Tropical root and tuber vegetables |
| --- | --- |

(b)

0,05 (5)

0,1

0,04

0212010

Cassava (Dasheen, eddoe/Japanese taro, tannia)

0212020

Sweet potatoes

0212030

Yams (Potato bean/yam bean, Mexican yam bean)

0212040

Arrowroot

0212990

Others

0213000

| (c) | Other root and tuber vegetables except sugar beet |
| --- | --- |

(c)

0213010

Beetroot

1

0,1

0,6

0213020

Carrots

2

0,3

0,6

0213030

Celeriac

0,3

0,1

0,6

0213040

Horseradish (Angelica roots, lovage roots, gentiana roots)

2

0,1

0,6

0213050

Jerusalem artichokes (Crosne)

0,05 (5)

0,1

0,6

0213060

Parsnips

2

0,1

0,6

0213070

Parsley root

2

0,1

0,6

0213080

Radishes (Black radish, Japanese radish, small radish and similar varieties, tiger nut (Cyperus esculentus))

0,08

0,1

3

0213090

Salsify (Scorzonera, Spanish salsify/Spanish oysterplant, edible burdock)

2

0,1

0,6

0213100

Swedes

0,05 (5)

0,1

0,6

0213110

Turnips

0,05 (5)

0,1

0,6

0213990

Others

0,05 (5)

0,1

0,6

0220000

| (ii) | Bulb vegetables |
| --- | --- |

(ii)

0,05 (5)

0220010

Garlic

0,3

0,1 (+)

0,8

0220020

Onions (Other bulb onions, silverskin onions)

0,3

0,1 (+)

0,8

0220030

Shallots

0,3

0,1 (+)

0,8

0220040

Spring onions and welsh onions (Other green onions and similar varieties)

1

2

3

0220990

Others

0,05 (5)

0,1 (+)

0,8

0230000

| (iii) | Fruiting vegetables |
| --- | --- |

(iii)

0,05 (5)

0231000

| (a) | Solanacea |
| --- | --- |

(a)

0231010

Tomatoes (Cherry tomatoes, Physalis spp., gojiberry, wolfberry (Lycium barbarum and L. chinense), tree tomato)

1

0,9

2

0231020

Peppers (Chilli peppers)

1

0,8

2

0231030

Aubergines (egg plants) (Pepino, antroewa/white eggplant (S. macrocarpon))

1

0,1 (+)

2

0231040

Okra (lady’s fingers)

0,5

0,01 (5)

0,01 (5)

0231990

Others

0,5

0,1 (+)

0,01 (5)

0232000

| (b) | Cucurbits — edible peel |
| --- | --- |

(b)

0,5

0,5

0,7

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes (Summer squash, marrow (patisson), lauki (Lagenaria siceraria), chayote, sopropo/bitter melon, snake gourd, angled luffa/teroi)

0232990

Others

0233000

| (c) | Cucurbits-inedible peel |
| --- | --- |

(c)

0,6

0,4

0,6

0233010

Melons (Kiwano)

0233020

Pumpkins (Winter squash, marrow (late variety))

0233030

Watermelons

0233990

Others

0234000

| (d) | Sweet corn (Baby corn) |
| --- | --- |

(d)

0,05 (5)

0,1 (+)

0,01 (5)

0239000

| (e) | Other fruiting vegetables |
| --- | --- |

(e)

0,05 (5)

0,1 (+)

0,01 (5)

0240000

| (iv) | Brassica vegetables |
| --- | --- |

(iv)

0,05 (5)

0,05 (5)

0241000

| (a) | Flowering brassica |
| --- | --- |

(a)

0,2

4

0241010

Broccoli (Calabrese, Broccoli raab, Chinese broccoli)

0241020

Cauliflower

0241990

Others

0242000

| (b) | Head brassica |
| --- | --- |

(b)

0242010

Brussels sprouts

0,2

0,01 (5)

0242020

Head cabbage (Pointed head cabbage, red cabbage, savoy cabbage, white cabbage)

0,3

4

0242990

Others

0,1 (+)

0,01 (5)

0243000

| (c) | Leafy brassica |
| --- | --- |

(c)

0,01 (5)

0243010

Chinese cabbage (Indian or Chinese) mustard, pak choi, Chinese flat cabbage/ai goo choi, choi sum, Peking cabbage/pe-tsai

0,7

0243020

Kale (Borecole/curly kale, collards, Portuguese Kale, Portuguese cabbage, cow cabbage)

0,1 (+)

0243990

Others

0,1 (+)

0244000

| (d) | Kohlrabi |
| --- | --- |

(d)

0,1 (+)

0,01 (5)

0250000

| (v) | Leaf vegetables & fresh herbs |
| --- | --- |

(v)

0251000

| (a) | Lettuce and other salad plants including Brassicacea |
| --- | --- |

(a)

15

0251010

Lamb’s lettuce (Italian corn salad)

5

15

15

0251020

Lettuce (Head lettuce, lollo rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce)

0,05 (5)

15

15

0251030

Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curly leaf endive, sugar loaf (C. endivia var. crispum/C. intybus var. foliosum), dandelion greens)

0,05 (5)

0,1 (+)

0,01 (5)

0251040

Cress (Mung bean sprouts, alfalfa sprouts)

0,05 (5)

15

15

0251050

Land cress

0,05 (5)

15

15

0251060

Rocket, Rucola (Wild rocket (Diplotaxis spp.))

0,05 (5)

15

15

0251070

Red mustard

0,05 (5)

15

15

0251080

Leaves and sprouts of Brassica spp, including turnip greens (Mizuna, leaves of peas and radish and other babyleaf crops, including brassica crops (crops harvested up to 8 true leaf stage), kohlrabi leaves)

0,05 (5)

15

15

0251990

Others

0,05 (5)

15

15

0252000

| (b) | Spinach & similar (leaves) |
| --- | --- |

(b)

0,05 (5)

15

0,1 (+)

30

0252010

Spinach (New Zealand spinach, amaranthus spinach (pak-khom, tampara), tajer leaves, bitterblad/bitawiri)

0252020

Purslane (Winter purslane/miner’s lettuce, garden purslane, common purslane, sorrel, glassworth, agretti (Salsola soda))

0252030

Beet leaves (chard) (Leaves of beetroot)

0252990

Others

0253000

| (c) | Vine leaves (grape leaves) (Malabar nightshade, banana leaves, climbing wattle (Acacia pennata)) |
| --- | --- |

(c)

0,05 (5)

0,05 (5)

0,01 (5)

0,01 (5)

0254000

| (d) | Water cress (Morning glory/Chinese convolvulus/water convolvulus/water spinach/kangkung (Ipomea aquatica), water clover, water mimosa) |
| --- | --- |

(d)

0,05 (5)

0,05 (5)

0,1 (+)

0,01 (5)

0255000

| (e) | Witloof |
| --- | --- |

(e)

0,05 (5)

0,05 (5)

0,1 (+)

0,01 (5)

0256000

| (f) | Herbs |
| --- | --- |

(f)

0,05 (5)

15

0,1 (+)

0,4 (+)

0256010

Chervil

20

0256020

Chives

0,01 (5)

0256030

Celery leaves (Fennel leaves, coriander leaves, dill leaves, caraway leaves, lovage, angelica, sweet cisely and other Apiacea leaves, culantro/stinking/long coriander/stink weed (Eryngium foetidum))

0,01 (5)

0256040

Parsley (leaves of root parsley)

20

0256050

Sage (Winter savory, summer savory, Borago officinalis leaves)

0,01 (5)

0256060

Rosemary

0,01 (5)

0256070

Thyme (Marjoram, oregano)

0,01 (5)

0256080

Basil (Balm leaves, mint, peppermint, holy basil, sweet basil, hairy basil, edible flowers (marigold flower and others), pennywort, wild betel leaf, curry leaves)

0,01 (5)

0256090

Bay leaves (laurel) (Lemon grass)

0,01 (5)

0256100

Tarragon (Hyssop)

0,01 (5)

0256990

Others

0,01 (5)

0260000

| (vi) | Legume vegetables (fresh) |
| --- | --- |

(vi)

0,05 (5)

0260010

Beans (with pods) (Green bean/French beans/snap beans, scarlet runner bean, slicing bean, yard long beans, guar beans, soya beans)

2

0,9

3

0260020

Beans (without pods) (Broad beans, flageolets, jack bean, lima bean, cowpea)

0,5

0,1 (+)

0,4

0260030

Peas (with pods) (Mangetout/sugar peas/snow peas)

2

0,1 (+)

4

0260040

Peas (without pods) (Garden pea, green pea, chickpea)

0,1

0,15

0,3

0260050

Lentils

0,2

0,1 (+)

0,01 (5)

0260990

Others

0,05 (5)

0,1 (+)

0,01 (5)

0270000

| (vii) | Stem vegetables (fresh) |
| --- | --- |

(vii)

0270010

Asparagus

0,1

0,05 (5)

0,01 (5)

0,01 (5)

0270020

Cardoons (Borago officinalis stems)

0,05 (5)

0,05 (5)

0,1 (+)

15

0270030

Celery

0,2

5

0,1 (+)

15

0270040

Fennel

0,05 (5)

0,2

0,1 (+)

15

0270050

Globe artichokes (Banana flower)

0,1

0,05 (5)

0,5

0,01 (5)

0270060

Leek

0,05 (5)

0,05 (5)

0,7

3

0270070

Rhubarb

0,05 (5)

0,05 (5)

0,01 (5)

15

0270080

Bamboo shoots

0,05 (5)

0,05 (5)

0,01 (5)

0,01 (5)

0270090

Palm hearts

0,05 (5)

0,05 (5)

0,01 (5)

0,01 (5)

0270990

Others

0,05 (5)

0,05 (5)

0,1 (+)

0,01 (5)

0280000

| (viii) | Fungi |
| --- | --- |

(viii)

0,05 (5)

0,05 (5)

0,01 (5)

0,01 (5)

0280010

Cultivated fungi (Common mushroom, oyster mushroom, shiitake, fungus mycelium (vegetative parts))

0280020

Wild fungi (Chanterelle, truffle, morel, cep)

0,04 (+)

0280990

Others

0290000

| (ix) | Sea weeds |
| --- | --- |

(ix)

0,05 (5)

0,05 (5)

0,01 (5)

0,01 (5)

0300000

| 3. | PULSES, DRY |
| --- | --- |

3.

0,05 (5)

0,2

0,4

0,2

0300010

Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)

0300020

Lentils

0300030

Peas (Chickpeas, field peas, chickling vetch)

0300040

Lupins

0300990

Others

0400000

| 4. | OILSEEDS AND OILFRUITS |
| --- | --- |

4.

0,05 (5)

0401000

| (i) | Oilseeds |
| --- | --- |

(i)

0401010

Linseed

0,05 (5)

0,1 (+)

0,01 (5)

0401020

Peanuts

0,05 (5)

0,02

0,04

0401030

Poppy seed

0,4

0,1 (+)

0,01 (5)

0401040

Sesame seed

0,05 (5)

0,1 (+)

0,01 (5)

0401050

Sunflower seed

0,05 (5)

0,1 (+)

1,5

0401060

Rape seed (Bird rapeseed, turnip rape)

0,4

0,6

0,5

0401070

Soya bean

0,07

0,2

0,3

0401080

Mustard seed

0,4

0,1 (+)

0,01 (5)

0401090

Cotton seed

0,05 (5)

0,1 (+)

0,5

0401100

Pumpkin seeds (Other seeds of Cucurbitaceae)

0,05 (5)

0,1 (+)

0,01 (5)

0401110

Safflower

0,05 (5)

0,1 (+)

0,01 (5)

0401120

Borage (Purple viper’s bugloss/Canary flower (Echium plantagineum), Corn Gromwell (Buglossoides arvensis))

0,05 (5)

0,1 (+)

0,01 (5)

0401130

Gold of pleasure

0,4

0,1 (+)

0,01 (5)

0401140

Hempseed

0,05 (5)

0,1 (+)

0,01 (5)

0401150

Castor bean

0,05 (5)

0,1 (+)

0,01 (5)

0401990

Others

0,05 (5)

0,1 (+)

0,01 (5)

0402000

| (ii) | Oilfruits |
| --- | --- |

(ii)

0,05 (5)

0,01 (5)

0,01 (5)

0402010

Olives for oil production

0402020

Palm nuts (palmoil kernels)

0402030

Palmfruit

0402040

Kapok

0402990

Others

0500000

| 5. | CEREALS |
| --- | --- |

5.

0,1

0500010

Barley

3

0,1 (+)

0,2

0500020

Buckwheat (Amaranthus, quinoa)

0,05 (5)

0,1 (+)

0,01 (5)

0500030

Maize

0,05 (5)

0,02

0,01 (5)

0500040

Millet (Foxtail millet, teff, finger millet, pearl millet)

0,05 (5)

0,1 (+)

0,8

0500050

Oats

2

0,1 (+)

0,2

0500060

Rice (Indian/wild rice (Zizania aquatica))

0,05 (5)

0,01 (5)

0,01 (5)

0500070

Rye

0,5

0,8

0,1

0500080

Sorghum

0,05 (5)

1,5

0,8

0500090

Wheat (Spelt, triticale)

0,5

0,8

0,1

0500990

Others (Canary grass seeds (Phalaris canariensis))

0,05 (5)

0,1 (+)

0,01 (5)

0600000

| 6. | TEA, COFFEE, HERBAL INFUSIONS AND COCOA |
| --- | --- |

6.

0,02 (5)

0610000

| (i) | Tea |
| --- | --- |

(i)

0,05 (5)

0,05 (5)

0,01 (5)

0,6 (+)

0620000

| (ii) | Coffee beans |
| --- | --- |

(ii)

0,1

0,05 (5)

0,01 (5)

0630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

0,05 (5)

0,1 (+)

0,5 (+)

0631000

| (a) | Flowers |
| --- | --- |

(a)

0,05 (5)

0631010

Camomille flowers

0631020

Hybiscus flowers

0631030

Rose petals

0631040

Jasmine flowers (Elderflowers (Sambucus nigra))

0631050

Lime (linden)

0631990

Others

0632000

| (b) | Leaves |
| --- | --- |

(b)

0,05 (5)

0632010

Strawberry leaves

0632020

Rooibos leaves (Ginkgo leaves)

0632030

Maté

0632990

Others

0633000

| (c) | Roots |
| --- | --- |

(c)

1

0633010

Valerian root

0633020

Ginseng root

0633990

Others

0639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

0,05 (5)

0640000

| (iv) | Cocoabeans (fermented or dried) |
| --- | --- |

(iv)

0,05 (5)

0,05 (5)

0,01 (5)

0650000

| (v) | Carob (st johns bread) |
| --- | --- |

(v)

0,05 (5)

0,05 (5)

0,01 (5)

0700000

| 7. | HOPS (dried) |
| --- | --- |

7.

0,05 (5)

0,05 (5)

0,01 (5)

0,02 (5)

0800000

| 8. | SPICES |
| --- | --- |

8.

0,05 (5)

(+)

0,02 (5)

0810000

| (i) | Seeds |
| --- | --- |

(i)

0,05 (5)

0,1 (+)

0,3

0810010

Anise

0810020

Black caraway

0810030

Celery seed (Lovage seed)

0810040

Coriander seed

0810050

Cumin seed

0810060

Dill seed

0810070

Fennel seed

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820000

| (ii) | Fruits and berries |
| --- | --- |

(ii)

0,05 (5)

0,3

0820010

Allspice

0,01 (5)

0820020

Sichuan pepper (Anise pepper, Japan pepper)

0,01 (5)

0820030

Caraway

0,1 (+)

0820040

Cardamom

0,01 (5)

0820050

Juniper berries

0,01 (5)

0820060

Pepper, black, green and white (Long pepper, pink pepper)

0,01 (5)

0820070

Vanilla pods

0,01 (5)

0820080

Tamarind

0,01 (5)

0820990

Others

0,01 (5)

0830000

| (iii) | Bark |
| --- | --- |

(iii)

0,05 (5)

0,01 (5)

4

0830010

Cinnamon (Cassia)

0830990

Others

0840000

| (iv) | Roots or rhizome |
| --- | --- |

(iv)

1

4

0840010

Liquorice

0,01 (5)

0840020

Ginger

0,01 (5)

0840030

Turmeric (Curcuma)

0,1 (+)

0840040

Horseradish

0,01 (5)

0840990

Others

0,01 (5)

0850000

| (v) | Buds |
| --- | --- |

(v)

0,05 (5)

0,01 (5)

4

0850010

Cloves

0850020

Capers

0850990

Others

0860000

| (vi) | Flower stigma |
| --- | --- |

(vi)

0,05 (5)

0,01 (5)

4

0860010

Saffron

0860990

Others

0870000

| (vii) | Aril |
| --- | --- |

(vii)

0,05 (5)

0,01 (5)

4

0870010

Mace

0870990

Others

0900000

| 9. | SUGAR PLANTS |
| --- | --- |

9.

0,05 (5)

0900010

Sugar beet (root)

0,1

0,1 (+)

0,5

0900020

Sugar cane

0,05 (5)

0,01 (5)

0,01 (5)

0900030

Chicory roots

0,05 (5)

0,1 (+)

0,01 (5)

0900990

Others

0,05 (5)

0,1 (+)

0,01 (5)

1000000

| 10. | PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS |
| --- | --- |

10.

0,05 (5)

1010000

| (i) | Tissue |
| --- | --- |

(i)

0,01 (5)

1011000

| (a) | Swine |
| --- | --- |

(a)

1011010

Muscle

0,05 (5)

0,1

1011020

Fat

0,05 (5)

0,05

1011030

Liver

0,5

0,7

1011040

Kidney

0,5

0,7

1011050

Edible offal

0,5

0,7

1011990

Others

0,05 (5)

0,02 (5)

1012000

| (b) | Bovine |
| --- | --- |

(b)

1012010

Muscle

0,05 (5)

0,1

1012020

Fat

0,05 (5)

0,1

1012030

Liver

0,5

0,7

1012040

Kidney

0,5

0,7

1012050

Edible offal

0,5

0,7

1012990

Others

0,05 (5)

0,02 (5)

1013000

| (c) | Sheep |
| --- | --- |

(c)

1013010

Muscle

0,05 (5)

0,1

1013020

Fat

0,05 (5)

0,1

1013030

Liver

0,5

0,7

1013040

Kidney

0,5

0,7

1013050

Edible offal

0,5

0,7

1013990

Others

0,05 (5)

0,02 (5)

1014000

| (d) | Goat |
| --- | --- |

(d)

1014010

Muscle

0,05 (5)

0,1

1014020

Fat

0,05 (5)

0,1

1014030

Liver

0,5

0,7

1014040

Kidney

0,5

0,7

1014050

Edible offal

0,5

0,7

1014990

Others

0,05 (5)

0,02 (5)

1015000

| (e) | Horses, asses, mules or hinnies |
| --- | --- |

(e)

1015010

Muscle

0,05 (5)

0,1

1015020

Fat

0,05 (5)

0,02 (5)

1015030

Liver

0,5

0,7

1015040

Kidney

0,5

0,7

1015050

Edible offal

0,5

0,7

1015990

Others

0,05 (5)

0,02 (5)

1016000

| (f) | Poultry -chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon |
| --- | --- |

(f)

0,05 (5)

1016010

Muscle

0,1

1016020

Fat

0,1

1016030

Liver

0,2

1016040

Kidney

0,02 (5)

1016050

Edible offal

0,02 (5)

1016990

Others

0,02 (5)

1017000

| (g) | Other farm animals (Rabbit, kangaroo, deer) |
| --- | --- |

(g)

1017010

Muscle

0,05 (5)

0,1

1017020

Fat

0,05 (5)

0,02 (5)

1017030

Liver

0,5

0,7

1017040

Kidney

0,5

0,7

1017050

Edible offal

0,5

0,7

1017990

Others

0,05 (5)

0,02 (5)

1020000

| (ii) | Milk |
| --- | --- |

(ii)

0,05 (5)

0,1

0,01 (5)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others

1030000

| (iii) | Bird eggs |
| --- | --- |

(iii)

0,05 (5)

0,15

0,01 (5)

1030010

Chicken

1030020

Duck

1030030

Goose

1030040

Quail

1030990

Others

1040000

| (iv) | Honey (Royal jelly, pollen, honey comb with honey (comb honey)) |
| --- | --- |

(iv)

0,05 (5)

0,02 (5)

0,05 (5)

1050000

| (v) | Amphibians and reptiles (Frog legs, crocodiles) |
| --- | --- |

(v)

0,05 (5)

0,02 (5)

0,01 (5)

1060000

| (vi) | Snails |
| --- | --- |

(vi)

0,05 (5)

0,02 (5)

0,01 (5)

1070000

| (vii) | Other terrestrial animal products (Wild game) |
| --- | --- |

(vii)

0,05 (5)

0,02 (5)

0,01 (5)

(F)= Fat soluble

| (R) | = | The residue definition differs for the following combinations pesticide-code number:
  Cyprodinil - code 1000000: Sum cyprodinil and metabolite CGA 304075 |
| --- | --- | --- |

(R)

=

The residue definition differs for the following combinations pesticide-code number:

Cyprodinil - code 1000000: Sum cyprodinil and metabolite CGA 304075

Fluopyram - code 1000000: sum fluopyram and fluopyram-benzamide (M25) expressed as fluopyram

| (+) | The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 19 October 2015, or, if that information is not submitted by that date, the lack of it.







  0220010 | Garlic |
| --- | --- | --- |
| 0220020 | Onions (Other bulb onions, silverskin onions) |
| 0220030 | Shallots |
| 0220990 | Others |
| 0231030 | Aubergines (egg plants) (Pepino, antroewa/white eggplant (S. macrocarpon)) |
| 0231990 | Others |
| 0234000 | (d) | Sweet corn (Baby corn) |

(+)

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 19 October 2015, or, if that information is not submitted by that date, the lack of it.

0220010

Garlic

0220020

Onions (Other bulb onions, silverskin onions)

0220030

Shallots

0220990

Others

0231030

Aubergines (egg plants) (Pepino, antroewa/white eggplant (S. macrocarpon))

0231990

Others

0234000

(d)

0239000

| (e) | Other fruiting vegetables |
| --- | --- |

(e)

0242990

Others

0243020

Kale (Borecole/curly kale, collards, Portuguese Kale, Portuguese cabbage, cow cabbage)

0243990

Others

0244000

| (d) | Kohlrabi |
| --- | --- |

(d)

0251030

Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curly leaf endive, sugar loaf (C. endivia var. crispum/C. intybus var. foliosum), dandelion greens)

0252000

| (b) | Spinach & similar (leaves) |
| --- | --- |

(b)

0252010

Spinach (New Zealand spinach, amaranthus spinach (pak-khom, tampara), tajer leaves, bitterblad/bitawiri)

0252020

Purslane (Winter purslane/miner’s lettuce, garden purslane, common purslane, sorrel, glassworth, agretti (Salsola soda))

0252030

Beet leaves (chard) (Leaves of beetroot)

0252990

Others

0254000

| (d) | Water cress (Morning glory/Chinese convolvulus/water convolvulus/water spinach/kangkung (Ipomea aquatica), water clover, water mimosa) |
| --- | --- |

(d)

0255000

| (e) | Witloof |
| --- | --- |

(e)

0256000

| (f) | Herbs |
| --- | --- |

(f)

0256010

Chervil

0256020

Chives

0256030

Celery leaves (Fennel leaves, coriander leaves, dill leaves, caraway leaves, lovage, angelica, sweet cisely and other Apiacea leaves, culantro/stinking/long coriander/stink weed (Eryngium foetidum))

0256040

Parsley (leaves of root parsley)

0256050

Sage (Winter savory, summer savory, Borago officinalis leaves)

0256060

Rosemary

0256070

Thyme (Marjoram, oregano)

0256080

Basil (Balm leaves, mint, peppermint, holy basil, sweet basil, hairy basil, edible flowers (marigold flower and others), pennywort, wild betel leaf, curry leaves)

0256090

Bay leaves (laurel) (Lemon grass)

0256100

Tarragon (Hyssop)

0256990

Others

0260020

Beans (without pods) (Broad beans, flageolets, jack bean, lima bean, cowpea)

0260030

Peas (with pods) (Mangetout/sugar peas/snow peas)

0260050

Lentils

0260990

Others

0270020

Cardoons (Borago officinalis stems)

0270030

Celery

0270040

Fennel

0270990

Others

0401010

Linseed

0401030

Poppy seed

0401040

Sesame seed

0401050

Sunflower seed

0401080

Mustard seed

0401090

Cotton seed

0401100

Pumpkin seeds (Other seeds of Cucurbitaceae)

0401110

Safflower

0401120

Borage (Purple viper’s bugloss/Canary flower (Echium plantagineum), Corn Gromwell (Buglossoides arvensis))

0401130

Gold of pleasure

0401140

Hempseed

0401150

Castor bean

0401990

Others

0500010

Barley

0500020

Buckwheat (Amaranthus, quinoa)

0500040

Millet (Foxtail millet, teff, finger millet, pearl millet)

0500050

Oats

0500990

Others (Canary grass seeds (Phalaris canariensis))

0630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

0631000

| (a) | Flowers |
| --- | --- |

(a)

0631010

Camomille flowers

0631020

Hybiscus flowers

0631030

Rose petals

0631040

Jasmine flowers (Elderflowers (Sambucus nigra))

0631050

Lime (linden)

0631990

Others

0632000

| (b) | Leaves |
| --- | --- |

(b)

0632010

Strawberry leaves

0632020

Rooibos leaves (Ginkgo leaves)

0632030

Maté

0632990

Others

0633000

| (c) | Roots |
| --- | --- |

(c)

0633010

Valerian root

0633020

Ginseng root

0633990

Others

0639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

0810000

| (i) | Seeds |
| --- | --- |

(i)

0810010

Anise

0810020

Black caraway

0810030

Celery seed (Lovage seed)

0810040

Coriander seed

0810050

Cumin seed

0810060

Dill seed

0810070

Fennel seed

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820030

Caraway

0840030

Turmeric (Curcuma)

0900010

Sugar beet (root)

0900030

Chicory roots

0900990

Others

| (+) | Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.







  0154050 | Rose hips |
| --- | --- | --- |
| 0256000 | (f) | Herbs |

(+)

Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.

0154050

Rose hips

0256000

(f)

0256010

Chervil

0256020

Chives

0256030

Celery leaves (Fennel leaves, coriander leaves, dill leaves, caraway leaves, lovage, angelica, sweet cisely and other Apiacea leaves, culantro/stinking/long coriander/stink weed (Eryngium foetidum))

0256040

Parsley (leaves of root parsley)

0256050

Sage (Winter savory, summer savory, Borago officinalis leaves)

0256060

Rosemary

0256070

Thyme (Marjoram, oregano)

0256080

Basil (Balm leaves, mint, peppermint, holy basil, sweet basil, hairy basil, edible flowers (marigold flower and others), pennywort, wild betel leaf, curry leaves)

0256090

Bay leaves (laurel) (Lemon grass)

0256100

Tarragon (Hyssop)

0256990

Others

| (+) | The following MRLs apply to dried wild mushrooms: 2,3 mg/kg for ceps, 1,2 mg/kg for dried wild mushrooms other than ceps. These MRLs shall be reviewed by 30 November 2014. Confirmatory data including any scientific evidence on the natural occurrence or formation of nicotine in the concerned crop will be evaluated. Reassessment of data may lead to modification of MRLs







  0280020 | Wild fungi (Chanterelle truffle morel cep) |
| --- | --- | --- |

(+)

The following MRLs apply to dried wild mushrooms: 2,3 mg/kg for ceps, 1,2 mg/kg for dried wild mushrooms other than ceps. These MRLs shall be reviewed by 30 November 2014. Confirmatory data including any scientific evidence on the natural occurrence or formation of nicotine in the concerned crop will be evaluated. Reassessment of data may lead to modification of MRLs

0280020

Wild fungi (Chanterelle truffle morel cep)

| (+) | Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.







  0610000 | (i) | Tea |
| --- | --- | --- | --- |

(+)

Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.

0610000

(i)

0630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

0631000

| (a) | Flowers |
| --- | --- |

(a)

0631010

Camomille flowers

0631020

Hybiscus flowers

0631030

Rose petals

0631040

Jasmine flowers (Elderflowers (Sambucus nigra))

0631050

Lime (linden)

0631990

Others

0632000

| (b) | Leaves |
| --- | --- |

(b)

0632010

Strawberry leaves

0632020

Rooibos leaves (Ginkgo leaves)

0632030

Maté

0632990

Others

0633000

| (c) | Roots |
| --- | --- |

(c)

0633010

Valerian root

0633020

Ginseng root

0633990

Others

0639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

0800000

| 8. | SPICES |
| --- | --- |

8.

0810000

| (i) | Seeds |
| --- | --- |

(i)

0810010

Anise

0810020

Black caraway

0810030

Celery seed (Lovage seed)

0810040

Coriander seed

0810050

Cumin seed

0810060

Dill seed

0810070

Fennel seed

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820000

| (ii) | Fruits and berries |
| --- | --- |

(ii)

0820010

Allspice

0820020

Sichuan pepper (Anise pepper, Japan pepper)

0820030

Caraway

0820040

Cardamom

0820050

Juniper berries

0820060

Pepper, black, green and white (Long pepper, pink pepper)

0820070

Vanilla pods

0820080

Tamarind

0820990

Others

0830000

| (iii) | Bark |
| --- | --- |

(iii)

0830010

Cinnamon (Cassia)

0830990

Others

0840000

| (iv) | Roots or rhizome |
| --- | --- |

(iv)

0840010

Liquorice

0840020

Ginger

0840030

Turmeric (Curcuma)

0840040

Horseradish

0840990

Others

0850000

| (v) | Buds |
| --- | --- |

(v)

0850010

Cloves

0850020

Capers

0850990

Others

0860000

| (vi) | Flower stigma |
| --- | --- |

(vi)

0860010

Saffron

0860990

Others

0870000

| (vii) | Aril |
| --- | --- |

(vii)

0870010

Mace

0870990

Others’

| (b) | The following column for 8-hydroxyquinoline is added:
  ‘Pesticide residues and maximum residue levels (mg/kg)








  Code number | Groups and examples of individual products to which the MRLs apply (6) | 8-hydroxyquinoline (sum of 8-hydroxyquinoline and its salts, expressed as 8-hydroxyquinoline) |
| --- | --- | --- | --- |
| (1) | (2) | (3) |
| 0100000 | 1. | FRUIT FRESH OR FROZEN NUTS |

(b)

The following column for 8-hydroxyquinoline is added:

‘Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply (6)

8-hydroxyquinoline (sum of 8-hydroxyquinoline and its salts, expressed as 8-hydroxyquinoline)

(1)

(2)

(3)

0100000

1.

0,01
   (7)

0110000

| (i) | Citrus fruit |
| --- | --- |

(i)

0110010

Grapefruit (Shaddocks, pomelos, sweeties, tangelo (except mineola), ugli and other hybrids)

0110020

Oranges (Bergamot, bitter orange, chinotto and other hybrids)

0110030

Lemons (Citron, lemon, Buddha’s hand (Citrus medica var. sarcodactylis))

0110040

Limes

0110050

Mandarins (Clementine, tangerine, mineola and other hybrids tangor (Citrus reticulata x sinensis))

0110990

Others

0120000

| (ii) | Tree nuts |
| --- | --- |

(ii)

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts (Filbert)

0120070

Macadamia

0120080

Pecans

0120090

Pine nuts

0120100

Pistachios

0120110

Walnuts

0120990

Others

0130000

| (iii) | Pome fruit |
| --- | --- |

(iii)

0130010

Apples (Crab apple)

0130020

Pears (Oriental pear)

0130030

Quinces

0130040

Medlar

0130050

Loquat

0130990

Others

0140000

| (iv) | Stone fruit |
| --- | --- |

(iv)

0140010

Apricots

0140020

Cherries (Sweet cherries, sour cherries)

0140030

Peaches (Nectarines and similar hybrids)

0140040

Plums (Damson, greengage, mirabelle, sloe, red date/Chinese date/Chinese jujube (Ziziphus zizyphus))

0140990

Others

0150000

| (v) | Berries & small fruit |
| --- | --- |

(v)

0151000

| (a) | Table and wine grapes |
| --- | --- |

(a)

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | Strawberries |
| --- | --- |

(b)

0153000

| (c) | Cane fruit |
| --- | --- |

(c)

0153010

Blackberries

0153020

Dewberries (Loganberries, tayberries, boysenberries, cloudberries and other Rubus hybrids)

0153030

Raspberries (Wineberries, arctic bramble/raspberry, (Rubus arcticus), nectar raspberries (Rubus arcticus x Rubus idaeus))

0153990

Others

0154000

| (d) | Other small fruit & berries |
| --- | --- |

(d)

0154010

Blueberries (Bilberries)

0154020

Cranberries (Cowberries/red bilberries (V. vitis-idaea))

0154030

Currants (red, black and white)

0154040

Gooseberries (Including hybrids with other Ribes species)

0154050

Rose hips

0154060

Mulberries (Arbutus berry)

0154070

Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta))

0154080

Elderberries (Black chokeberry/appleberry, mountain ash, buckthorn/sea sallowthorn, hawthorn, serviceberries, and other treeberries)

0154990

Others

0160000

| (vi) | Miscellaneous fruit |
| --- | --- |

(vi)

0161000

| (a) | Edible peel |
| --- | --- |

(a)

0161010

Dates

0161020

Figs

0161030

Table olives

0161040

Kumquats (Marumi kumquats, nagami kumquats, limequats (Citrus aurantifolia x Fortunella spp.))

0161050

Carambola (Bilimbi)

0161060

Persimmon

0161070

Jambolan (java plum) (Java apple/water apple, pomerac, rose apple, Brazilean cherry, Surinam cherry/grumichama (Eugenia uniflora))

0161990

Others

0162000

| (b) | Inedible peel, small |
| --- | --- |

(b)

0162010

Kiwi

0162020

Lychee (Litchi) (Pulasan, rambutan/hairy litchi, longan, mangosteen, langsat, salak)

0162030

Passion fruit

0162040

Prickly pear (cactus fruit)

0162050

Star apple

0162060

American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel/yellow sapote, mammey sapote)

0162990

Others

0163000

| (c) | Inedible peel, large |
| --- | --- |

(c)

0163010

Avocados

0163020

Bananas (Dwarf banana, plantain, apple banana)

0163030

Mangoes

0163040

Papaya

0163050

Pomegranate

0163060

Cherimoya (Custard apple, sugar apple/sweetsop, ilama (Annona diversifolia) and other medium sized Annonaceae fruits)

0163070

Guava (Red pitaya/dragon fruit (Hylocereus undatus))

0163080

Pineapples

0163090

Bread fruit (Jackfruit)

0163100

Durian

0163110

Soursop (guanabana)

0163990

Others

0200000

| 2. | VEGETABLES FRESH OR FROZEN |
| --- | --- |

2.

0210000

| (i) | Root and tuber vegetables |
| --- | --- |

(i)

0,01 (7)

0211000

| (a) | Potatoes |
| --- | --- |

(a)

0212000

| (b) | Tropical root and tuber vegetables |
| --- | --- |

(b)

0212010

Cassava (Dasheen, eddoe/Japanese taro, tannia)

0212020

Sweet potatoes

0212030

Yams (Potato bean/yam bean, Mexican yam bean)

0212040

Arrowroot

0212990

Others

0213000

| (c) | Other root and tuber vegetables except sugar beet |
| --- | --- |

(c)

0213010

Beetroot

0213020

Carrots

0213030

Celeriac

0213040

Horseradish (Angelica roots, lovage roots, gentiana roots)

0213050

Jerusalem artichokes (Crosne)

0213060

Parsnips

0213070

Parsley root

0213080

Radishes (Black radish, Japanese radish, small radish and similar varieties, tiger nut (Cyperus esculentus))

0213090

Salsify (Scorzonera, Spanish salsify/Spanish oysterplant, edible burdock)

0213100

Swedes

0213110

Turnips

0213990

Others

0220000

| (ii) | Bulb vegetables |
| --- | --- |

(ii)

0,01 (7)

0220010

Garlic

0220020

Onions (Other bulb onions, silverskin onions)

0220030

Shallots

0220040

Spring onions and welsh onions (Other green onions and similar varieties)

0220990

Others

0230000

| (iii) | Fruiting vegetables |
| --- | --- |

(iii)

0231000

| (a) | Solanacea |
| --- | --- |

(a)

0231010

Tomatoes (Cherry tomatoes, Physalis spp., gojiberry, wolfberry (Lycium barbarum and L. chinense), tree tomato)

0,1

0231020

Peppers (Chilli peppers)

0,01 (7)

0231030

Aubergines (egg plants) (Pepino, antroewa/white eggplant (S. macrocarpon))

0,01 (7)

0231040

Okra (lady’s fingers)

0,01 (7)

0231990

Others

0,01 (7)

0232000

| (b) | Cucurbits — edible peel |
| --- | --- |

(b)

0,01 (7)

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes (Summer squash, marrow (patisson), lauki (Lagenaria siceraria), chayote, sopropo/bitter melon, snake gourd, angled luffa/teroi)

0232990

Others

0233000

| (c) | Cucurbits-inedible peel |
| --- | --- |

(c)

0,01 (7)

0233010

Melons (Kiwano)

0233020

Pumpkins (Winter squash, marrow (late variety))

0233030

Watermelons

0233990

Others

0234000

| (d) | Sweet corn (Baby corn) |
| --- | --- |

(d)

0,01 (7)

0239000

| (e) | Other fruiting vegetables |
| --- | --- |

(e)

0,01 (7)

0240000

| (iv) | Brassica vegetables |
| --- | --- |

(iv)

0,01 (7)

0241000

| (a) | Flowering brassica |
| --- | --- |

(a)

0241010

Broccoli (Calabrese, Broccoli raab, Chinese broccoli)

0241020

Cauliflower

0241990

Others

0242000

| (b) | Head brassica |
| --- | --- |

(b)

0242010

Brussels sprouts

0242020

Head cabbage (Pointed head cabbage, red cabbage, savoy cabbage, white cabbage)

0242990

Others

0243000

| (c) | Leafy brassica |
| --- | --- |

(c)

0243010

Chinese cabbage (Indian or Chinese) mustard, pak choi, Chinese flat cabbage/ai goo choi, choi sum, Peking cabbage/pe-tsai

0243020

Kale (Borecole/curly kale, collards, Portuguese Kale, Portuguese cabbage, cow cabbage)

0243990

Others

0244000

| (d) | Kohlrabi |
| --- | --- |

(d)

0250000

| (v) | Leaf vegetables & fresh herbs |
| --- | --- |

(v)

0,01 (7)

0251000

| (a) | Lettuce and other salad plants including Brassicacea |
| --- | --- |

(a)

0251010

Lamb’s lettuce (Italian corn salad)

0251020

Lettuce (Head lettuce, lollo rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce)

0251030

Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curly leaf endive, sugar loaf (C. endivia var. crispum/C. intybus var. foliosum), dandelion greens)

0251040

Cress (Mung bean sprouts, alfalfa sprouts)

0251050

Land cress

0251060

Rocket, Rucola (Wild rocket (Diplotaxis spp.))

0251070

Red mustard

0251080

Leaves and sprouts of Brassica spp, including turnip greens (Mizuna, leaves of peas and radish and other babyleaf crops, including brassica crops (crops harvested up to 8 true leaf stage), kohlrabi leaves)

0251990

Others

0252000

| (b) | Spinach & similar (leaves) |
| --- | --- |

(b)

0252010

Spinach (New Zealand spinach, amaranthus spinach (pak-khom, tampara), tajer leaves, bitterblad/bitawiri)

0252020

Purslane (Winter purslane/miner’s lettuce, garden purslane, common purslane, sorrel, glassworth, agretti (Salsola soda))

0252030

Beet leaves (chard) (Leaves of beetroot)

0252990

Others

0253000

| (c) | Vine leaves (grape leaves) (Malabar nightshade, banana leaves, climbing wattle (Acacia pennata)) |
| --- | --- |

(c)

0254000

| (d) | Water cress (Morning glory/Chinese convolvulus/water convolvulus/water spinach/kangkung (Ipomea aquatica), water clover, water mimosa) |
| --- | --- |

(d)

0255000

| (e) | Witloof |
| --- | --- |

(e)

0256000

| (f) | Herbs |
| --- | --- |

(f)

0256010

Chervil

0256020

Chives

0256030

Celery leaves (Fennel leaves, coriander leaves, dill leaves, caraway leaves, lovage, angelica, sweet cisely and other Apiacea leaves, culantro/stinking/long coriander/stink weed (Eryngium foetidum))

0256040

Parsley (leaves of root parsley)

0256050

Sage (Winter savory, summer savory, Borago officinalis leaves)

0256060

Rosemary

0256070

Thyme (Marjoram, oregano)

0256080

Basil (Balm leaves, mint, peppermint, holy basil, sweet basil, hairy basil, edible flowers (marigold flower and others), pennywort, wild betel leaf, curry leaves)

0256090

Bay leaves (laurel) (Lemon grass)

0256100

Tarragon (Hyssop)

0256990

Others

0260000

| (vi) | Legume vegetables (fresh) |
| --- | --- |

(vi)

0,01 (7)

0260010

Beans (with pods) (Green bean/French beans/snap beans, scarlet runner bean, slicing bean, yard long beans, guar beans, soya beans)

0260020

Beans (without pods) (Broad beans, flageolets, jack bean, lima bean, cowpea)

0260030

Peas (with pods) (Mangetout/sugar peas/snow peas)

0260040

Peas (without pods) (Garden pea, green pea, chickpea)

0260050

Lentils

0260990

Others

0270000

| (vii) | Stem vegetables (fresh) |
| --- | --- |

(vii)

0,01 (7)

0270010

Asparagus

0270020

Cardoons (Borago officinalis stems)

0270030

Celery

0270040

Fennel

0270050

Globe artichokes (Banana flower)

0270060

Leek

0270070

Rhubarb

0270080

Bamboo shoots

0270090

Palm hearts

0270990

Others

0280000

| (viii) | Fungi |
| --- | --- |

(viii)

0,01 (7)

0280010

Cultivated fungi (Common mushroom, oyster mushroom, shiitake, fungus mycelium (vegetative parts))

0280020

Wild fungi (Chanterelle, truffle, morel, cep)

0280990

Others

0290000

| (ix) | Sea weeds |
| --- | --- |

(ix)

0,01 (7)

0300000

| 3. | PULSES, DRY |
| --- | --- |

3.

0,01 (7)

0300010

Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)

0300020

Lentils

0300030

Peas (Chickpeas, field peas, chickling vetch)

0300040

Lupins

0300990

Others

0400000

| 4. | OILSEEDS AND OILFRUITS |
| --- | --- |

4.

0,01 (7)

0401000

| (i) | Oilseeds |
| --- | --- |

(i)

0401010

Linseed

0401020

Peanuts

0401030

Poppy seed

0401040

Sesame seed

0401050

Sunflower seed

0401060

Rape seed (Bird rapeseed, turnip rape)

0401070

Soya bean

0401080

Mustard seed

0401090

Cotton seed

0401100

Pumpkin seeds (Other seeds of Cucurbitaceae)

0401110

Safflower

0401120

Borage (Purple viper’s bugloss/Canary flower (Echium plantagineum), Corn Gromwell (Buglossoides arvensis))

0401130

Gold of pleasure

0401140

Hempseed

0401150

Castor bean

0401990

Others

0402000

| (ii) | Oilfruits |
| --- | --- |

(ii)

0402010

Olives for oil production

0402020

Palm nuts (palmoil kernels)

0402030

Palmfruit

0402040

Kapok

0402990

Others

0500000

| 5. | CEREALS |
| --- | --- |

5.

0,01 (7)

0500010

Barley

0500020

Buckwheat (Amaranthus, quinoa)

0500030

Maize

0500040

Millet (Foxtail millet, teff, finger millet, pearl millet)

0500050

Oats

0500060

Rice (Indian/wild rice (Zizania aquatica))

0500070

Rye

0500080

Sorghum

0500090

Wheat (Spelt, triticale)

0500990

Others (Canary grass seeds (Phalaris canariensis))

0600000

| 6. | TEA, COFFEE, HERBAL INFUSIONS AND COCOA |
| --- | --- |

6.

0,01 (7)

0610000

| (i) | Tea |
| --- | --- |

(i)

0620000

| (ii) | Coffee beans |
| --- | --- |

(ii)

0630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

0631000

| (a) | Flowers |
| --- | --- |

(a)

0631010

Camomille flowers

0631020

Hybiscus flowers

0631030

Rose petals

0631040

Jasmine flowers (Elderflowers (Sambucus nigra))

0631050

Lime (linden)

0631990

Others

0632000

| (b) | Leaves |
| --- | --- |

(b)

0632010

Strawberry leaves

0632020

Rooibos leaves (Ginkgo leaves)

0632030

Maté

0632990

Others

0633000

| (c) | Roots |
| --- | --- |

(c)

0633010

Valerian root

0633020

Ginseng root

0633990

Others

0639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

0640000

| (iv) | Cocoabeans (fermented or dried) |
| --- | --- |

(iv)

0650000

| (v) | Carob (st johns bread) |
| --- | --- |

(v)

0700000

| 7. | HOPS (dried) |
| --- | --- |

7.

0,01 (7)

0800000

| 8. | SPICES |
| --- | --- |

8.

0,01 (7)

0810000

| (i) | Seeds |
| --- | --- |

(i)

0810010

Anise

0810020

Black caraway

0810030

Celery seed (Lovage seed)

0810040

Coriander seed

0810050

Cumin seed

0810060

Dill seed

0810070

Fennel seed

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820000

| (ii) | Fruits and berries |
| --- | --- |

(ii)

0820010

Allspice

0820020

Sichuan pepper (Anise pepper, Japan pepper)

0820030

Caraway

0820040

Cardamom

0820050

Juniper berries

0820060

Pepper, black, green and white (Long pepper, pink pepper)

0820070

Vanilla pods

0820080

Tamarind

0820990

Others

0830000

| (iii) | Bark |
| --- | --- |

(iii)

0830010

Cinnamon (Cassia)

0830990

Others

0840000

| (iv) | Roots or rhizome |
| --- | --- |

(iv)

0840010

Liquorice

0840020

Ginger

0840030

Turmeric (Curcuma)

0840040

Horseradish

0840990

Others

0850000

| (v) | Buds |
| --- | --- |

(v)

0850010

Cloves

0850020

Capers

0850990

Others

0860000

| (vi) | Flower stigma |
| --- | --- |

(vi)

0860010

Saffron

0860990

Others

0870000

| (vii) | Aril |
| --- | --- |

(vii)

0870010

Mace

0870990

Others

0900000

| 9. | SUGAR PLANTS |
| --- | --- |

9.

0,01 (7)

0900010

Sugar beet (root)

0900020

Sugar cane

0900030

Chicory roots

0900990

Others

1000000

| 10. | PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS |
| --- | --- |

10.

0,01 (7)

1010000

| (i) | Tissue |
| --- | --- |

(i)

1011000

| (a) | Swine |
| --- | --- |

(a)

1011010

Muscle

1011020

Fat

1011030

Liver

1011040

Kidney

1011050

Edible offal

1011990

Others

1012000

| (b) | Bovine |
| --- | --- |

(b)

1012010

Muscle

1012020

Fat

1012030

Liver

1012040

Kidney

1012050

Edible offal

1012990

Others

1013000

| (c) | Sheep |
| --- | --- |

(c)

1013010

Muscle

1013020

Fat

1013030

Liver

1013040

Kidney

1013050

Edible offal

1013990

Others

1014000

| (d) | Goat |
| --- | --- |

(d)

1014010

Muscle

1014020

Fat

1014030

Liver

1014040

Kidney

1014050

Edible offal

1014990

Others

1015000

| (e) | Horses, asses, mules or hinnies |
| --- | --- |

(e)

1015010

Muscle

1015020

Fat

1015030

Liver

1015040

Kidney

1015050

Edible offal

1015990

Others

1016000

| (f) | Poultry -chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon |
| --- | --- |

(f)

1016010

Muscle

1016020

Fat

1016030

Liver

1016040

Kidney

1016050

Edible offal

1016990

Others

1017000

| (g) | Other farm animals (Rabbit, kangaroo, deer) |
| --- | --- |

(g)

1017010

Muscle

1017020

Fat

1017030

Liver

1017040

Kidney

1017050

Edible offal

1017990

Others

1020000

| (ii) | Milk |
| --- | --- |

(ii)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others

1030000

| (iii) | Bird eggs |
| --- | --- |

(iii)

1030010

Chicken

1030020

Duck

1030030

Goose

1030040

Quail

1030990

Others

1040000

| (iv) | Honey (Royal jelly, pollen, honey comb with honey (comb honey)) |
| --- | --- |

(iv)

1050000

| (v) | Amphibians and reptiles (Frog legs, crocodiles) |
| --- | --- |

(v)

1060000

| (vi) | Snails |
| --- | --- |

(vi)

1070000

| (vii) | Other terrestrial animal products (Wild game) |
| --- | --- |

(vii)

| (3) | In Part B of Annex III, the column for pendimethalin is replaced by the following:
  ‘Pesticide residues and maximum residue levels (mg/kg)








  Code number | Groups and examples of individual products to which the MRLs apply (8) | Pendimethalin (F) |
| --- | --- | --- | --- |
| (1) | (2) | (3) |
| 0130040 | Medlar | 0,05 (9) |
| 0130050 | Loquat | 0,05 (9) |
| 0154050 | Rose hips | 0,05 (9) |
| 0154060 | Mulberries (Arbutus berry) | 0,05 (9) |
| 0154070 | Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta)) | 0,05 (9) |
| 0154080 | Elderberries (Black chokeberry/appleberry, mountain ash, buckthorn/sea sallowthorn, hawthorn, serviceberries, and other treeberries) | 0,05 (9) |
| 0161050 | Carambola (Bilimbi) | 0,05 (9) |
| 0161060 | Persimmon | 0,05 (9) |
| 0161070 | Jambolan (java plum) (Java apple/water apple, pomerac, rose apple, Brazilean cherry, Surinam cherry/grumichama (Eugenia uniflora)) | 0,05 (9) |
| 0162040 | Prickly pear (cactus fruit) | 0,05 (9) |
| 0162050 | Star apple | 0,05 (9) |
| 0162060 | American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel/yellow sapote, mammey sapote) | 0,05 (9) |
| 0163060 | Cherimoya (Custard apple, sugar apple/sweetsop, ilama (Annona diversifolia) and other medium sized Annonaceae fruits) | 0,05 (9) |
| 0163070 | Guava (Red pitaya/dragon fruit (Hylocereus undatus)) | 0,05 (9) |
| 0163090 | Bread fruit (Jackfruit) | 0,05 (9) |
| 0163100 | Durian | 0,05 (9) |
| 0163110 | Soursop (guanabana) | 0,05 (9) |
| 0212040 | Arrowroot | 0,05 (9) |
| 0251050 | Land cress | 0,05 (9) |
| 0251070 | Red mustard | 0,05 (9) |
| 0252020 | Purslane (Winter purslane/miner’s lettuce, garden purslane, common purslane, sorrel, glassworth, agretti (Salsola soda)) | 0,05 (9) |
| 0253000 | (c) | Vine leaves (grape leaves) (Malabar nightshade, banana leaves, climbing wattle (Acacia pennata)) |

(3)

In Part B of Annex III, the column for pendimethalin is replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply (8)

Pendimethalin (F)

(1)

(2)

(3)

0130040

Medlar

0,05 (9)

0130050

Loquat

0,05 (9)

0154050

Rose hips

0,05 (9)

0154060

Mulberries (Arbutus berry)

0,05 (9)

0154070

Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta))

0,05 (9)

0154080

Elderberries (Black chokeberry/appleberry, mountain ash, buckthorn/sea sallowthorn, hawthorn, serviceberries, and other treeberries)

0,05 (9)

0161050

Carambola (Bilimbi)

0,05 (9)

0161060

Persimmon

0,05 (9)

0161070

Jambolan (java plum) (Java apple/water apple, pomerac, rose apple, Brazilean cherry, Surinam cherry/grumichama (Eugenia uniflora))

0,05 (9)

0162040

Prickly pear (cactus fruit)

0,05 (9)

0162050

Star apple

0,05 (9)

0162060

American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel/yellow sapote, mammey sapote)

0,05 (9)

0163060

Cherimoya (Custard apple, sugar apple/sweetsop, ilama (Annona diversifolia) and other medium sized Annonaceae fruits)

0,05 (9)

0163070

Guava (Red pitaya/dragon fruit (Hylocereus undatus))

0,05 (9)

0163090

Bread fruit (Jackfruit)

0,05 (9)

0163100

Durian

0,05 (9)

0163110

Soursop (guanabana)

0,05 (9)

0212040

Arrowroot

0,05 (9)

0251050

Land cress

0,05 (9)

0251070

Red mustard

0,05 (9)

0252020

Purslane (Winter purslane/miner’s lettuce, garden purslane, common purslane, sorrel, glassworth, agretti (Salsola soda))

0,05 (9)

0253000

(c)

0,05 (9)

0256050

Sage (Winter savory, summer savory, Borago officinalis leaves)

2

0256060

Rosemary

0,6

0256070

Thyme (Marjoram, oregano)

0,6

0256080

Basil (Balm leaves, mint, peppermint, holy basil, sweet basil, hairy basil, edible flowers (marigold flower and others), pennywort, wild betel leaf, curry leaves)

0,6

0256090

Bay leaves (laurel) (Lemon grass)

0,6

0256100

Tarragon (Hyssop)

0,6

0270080

Bamboo shoots

0,05 (9)

0270090

Palm hearts

0,05 (9)

0290000

| (ix) | Sea weeds |
| --- | --- |

(ix)

0401110

Safflower

0,1 (9)

0401120

Borage (Purple viper’s bugloss/Canary flower (Echium plantagineum), Corn Gromwell (Buglossoides arvensis))

0,1 (9)

0401130

Gold of pleasure

0,1 (9)

0401150

Castor bean

0,1 (9)

0402020

Palm nuts (palmoil kernels)

0,1 (9)

0402030

Palmfruit

0,1 (9)

0402040

Kapok

0,1 (9)

0620000

| (ii) | Coffee beans |
| --- | --- |

(ii)

0,1 (9)

0630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

0631000

| (a) | Flowers |
| --- | --- |

(a)

0,1 (9)

0631010

Camomille flowers

0,1 (9)

0631020

Hybiscus flowers

0,1 (9)

0631030

Rose petals

0,1 (9)

0631040

Jasmine flowers (Elderflowers (Sambucus nigra))

0,1 (9)

0631050

Lime (linden)

0,1 (9)

0631990

Others

0,1 (9)

0632000

| (b) | Leaves |
| --- | --- |

(b)

0,1 (9)

0632010

Strawberry leaves

0,1 (9)

0632020

Rooibos leaves (Ginkgo leaves)

0,1 (9)

0632030

Maté

0,1 (9)

0632990

Others

0,1 (9)

0633000

| (c) | Roots |
| --- | --- |

(c)

0,5

0633010

Valerian root

0,5

0633020

Ginseng root

0,5

0633990

Others

0,5

0639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

0,1 (9)

0640000

| (iv) | Cocoabeans (fermented or dried) |
| --- | --- |

(iv)

0,1 (9)

0650000

| (v) | Carob (st johns bread) |
| --- | --- |

(v)

0,1 (9)

0800000

| 8. | SPICES |
| --- | --- |

8.

0,1 (9)

0810000

| (i) | Seeds |
| --- | --- |

(i)

0,1 (9)

0810010

Anise

0,1 (9)

0810020

Black caraway

0,1 (9)

0810030

Celery seed (Lovage seed)

0,1 (9)

0810040

Coriander seed

0,1 (9)

0810050

Cumin seed

0,1 (9)

0810060

Dill seed

0,1 (9)

0810070

Fennel seed

0,1 (9)

0810080

Fenugreek

0,1 (9)

0810090

Nutmeg

0,1 (9)

0810990

Others

0,1 (9)

0820000

| (ii) | Fruits and berries |
| --- | --- |

(ii)

0,1 (9)

0820010

Allspice

0,1 (9)

0820020

Sichuan pepper (Anise pepper, Japan pepper)

0,1 (9)

0820030

Caraway

0,1 (9)

0820040

Cardamom

0,1 (9)

0820050

Juniper berries

0,1 (9)

0820060

Pepper, black, green and white (Long pepper, pink pepper)

0,1 (9)

0820070

Vanilla pods

0,1 (9)

0820080

Tamarind

0,1 (9)

0820990

Others

0,1 (9)

0830000

| (iii) | Bark |
| --- | --- |

(iii)

0,1 (9)

0830010

Cinnamon (Cassia)

0,1 (9)

0830990

Others

0,1 (9)

0840000

| (iv) | Roots or rhizome |
| --- | --- |

(iv)

0,1 (9)

0840010

Liquorice

0,1 (9)

0840020

Ginger

0,1 (9)

0840030

Turmeric (Curcuma)

0,1 (9)

0840040

Horseradish

0,1 (9)

0840990

Others

0,1 (9)

0850000

| (v) | Buds |
| --- | --- |

(v)

0,1 (9)

0850010

Cloves

0,1 (9)

0850020

Capers

0,1 (9)

0850990

Others

0,1 (9)

0860000

| (vi) | Flower stigma |
| --- | --- |

(vi)

0,1 (9)

0860010

Saffron

0,1 (9)

0860990

Others

0,1 (9)

0870000

| (vii) | Aril |
| --- | --- |

(vii)

0,1 (9)

0870010

Mace

0,1 (9)

0870990

Others

0,1 (9)

0900000

| 9. | SUGAR PLANTS |
| --- | --- |

9.

0,05 (9)

0900010

Sugar beet (root)

0,05 (9)

0900020

Sugar cane

0,05 (9)

0900030

Chicory roots

0,05 (9)

0900990

Others

0,05 (9)

1015000

| (e) | Horses, asses, mules or hinnies |
| --- | --- |

(e)

0,05 (9)

1015010

Muscle

0,05 (9)

1015020

Fat

0,05 (9)

1015030

Liver

0,05 (9)

1015040

Kidney

0,05 (9)

1015050

Edible offal

0,05 (9)

1015990

Others

0,05 (9)

1017000

| (g) | Other farm animals (Rabbit, kangaroo, deer) |
| --- | --- |

(g)

0,05 (9)

1017010

Muscle

0,05 (9)

1017020

Fat

0,05 (9)

1017030

Liver

0,05 (9)

1017040

Kidney

0,05 (9)

1017050

Edible offal

0,05 (9)

1017990

Others

0,05 (9)

1030020

Duck

0,05 (9)

1030030

Goose

0,05 (9)

1030040

Quail

0,05 (9)

1030990

Others

0,05 (9)

1040000

| (iv) | Honey (Royal jelly, pollen, honey comb with honey (comb honey)) |
| --- | --- |

(iv)

0,05
   (9)

1050000

| (v) | Amphibians and reptiles (Frog legs, crocodiles) |
| --- | --- |

(v)

0,05
   (9)

1060000

| (vi) | Snails |
| --- | --- |

(vi)

0,05
   (9)

1070000

| (vii) | Other terrestrial animal products (Wild game) |
| --- | --- |

(vii)

0,05
   (9)

(F)= Fat soluble’

---

(1)  For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

(2)  Indicates lower limit of analytical determination

(3)  Pesticide-code combination for which the MRL as set in Annex III Part B applies.

(F)= Fat soluble

Trifloxystrobin (F) (R)

| (R) | = | The residue definition differs for the following combinations pesticide-code number:
  Trifloxystrobin- code 1000000: the sum of trifloxystrobin and its metabolite (E, E)-methoxyimino- {2-[1-(3-trifluoromethyl-phenyl)-ethylideneamino-oxymethyl]-phenyl}-acetic acid (CGA 321113)’ |
| --- | --- | --- |

(R)

=

The residue definition differs for the following combinations pesticide-code number:

Trifloxystrobin- code 1000000: the sum of trifloxystrobin and its metabolite (E, E)-methoxyimino- {2-[1-(3-trifluoromethyl-phenyl)-ethylideneamino-oxymethyl]-phenyl}-acetic acid (CGA 321113)’

(4)  For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

(5)  Indicates lower limit of analytical determination

(F)= Fat soluble

Cyprodinil (F) (R)

| (R) | = | The residue definition differs for the following combinations pesticide-code number:
  Cyprodinil - code 1000000: Sum cyprodinil and metabolite CGA 304075 |
| --- | --- | --- |

(R)

=

The residue definition differs for the following combinations pesticide-code number:

Cyprodinil - code 1000000: Sum cyprodinil and metabolite CGA 304075

Fluopyram (R)

Fluopyram - code 1000000: sum fluopyram and fluopyram-benzamide (M25) expressed as fluopyram

| (+) | The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 19 October 2015, or, if that information is not submitted by that date, the lack of it.







  0220010 | Garlic |
| --- | --- | --- |
| 0220020 | Onions (Other bulb onions, silverskin onions) |
| 0220030 | Shallots |
| 0220990 | Others |
| 0231030 | Aubergines (egg plants) (Pepino, antroewa/white eggplant (S. macrocarpon)) |
| 0231990 | Others |
| 0234000 | (d) | Sweet corn (Baby corn) |

(+)

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 19 October 2015, or, if that information is not submitted by that date, the lack of it.

0220010

Garlic

0220020

Onions (Other bulb onions, silverskin onions)

0220030

Shallots

0220990

Others

0231030

Aubergines (egg plants) (Pepino, antroewa/white eggplant (S. macrocarpon))

0231990

Others

0234000

(d)

0239000

| (e) | Other fruiting vegetables |
| --- | --- |

(e)

0242990

Others

0243020

Kale (Borecole/curly kale, collards, Portuguese Kale, Portuguese cabbage, cow cabbage)

0243990

Others

0244000

| (d) | Kohlrabi |
| --- | --- |

(d)

0251030

Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curly leaf endive, sugar loaf (C. endivia var. crispum/C. intybus var. foliosum), dandelion greens)

0252000

| (b) | Spinach & similar (leaves) |
| --- | --- |

(b)

0252010

Spinach (New Zealand spinach, amaranthus spinach (pak-khom, tampara), tajer leaves, bitterblad/bitawiri)

0252020

Purslane (Winter purslane/miner’s lettuce, garden purslane, common purslane, sorrel, glassworth, agretti (Salsola soda))

0252030

Beet leaves (chard) (Leaves of beetroot)

0252990

Others

0254000

| (d) | Water cress (Morning glory/Chinese convolvulus/water convolvulus/water spinach/kangkung (Ipomea aquatica), water clover, water mimosa) |
| --- | --- |

(d)

0255000

| (e) | Witloof |
| --- | --- |

(e)

0256000

| (f) | Herbs |
| --- | --- |

(f)

0256010

Chervil

0256020

Chives

0256030

Celery leaves (Fennel leaves, coriander leaves, dill leaves, caraway leaves, lovage, angelica, sweet cisely and other Apiacea leaves, culantro/stinking/long coriander/stink weed (Eryngium foetidum))

0256040

Parsley (leaves of root parsley)

0256050

Sage (Winter savory, summer savory, Borago officinalis leaves)

0256060

Rosemary

0256070

Thyme (Marjoram, oregano)

0256080

Basil (Balm leaves, mint, peppermint, holy basil, sweet basil, hairy basil, edible flowers (marigold flower and others), pennywort, wild betel leaf, curry leaves)

0256090

Bay leaves (laurel) (Lemon grass)

0256100

Tarragon (Hyssop)

0256990

Others

0260020

Beans (without pods) (Broad beans, flageolets, jack bean, lima bean, cowpea)

0260030

Peas (with pods) (Mangetout/sugar peas/snow peas)

0260050

Lentils

0260990

Others

0270020

Cardoons (Borago officinalis stems)

0270030

Celery

0270040

Fennel

0270990

Others

0401010

Linseed

0401030

Poppy seed

0401040

Sesame seed

0401050

Sunflower seed

0401080

Mustard seed

0401090

Cotton seed

0401100

Pumpkin seeds (Other seeds of Cucurbitaceae)

0401110

Safflower

0401120

Borage (Purple viper’s bugloss/Canary flower (Echium plantagineum), Corn Gromwell (Buglossoides arvensis))

0401130

Gold of pleasure

0401140

Hempseed

0401150

Castor bean

0401990

Others

0500010

Barley

0500020

Buckwheat (Amaranthus, quinoa)

0500040

Millet (Foxtail millet, teff, finger millet, pearl millet)

0500050

Oats

0500990

Others (Canary grass seeds (Phalaris canariensis))

0630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

0631000

| (a) | Flowers |
| --- | --- |

(a)

0631010

Camomille flowers

0631020

Hybiscus flowers

0631030

Rose petals

0631040

Jasmine flowers (Elderflowers (Sambucus nigra))

0631050

Lime (linden)

0631990

Others

0632000

| (b) | Leaves |
| --- | --- |

(b)

0632010

Strawberry leaves

0632020

Rooibos leaves (Ginkgo leaves)

0632030

Maté

0632990

Others

0633000

| (c) | Roots |
| --- | --- |

(c)

0633010

Valerian root

0633020

Ginseng root

0633990

Others

0639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

0810000

| (i) | Seeds |
| --- | --- |

(i)

0810010

Anise

0810020

Black caraway

0810030

Celery seed (Lovage seed)

0810040

Coriander seed

0810050

Cumin seed

0810060

Dill seed

0810070

Fennel seed

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820030

Caraway

0840030

Turmeric (Curcuma)

0900010

Sugar beet (root)

0900030

Chicory roots

0900990

Others

Nicotine

| (+) | Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.







  0154050 | Rose hips |
| --- | --- | --- |
| 0256000 | (f) | Herbs |

(+)

Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.

0154050

Rose hips

0256000

(f)

0256010

Chervil

0256020

Chives

0256030

Celery leaves (Fennel leaves, coriander leaves, dill leaves, caraway leaves, lovage, angelica, sweet cisely and other Apiacea leaves, culantro/stinking/long coriander/stink weed (Eryngium foetidum))

0256040

Parsley (leaves of root parsley)

0256050

Sage (Winter savory, summer savory, Borago officinalis leaves)

0256060

Rosemary

0256070

Thyme (Marjoram, oregano)

0256080

Basil (Balm leaves, mint, peppermint, holy basil, sweet basil, hairy basil, edible flowers (marigold flower and others), pennywort, wild betel leaf, curry leaves)

0256090

Bay leaves (laurel) (Lemon grass)

0256100

Tarragon (Hyssop)

0256990

Others

| (+) | The following MRLs apply to dried wild mushrooms: 2,3 mg/kg for ceps, 1,2 mg/kg for dried wild mushrooms other than ceps. These MRLs shall be reviewed by 30 November 2014. Confirmatory data including any scientific evidence on the natural occurrence or formation of nicotine in the concerned crop will be evaluated. Reassessment of data may lead to modification of MRLs







  0280020 | Wild fungi (Chanterelle truffle morel cep) |
| --- | --- | --- |

(+)

The following MRLs apply to dried wild mushrooms: 2,3 mg/kg for ceps, 1,2 mg/kg for dried wild mushrooms other than ceps. These MRLs shall be reviewed by 30 November 2014. Confirmatory data including any scientific evidence on the natural occurrence or formation of nicotine in the concerned crop will be evaluated. Reassessment of data may lead to modification of MRLs

0280020

Wild fungi (Chanterelle truffle morel cep)

| (+) | Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.







  0610000 | (i) | Tea |
| --- | --- | --- | --- |

(+)

Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.

0610000

(i)

0630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

0631000

| (a) | Flowers |
| --- | --- |

(a)

0631010

Camomille flowers

0631020

Hybiscus flowers

0631030

Rose petals

0631040

Jasmine flowers (Elderflowers (Sambucus nigra))

0631050

Lime (linden)

0631990

Others

0632000

| (b) | Leaves |
| --- | --- |

(b)

0632010

Strawberry leaves

0632020

Rooibos leaves (Ginkgo leaves)

0632030

Maté

0632990

Others

0633000

| (c) | Roots |
| --- | --- |

(c)

0633010

Valerian root

0633020

Ginseng root

0633990

Others

0639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

0800000

| 8. | SPICES |
| --- | --- |

8.

0810000

| (i) | Seeds |
| --- | --- |

(i)

0810010

Anise

0810020

Black caraway

0810030

Celery seed (Lovage seed)

0810040

Coriander seed

0810050

Cumin seed

0810060

Dill seed

0810070

Fennel seed

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820000

| (ii) | Fruits and berries |
| --- | --- |

(ii)

0820010

Allspice

0820020

Sichuan pepper (Anise pepper, Japan pepper)

0820030

Caraway

0820040

Cardamom

0820050

Juniper berries

0820060

Pepper, black, green and white (Long pepper, pink pepper)

0820070

Vanilla pods

0820080

Tamarind

0820990

Others

0830000

| (iii) | Bark |
| --- | --- |

(iii)

0830010

Cinnamon (Cassia)

0830990

Others

0840000

| (iv) | Roots or rhizome |
| --- | --- |

(iv)

0840010

Liquorice

0840020

Ginger

0840030

Turmeric (Curcuma)

0840040

Horseradish

0840990

Others

0850000

| (v) | Buds |
| --- | --- |

(v)

0850010

Cloves

0850020

Capers

0850990

Others

0860000

| (vi) | Flower stigma |
| --- | --- |

(vi)

0860010

Saffron

0860990

Others

0870000

| (vii) | Aril |
| --- | --- |

(vii)

0870010

Mace

0870990

Others’

(6)  For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

(7)  Indicates lower limit of analytical determination’

(8)  For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

(9)  Indicates lower limit of analytical determination

(F)= Fat soluble’

---

| 19.10.2013 | EN | Official Journal of the European Union | L 279/57 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/57

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1005/2013

of 17 October 2013

approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [Emmental français est-central (PGI)]

THE EUROPEAN COMMISSION,

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

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

Whereas:

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

(1)

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

| (2) | In accordance with the first subparagraph of Article 9(1) of Regulation (EC) No 510/2006, the Commission has examined France’s application for the approval of amendments to the specification for the protected geographical indication ‘Emmental français est-central’, registered under Commission Regulation (EC) No 1107/96 (3). |
| --- | --- |

(2)

In accordance with the first subparagraph of Article 9(1) of Regulation (EC) No 510/2006, the Commission has examined France’s application for the approval of amendments to the specification for the protected geographical indication ‘Emmental français est-central’, registered under Commission Regulation (EC) No 1107/96 (3).

| (3) | Since the amendments in question are not minor, the Commission published the amendment application in the Official Journal of the European Union
   (4), as required by Article 6(2) of Regulation (EC) No 510/2006. As no statement of objection under Article 7 of that Regulation has been received by the Commission, the amendments to the specification should be approved, |
| --- | --- |

(3)

Since the amendments in question are not minor, the Commission published the amendment application in the Official Journal of the European Union
   (4), as required by Article 6(2) of Regulation (EC) No 510/2006. As no statement of objection under Article 7 of that Regulation has been received by the Commission, the amendments to the specification should be approved,

HAS ADOPTED THIS REGULATION:

Article 1

The amendments to the specification published in the Official Journal of the European Union regarding the name in the Annex to this Regulation are hereby approved.

Article 2

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

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

Done at Brussels, 17 October 2013.

For the Commission, On behalf of the President,

Dacian CIOLOȘ

Member of the Commission

---

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

1

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

2

(3)  OJ L 148, 21.6.1996, p. 1.

3

(4)  OJ C 352, 16.11.2012, p. 17.

4

---

ANNEX

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

Class 1.3.   Cheeses

FRANCE

Emmental français est-central (PGI)

---

| 19.10.2013 | EN | Official Journal of the European Union | L 279/59 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/59

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1006/2013

of 18 October 2013

concerning the authorisation of L-cystine as a feed additive for all animal species

(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-cystine as a feed additive in the functional group ‘amino acids, their salts and analogues’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-cystine as a feed additive in the functional group ‘amino acids, their salts and analogues’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of L-cystine as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’. |
| --- | --- |

(3)

That application concerns the authorisation of L-cystine as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 March 2013 (2) that, under the proposed conditions of use, L-cystine does not have an adverse effect on animal health, human health or the environment and that it may be considered efficacious to contribute to the requirements for sulphur-containing amino acids in all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 March 2013 (2) that, under the proposed conditions of use, L-cystine does not have an adverse effect on animal health, human health or the environment and that it may be considered efficacious to contribute to the requirements for sulphur-containing amino acids in all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of that substance shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised, as specified in the Annex to this Regulation. |
| --- | --- |

(5)

The assessment of that substance shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised, as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(6)

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

The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 18 October 2013.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  EFSA Journal 2013; 11(4):3173.

2

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of complete feed with a moisture content of 12 % |
| Category of nutritional additives. Functional group: amino acids, their salts and analogues |
| 3c391 | — | L-cystine | | Additive composition

  Crystalline powder produced by hydrolysis of natural keratin from poultry feathers with a minimum L-cystine content of 98,5 % |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: amino acids, their salts and analogues

3c391

—

L-cystine

Additive composition

Crystalline powder produced by hydrolysis of natural keratin from poultry feathers with a minimum L-cystine content of 98,5 %

| | Characterisation of the active substance

  IUPAC name: (2R)-2-amino-3-[(2R)-2-amino-3-hydroxy-3-oxopropyl] disulfanyl-propanoic acid
  CAS number: 56-89-3
  Chemical formula: C6H12N2O4S2 |
| --- | --- |

Characterisation of the active substance

IUPAC name: (2R)-2-amino-3-[(2R)-2-amino-3-hydroxy-3-oxopropyl] disulfanyl-propanoic acid

CAS number: 56-89-3

Chemical formula: C6H12N2O4S2

| | Analytical methods
   (1)

  For the determination of L-cystine in the feed additive:
  Titrimetry, European Pharmacopoeia (Ph. Eur. 6.0, method 01/2008-0998).
  For the determination of cystine in premixtures, compound feed and feed materials:
  Ion exchange chromatography method with post-column derivatisation and photometric detection: Commission Regulation (EC) No 152/2009 (2) (Annex III, F). |
| --- | --- |

Analytical methods
   (1)

For the determination of L-cystine in the feed additive:

Titrimetry, European Pharmacopoeia (Ph. Eur. 6.0, method 01/2008-0998).

For the determination of cystine in premixtures, compound feed and feed materials:

Ion exchange chromatography method with post-column derivatisation and photometric detection: Commission Regulation (EC) No 152/2009 (2) (Annex III, F).

All animal species

—

—

—

| 1. | For user safety: Breathing protection, safety glasses and gloves should be worn during handling. |
| --- | --- |

1.

For user safety: Breathing protection, safety glasses and gloves should be worn during handling.

| 2. | Indicate in the directions for use of the additive and premixtures:






  — | Processing stability and storage conditions. |
| --- | --- | --- |

2.

Indicate in the directions for use of the additive and premixtures:

—

Processing stability and storage conditions.

| — | Supplementation with L-cystine shall depend on the requirements of the target animals for sulphur-containing amino acids and the level of other sulphur-containing amino acids in the ration. |
| --- | --- |

—

Supplementation with L-cystine shall depend on the requirements of the target animals for sulphur-containing amino acids and the level of other sulphur-containing amino acids in the ration.

8 November 2023

---

(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx

(2)  OJ L 54, 26.2.2009, p. 1.

---

| 19.10.2013 | EN | Official Journal of the European Union | L 279/61 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/61

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1007/2013

of 18 October 2013

adding to the 2013/14 fishing quotas of anchovy in the Bay of Biscay the quantities withheld by France and Spain in the fishing season 2012/13 pursuant to Article 4(2) of Council Regulation (EC) No 847/96

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 847/96 of 6 May 1996 introducing additional conditions for year-to-year management of TACs and quotas (1), and in particular Article 4(2) thereof,

Whereas:

| (1) | According to Article 4(2) of Regulation (EC) No 847/96, Member States may ask the Commission, before 31 October of the year of application of a fishing quota allocated to them, to withhold a maximum of 10 % of that quota to be transferred to the following year. The Commission is to add to the relevant quota the quantity withheld. |
| --- | --- |

(1)

According to Article 4(2) of Regulation (EC) No 847/96, Member States may ask the Commission, before 31 October of the year of application of a fishing quota allocated to them, to withhold a maximum of 10 % of that quota to be transferred to the following year. The Commission is to add to the relevant quota the quantity withheld.

| (2) | TAC and Member State quotas for the stock of anchovy in the Bay of Biscay (ICES subarea VIII) are set for an annual management season running from 1 July to 30 June of the following year. |
| --- | --- |

(2)

TAC and Member State quotas for the stock of anchovy in the Bay of Biscay (ICES subarea VIII) are set for an annual management season running from 1 July to 30 June of the following year.

| (3) | Council Regulation (EU) No 694/2012 of 27 July 2012 establishing the fishing opportunities for anchovy in the Bay of Biscay for the 2012/13 fishing season (2) fixes the fishing quotas for anchovy in the Bay of Biscay (ICES subarea VIII) for the period starting on the 1 July 2012 and ending on the 30 June 2013. |
| --- | --- |

(3)

Council Regulation (EU) No 694/2012 of 27 July 2012 establishing the fishing opportunities for anchovy in the Bay of Biscay for the 2012/13 fishing season (2) fixes the fishing quotas for anchovy in the Bay of Biscay (ICES subarea VIII) for the period starting on the 1 July 2012 and ending on the 30 June 2013.

| (4) | Council Regulation (EU) No 713/2013 of 23 July 2013 establishing the fishing opportunities for anchovy in the Bay of Biscay for the 2013/14 fishing season (3) fixes the fishing quotas for anchovy in the Bay of Biscay (ICES subarea VIII) for the period starting on the 1 July 2013 and ending on the 30 June 2014. |
| --- | --- |

(4)

Council Regulation (EU) No 713/2013 of 23 July 2013 establishing the fishing opportunities for anchovy in the Bay of Biscay for the 2013/14 fishing season (3) fixes the fishing quotas for anchovy in the Bay of Biscay (ICES subarea VIII) for the period starting on the 1 July 2013 and ending on the 30 June 2014.

| (5) | Pursuant to the relevant fishing opportunities Regulations and after taking into account exchanges of fishing opportunities in accordance with Article 20(5) of Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (4) and quota transfers in accordance with Article 4(2) of Regulation (EC) No 847/96 quotas for anchovy in the Bay of Biscay available to France and Spain at the end of fishing season 2012/13 amounted respectively to 4 876 tonnes and 16 460 tonnes. |
| --- | --- |

(5)

Pursuant to the relevant fishing opportunities Regulations and after taking into account exchanges of fishing opportunities in accordance with Article 20(5) of Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (4) and quota transfers in accordance with Article 4(2) of Regulation (EC) No 847/96 quotas for anchovy in the Bay of Biscay available to France and Spain at the end of fishing season 2012/13 amounted respectively to 4 876 tonnes and 16 460 tonnes.

| (6) | At the end of fishing season 2012/13, France and Spain reported catches of anchovy in the Bay of Biscay for a respective total amount of 4 805,1 tonnes and 11 275,2 tonnes. |
| --- | --- |

(6)

At the end of fishing season 2012/13, France and Spain reported catches of anchovy in the Bay of Biscay for a respective total amount of 4 805,1 tonnes and 11 275,2 tonnes.

| (7) | Pursuant to Article 4(2) of Regulation (EC) No 847/96, France and Spain have both requested that part of their anchovy’s quota in the Bay of Biscay for their fishing season 2012/13 be withheld and transferred to the following fishing season. Within the limits indicated in that Regulation, the quantities withheld should be added to the quota for fishing season 2013/14. |
| --- | --- |

(7)

Pursuant to Article 4(2) of Regulation (EC) No 847/96, France and Spain have both requested that part of their anchovy’s quota in the Bay of Biscay for their fishing season 2012/13 be withheld and transferred to the following fishing season. Within the limits indicated in that Regulation, the quantities withheld should be added to the quota for fishing season 2013/14.

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

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

HAS ADOPTED THIS REGULATION:

Article 1

1.   The fishing quota for anchovy fixed for France in the Bay of Biscay in Regulation (EU) No 713/2013 is increased by 70,9 tonnes.

2.   The fishing quota for anchovy fixed for Spain in the Bay of Biscay in Regulation (EU) No 713/2013 is increased by 1 646 tonnes.

Article 2

This Regulation shall enter into force on the 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, 18 October 2013.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 115, 9.5.1996, p. 3.

1

(2)  OJ L 203, 31.7.2012, p. 26.

2

(3)  OJ L 201, 26.7.2013, p. 8.

3

(4)  OJ L 358, 31.12.2002, p. 59.

4

---

| 19.10.2013 | EN | Official Journal of the European Union | L 279/63 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/63

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1008/2013

of 18 October 2013

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

THE EUROPEAN COMMISSION,

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

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

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

Whereas:

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

(1)

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

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

Done at Brussels, 18 October 2013.

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 |
| 0702 00 00 | MA | 53,1 |
| MK | 47,7 |
| ZZ | 50,4 |
| 0707 00 05 | MK | 54,3 |
| TR | 126,8 |
| ZZ | 90,6 |
| 0709 93 10 | TR | 144,2 |
| ZZ | 144,2 |
| 0805 50 10 | AR | 100,6 |
| CL | 101,0 |
| IL | 97,0 |
| TR | 87,3 |
| ZA | 102,0 |
| ZZ | 97,6 |
| 0806 10 10 | BR | 254,7 |
| TR | 151,4 |
| ZZ | 203,1 |
| 0808 10 80 | CL | 154,8 |
| NZ | 116,7 |
| US | 156,2 |
| ZA | 120,6 |
| ZZ | 137,1 |
| 0808 30 90 | TR | 126,8 |
| ZZ | 126,8 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MA

53,1

MK

47,7

ZZ

50,4

0707 00 05

MK

54,3

TR

126,8

ZZ

90,6

0709 93 10

TR

144,2

ZZ

144,2

0805 50 10

AR

100,6

CL

101,0

IL

97,0

TR

87,3

ZA

102,0

ZZ

97,6

0806 10 10

BR

254,7

TR

151,4

ZZ

203,1

0808 10 80

CL

154,8

NZ

116,7

US

156,2

ZA

120,6

ZZ

137,1

0808 30 90

TR

126,8

ZZ

126,8

---

(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’.

---

| 19.10.2013 | EN | Official Journal of the European Union | L 279/65 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/65

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1009/2013

of 18 October 2013

fixing the allocation coefficient to be applied to applications for import licences for olive oil lodged from 14 to 15 October 2013 under the Tunisian tariff quota and suspending the issue of import licences for the month of October 2013

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 Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (2), and in particular Article 7(2) thereof,

Whereas:

| (1) | Article 3(1) and (2) of Protocol No 1 (3) to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the Republic of Tunisia, of the other part (4), opens a tariff quota at a zero rate of duty for imports of untreated olive oil falling within CN codes 1509 10 10 and 1509 10 90, wholly obtained in Tunisia and transported direct from that country to the European Union, up to the limit laid down for each year. |
| --- | --- |

(1)

Article 3(1) and (2) of Protocol No 1 (3) to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the Republic of Tunisia, of the other part (4), opens a tariff quota at a zero rate of duty for imports of untreated olive oil falling within CN codes 1509 10 10 and 1509 10 90, wholly obtained in Tunisia and transported direct from that country to the European Union, up to the limit laid down for each year.

| (2) | Article 2(2) of Commission Regulation (EC) No 1918/2006 of 20 December 2006 opening and providing for the administration of tariff quota for olive oil originating in Tunisia (5) lays down monthly quantitative limits for the issue of import licences. |
| --- | --- |

(2)

Article 2(2) of Commission Regulation (EC) No 1918/2006 of 20 December 2006 opening and providing for the administration of tariff quota for olive oil originating in Tunisia (5) lays down monthly quantitative limits for the issue of import licences.

| (3) | Import licence applications have been submitted to the competent authorities under Article 3(1) of Regulation (EC) No 1918/2006 in respect of a total quantity exceeding the limit laid down for the month of October in Article 2(2) of that Regulation. |
| --- | --- |

(3)

Import licence applications have been submitted to the competent authorities under Article 3(1) of Regulation (EC) No 1918/2006 in respect of a total quantity exceeding the limit laid down for the month of October in Article 2(2) of that Regulation.

| (4) | In these circumstances, the Commission must set an allocation coefficient allowing import licences to be issued in proportion to the quantity available. |
| --- | --- |

(4)

In these circumstances, the Commission must set an allocation coefficient allowing import licences to be issued in proportion to the quantity available.

| (5) | Since the limit for the month of October has been reached, no more import licences can be issued for that month, |
| --- | --- |

(5)

Since the limit for the month of October has been reached, no more import licences can be issued for that month,

HAS ADOPTED THIS REGULATION:

Article 1

The quantities for which import licence applications were lodged for 14 and 15 October 2013 under Article 3(1) of Regulation (EC) No 1918/2006 shall be multiplied by an allocation coefficient of 39,536727 %.

The issue of import licences in respect of amounts applied for as from 21 October 2013 shall be suspended for October 2013.

Article 2

This Regulation shall enter into force on 19 October 2013.

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

Done at Brussels, 18 October 2013.

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 238, 1.9.2006, p. 13.

2

(3)  OJ L 97, 30.3.1998, p. 57.

3

(4)  OJ L 97, 30.3.1998, p. 2.

4

(5)  OJ L 365, 21.12.2006, p. 84.

5

---

DECISIONS

| 19.10.2013 | EN | Official Journal of the European Union | L 279/66 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/66

---

POLITICAL AND SECURITY COMMITTEE DECISION EUPOL RD CONGO/1/2013

of 8 October 2013

extending the mandate of the Head of Mission of the European Union police mission undertaken in the framework of reform of the security sector (SSR) and its interface with the system of justice in the Democratic Republic of the Congo (EUPOL RD Congo)

(2013/511/CFSP)

THE POLITICAL AND SECURITY COMMITTEE,

Having regard to the Treaty on European Union, and in particular the third paragraph of Article 38 thereof,

Having regard to Council Decision 2010/576/CFSP of 23 September 2010 on the European Union police mission undertaken in the framework of reform of the security sector (SSR) and its interface with the system of justice in the Democratic Republic of the Congo (EUPOL RD Congo) (1), and in particular Article 10(1) thereof,

Whereas:

| (1) | Pursuant to Article 10(1) of Decision 2010/576/CFSP, the Political and Security Committee ('PSC') is authorised, in accordance with the third paragraph of Article 38 of the Treaty, to take the relevant decisions for the purpose of exercising political control and strategic direction of EUPOL RD Congo. This authorisation includes the power to appoint a Head of Mission, upon a proposal of the High Representative of the Union for Foreign Affairs and Security Policy ('High Representative'). |
| --- | --- |

(1)

Pursuant to Article 10(1) of Decision 2010/576/CFSP, the Political and Security Committee ('PSC') is authorised, in accordance with the third paragraph of Article 38 of the Treaty, to take the relevant decisions for the purpose of exercising political control and strategic direction of EUPOL RD Congo. This authorisation includes the power to appoint a Head of Mission, upon a proposal of the High Representative of the Union for Foreign Affairs and Security Policy ('High Representative').

| (2) | On 8 October 2010, following a proposal by the High Representative, the PSC, pursuant to Decision EUPOL RD Congo/1/2010 (2), appointed Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo with effect from 1 October 2010. |
| --- | --- |

(2)

On 8 October 2010, following a proposal by the High Representative, the PSC, pursuant to Decision EUPOL RD Congo/1/2010 (2), appointed Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo with effect from 1 October 2010.

| (3) | On 16 September 2011, following a proposal by the High Representative, the PSC, pursuant to Decision EUPOL RD Congo/1/2011 (3), extended the mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo until 30 September 2012. |
| --- | --- |

(3)

On 16 September 2011, following a proposal by the High Representative, the PSC, pursuant to Decision EUPOL RD Congo/1/2011 (3), extended the mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo until 30 September 2012.

| (4) | On 25 September 2012, following a proposal by the High Representative, the PSC, pursuant to Decision EUPOL RD Congo/1/2012 (4), extended the mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo until 30 September 2013. |
| --- | --- |

(4)

On 25 September 2012, following a proposal by the High Representative, the PSC, pursuant to Decision EUPOL RD Congo/1/2012 (4), extended the mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo until 30 September 2013.

| (5) | On 23 September 2013, the Council adopted Decision 2013/467/CFSP (5) extending the duration of EUPOL RD Congo until 30 September 2014. |
| --- | --- |

(5)

On 23 September 2013, the Council adopted Decision 2013/467/CFSP (5) extending the duration of EUPOL RD Congo until 30 September 2014.

| (6) | On 10 September 2013, the High Representative proposed the extension of the mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo until 30 September 2014. |
| --- | --- |

(6)

On 10 September 2013, the High Representative proposed the extension of the mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo until 30 September 2014.

| (7) | Since the current mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo expired on 30 September 2013, this Decision should apply from 1 October 2013, |
| --- | --- |

(7)

Since the current mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo expired on 30 September 2013, this Decision should apply from 1 October 2013,

HAS ADOPTED THIS DECISION:

Article 1

The mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of the European Union police mission undertaken in the framework of reform of the security sector (SSR) and its interface with the system of justice in the Democratic Republic of the Congo (EUPOL RD Congo) is hereby extended until 30 September 2014.

Article 2

This Decision shall enter into force on the date of its adoption.

It shall apply from 1 October 2013.

Done at Brussels, 8 October 2013.

For the Political and Security Committee

The Chairperson

W. STEVENS

---

(1)  OJ L 254, 29.9.2010, p. 33.

1

(2)  OJ L 266, 9.10.2010, p. 60.

2

(3)  OJ L 245, 22.9.2011, p. 21.

3

(4)  OJ L 264, 29.9.2012, p. 13.

4

(5)  OJ L 252, 24.9.2013, p. 27.

5

---

| 19.10.2013 | EN | Official Journal of the European Union | L 279/67 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/67

---

COMMISSION IMPLEMENTING DECISION

of 17 October 2013

concerning a financial contribution by the Union to certain Member States to support voluntary surveillance studies on honeybee colony losses for the season 2013–2014

(notified under document C(2013) 6742)

(Only the Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Polish, Portuguese, Slovak, Spanish and Swedish texts are authentic)

(2013/512/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field (1), and in particular Article 23 thereof,

Whereas:

| (1) | The Communication from the Commission to the European Parliament and the Council on honeybee health (2) gives an overview of the Commission’s actions already undertaken and ongoing as regards honeybee health in the EU. The main subject issue of the Communication is the increased mortality of bees observed worldwide. |
| --- | --- |

(1)

The Communication from the Commission to the European Parliament and the Council on honeybee health (2) gives an overview of the Commission’s actions already undertaken and ongoing as regards honeybee health in the EU. The main subject issue of the Communication is the increased mortality of bees observed worldwide.

| (2) | In 2009 the EFSA project ‘Bee mortality and bee surveillance in Europe’ (3) concluded that the surveillance systems in the EU are, in general, weak and that there is a lack of data at Member States level and a lack of comparable data at EU level. |
| --- | --- |

(2)

In 2009 the EFSA project ‘Bee mortality and bee surveillance in Europe’ (3) concluded that the surveillance systems in the EU are, in general, weak and that there is a lack of data at Member States level and a lack of comparable data at EU level.

| (3) | In order to improve the availability of data on bee mortality the Commission decided to assist and support certain surveillance studies in Member States on honeybee losses. |
| --- | --- |

(3)

In order to improve the availability of data on bee mortality the Commission decided to assist and support certain surveillance studies in Member States on honeybee losses.

| (4) | Commission Implementing Decision 2012/362/EU (4) granted a financial contribution to the voluntary surveillance study programs on honeybee colony losses implemented by Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom for the season 2012–2013. |
| --- | --- |

(4)

Commission Implementing Decision 2012/362/EU (4) granted a financial contribution to the voluntary surveillance study programs on honeybee colony losses implemented by Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom for the season 2012–2013.

| (5) | The studies provide for three field visits in the apiaries to be carried out before winter, after winter and during the productive season. |
| --- | --- |

(5)

The studies provide for three field visits in the apiaries to be carried out before winter, after winter and during the productive season.

| (6) | It is important in this type of study to have comparable data in relation with the losses which are collected in different years. This is particularly valid for surveillance studies on honeybee losses because the climatic conditions alter significantly the results. Therefore, such studies if conducted only for one year can only give partial data which do not offer enough grounds to draw conclusions or trends on such losses. |
| --- | --- |

(6)

It is important in this type of study to have comparable data in relation with the losses which are collected in different years. This is particularly valid for surveillance studies on honeybee losses because the climatic conditions alter significantly the results. Therefore, such studies if conducted only for one year can only give partial data which do not offer enough grounds to draw conclusions or trends on such losses.

| (7) | For the reasons explained above, it is opportune to continue the voluntary surveillance studies on honeybee colony losses in the season starting with the pre-winter control in fall 2013, to be finalised with the post-winter and full productive season controls in 2014. |
| --- | --- |

(7)

For the reasons explained above, it is opportune to continue the voluntary surveillance studies on honeybee colony losses in the season starting with the pre-winter control in fall 2013, to be finalised with the post-winter and full productive season controls in 2014.

| (8) | The studies to be carried out in the season 2013–2014 are based on the document ‘Basis for a pilot surveillance project on honey bee colony losses’ (5) produced by the EU reference laboratory (EURL) for bee health listed in Part II of Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council (6), which provides guidance to Member States to elaborate their voluntary surveillance studies programs. |
| --- | --- |

(8)

The studies to be carried out in the season 2013–2014 are based on the document ‘Basis for a pilot surveillance project on honey bee colony losses’ (5) produced by the EU reference laboratory (EURL) for bee health listed in Part II of Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council (6), which provides guidance to Member States to elaborate their voluntary surveillance studies programs.

| (9) | The same Member States which took part to the first voluntary surveillance studies on honeybee colony losses in 2012–2013 were invited to send to the Commission their programs for the season 2013–2014 based on the technical document of the EURL for bee health. |
| --- | --- |

(9)

The same Member States which took part to the first voluntary surveillance studies on honeybee colony losses in 2012–2013 were invited to send to the Commission their programs for the season 2013–2014 based on the technical document of the EURL for bee health.

| (10) | Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom have drawn up voluntary surveillance study programs on honeybee colony losses in line with the technical document ‘Basis for a pilot surveillance project on honey bee colony losses’ and have requested EU financial support. |
| --- | --- |

(10)

Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom have drawn up voluntary surveillance study programs on honeybee colony losses in line with the technical document ‘Basis for a pilot surveillance project on honey bee colony losses’ and have requested EU financial support.

| (11) | A financial contribution should be granted as from 1 July 2013 to the voluntary surveillance study programs on honeybee colony losses implemented by Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom. |
| --- | --- |

(11)

A financial contribution should be granted as from 1 July 2013 to the voluntary surveillance study programs on honeybee colony losses implemented by Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom.

| (12) | Under Council Regulation (EC) No 1290/2005 (7), veterinary measures are to be financed under the European Agricultural Guarantee Fund. For financial control purposes, Articles 9, 36 and 37 of that Regulation are to apply. |
| --- | --- |

(12)

Under Council Regulation (EC) No 1290/2005 (7), veterinary measures are to be financed under the European Agricultural Guarantee Fund. For financial control purposes, Articles 9, 36 and 37 of that Regulation are to apply.

| (13) | The payment of the financial contribution should be subject to the condition that the surveillance study programs planned have actually been carried out and that the authorities supply all the necessary information to the Commission and to the EURL for bee health. |
| --- | --- |

(13)

The payment of the financial contribution should be subject to the condition that the surveillance study programs planned have actually been carried out and that the authorities supply all the necessary information to the Commission and to the EURL for bee health.

| (14) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(14)

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

HAS ADOPTED THIS DECISION:

Article 1

1.   The Union shall grant Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom financial assistance for their surveillance study programs on honeybee colony losses.

2.   The financial contribution by the Union

| (a) | shall be at the rate of 70 % of the eligible costs to be incurred by each Member State referred to in paragraph 1 for the surveillance study programmes on honeybee colony losses and specified in Annex I for the period from 1 July 2013 to 30 September 2014; |
| --- | --- |

(a)

shall be at the rate of 70 % of the eligible costs to be incurred by each Member State referred to in paragraph 1 for the surveillance study programmes on honeybee colony losses and specified in Annex I for the period from 1 July 2013 to 30 September 2014;

| (b) | shall not exceed the following:






  (1) | EUR 26 837 for Belgium, |
| --- | --- | --- |

(b)

shall not exceed the following:

(1)

EUR 26 837 for Belgium,

| (2) | EUR 116 417 for Denmark, |
| --- | --- |

(2)

EUR 116 417 for Denmark,

| (3) | EUR 160 445 for Germany, |
| --- | --- |

(3)

EUR 160 445 for Germany,

| (4) | EUR 64 868 for Estonia, |
| --- | --- |

(4)

EUR 64 868 for Estonia,

| (5) | EUR 78 421 for Greece, |
| --- | --- |

(5)

EUR 78 421 for Greece,

| (6) | EUR 148 047 for Spain, |
| --- | --- |

(6)

EUR 148 047 for Spain,

| (7) | EUR 288 801 for France, |
| --- | --- |

(7)

EUR 288 801 for France,

| (8) | EUR 142 212 for Italy, |
| --- | --- |

(8)

EUR 142 212 for Italy,

| (9) | EUR 86 310 for Latvia, |
| --- | --- |

(9)

EUR 86 310 for Latvia,

| (10) | EUR 70 273 for Lithuania, |
| --- | --- |

(10)

EUR 70 273 for Lithuania,

| (11) | EUR 114 209 for Hungary, |
| --- | --- |

(11)

EUR 114 209 for Hungary,

| (12) | EUR 128 015 for Poland, |
| --- | --- |

(12)

EUR 128 015 for Poland,

| (13) | EUR 29 159 for Portugal, |
| --- | --- |

(13)

EUR 29 159 for Portugal,

| (14) | EUR 92 240 for Slovakia, |
| --- | --- |

(14)

EUR 92 240 for Slovakia,

| (15) | EUR 117 416 for Finland, |
| --- | --- |

(15)

EUR 117 416 for Finland,

| (16) | EUR 74 389 for Sweden, |
| --- | --- |

(16)

EUR 74 389 for Sweden,

| (17) | EUR 109 871 for the United Kingdom, |
| --- | --- |

(17)

EUR 109 871 for the United Kingdom,

| (c) | shall not exceed EUR 348 per visit of an apiary. |
| --- | --- |

(c)

shall not exceed EUR 348 per visit of an apiary.

Article 2

1.   The maximum overall contribution authorised by this Decision for the costs incurred for the programmes referred to in Article 1 is set at EUR 1 847 930 to be financed from the General Budget of the European Union.

2.   Expenditure relating to staff costs for performing laboratory tests, sampling or monitoring, and to consumables and overheads dedicated to the surveillance studies shall be eligible in accordance with the rules set out in Annex III.

3.   The Union’s financial assistance shall be paid following presentation and approval of the reports and supporting documents referred to Article 3(2) and (3).

Article 3

1.   The programs shall be carried out in accordance with the technical document ‘Basis for a pilot surveillance project on honey bee colony losses’ and in accordance with the surveillance study programs on honeybee colony losses presented by the Member States.

2.   Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom shall submit to the Commission:

| — | no later than 1 March 2014 an intermediate technical report on the first visit provided for in the surveillance study program, and |
| --- | --- |

—

no later than 1 March 2014 an intermediate technical report on the first visit provided for in the surveillance study program, and

| — | no later than 31 October 2014 a final technical report on the second and third visits provided for in the surveillance study program, |
| --- | --- |

—

no later than 31 October 2014 a final technical report on the second and third visits provided for in the surveillance study program,

| — | the technical report should be in conformity to a model to be established by the Commission in cooperation with the EU Reference Laboratory for bee health. |
| --- | --- |

—

the technical report should be in conformity to a model to be established by the Commission in cooperation with the EU Reference Laboratory for bee health.

3.   Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom shall submit to the Commission:

| — | no later than 31 December 2014, a paper version and an electronic version of their financial report drawn up in accordance with Annex II, |
| --- | --- |

—

no later than 31 December 2014, a paper version and an electronic version of their financial report drawn up in accordance with Annex II,

| — | on request by the Commission, the supporting documents, evidencing all the expenditure referred to in the application for reimbursement. |
| --- | --- |

—

on request by the Commission, the supporting documents, evidencing all the expenditure referred to in the application for reimbursement.

4.   The outcome of the studies shall be made available to the Commission and the EU Reference Laboratory for bee health.

Article 4

This Decision is addressed to the Kingdom of Belgium, the Kingdom of Denmark, the Federal Republic of Germany, the Republic of Estonia, the Hellenic Republic, the Kingdom of Spain, the French Republic, the Italian Republic, the Republic of Latvia, the Republic of Lithuania, Hungary, the Republic of Poland, the Portuguese Republic, the Slovak Republic, the Republic of Finland, the Kingdom of Sweden and the United Kingdom of Great Britain and Northern Ireland.

Done at Brussels, 17 October 2013.

For the Commission

Tonio BORG

Member of the Commission

---

(1)  OJ L 155, 18.6.2009, p. 30.

1

(2)  COM(2010) 714 final.

2

(3)  Available at: http://www.efsa.europa.eu/en/efsajournal/doc/154r.pdf

3

(4)  Commission Implementing Decision 2012/362/EU of 4 July 2012 concerning a financial contribution by the Union to certain Member States to support voluntary surveillance studies on honeybee colony losses (OJ L 176, 6.7.2012, p. 65).

4

(5)  Available at: http://ec.europa.eu/food/animal/liveanimals/bees/docs/annex_i_pilot_project_en.pdf

5

(6)  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

6

(7)  Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (OJ L 209, 11.8.2005, p. 1).

7

---

ANNEX I

| MS | Number of apiaries | Number of visits per apiary foreseen in the surveillance study | Total direct costs
  (Laboratory tests + visits for sampling and monitoring) | Overheads
  (7 %) | Total cost | EU contribution
  (70 %) |
| --- | --- | --- | --- | --- | --- | --- |
| BE | 150 | 3 | 35 830 | 2 508 | 38 338 | 26 837 |
| DK | 200 | 3 | 155 430 | 10 880 | 166 310 | 116 417 |
| DE | 220 | 3 | 214 212 | 14 995 | 229 207 | 160 445 |
| EE | 196 | 3 | 86 606 | 6 062 | 92 668 | 64 868 |
| EL | 200 | 3 | 104 701 | 7 329 | 112 030 | 78 421 |
| ES | 203 | 3 | 197 659 | 13 836 | 211 495 | 148 047 |
| FR | 396 | 3 | 385 581 | 26 991 | 412 572 | 288 801 |
| IT | 195 | 3 | 189 870 | 13 291 | 203 161 | 142 212 |
| LV | 193 | 3 | 115 234 | 8 066 | 123 300 | 86 310 |
| LT | 193 | 3 | 93 822 | 6 568 | 100 390 | 70 273 |
| HU | 196 | 3 | 152 483 | 10 674 | 163 157 | 114 209 |
| PL | 190 | 3 | 170 915 | 11 964 | 182 879 | 128 015 |
| PT | 145 | 3 | 38 930 | 2 725 | 41 655 | 29 159 |
| SK | 200 | 3 | 123 151 | 8 621 | 131 772 | 92 240 |
| FI | 161 | 3 | 156 764 | 10 973 | 167 737 | 117 416 |
| SE | 150 | 3 | 99 318 | 6 952 | 106 270 | 74 389 |
| UK | 200 | 3 | 146 691 | 10 268 | 156 959 | 109 871 |
| Total | | | 2 467 197 | 172 703 | 2 639 900 | 1 847 930 |

MS

Number of apiaries

Number of visits per apiary foreseen in the surveillance study

Total direct costs

(Laboratory tests + visits for sampling and monitoring)

Overheads

(7 %)

Total cost

EU contribution

(70 %)

BE

150

3

35 830

2 508

38 338

26 837

DK

200

3

155 430

10 880

166 310

116 417

DE

220

3

214 212

14 995

229 207

160 445

EE

196

3

86 606

6 062

92 668

64 868

EL

200

3

104 701

7 329

112 030

78 421

ES

203

3

197 659

13 836

211 495

148 047

FR

396

3

385 581

26 991

412 572

288 801

IT

195

3

189 870

13 291

203 161

142 212

LV

193

3

115 234

8 066

123 300

86 310

LT

193

3

93 822

6 568

100 390

70 273

HU

196

3

152 483

10 674

163 157

114 209

PL

190

3

170 915

11 964

182 879

128 015

PT

145

3

38 930

2 725

41 655

29 159

SK

200

3

123 151

8 621

131 772

92 240

FI

161

3

156 764

10 973

167 737

117 416

SE

150

3

99 318

6 952

106 270

74 389

UK

200

3

146 691

10 268

156 959

109 871

Total

2 467 197

172 703

2 639 900

1 847 930

---

ANNEX II

MODEL FOR A FINANCIAL REPORT ON VOLUNTARY SURVEILLANCE STUDIES ON HONEYBEE COLONY LOSSES

| Total expenditure for the project (real costs, VAT excl.) |
| --- |
| Member State: | | Number of apiaries visited: |
| | | Total number of colonies sampled: |

Total expenditure for the project (real costs, VAT excl.)

Member State:

Number of apiaries visited:

Total number of colonies sampled:

| Laboratory costs |
| --- |
| Staff category | Number of working days | Daily rate | Total |
| ... | | | |
| ... | | | |
| | | | |
| Consumables (description) | Quantity | Unit cost | Total |
| ... | | | |
| ... | | | |

Laboratory costs

Staff category

Number of working days

Daily rate

Total

...

...

Consumables (description)

Quantity

Unit cost

Total

...

...

| Sampling and monitoring costs (apiary visits) |
| --- |
| Staff category | Number of working days | Daily rate | Total |
| ... | | | |
| ... | | | |
| | | | |
| Consumables (description) | Quantity | Unit cost | Total |
| ... | | | |
| ... | | | |

Sampling and monitoring costs (apiary visits)

Staff category

Number of working days

Daily rate

Total

...

...

Consumables (description)

Quantity

Unit cost

Total

...

...

Certification by the beneficiary

We certify that:

| — | the expenditure listed above was incurred in the performance of tasks described in the technical document ‘Basis for a pilot surveillance project on honey bee colony losses’ (1) and directly related to the implementation of the surveillance study programme for which financial support was granted according to Commission Implementing Decision 2013/512/EU, |
| --- | --- |

—

the expenditure listed above was incurred in the performance of tasks described in the technical document ‘Basis for a pilot surveillance project on honey bee colony losses’ (1) and directly related to the implementation of the surveillance study programme for which financial support was granted according to Commission Implementing Decision 2013/512/EU,

| — | the expenditure was actually incurred, accurately accounted for and eligible under the provisions of Implementing Decision 2013/512/EU, |
| --- | --- |

—

the expenditure was actually incurred, accurately accounted for and eligible under the provisions of Implementing Decision 2013/512/EU,

| — | all supporting documents relating to the expenditure are available for auditing, |
| --- | --- |

—

all supporting documents relating to the expenditure are available for auditing,

| — | no other Union contribution was requested for the projects listed in Commission Implementing Decision 2013/512/EU. |
| --- | --- |

—

no other Union contribution was requested for the projects listed in Commission Implementing Decision 2013/512/EU.

Date:

Name and signature of the financial officer responsible:

---

(1)  Available at http://ec.europa.eu/food/animal/liveanimals/bees/docs/annex_i_pilot_project_en.pdf

---

ANNEX III

ELIGIBILITY RULES

1.   Laboratory costs

| — | Staff costs shall be limited to actual attributable labour costs (basic salary, social charges and retirement costs) accrued in implementation of the study and performing laboratory tests. To this end monthly time sheets have to be maintained. |
| --- | --- |

—

Staff costs shall be limited to actual attributable labour costs (basic salary, social charges and retirement costs) accrued in implementation of the study and performing laboratory tests. To this end monthly time sheets have to be maintained.

| — | Daily rate will be calculated on a 220 working days/year. |
| --- | --- |

—

Daily rate will be calculated on a 220 working days/year.

| — | Reimbursement of consumables shall be based on actual costs incurred by Member States to perform the tests at the laboratory. |
| --- | --- |

—

Reimbursement of consumables shall be based on actual costs incurred by Member States to perform the tests at the laboratory.

| — | Staff costs for coordination, planning and transport are not eligible. Test kits, reagents and all consumables shall only be reimbursed if used specifically in the performance of the following tests. |
| --- | --- |

—

Staff costs for coordination, planning and transport are not eligible. Test kits, reagents and all consumables shall only be reimbursed if used specifically in the performance of the following tests.

| — | Varroa count (washing) to be carried out on all colonies visited at the first visit and on symptomatic colonies in the following visits. |
| --- | --- |

—

Varroa count (washing) to be carried out on all colonies visited at the first visit and on symptomatic colonies in the following visits.

| — | Detection and characterisation of the small hive beetle (Aethina tumida) and the tropilaelaps mite) to be carried out at the clinical inspection. |
| --- | --- |

—

Detection and characterisation of the small hive beetle (Aethina tumida) and the tropilaelaps mite) to be carried out at the clinical inspection.

| — | Clinical observation (including symptom observation foulbrood, nosema, viruses) microsporidian parasite (nosema spp.) spore counts, cultures, microscopic examination and biochemical tests to identify the causal agent European foulbrood (Melissococcus plutonius) and American foulbrood (Paenibacillus larvae) on symptomatic colonies. |
| --- | --- |

—

Clinical observation (including symptom observation foulbrood, nosema, viruses) microsporidian parasite (nosema spp.) spore counts, cultures, microscopic examination and biochemical tests to identify the causal agent European foulbrood (Melissococcus plutonius) and American foulbrood (Paenibacillus larvae) on symptomatic colonies.

| — | American foulbrood — confirmation of the identity of the causal agent American foulbrood and European foulbrood via Polymerase Chain Reaction (PCR) on symptomatic colonies. |
| --- | --- |

—

American foulbrood — confirmation of the identity of the causal agent American foulbrood and European foulbrood via Polymerase Chain Reaction (PCR) on symptomatic colonies.

| — | CBPV test (PCR) on symptomatic colonies. |
| --- | --- |

—

CBPV test (PCR) on symptomatic colonies.

2.   Sampling and monitoring costs

| — | Costs for sampling and monitoring can only be claimed if they are directly linked to visits of apiaries and are limited to the time actually spent at the apiaries. Staff costs shall be limited to actual attributable labour costs (basic salary, social charges and retirement costs) accrued in implementation of the study, To this end monthly time sheets have to be maintained. |
| --- | --- |

—

Costs for sampling and monitoring can only be claimed if they are directly linked to visits of apiaries and are limited to the time actually spent at the apiaries. Staff costs shall be limited to actual attributable labour costs (basic salary, social charges and retirement costs) accrued in implementation of the study, To this end monthly time sheets have to be maintained.

| — | Staff costs for coordination, planning and transport are not eligible. |
| --- | --- |

—

Staff costs for coordination, planning and transport are not eligible.

| — | Daily rate will be calculated on a 220 working days/year. |
| --- | --- |

—

Daily rate will be calculated on a 220 working days/year.

| — | Reimbursement of consumables shall be based on actual costs incurred by Member States and shall only be reimbursed if used specifically during visits to the apiaries. |
| --- | --- |

—

Reimbursement of consumables shall be based on actual costs incurred by Member States and shall only be reimbursed if used specifically during visits to the apiaries.

3.   Overheads

A flat rate contribution of 7 % calculated on the basis of all direct eligible costs may be claimed.

4.   The expenditure submitted by the Member States for a financial contribution by the Union shall be expressed in euro and shall exclude value added tax (VAT) and all other taxes.

---

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

| 19.10.2013 | EN | Official Journal of the European Union | L 279/73 |
| --- | --- | --- | --- |

19.10.2013

EN

Official Journal of the European Union

L 279/73

---

DECISION No 1/2013 OF THE EU-MONACO JOINT COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE PRINCIPALITY OF MONACO ON THE APPLICATION OF CERTAIN COMMUNITY ACTS ON THE TERRITORY OF THE PRINCIPALITY OF MONACO

of 12 July 2013

amending the Annex to the Agreement

(2013/513/EU)

THE JOINT COMMITTEE,

Having regard to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco (1), signed in Brussels on 4 December 2003 (hereinafter referred to as ‘the Agreement’), and in particular Article 1(1) thereof,

Whereas:

| (1) | Since the entry into force of the Agreement on 1 May 2004, the Union has adopted a number of acts that fall within its scope and some acts appearing in the Annex have been repealed. A Decision of the Joint Committee is therefore necessary to update the Annex to include the new acts and to delete the acts that have been repealed. |
| --- | --- |

(1)

Since the entry into force of the Agreement on 1 May 2004, the Union has adopted a number of acts that fall within its scope and some acts appearing in the Annex have been repealed. A Decision of the Joint Committee is therefore necessary to update the Annex to include the new acts and to delete the acts that have been repealed.

| (2) | It is recalled that acts of the European Commission adopted in application of the acts listed in the Annex to the Agreement are applicable on the territory of Monaco without the need for a Joint Committee Decision, as provided for by Article 1(2) of the Agreement, |
| --- | --- |

(2)

It is recalled that acts of the European Commission adopted in application of the acts listed in the Annex to the Agreement are applicable on the territory of Monaco without the need for a Joint Committee Decision, as provided for by Article 1(2) of the Agreement,

HAS ADOPTED THIS DECISION:

Article 1

The text set out in the Annex to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco is replaced by the text set out in the Annex to this Decision.

Article 2

This Decision shall enter into force on the day of its adoption.

Done at Monaco, 12 July 2013.

For the Joint Committee

The President

Stéphane VALÉRI

---

(1)  OJ L 332, 19.12.2003, p. 42.

1

---

ANNEX

‘ANNEX

I.   MEDICINAL PRODUCTS

ACTS REFERRED TO

| 1. | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by:






  — | Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, 27.10.2012, p. 1); |
| --- | --- | --- |

1.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by:

—

Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, 27.10.2012, p. 1);

| — | Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174, 1.7.2011, p. 74); |
| --- | --- |

—

Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174, 1.7.2011, p. 74);

| — | Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 348, 31.12.2010, p. 74); |
| --- | --- |

—

Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 348, 31.12.2010, p. 74);

| — | Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (OJ L 242, 15.9.2009, p. 3); |
| --- | --- |

—

Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (OJ L 242, 15.9.2009, p. 3);

| — | Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (OJ L 168, 30.6.2009, p. 33); |
| --- | --- |

—

Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (OJ L 168, 30.6.2009, p. 33);

| — | Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission (OJ L 81, 20.3.2008, p. 51); |
| --- | --- |

—

Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission (OJ L 81, 20.3.2008, p. 51);

| — | Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121); |
| --- | --- |

—

Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121);

| — | Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1); |
| --- | --- |

—

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1);

| — | Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, p. 34); |
| --- | --- |

—

Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, p. 34);

| — | Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, p. 85); |
| --- | --- |

—

Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, p. 85);

| — | Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 159, 27.6.2003, p. 46); and |
| --- | --- |

—

Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 159, 27.6.2003, p. 46); and

| — | Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30). |
| --- | --- |

—

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30).

| 2. | Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended by:






  — | Regulation (EU) no 1027/2012 of the European Parliament and of the Council of 25 October 2012 as regards pharmacovigilance (OJ L 316, 14.11.2012, p. 38); |
| --- | --- | --- |

2.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended by:

—

Regulation (EU) no 1027/2012 of the European Parliament and of the Council of 25 October 2012 as regards pharmacovigilance (OJ L 316, 14.11.2012, p. 38);

| — | Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (OJ L 348, 31.12.2010, p. 1); |
| --- | --- |

—

Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (OJ L 348, 31.12.2010, p. 1);

| — | Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11); |
| --- | --- |

—

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11);

| — | Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Two (OJ L 87, 31.3.2009, p. 109); |
| --- | --- |

—

Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Two (OJ L 87, 31.3.2009, p. 109);

| — | Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121); and |
| --- | --- |

—

Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121); and

| — | Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1). |
| --- | --- |

—

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).

| 3. | 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, as amended by:






  — | Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four (OJ L 188, 18.7.2009, p. 14); |
| --- | --- | --- |

3.

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, as amended by:

—

Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four (OJ L 188, 18.7.2009, p. 14);

| — | Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (OJ L 168, 30.6.2009, p. 33); |
| --- | --- |

—

Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (OJ L 168, 30.6.2009, p. 33);

| — | Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11); |
| --- | --- |

—

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11);

| — | Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (OJ L 44, 14.2.2009, p. 10); and |
| --- | --- |

—

Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (OJ L 44, 14.2.2009, p. 10); and

| — | Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58). |
| --- | --- |

—

Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58).

| 4. | Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products, as amended by:






  — | Council Regulation (EC) No 2743/98 of 14 December 1998 (OJ L 345, 19.12.1998, p. 3); |
| --- | --- | --- |

4.

Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products, as amended by:

—

Council Regulation (EC) No 2743/98 of 14 December 1998 (OJ L 345, 19.12.1998, p. 3);

| — | Commission Regulation (EC) No 494/2003 of 18 March 2003 (OJ L 73, 19.3.2003, p. 6); |
| --- | --- |

—

Commission Regulation (EC) No 494/2003 of 18 March 2003 (OJ L 73, 19.3.2003, p. 6);

| — | Council Regulation (EC) No 1905/2005 of 14 November 2005 (OJ L 304, 23.11.2005, p. 1); |
| --- | --- |

—

Council Regulation (EC) No 1905/2005 of 14 November 2005 (OJ L 304, 23.11.2005, p. 1);

| — | Commission Regulation (EC) No 312/2008 of 3 April 2008 (OJ L 93, 4.4.2008, p. 8); |
| --- | --- |

—

Commission Regulation (EC) No 312/2008 of 3 April 2008 (OJ L 93, 4.4.2008, p. 8);

| — | Commission Regulation (EC) No 249/2009 of 23 March 2009 (OJ L 79, 25.3.2009, p. 34); |
| --- | --- |

—

Commission Regulation (EC) No 249/2009 of 23 March 2009 (OJ L 79, 25.3.2009, p. 34);

| — | Commission Regulation (EU) No 261/2010 of 25 March 2010 (OJ L 80, 26.3.2010, p. 36); |
| --- | --- |

—

Commission Regulation (EU) No 261/2010 of 25 March 2010 (OJ L 80, 26.3.2010, p. 36);

| — | Commission Regulation (EU) No 301/2011 of 28 March 2011 (OJ L 81, 29.3.2011, p. 5); |
| --- | --- |

—

Commission Regulation (EU) No 301/2011 of 28 March 2011 (OJ L 81, 29.3.2011, p. 5);

| — | Commission Regulation (EU) No 273/2012 of 27 March 2012 (OJ L 90, 28.3.2012, p. 11); and |
| --- | --- |

—

Commission Regulation (EU) No 273/2012 of 27 March 2012 (OJ L 90, 28.3.2012, p. 11); and

| — | Commission Regulation (EU) No 220/2013 of 13 March 2013 (OJ L 70, 14.3.2013, p. 1). |
| --- | --- |

—

Commission Regulation (EU) No 220/2013 of 13 March 2013 (OJ L 70, 14.3.2013, p. 1).

| 5. | Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11). |
| --- | --- |

5.

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

| 6. | Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (OJ L 194, 25.7.2009, p. 7). |
| --- | --- |

6.

Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (OJ L 194, 25.7.2009, p. 7).

| 7. | Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as amended by:






  — | Commission Regulation (EU) No 758/2010 of 24 August 2010 (OJ L 223, 25.8.2010, p. 37); |
| --- | --- | --- |

7.

Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as amended by:

—

Commission Regulation (EU) No 758/2010 of 24 August 2010 (OJ L 223, 25.8.2010, p. 37);

| — | Commission Regulation (EU) No 759/2010 of 24 August 2010 (OJ L 223, 25.8.2010, p. 39); |
| --- | --- |

—

Commission Regulation (EU) No 759/2010 of 24 August 2010 (OJ L 223, 25.8.2010, p. 39);

| — | Commission Regulation (EU) No 761/2010 of 25 August 2010 (OJ L 224, 26.8.2010, p. 1); |
| --- | --- |

—

Commission Regulation (EU) No 761/2010 of 25 August 2010 (OJ L 224, 26.8.2010, p. 1);

| — | Commission Regulation (EU) No 890/2010 of 8 October 2010 (OJ L 266, 9.10.2010, p. 1); |
| --- | --- |

—

Commission Regulation (EU) No 890/2010 of 8 October 2010 (OJ L 266, 9.10.2010, p. 1);

| — | Commission Regulation (EU) No 914/2010 of 12 October 2010 (OJ L 269, 13.10.2010, p. 5); |
| --- | --- |

—

Commission Regulation (EU) No 914/2010 of 12 October 2010 (OJ L 269, 13.10.2010, p. 5);

| — | Commission Regulation (EU) No 362/2011 of 13 April 2011 (OJ L 100, 14.4.2011, p. 26); |
| --- | --- |

—

Commission Regulation (EU) No 362/2011 of 13 April 2011 (OJ L 100, 14.4.2011, p. 26);

| — | Commission Regulation (EU) No 363/2011 of 13 April 2011 (OJ L 100, 14.4.2011, p. 28); |
| --- | --- |

—

Commission Regulation (EU) No 363/2011 of 13 April 2011 (OJ L 100, 14.4.2011, p. 28);

| — | Commission Implementing Regulation (EU) No 84/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 1); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 84/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 1);

| — | Commission Implementing Regulation (EU) No 85/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 4); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 85/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 4);

| — | Commission Implementing Regulation (EU) No 86/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 6); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 86/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 6);

| — | Commission Implementing Regulation (EU) No 107/2012 of 8 February 2012 (OJ L 36, 9.2.2012, p. 25); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 107/2012 of 8 February 2012 (OJ L 36, 9.2.2012, p. 25);

| — | Commission Implementing Regulation (EU) No 122/2012 of 13 February 2012 (OJ L 40, 14.2.2012, p. 2); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 122/2012 of 13 February 2012 (OJ L 40, 14.2.2012, p. 2);

| — | Commission Implementing Regulation (EU) No 123/2012 of 13 February 2012 (OJ L 40, 14.2.2012, p. 4); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 123/2012 of 13 February 2012 (OJ L 40, 14.2.2012, p. 4);

| — | Commission Implementing Regulation (EU) No 201/2012 of 8 March 2012 (OJ L 71, 9.3.2012, p. 37); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 201/2012 of 8 March 2012 (OJ L 71, 9.3.2012, p. 37);

| — | Commission Implementing Regulation (EU) No 202/2012 of 8 March 2012 (OJ L 71, 9.3.2012, p. 40); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 202/2012 of 8 March 2012 (OJ L 71, 9.3.2012, p. 40);

| — | Commission Implementing Regulation (EU) No 221/2012 of 14 March 2012 (OJ L 75, 15.3.2012, p. 7); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 221/2012 of 14 March 2012 (OJ L 75, 15.3.2012, p. 7);

| — | Commission Implementing Regulation (EU) No 222/2012 of 14 March 2012 (OJ L 75, 15.3.2012, p. 10); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 222/2012 of 14 March 2012 (OJ L 75, 15.3.2012, p. 10);

| — | Commission Implementing Regulation (EU) No 436/2012 of 23 May 2012 (OJ L 134, 24.5.2012, p. 10); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 436/2012 of 23 May 2012 (OJ L 134, 24.5.2012, p. 10);

| — | Commission Implementing Regulation (EU) No 466/2012 of 1 June 2012 (OJ L 143, 2.6.2012, p. 2); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 466/2012 of 1 June 2012 (OJ L 143, 2.6.2012, p. 2);

| — | Commission Implementing Regulation (EU) No 1161/2012 of 7 December 2012 (OJ L 336, 8.12.2012, p. 14); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 1161/2012 of 7 December 2012 (OJ L 336, 8.12.2012, p. 14);

| — | Commission Implementing Regulation (EU) No 1186/2012 of 11 December 2012 (OJ L 338, 12.12.2012, p. 20); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 1186/2012 of 11 December 2012 (OJ L 338, 12.12.2012, p. 20);

| — | Commission Implementing Regulation (EU) No 1191/2012 of 12 December 2012 (OJ L 340, 13.12.2012, p. 35); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 1191/2012 of 12 December 2012 (OJ L 340, 13.12.2012, p. 35);

| — | Commission Implementing Regulation (EU) No 59/2013 of 23 January 2013 (OJ L 21, 24.1.2013, p. 21); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 59/2013 of 23 January 2013 (OJ L 21, 24.1.2013, p. 21);

| — | Commission Implementing Regulation (EU) No 115/2013 of 8 February 2013 (OJ L 38, 9.2.2013, p. 11.); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 115/2013 of 8 February 2013 (OJ L 38, 9.2.2013, p. 11.);

| — | Commission Implementing Regulation (EU) No 116/2013 of 8 February 2013 (OJ L 38, 9.2.2013, p. 14); |
| --- | --- |

—

Commission Implementing Regulation (EU) No 116/2013 of 8 February 2013 (OJ L 38, 9.2.2013, p. 14);

| — | Commission Implementing Regulation (EU) No 394/2013 of 29 April 2013 (OJ L 118, 30.4.2013, p. 17); and |
| --- | --- |

—

Commission Implementing Regulation (EU) No 394/2013 of 29 April 2013 (OJ L 118, 30.4.2013, p. 17); and

| — | Commission Implementing Regulation (EU) No 406/2013 of 2 May 2013 (OJ L 121, 3.5.2013, p. 42). |
| --- | --- |

—

Commission Implementing Regulation (EU) No 406/2013 of 2 May 2013 (OJ L 121, 3.5.2013, p. 42).

| 8. | Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 150, 9.6.2012, p. 68). |
| --- | --- |

8.

Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 150, 9.6.2012, p. 68).

| 9. | Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 209, 4.8.2012, p. 4). |
| --- | --- |

9.

Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 209, 4.8.2012, p. 4).

| 10. | Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (OJ L 65, 8.3.2013, p. 17). |
| --- | --- |

10.

Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (OJ L 65, 8.3.2013, p. 17).

| 11. | Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1). |
| --- | --- |

11.

Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1).

| 12. | Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10). |
| --- | --- |

12.

Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10).

| 13. | Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121), as amended by Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 (OJ L 348, 31.12.2010, p. 1). |
| --- | --- |

13.

Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121), as amended by Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 (OJ L 348, 31.12.2010, p. 1).

| 14. | Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10). |
| --- | --- |

14.

Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10).

| 15. | Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1), as amended by:






  — | Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 (OJ L 152, 16.6.2009, p. 1); and |
| --- | --- | --- |

15.

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1), as amended by:

—

Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 (OJ L 152, 16.6.2009, p. 1); and

| — | Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 (OJ L 378, 27.12.2006, p. 20). |
| --- | --- |

—

Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 (OJ L 378, 27.12.2006, p. 20).

| 16. | Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, p. 6). |
| --- | --- |

16.

Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, p. 6).

| 17. | Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, p. 4). |
| --- | --- |

17.

Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, p. 4).

| 18. | Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13). |
| --- | --- |

18.

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13).

| 19. | Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44), as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ L 87, 31.3.2009, p. 109). |
| --- | --- |

19.

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44), as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ L 87, 31.3.2009, p. 109).

| 20. | Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28) as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ L 87, 31.3.2009, p. 109). |
| --- | --- |

20.

Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28) as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ L 87, 31.3.2009, p. 109).

| 21. | Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22). |
| --- | --- |

21.

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).

| 22. | Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines (OJ L 135, 3.6.2003, p. 5), as amended by:






  — | Commission Regulation (EC) No 1876/2004 of 28 October 2004 (OJ L 326, 29.10.2004, p. 22); and |
| --- | --- | --- |

22.

Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines (OJ L 135, 3.6.2003, p. 5), as amended by:

—

Commission Regulation (EC) No 1876/2004 of 28 October 2004 (OJ L 326, 29.10.2004, p. 22); and

| — | Commission Regulation (EC) No 1662/2005 of 11 October 2005 (OJ L 267, 12.10.2005, p. 19). |
| --- | --- |

—

Commission Regulation (EC) No 1662/2005 of 11 October 2005 (OJ L 267, 12.10.2005, p. 19).

| 23. | Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1), as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14). |
| --- | --- |

23.

Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1), as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14).

| 24. | Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70). |
| --- | --- |

24.

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70).

| 25. | Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8). |
| --- | --- |

25.

Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8).

| 26. | Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34), as amended by:






  — | Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 (OJ L 378, 27.12.2006, p. 1); and |
| --- | --- | --- |

26.

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34), as amended by:

—

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 (OJ L 378, 27.12.2006, p. 1); and

| — | Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14). |
| --- | --- |

—

Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14).

| 27. | Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30) (only as regards the collection and testing of blood and blood components used as starting materials for manufacturing medicinal products). |
| --- | --- |

27.

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30) (only as regards the collection and testing of blood and blood components used as starting materials for manufacturing medicinal products).

| 28. | Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48) (only as regards the procurement, donation, coding and testing of tissue and cells, as well as the coding of donations and packaging thereof, used as starting materials for advanced therapy medicinal products as referred to in Regulation (EC) No 1394/2007 of the European Parliament and of the Council). |
| --- | --- |

28.

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48) (only as regards the procurement, donation, coding and testing of tissue and cells, as well as the coding of donations and packaging thereof, used as starting materials for advanced therapy medicinal products as referred to in Regulation (EC) No 1394/2007 of the European Parliament and of the Council).

II.   COSMETICS

ACTS REFERRED TO

| 1. | Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.9.1976, p. 169), as amended by:






  — | Council Directive 79/661/EEC of 24 July 1979 (OJ L 192, 31.7.1979, p. 35); |
| --- | --- | --- |

1.

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.9.1976, p. 169), as amended by:

—

Council Directive 79/661/EEC of 24 July 1979 (OJ L 192, 31.7.1979, p. 35);

| — | Commission Directive 82/147/EEC of 11 February 1982 (OJ L 63, 6.3.1982, p. 26); |
| --- | --- |

—

Commission Directive 82/147/EEC of 11 February 1982 (OJ L 63, 6.3.1982, p. 26);

| — | Council Directive 82/368/EEC of 17 May 1982 (OJ L 167, 15.6.1982, p. 1); |
| --- | --- |

—

Council Directive 82/368/EEC of 17 May 1982 (OJ L 167, 15.6.1982, p. 1);

| — | Commission Directive 83/191/EEC of 30 March 1983 (OJ L 109, 26.4.1983, p. 25); |
| --- | --- |

—

Commission Directive 83/191/EEC of 30 March 1983 (OJ L 109, 26.4.1983, p. 25);

| — | Commission Directive 83/341/EEC of 29 June 1983 (OJ L 188, 13.7.1983, p. 15); |
| --- | --- |

—

Commission Directive 83/341/EEC of 29 June 1983 (OJ L 188, 13.7.1983, p. 15);

| — | Commission Directive 83/496/EEC of 22 September 1983 (OJ L 275, 8.10.1983, p. 20); |
| --- | --- |

—

Commission Directive 83/496/EEC of 22 September 1983 (OJ L 275, 8.10.1983, p. 20);

| — | Council Directive 83/574/EEC of 26 October 1983 (OJ L 332, 28.11.1983, p. 38); |
| --- | --- |

—

Council Directive 83/574/EEC of 26 October 1983 (OJ L 332, 28.11.1983, p. 38);

| — | Commission Directive 84/415/EEC of 18 July 1984 (OJ L 228, 25.8.1984, p. 31); |
| --- | --- |

—

Commission Directive 84/415/EEC of 18 July 1984 (OJ L 228, 25.8.1984, p. 31);

| — | Commission Directive 85/391/EEC of 16 July 1985 (OJ L 224, 22.8.1985, p. 40); |
| --- | --- |

—

Commission Directive 85/391/EEC of 16 July 1985 (OJ L 224, 22.8.1985, p. 40);

| — | Commission Directive 86/179/EEC of 28 February 1986 (OJ L 138, 24.5.1986, p. 40); |
| --- | --- |

—

Commission Directive 86/179/EEC of 28 February 1986 (OJ L 138, 24.5.1986, p. 40);

| — | Commission Directive 86/199/EEC of 26 March 1986 (OJ L 149, 3.6.1986, p. 38); |
| --- | --- |

—

Commission Directive 86/199/EEC of 26 March 1986 (OJ L 149, 3.6.1986, p. 38);

| — | Commission Directive 87/137/EEC of 2 February 1987 (OJ L 56, 26.2.1987, p. 20); |
| --- | --- |

—

Commission Directive 87/137/EEC of 2 February 1987 (OJ L 56, 26.2.1987, p. 20);

| — | Commission Directive 88/233/EEC of 2 March 1988 (OJ L 105, 26.4.1988, p. 11); |
| --- | --- |

—

Commission Directive 88/233/EEC of 2 March 1988 (OJ L 105, 26.4.1988, p. 11);

| — | Council Directive 88/667/EEC of 21 December 1988 (OJ L 382, 31.12.1988, p. 46); |
| --- | --- |

—

Council Directive 88/667/EEC of 21 December 1988 (OJ L 382, 31.12.1988, p. 46);

| — | Commission Directive 89/174/EEC of 21 February 1989 (OJ L 64, 8.3.1989, p. 10); |
| --- | --- |

—

Commission Directive 89/174/EEC of 21 February 1989 (OJ L 64, 8.3.1989, p. 10);

| — | Council Directive 89/679/EEC of 21 December 1989 (OJ L 398, 30.12.1989, p. 25); |
| --- | --- |

—

Council Directive 89/679/EEC of 21 December 1989 (OJ L 398, 30.12.1989, p. 25);

| — | Commission Directive 90/121/EEC of 20 February 1990 (OJ L 71, 17.3.1990, p. 40); |
| --- | --- |

—

Commission Directive 90/121/EEC of 20 February 1990 (OJ L 71, 17.3.1990, p. 40);

| — | Commission Directive 91/184/EEC of 12 March 1991 (OJ L 91, 12.4.1991, p. 59); |
| --- | --- |

—

Commission Directive 91/184/EEC of 12 March 1991 (OJ L 91, 12.4.1991, p. 59);

| — | Commission Directive 92/8/EEC of 18 February 1992 (OJ L 70, 17.3.1992, p. 23); |
| --- | --- |

—

Commission Directive 92/8/EEC of 18 February 1992 (OJ L 70, 17.3.1992, p. 23);

| — | Commission Directive 92/86/EEC of 21 October 1992 (OJ L 325, 11.11.1992, p. 18); |
| --- | --- |

—

Commission Directive 92/86/EEC of 21 October 1992 (OJ L 325, 11.11.1992, p. 18);

| — | Council Directive 93/35/EEC of 14 June 1993 (OJ L 151, 23.6.1993, p. 32); |
| --- | --- |

—

Council Directive 93/35/EEC of 14 June 1993 (OJ L 151, 23.6.1993, p. 32);

| — | Commission Directive 93/47/EEC of 22 June 1993 (OJ L 203, 13.8.1993, p. 24); |
| --- | --- |

—

Commission Directive 93/47/EEC of 22 June 1993 (OJ L 203, 13.8.1993, p. 24);

| — | Commission Directive 94/32/EC of 29 June 1994 (OJ L 181, 15.7.1994, p. 31); |
| --- | --- |

—

Commission Directive 94/32/EC of 29 June 1994 (OJ L 181, 15.7.1994, p. 31);

| — | Commission Directive 95/34/EC of 10 July 1995 (OJ L 167, 18.7.1995, p. 19); |
| --- | --- |

—

Commission Directive 95/34/EC of 10 July 1995 (OJ L 167, 18.7.1995, p. 19);

| — | Commission Directive 96/41/EC of 25 June 1996 (OJ L 198, 8.8.1996, p. 36); |
| --- | --- |

—

Commission Directive 96/41/EC of 25 June 1996 (OJ L 198, 8.8.1996, p. 36);

| — | Commission Directive 97/1/EC of 10 January 1997 (OJ L 16, 18.1.1997, p. 85); |
| --- | --- |

—

Commission Directive 97/1/EC of 10 January 1997 (OJ L 16, 18.1.1997, p. 85);

| — | Commission Directive 97/18/EC of 17 April 1997 (OJ L 114, 1.5.1997, p. 43); |
| --- | --- |

—

Commission Directive 97/18/EC of 17 April 1997 (OJ L 114, 1.5.1997, p. 43);

| — | Commission Directive 97/45/EC of 14 July 1997 (OJ L 196, 24.7.1997, p. 77); |
| --- | --- |

—

Commission Directive 97/45/EC of 14 July 1997 (OJ L 196, 24.7.1997, p. 77);

| — | Commission Directive 98/16/EC of 5 March 1998 (OJ L 77, 14.3.1998, p. 44); |
| --- | --- |

—

Commission Directive 98/16/EC of 5 March 1998 (OJ L 77, 14.3.1998, p. 44);

| — | Commission Directive 98/62/EC of 3 September 1998 (OJ L 253, 15.9.1998, p. 20); |
| --- | --- |

—

Commission Directive 98/62/EC of 3 September 1998 (OJ L 253, 15.9.1998, p. 20);

| — | Commission Directive 2000/6/EC of 29 February 2000 (OJ L 56, 1.3.2000, p. 42); |
| --- | --- |

—

Commission Directive 2000/6/EC of 29 February 2000 (OJ L 56, 1.3.2000, p. 42);

| — | Commission Directive 2000/11/EC of 10 March 2000 (OJ L 65, 14.3.2000, p. 22); |
| --- | --- |

—

Commission Directive 2000/11/EC of 10 March 2000 (OJ L 65, 14.3.2000, p. 22);

| — | Commission Directive 2000/41/EC of 19 June 2000 (OJ L 145, 20.6.2000, p. 25); |
| --- | --- |

—

Commission Directive 2000/41/EC of 19 June 2000 (OJ L 145, 20.6.2000, p. 25);

| — | Commission Directive 2002/34/EC of 15 April 2002 (OJ L 102, 18.4.2002, p. 19); |
| --- | --- |

—

Commission Directive 2002/34/EC of 15 April 2002 (OJ L 102, 18.4.2002, p. 19);

| — | Commission Directive 2003/1/EC of 6 January 2003 (OJ L 5, 10.1.2003, p. 14); |
| --- | --- |

—

Commission Directive 2003/1/EC of 6 January 2003 (OJ L 5, 10.1.2003, p. 14);

| — | Commission Directive 2003/16/EC of 19 February 2003 (OJ L 46, 20.2.2003, p. 24); |
| --- | --- |

—

Commission Directive 2003/16/EC of 19 February 2003 (OJ L 46, 20.2.2003, p. 24);

| — | Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 (OJ L 66, 11.3.2003, p. 26); |
| --- | --- |

—

Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 (OJ L 66, 11.3.2003, p. 26);

| — | Commission Directive 2003/80/EC of 5 September 2003 (OJ L 224, 6.9.2003, p. 27); |
| --- | --- |

—

Commission Directive 2003/80/EC of 5 September 2003 (OJ L 224, 6.9.2003, p. 27);

| — | Commission Directive 2003/83/EC of 24 September 2003 (OJ L 238, 25.9.2003, p. 23); |
| --- | --- |

—

Commission Directive 2003/83/EC of 24 September 2003 (OJ L 238, 25.9.2003, p. 23);

| — | Commission Directive 2004/87/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 4); |
| --- | --- |

—

Commission Directive 2004/87/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 4);

| — | Commission Directive 2004/88/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 5); |
| --- | --- |

—

Commission Directive 2004/88/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 5);

| — | Commission Directive 2004/94/EC of 15 September 2004 (OJ L 294, 17.9.2004, p. 28); |
| --- | --- |

—

Commission Directive 2004/94/EC of 15 September 2004 (OJ L 294, 17.9.2004, p. 28);

| — | Commission Directive 2004/93/EC of 21 September 2004 (OJ L 300, 25.9.2004, p. 13); |
| --- | --- |

—

Commission Directive 2004/93/EC of 21 September 2004 (OJ L 300, 25.9.2004, p. 13);

| — | Commission Directive 2005/9/EC of 28 January 2005 (OJ L 27, 29.1.2005, p. 46); |
| --- | --- |

—

Commission Directive 2005/9/EC of 28 January 2005 (OJ L 27, 29.1.2005, p. 46);

| — | Commission Directive 2005/42/EC of 20 June 2005 (OJ L 158, 21.6.2005, p. 17); |
| --- | --- |

—

Commission Directive 2005/42/EC of 20 June 2005 (OJ L 158, 21.6.2005, p. 17);

| — | Commission Directive 2005/52/EC of 9 September 2005 (OJ L 234, 10.9.2005, p. 9); |
| --- | --- |

—

Commission Directive 2005/52/EC of 9 September 2005 (OJ L 234, 10.9.2005, p. 9);

| — | Commission Directive 2005/80/EC of 21 November 2005 (OJ L 303, 22.11.2005, p. 32); |
| --- | --- |

—

Commission Directive 2005/80/EC of 21 November 2005 (OJ L 303, 22.11.2005, p. 32);

| — | Commission Directive 2006/65/EC of 19 July 2006 (OJ L 198, 20.7.2006, p. 11); |
| --- | --- |

—

Commission Directive 2006/65/EC of 19 July 2006 (OJ L 198, 20.7.2006, p. 11);

| — | Commission Directive 2006/78/EC of 29 September 2006 (OJ L 271, 30.9.2006, p. 56); |
| --- | --- |

—

Commission Directive 2006/78/EC of 29 September 2006 (OJ L 271, 30.9.2006, p. 56);

| — | Commission Directive 2007/1/EC of 29 January 2007 (OJ L 25, 1.2.2007, p. 9); |
| --- | --- |

—

Commission Directive 2007/1/EC of 29 January 2007 (OJ L 25, 1.2.2007, p. 9);

| — | Commission Directive 2007/17/EC of 22 March 2007 (OJ L 82, 23.3.2007, p. 27); |
| --- | --- |

—

Commission Directive 2007/17/EC of 22 March 2007 (OJ L 82, 23.3.2007, p. 27);

| — | Commission Directive 2007/22/EC of 17 April 2007 (OJ L 101, 18.4.2007, p. 11); |
| --- | --- |

—

Commission Directive 2007/22/EC of 17 April 2007 (OJ L 101, 18.4.2007, p. 11);

| — | Commission Directive 2007/53/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 19); |
| --- | --- |

—

Commission Directive 2007/53/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 19);

| — | Commission Directive 2007/54/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 21); |
| --- | --- |

—

Commission Directive 2007/54/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 21);

| — | Commission Directive 2007/67/EC of 22 November 2007 (OJ L 305, 23.11.2007, p. 22); |
| --- | --- |

—

Commission Directive 2007/67/EC of 22 November 2007 (OJ L 305, 23.11.2007, p. 22);

| — | Commission Directive 2008/14/EC of 15 February 2008 (OJ L 42, 16.2.2008, p. 43); |
| --- | --- |

—

Commission Directive 2008/14/EC of 15 February 2008 (OJ L 42, 16.2.2008, p. 43);

| — | Commission Directive 2008/42/EC of 3 April 2008 (OJ L 93, 4.4.2008, p. 13); |
| --- | --- |

—

Commission Directive 2008/42/EC of 3 April 2008 (OJ L 93, 4.4.2008, p. 13);

| — | Commission Directive 2008/88/EC of 23 September 2008 (OJ L 256, 24.9.2008, p. 12); |
| --- | --- |

—

Commission Directive 2008/88/EC of 23 September 2008 (OJ L 256, 24.9.2008, p. 12);

| — | Commission Directive 2008/123/EC of 18 December 2008 (OJ L 340, 19.12.2008, p. 71); |
| --- | --- |

—

Commission Directive 2008/123/EC of 18 December 2008 (OJ L 340, 19.12.2008, p. 71);

| — | Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008 (OJ L 345, 23.12.2008, p. 68); |
| --- | --- |

—

Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008 (OJ L 345, 23.12.2008, p. 68);

| — | Commission Directive 2009/6/EC of 4 February 2009 (OJ L 36, 5.2.2009, p. 15); |
| --- | --- |

—

Commission Directive 2009/6/EC of 4 February 2009 (OJ L 36, 5.2.2009, p. 15);

| — | Commission Directive 2009/36/EC of 16 April 2009 (OJ L 98, 17.4.2009, p. 31); |
| --- | --- |

—

Commission Directive 2009/36/EC of 16 April 2009 (OJ L 98, 17.4.2009, p. 31);

| — | Commission Directive 2009/129/EC of 9 October 2009 (OJ L 267, 10.10.2009, p. 18); |
| --- | --- |

—

Commission Directive 2009/129/EC of 9 October 2009 (OJ L 267, 10.10.2009, p. 18);

| — | Commission Directive 2009/130/EC of 12 October 2009 (OJ L 268, 13.10.2009, p. 5); |
| --- | --- |

—

Commission Directive 2009/130/EC of 12 October 2009 (OJ L 268, 13.10.2009, p. 5);

| — | Commission Directive 2009/134/EC of 28 October 2009 (OJ L 282, 29.10.2009, p. 15); |
| --- | --- |

—

Commission Directive 2009/134/EC of 28 October 2009 (OJ L 282, 29.10.2009, p. 15);

| — | Commission Directive 2009/159/EU of 16 December 2009 (OJ L 336, 18.12.2009, p. 29); |
| --- | --- |

—

Commission Directive 2009/159/EU of 16 December 2009 (OJ L 336, 18.12.2009, p. 29);

| — | Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 (OJ L 342, 22.12.2009, p. 59); |
| --- | --- |

—

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 (OJ L 342, 22.12.2009, p. 59);

| — | Commission Directive 2009/164/EU of 22 December 2009 (OJ L 344, 23.12.2009, p. 41); |
| --- | --- |

—

Commission Directive 2009/164/EU of 22 December 2009 (OJ L 344, 23.12.2009, p. 41);

| — | Commission Directive 2010/3/EU of 1 February 2010 (OJ L 29, 2.2.2010, p. 5); |
| --- | --- |

—

Commission Directive 2010/3/EU of 1 February 2010 (OJ L 29, 2.2.2010, p. 5);

| — | Commission Directive 2010/4/EU of 8 February 2010 (OJ L 36, 9.2.2010, p. 21); |
| --- | --- |

—

Commission Directive 2010/4/EU of 8 February 2010 (OJ L 36, 9.2.2010, p. 21);

| — | Commission Directive 2011/59/EU of 13 May 2011 (OJ L 125, 14.5.2011, p. 17); |
| --- | --- |

—

Commission Directive 2011/59/EU of 13 May 2011 (OJ L 125, 14.5.2011, p. 17);

| — | Council Directive 2011/84/EU of 20 September 2011 (OJ L 283, 29.10.2011, p. 36); and |
| --- | --- |

—

Council Directive 2011/84/EU of 20 September 2011 (OJ L 283, 29.10.2011, p. 36); and

| — | Commission Implementing Directive 2012/21/EU of 2 August 2012 (OJ L 208, 3.8.2012, p. 8). |
| --- | --- |

—

Commission Implementing Directive 2012/21/EU of 2 August 2012 (OJ L 208, 3.8.2012, p. 8).

Directive 76/768/EEC will be repealed with effect from 11 July 2013 and will be replaced by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

| 2. | Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), as amended by:






  — | Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 114, 25.4.2013, p. 1); and |
| --- | --- | --- |

2.

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), as amended by:

—

Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 114, 25.4.2013, p. 1); and

| — | Commission Regulation (EU) No 483/2013 of 24 May 2013 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 139, 25.5.2013, p. 8). |
| --- | --- |

—

Commission Regulation (EU) No 483/2013 of 24 May 2013 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 139, 25.5.2013, p. 8).

| 3. | Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 383, 31.12.1980, p. 27), as amended by Commission Directive 87/143/EEC of 10 February 1987 (OJ L 57, 27.2.1987, p. 56). |
| --- | --- |

3.

Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 383, 31.12.1980, p. 27), as amended by Commission Directive 87/143/EEC of 10 February 1987 (OJ L 57, 27.2.1987, p. 56).

| 4. | Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 185, 30.6.1982, p. 1), as amended by Commission Directive 90/207/EEC of 4 April 1990 (OJ L 108, 28.4.1990, p. 92). |
| --- | --- |

4.

Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 185, 30.6.1982, p. 1), as amended by Commission Directive 90/207/EEC of 4 April 1990 (OJ L 108, 28.4.1990, p. 92).

| 5. | Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 291, 24.10.1983, p. 9). |
| --- | --- |

5.

Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 291, 24.10.1983, p. 9).

| 6. | Commission Directive 85/490/EEC of 11 October 1985 on the approximation of laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 295, 7.11.1985, p. 30). |
| --- | --- |

6.

Commission Directive 85/490/EEC of 11 October 1985 on the approximation of laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 295, 7.11.1985, p. 30).

| 7. | Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking the composition of cosmetic products (OJ L 231, 14.9.1993, p. 34). |
| --- | --- |

7.

Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking the composition of cosmetic products (OJ L 231, 14.9.1993, p. 34).

| 8. | Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products (OJ L 140, 23.6.1995, p. 26), as amended by:






  — | Commission Directive 2006/81/EC of 23 October 2006 (OJ L 362, 20.12.2006, p. 92); and |
| --- | --- | --- |

8.

Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products (OJ L 140, 23.6.1995, p. 26), as amended by:

—

Commission Directive 2006/81/EC of 23 October 2006 (OJ L 362, 20.12.2006, p. 92); and

| — | Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (OJ L 236, 23.9.2003, p. 33). |
| --- | --- |

—

Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (OJ L 236, 23.9.2003, p. 33).

Commission Directive 95/17/EC will be repealed with effect from 11 July 2013.

| 9. | Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 178, 28.7.1995, p. 20). |
| --- | --- |

9.

Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 178, 28.7.1995, p. 20).

| 10. | Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 213, 22.8.1996, p. 8). |
| --- | --- |

10.

Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 213, 22.8.1996, p. 8).

| 11. | Commission Decision of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products (OJ L 132, 1.6.1996, p. 1) as amended by Commission Decision 2006/257/EC (OJ L 97, 5.4.2006, p. 1). |
| --- | --- |

11.

Commission Decision of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products (OJ L 132, 1.6.1996, p. 1) as amended by Commission Decision 2006/257/EC (OJ L 97, 5.4.2006, p. 1).

III.   MEDICAL DEVICES

ACTS REFERRED TO

| 1. | Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17), as amended by:






  — | Council Directive 93/42/EEC of 14 June 1993 (OJ L 169, 12.7.1993, p. 1); |
| --- | --- | --- |

1.

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17), as amended by:

—

Council Directive 93/42/EEC of 14 June 1993 (OJ L 169, 12.7.1993, p. 1);

| — | Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1); |
| --- | --- |

—

Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1);

| — | Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1); and |
| --- | --- |

—

Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1); and

| — | Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ L 247, 21.9.2007, p. 21). |
| --- | --- |

—

Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ L 247, 21.9.2007, p. 21).

| 2. | Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1), as amended by:






  — | Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1); |
| --- | --- | --- |

2.

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1), as amended by:

—

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1);

| — | Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma (OJ L 313, 13.12.2000, p. 22); |
| --- | --- |

—

Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma (OJ L 313, 13.12.2000, p. 22);

| — | Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (OJ L 6, 10.1.2002, p. 50); |
| --- | --- |

—

Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (OJ L 6, 10.1.2002, p. 50);

| — | Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1); and |
| --- | --- |

—

Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1); and

| — | Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ L 247, 21.9.2007, p. 21). |
| --- | --- |

—

Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ L 247, 21.9.2007, p. 21).

| 3. | Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), as amended by:






  — | Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1); |
| --- | --- | --- |

3.

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), as amended by:

—

Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1);

| — | Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14); and |
| --- | --- |

—

Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14); and

| — | Commission Directive 2011/100/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 50). |
| --- | --- |

—

Commission Directive 2011/100/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 50).

| 4. | Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices (OJ L 131, 16.5.2002, p. 17), as amended by:






  — | Commission Decision 2009/108/EC of 3 February 2009 (OJ L 39, 10.2.2009, p. 34); |
| --- | --- | --- |

4.

Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices (OJ L 131, 16.5.2002, p. 17), as amended by:

—

Commission Decision 2009/108/EC of 3 February 2009 (OJ L 39, 10.2.2009, p. 34);

| — | Commission Decision 2009/886/EC of 27 November 2009 (OJ L 318, 4.12.2009, p. 25); and |
| --- | --- |

—

Commission Decision 2009/886/EC of 27 November 2009 (OJ L 318, 4.12.2009, p. 25); and

| — | Commission Decision 2011/869/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 63). |
| --- | --- |

—

Commission Decision 2011/869/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 63).

| 5. | Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p. 43). |
| --- | --- |

5.

Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p. 43).

| 6. | Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18). |
| --- | --- |

6.

Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).

| 7. | Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p. 41). |
| --- | --- |

7.

Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p. 41).

| 8. | Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p. 45). |
| --- | --- |

8.

Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p. 45).

| 9. | Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p. 28). |
| --- | --- |

9.

Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p. 28).

| 10. | Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).’ |
| --- | --- |

10.

Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).’

---