# Official Journal L 102/2010

| | ISSN 1725-2555
  doi:10.3000/17252555.L_2010.102.eng |
| --- | --- |
| Official Journal
  of the European Union | L 102 |
| | |
| English edition | Legislation | Volume 5323 April 2010 |

ISSN 1725-2555

doi:10.3000/17252555.L_2010.102.eng

Official Journal

of the European Union

L 102

English edition

Legislation

Volume 5323 April 2010

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Regulation (EU) No 330/2010 of 20 April 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of vertical agreements and concerted practices (
  1
  ) | 1 |
| | * | Commission Regulation (EU) No 331/2010 of 22 April 2010 amending Regulation (EC) No 1580/2007 as regards the trigger levels for additional duties on cucumbers and cherries, other than sour cherries | 8 |
| | * | Commission Regulation (EU) No 332/2010 of 22 April 2010 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for Israel in the list of third countries, territories, zones or compartments (
  1
  ) | 10 |
| | * | Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Calpis Co. Ltd. Japan, represented in the European Union by Calpis Co. Ltd. Europe Representative Office) (
  1
  ) | 19 |
| | * | Commission Regulation (EU) No 334/2010 of 22 April 2010 amending Regulation (EC) No 721/2008 as regards the composition of feed additives (
  1
  ) | 21 |
| | * | Commission Regulation (EU) No 335/2010 of 22 April 2010 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species (
  1
  ) | 22 |
| | * | Commission Regulation (EU) No 336/2010 of 21 April 2010 concerning the classification of certain goods in the Combined Nomenclature | 25 |
| | | Commission Regulation (EU) No 337/2010 of 22 April 2010 establishing the standard import values for determining the entry price of certain fruit and vegetables | 27 |
| | | Commission Regulation (EU) No 338/2010 of 22 April 2010 fixing the export refunds on beef and veal | 29 |
| | | Commission Regulation (EU) No 339/2010 of 22 April 2010 granting no export refund for butter in the framework of the standing invitation to tender provided for in Regulation (EC) No 619/2008 | 33 |
| | | Commission Regulation (EU) No 340/2010 of 22 April 2010 granting no export refund for skimmed milk powder in the framework of the standing invitation to tender provided for in Regulation (EC) No 619/2008 | 34 |
| | | Commission Regulation (EU) No 341/2010 of 22 April 2010 fixing the export refunds on eggs | 35 |
| | | Commission Regulation (EU) No 342/2010 of 22 April 2010 fixing the export refunds on poultrymeat | 37 |
| | | Commission Regulation (EU) No 343/2010 of 22 April 2010 fixing the export refunds on pigmeat | 39 |
| | | Commission Regulation (EU) No 344/2010 of 22 April 2010 fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95 | 41 |
| | | Commission Regulation (EU) No 345/2010 of 22 April 2010 fixing the rates of the refunds applicable to eggs and egg yolks exported in the form of goods not covered by Annex I to the Treaty | 43 |
| | | DECISIONS |
| | | 2010/227/EU |
| | * | Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed)
  (notified under document C(2010) 2363)

   (
  1
  ) | 45 |
| | | 2010/228/EU |
| | * | Commission Decision of 21 April 2010 authorising the placing on the market of puree and concentrate of the fruits of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document C(2010) 2397) | 49 |
| | | 2010/229/EU |
| | * | Commission Decision of 22 April 2010 concerning the draft Decree from Italy setting out standards governing the labelling of shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk, as well as milk products
  (notified under document C(2010) 2436)

   (
  1
  ) | 52 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Regulation (EU) No 330/2010 of 20 April 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of vertical agreements and concerted practices (
  1
  )

1

1

*

Commission Regulation (EU) No 331/2010 of 22 April 2010 amending Regulation (EC) No 1580/2007 as regards the trigger levels for additional duties on cucumbers and cherries, other than sour cherries

8

*

Commission Regulation (EU) No 332/2010 of 22 April 2010 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for Israel in the list of third countries, territories, zones or compartments (
  1
  )

1

10

*

Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Calpis Co. Ltd. Japan, represented in the European Union by Calpis Co. Ltd. Europe Representative Office) (
  1
  )

Bacillus subtilis

1

19

*

Commission Regulation (EU) No 334/2010 of 22 April 2010 amending Regulation (EC) No 721/2008 as regards the composition of feed additives (
  1
  )

1

21

*

Commission Regulation (EU) No 335/2010 of 22 April 2010 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species (
  1
  )

1

22

*

Commission Regulation (EU) No 336/2010 of 21 April 2010 concerning the classification of certain goods in the Combined Nomenclature

25

Commission Regulation (EU) No 337/2010 of 22 April 2010 establishing the standard import values for determining the entry price of certain fruit and vegetables

27

Commission Regulation (EU) No 338/2010 of 22 April 2010 fixing the export refunds on beef and veal

29

Commission Regulation (EU) No 339/2010 of 22 April 2010 granting no export refund for butter in the framework of the standing invitation to tender provided for in Regulation (EC) No 619/2008

33

Commission Regulation (EU) No 340/2010 of 22 April 2010 granting no export refund for skimmed milk powder in the framework of the standing invitation to tender provided for in Regulation (EC) No 619/2008

34

Commission Regulation (EU) No 341/2010 of 22 April 2010 fixing the export refunds on eggs

35

Commission Regulation (EU) No 342/2010 of 22 April 2010 fixing the export refunds on poultrymeat

37

Commission Regulation (EU) No 343/2010 of 22 April 2010 fixing the export refunds on pigmeat

39

Commission Regulation (EU) No 344/2010 of 22 April 2010 fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95

41

Commission Regulation (EU) No 345/2010 of 22 April 2010 fixing the rates of the refunds applicable to eggs and egg yolks exported in the form of goods not covered by Annex I to the Treaty

43

DECISIONS

2010/227/EU

*

Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed)
  (notified under document C(2010) 2363)

   (
  1
  )

(notified under document C(2010) 2363)

1

45

2010/228/EU

*

Commission Decision of 21 April 2010 authorising the placing on the market of puree and concentrate of the fruits of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document C(2010) 2397)

Morinda citrifolia

(notified under document C(2010) 2397)

49

2010/229/EU

*

Commission Decision of 22 April 2010 concerning the draft Decree from Italy setting out standards governing the labelling of shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk, as well as milk products
  (notified under document C(2010) 2436)

   (
  1
  )

(notified under document C(2010) 2436)

1

52

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

---

(1)   Text with EEA relevance

1

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

EN

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

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

---

II Non-legislative acts

REGULATIONS

| 23.4.2010 | EN | Official Journal of the European Union | L 102/1 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/1

---

COMMISSION REGULATION (EU) No 330/2010

of 20 April 2010

on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of vertical agreements and concerted practices

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation No 19/65/EEC of the Council of 2 March 1965 on the application of Article 85(3) of the Treaty to certain categories of agreements and concerted practices (1), and in particular Article 1 thereof,

Having published a draft of this Regulation,

After consulting the Advisory Committee on Restrictive Practices and Dominant Positions,

Whereas:

| (1) | Regulation No 19/65/EEC empowers the Commission to apply Article 101(3) of the Treaty on the Functioning of the European Union (*1) by regulation to certain categories of vertical agreements and corresponding concerted practices falling within Article 101(1) of the Treaty. |
| --- | --- |

(1)

Regulation No 19/65/EEC empowers the Commission to apply Article 101(3) of the Treaty on the Functioning of the European Union (*1) by regulation to certain categories of vertical agreements and corresponding concerted practices falling within Article 101(1) of the Treaty.

| (2) | Commission Regulation (EC) No 2790/1999 of 22 December 1999 on the application of Article 81(3) of the Treaty to categories of vertical agreements and concerted practices (2) defines a category of vertical agreements which the Commission regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty. In view of the overall positive experience with the application of that Regulation, which expires on 31 May 2010, and taking into account further experience acquired since its adoption, it is appropriate to adopt a new block exemption regulation. |
| --- | --- |

(2)

Commission Regulation (EC) No 2790/1999 of 22 December 1999 on the application of Article 81(3) of the Treaty to categories of vertical agreements and concerted practices (2) defines a category of vertical agreements which the Commission regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty. In view of the overall positive experience with the application of that Regulation, which expires on 31 May 2010, and taking into account further experience acquired since its adoption, it is appropriate to adopt a new block exemption regulation.

| (3) | The category of agreements which can be regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty includes vertical agreements for the purchase or sale of goods or services where those agreements are concluded between non-competing undertakings, between certain competitors or by certain associations of retailers of goods. It also includes vertical agreements containing ancillary provisions on the assignment or use of intellectual property rights. The term ‘vertical agreements’ should include the corresponding concerted practices. |
| --- | --- |

(3)

The category of agreements which can be regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty includes vertical agreements for the purchase or sale of goods or services where those agreements are concluded between non-competing undertakings, between certain competitors or by certain associations of retailers of goods. It also includes vertical agreements containing ancillary provisions on the assignment or use of intellectual property rights. The term ‘vertical agreements’ should include the corresponding concerted practices.

| (4) | For the application of Article 101(3) of the Treaty by regulation, it is not necessary to define those vertical agreements which are capable of falling within Article 101(1) of the Treaty. In the individual assessment of agreements under Article 101(1) of the Treaty, account has to be taken of several factors, and in particular the market structure on the supply and purchase side. |
| --- | --- |

(4)

For the application of Article 101(3) of the Treaty by regulation, it is not necessary to define those vertical agreements which are capable of falling within Article 101(1) of the Treaty. In the individual assessment of agreements under Article 101(1) of the Treaty, account has to be taken of several factors, and in particular the market structure on the supply and purchase side.

| (5) | The benefit of the block exemption established by this Regulation should be limited to vertical agreements for which it can be assumed with sufficient certainty that they satisfy the conditions of Article 101(3) of the Treaty. |
| --- | --- |

(5)

The benefit of the block exemption established by this Regulation should be limited to vertical agreements for which it can be assumed with sufficient certainty that they satisfy the conditions of Article 101(3) of the Treaty.

| (6) | Certain types of vertical agreements can improve economic efficiency within a chain of production or distribution by facilitating better coordination between the participating undertakings. In particular, they can lead to a reduction in the transaction and distribution costs of the parties and to an optimisation of their sales and investment levels. |
| --- | --- |

(6)

Certain types of vertical agreements can improve economic efficiency within a chain of production or distribution by facilitating better coordination between the participating undertakings. In particular, they can lead to a reduction in the transaction and distribution costs of the parties and to an optimisation of their sales and investment levels.

| (7) | The likelihood that such efficiency-enhancing effects will outweigh any anti-competitive effects due to restrictions contained in vertical agreements depends on the degree of market power of the parties to the agreement and, therefore, on the extent to which those undertakings face competition from other suppliers of goods or services regarded by their customers as interchangeable or substitutable for one another, by reason of the products' characteristics, their prices and their intended use. |
| --- | --- |

(7)

The likelihood that such efficiency-enhancing effects will outweigh any anti-competitive effects due to restrictions contained in vertical agreements depends on the degree of market power of the parties to the agreement and, therefore, on the extent to which those undertakings face competition from other suppliers of goods or services regarded by their customers as interchangeable or substitutable for one another, by reason of the products' characteristics, their prices and their intended use.

| (8) | It can be presumed that, where the market share held by each of the undertakings party to the agreement on the relevant market does not exceed 30 %, vertical agreements which do not contain certain types of severe restrictions of competition generally lead to an improvement in production or distribution and allow consumers a fair share of the resulting benefits. |
| --- | --- |

(8)

It can be presumed that, where the market share held by each of the undertakings party to the agreement on the relevant market does not exceed 30 %, vertical agreements which do not contain certain types of severe restrictions of competition generally lead to an improvement in production or distribution and allow consumers a fair share of the resulting benefits.

| (9) | Above the market share threshold of 30 %, there can be no presumption that vertical agreements falling within the scope of Article 101(1) of the Treaty will usually give rise to objective advantages of such a character and size as to compensate for the disadvantages which they create for competition. At the same time, there is no presumption that those vertical agreements are either caught by Article 101(1) of the Treaty or that they fail to satisfy the conditions of Article 101(3) of the Treaty. |
| --- | --- |

(9)

Above the market share threshold of 30 %, there can be no presumption that vertical agreements falling within the scope of Article 101(1) of the Treaty will usually give rise to objective advantages of such a character and size as to compensate for the disadvantages which they create for competition. At the same time, there is no presumption that those vertical agreements are either caught by Article 101(1) of the Treaty or that they fail to satisfy the conditions of Article 101(3) of the Treaty.

| (10) | This Regulation should not exempt vertical agreements containing restrictions which are likely to restrict competition and harm consumers or which are not indispensable to the attainment of the efficiency-enhancing effects. In particular, vertical agreements containing certain types of severe restrictions of competition such as minimum and fixed resale-prices, as well as certain types of territorial protection, should be excluded from the benefit of the block exemption established by this Regulation irrespective of the market share of the undertakings concerned. |
| --- | --- |

(10)

This Regulation should not exempt vertical agreements containing restrictions which are likely to restrict competition and harm consumers or which are not indispensable to the attainment of the efficiency-enhancing effects. In particular, vertical agreements containing certain types of severe restrictions of competition such as minimum and fixed resale-prices, as well as certain types of territorial protection, should be excluded from the benefit of the block exemption established by this Regulation irrespective of the market share of the undertakings concerned.

| (11) | In order to ensure access to or to prevent collusion on the relevant market, certain conditions should be attached to the block exemption. To this end, the exemption of non-compete obligations should be limited to obligations which do not exceed a defined duration. For the same reasons, any direct or indirect obligation causing the members of a selective distribution system not to sell the brands of particular competing suppliers should be excluded from the benefit of this Regulation. |
| --- | --- |

(11)

In order to ensure access to or to prevent collusion on the relevant market, certain conditions should be attached to the block exemption. To this end, the exemption of non-compete obligations should be limited to obligations which do not exceed a defined duration. For the same reasons, any direct or indirect obligation causing the members of a selective distribution system not to sell the brands of particular competing suppliers should be excluded from the benefit of this Regulation.

| (12) | The market-share limitation, the non-exemption of certain vertical agreements and the conditions provided for in this Regulation normally ensure that the agreements to which the block exemption applies do not enable the participating undertakings to eliminate competition in respect of a substantial part of the products in question. |
| --- | --- |

(12)

The market-share limitation, the non-exemption of certain vertical agreements and the conditions provided for in this Regulation normally ensure that the agreements to which the block exemption applies do not enable the participating undertakings to eliminate competition in respect of a substantial part of the products in question.

| (13) | The Commission may withdraw the benefit of this Regulation, pursuant to Article 29(1) of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (3), where it finds in a particular case that an agreement to which the exemption provided for in this Regulation applies nevertheless has effects which are incompatible with Article 101(3) of the Treaty. |
| --- | --- |

(13)

The Commission may withdraw the benefit of this Regulation, pursuant to Article 29(1) of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (3), where it finds in a particular case that an agreement to which the exemption provided for in this Regulation applies nevertheless has effects which are incompatible with Article 101(3) of the Treaty.

| (14) | The competition authority of a Member State may withdraw the benefit of this Regulation pursuant to Article 29(2) of Regulation (EC) No 1/2003 in respect of the territory of that Member State, or a part thereof where, in a particular case, an agreement to which the exemption provided for in this Regulation applies nevertheless has effects which are incompatible with Article 101(3) of the Treaty in the territory of that Member State, or in a part thereof, and where such territory has all the characteristics of a distinct geographic market. |
| --- | --- |

(14)

The competition authority of a Member State may withdraw the benefit of this Regulation pursuant to Article 29(2) of Regulation (EC) No 1/2003 in respect of the territory of that Member State, or a part thereof where, in a particular case, an agreement to which the exemption provided for in this Regulation applies nevertheless has effects which are incompatible with Article 101(3) of the Treaty in the territory of that Member State, or in a part thereof, and where such territory has all the characteristics of a distinct geographic market.

| (15) | In determining whether the benefit of this Regulation should be withdrawn pursuant to Article 29 of Regulation (EC) No 1/2003, the anti-competitive effects that may derive from the existence of parallel networks of vertical agreements that have similar effects which significantly restrict access to a relevant market or competition therein are of particular importance. Such cumulative effects may for example arise in the case of selective distribution or non compete obligations. |
| --- | --- |

(15)

In determining whether the benefit of this Regulation should be withdrawn pursuant to Article 29 of Regulation (EC) No 1/2003, the anti-competitive effects that may derive from the existence of parallel networks of vertical agreements that have similar effects which significantly restrict access to a relevant market or competition therein are of particular importance. Such cumulative effects may for example arise in the case of selective distribution or non compete obligations.

| (16) | In order to strengthen supervision of parallel networks of vertical agreements which have similar anti-competitive effects and which cover more than 50 % of a given market, the Commission may by regulation declare this Regulation inapplicable to vertical agreements containing specific restraints relating to the market concerned, thereby restoring the full application of Article 101 of the Treaty to such agreements, |
| --- | --- |

(16)

In order to strengthen supervision of parallel networks of vertical agreements which have similar anti-competitive effects and which cover more than 50 % of a given market, the Commission may by regulation declare this Regulation inapplicable to vertical agreements containing specific restraints relating to the market concerned, thereby restoring the full application of Article 101 of the Treaty to such agreements,

HAS ADOPTED THIS REGULATION:

Article 1

Definitions

1.   For the purposes of this Regulation, the following definitions shall apply:

| (a) | ‘vertical agreement’ means an agreement or concerted practice entered into between two or more undertakings each of which operates, for the purposes of the agreement or the concerted practice, at a different level of the production or distribution chain, and relating to the conditions under which the parties may purchase, sell or resell certain goods or services; |
| --- | --- |

(a)

‘vertical agreement’ means an agreement or concerted practice entered into between two or more undertakings each of which operates, for the purposes of the agreement or the concerted practice, at a different level of the production or distribution chain, and relating to the conditions under which the parties may purchase, sell or resell certain goods or services;

| (b) | ‘vertical restraint’ means a restriction of competition in a vertical agreement falling within the scope of Article 101(1) of the Treaty; |
| --- | --- |

(b)

‘vertical restraint’ means a restriction of competition in a vertical agreement falling within the scope of Article 101(1) of the Treaty;

| (c) | ‘competing undertaking’ means an actual or potential competitor; ‘actual competitor’ means an undertaking that is active on the same relevant market; ‘potential competitor’ means an undertaking that, in the absence of the vertical agreement, would, on realistic grounds and not just as a mere theoretical possibility, in case of a small but permanent increase in relative prices be likely to undertake, within a short period of time, the necessary additional investments or other necessary switching costs to enter the relevant market; |
| --- | --- |

(c)

‘competing undertaking’ means an actual or potential competitor; ‘actual competitor’ means an undertaking that is active on the same relevant market; ‘potential competitor’ means an undertaking that, in the absence of the vertical agreement, would, on realistic grounds and not just as a mere theoretical possibility, in case of a small but permanent increase in relative prices be likely to undertake, within a short period of time, the necessary additional investments or other necessary switching costs to enter the relevant market;

| (d) | ‘non-compete obligation’ means any direct or indirect obligation causing the buyer not to manufacture, purchase, sell or resell goods or services which compete with the contract goods or services, or any direct or indirect obligation on the buyer to purchase from the supplier or from another undertaking designated by the supplier more than 80 % of the buyer's total purchases of the contract goods or services and their substitutes on the relevant market, calculated on the basis of the value or, where such is standard industry practice, the volume of its purchases in the preceding calendar year; |
| --- | --- |

(d)

‘non-compete obligation’ means any direct or indirect obligation causing the buyer not to manufacture, purchase, sell or resell goods or services which compete with the contract goods or services, or any direct or indirect obligation on the buyer to purchase from the supplier or from another undertaking designated by the supplier more than 80 % of the buyer's total purchases of the contract goods or services and their substitutes on the relevant market, calculated on the basis of the value or, where such is standard industry practice, the volume of its purchases in the preceding calendar year;

| (e) | ‘selective distribution system’ means a distribution system where the supplier undertakes to sell the contract goods or services, either directly or indirectly, only to distributors selected on the basis of specified criteria and where these distributors undertake not to sell such goods or services to unauthorised distributors within the territory reserved by the supplier to operate that system; |
| --- | --- |

(e)

‘selective distribution system’ means a distribution system where the supplier undertakes to sell the contract goods or services, either directly or indirectly, only to distributors selected on the basis of specified criteria and where these distributors undertake not to sell such goods or services to unauthorised distributors within the territory reserved by the supplier to operate that system;

| (f) | ‘intellectual property rights’ includes industrial property rights, know how, copyright and neighbouring rights; |
| --- | --- |

(f)

‘intellectual property rights’ includes industrial property rights, know how, copyright and neighbouring rights;

| (g) | ‘know-how’ means a package of non-patented practical information, resulting from experience and testing by the supplier, which is secret, substantial and identified: in this context, ‘secret’ means that the know-how is not generally known or easily accessible; ‘substantial’ means that the know-how is significant and useful to the buyer for the use, sale or resale of the contract goods or services; ‘identified’ means that the know-how is described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality; |
| --- | --- |

(g)

‘know-how’ means a package of non-patented practical information, resulting from experience and testing by the supplier, which is secret, substantial and identified: in this context, ‘secret’ means that the know-how is not generally known or easily accessible; ‘substantial’ means that the know-how is significant and useful to the buyer for the use, sale or resale of the contract goods or services; ‘identified’ means that the know-how is described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality;

| (h) | ‘buyer’ includes an undertaking which, under an agreement falling within Article 101(1) of the Treaty, sells goods or services on behalf of another undertaking; |
| --- | --- |

(h)

‘buyer’ includes an undertaking which, under an agreement falling within Article 101(1) of the Treaty, sells goods or services on behalf of another undertaking;

| (i) | ‘customer of the buyer’ means an undertaking not party to the agreement which purchases the contract goods or services from a buyer which is party to the agreement. |
| --- | --- |

(i)

‘customer of the buyer’ means an undertaking not party to the agreement which purchases the contract goods or services from a buyer which is party to the agreement.

2.   For the purposes of this Regulation, the terms ‘undertaking’, ‘supplier’ and ‘buyer’ shall include their respective connected undertakings.

‘Connected undertakings’ means:

| (a) | undertakings in which a party to the agreement, directly or indirectly:






  (i) | has the power to exercise more than half the voting rights, or |
| --- | --- | --- |

(a)

undertakings in which a party to the agreement, directly or indirectly:

(i)

has the power to exercise more than half the voting rights, or

| (ii) | has the power to appoint more than half the members of the supervisory board, board of management or bodies legally representing the undertaking, or |
| --- | --- |

(ii)

has the power to appoint more than half the members of the supervisory board, board of management or bodies legally representing the undertaking, or

| (iii) | has the right to manage the undertaking's affairs; |
| --- | --- |

(iii)

has the right to manage the undertaking's affairs;

| (b) | undertakings which directly or indirectly have, over a party to the agreement, the rights or powers listed in point (a); |
| --- | --- |

(b)

undertakings which directly or indirectly have, over a party to the agreement, the rights or powers listed in point (a);

| (c) | undertakings in which an undertaking referred to in point (b) has, directly or indirectly, the rights or powers listed in point (a); |
| --- | --- |

(c)

undertakings in which an undertaking referred to in point (b) has, directly or indirectly, the rights or powers listed in point (a);

| (d) | undertakings in which a party to the agreement together with one or more of the undertakings referred to in points (a), (b) or (c), or in which two or more of the latter undertakings, jointly have the rights or powers listed in point (a); |
| --- | --- |

(d)

undertakings in which a party to the agreement together with one or more of the undertakings referred to in points (a), (b) or (c), or in which two or more of the latter undertakings, jointly have the rights or powers listed in point (a);

| (e) | undertakings in which the rights or the powers listed in point (a) are jointly held by:






  (i) | parties to the agreement or their respective connected undertakings referred to in points (a) to (d), or |
| --- | --- | --- |

(e)

undertakings in which the rights or the powers listed in point (a) are jointly held by:

(i)

parties to the agreement or their respective connected undertakings referred to in points (a) to (d), or

| (ii) | one or more of the parties to the agreement or one or more of their connected undertakings referred to in points (a) to (d) and one or more third parties. |
| --- | --- |

(ii)

one or more of the parties to the agreement or one or more of their connected undertakings referred to in points (a) to (d) and one or more third parties.

Article 2

Exemption

1.   Pursuant to Article 101(3) of the Treaty and subject to the provisions of this Regulation, it is hereby declared that Article 101(1) of the Treaty shall not apply to vertical agreements.

This exemption shall apply to the extent that such agreements contain vertical restraints.

2.   The exemption provided for in paragraph 1 shall apply to vertical agreements entered into between an association of undertakings and its members, or between such an association and its suppliers, only if all its members are retailers of goods and if no individual member of the association, together with its connected undertakings, has a total annual turnover exceeding EUR 50 million. Vertical agreements entered into by such associations shall be covered by this Regulation without prejudice to the application of Article 101 of the Treaty to horizontal agreements concluded between the members of the association or decisions adopted by the association.

3.   The exemption provided for in paragraph 1 shall apply to vertical agreements containing provisions which relate to the assignment to the buyer or use by the buyer of intellectual property rights, provided that those provisions do not constitute the primary object of such agreements and are directly related to the use, sale or resale of goods or services by the buyer or its customers. The exemption applies on condition that, in relation to the contract goods or services, those provisions do not contain restrictions of competition having the same object as vertical restraints which are not exempted under this Regulation.

4.   The exemption provided for in paragraph 1 shall not apply to vertical agreements entered into between competing undertakings. However, it shall apply where competing undertakings enter into a non-reciprocal vertical agreement and:

| (a) | the supplier is a manufacturer and a distributor of goods, while the buyer is a distributor and not a competing undertaking at the manufacturing level; or |
| --- | --- |

(a)

the supplier is a manufacturer and a distributor of goods, while the buyer is a distributor and not a competing undertaking at the manufacturing level; or

| (b) | the supplier is a provider of services at several levels of trade, while the buyer provides its goods or services at the retail level and is not a competing undertaking at the level of trade where it purchases the contract services. |
| --- | --- |

(b)

the supplier is a provider of services at several levels of trade, while the buyer provides its goods or services at the retail level and is not a competing undertaking at the level of trade where it purchases the contract services.

5.   This Regulation shall not apply to vertical agreements the subject matter of which falls within the scope of any other block exemption regulation, unless otherwise provided for in such a regulation.

Article 3

Market share threshold

1.   The exemption provided for in Article 2 shall apply on condition that the market share held by the supplier does not exceed 30 % of the relevant market on which it sells the contract goods or services and the market share held by the buyer does not exceed 30 % of the relevant market on which it purchases the contract goods or services.

2.   For the purposes of paragraph 1, where in a multi party agreement an undertaking buys the contract goods or services from one undertaking party to the agreement and sells the contract goods or services to another undertaking party to the agreement, the market share of the first undertaking must respect the market share threshold provided for in that paragraph both as a buyer and a supplier in order for the exemption provided for in Article 2 to apply.

Article 4

Restrictions that remove the benefit of the block exemption — hardcore restrictions

The exemption provided for in Article 2 shall not apply to vertical agreements which, directly or indirectly, in isolation or in combination with other factors under the control of the parties, have as their object:

| (a) | the restriction of the buyer's ability to determine its sale price, without prejudice to the possibility of the supplier to impose a maximum sale price or recommend a sale price, provided that they do not amount to a fixed or minimum sale price as a result of pressure from, or incentives offered by, any of the parties; |
| --- | --- |

(a)

the restriction of the buyer's ability to determine its sale price, without prejudice to the possibility of the supplier to impose a maximum sale price or recommend a sale price, provided that they do not amount to a fixed or minimum sale price as a result of pressure from, or incentives offered by, any of the parties;

| (b) | the restriction of the territory into which, or of the customers to whom, a buyer party to the agreement, without prejudice to a restriction on its place of establishment, may sell the contract goods or services, except:






  (i) | the restriction of active sales into the exclusive territory or to an exclusive customer group reserved to the supplier or allocated by the supplier to another buyer, where such a restriction does not limit sales by the customers of the buyer, |
| --- | --- | --- |

(b)

the restriction of the territory into which, or of the customers to whom, a buyer party to the agreement, without prejudice to a restriction on its place of establishment, may sell the contract goods or services, except:

(i)

the restriction of active sales into the exclusive territory or to an exclusive customer group reserved to the supplier or allocated by the supplier to another buyer, where such a restriction does not limit sales by the customers of the buyer,

| (ii) | the restriction of sales to end users by a buyer operating at the wholesale level of trade, |
| --- | --- |

(ii)

the restriction of sales to end users by a buyer operating at the wholesale level of trade,

| (iii) | the restriction of sales by the members of a selective distribution system to unauthorised distributors within the territory reserved by the supplier to operate that system, and |
| --- | --- |

(iii)

the restriction of sales by the members of a selective distribution system to unauthorised distributors within the territory reserved by the supplier to operate that system, and

| (iv) | the restriction of the buyer's ability to sell components, supplied for the purposes of incorporation, to customers who would use them to manufacture the same type of goods as those produced by the supplier; |
| --- | --- |

(iv)

the restriction of the buyer's ability to sell components, supplied for the purposes of incorporation, to customers who would use them to manufacture the same type of goods as those produced by the supplier;

| (c) | the restriction of active or passive sales to end users by members of a selective distribution system operating at the retail level of trade, without prejudice to the possibility of prohibiting a member of the system from operating out of an unauthorised place of establishment; |
| --- | --- |

(c)

the restriction of active or passive sales to end users by members of a selective distribution system operating at the retail level of trade, without prejudice to the possibility of prohibiting a member of the system from operating out of an unauthorised place of establishment;

| (d) | the restriction of cross-supplies between distributors within a selective distribution system, including between distributors operating at different level of trade; |
| --- | --- |

(d)

the restriction of cross-supplies between distributors within a selective distribution system, including between distributors operating at different level of trade;

| (e) | the restriction, agreed between a supplier of components and a buyer who incorporates those components, of the supplier’s ability to sell the components as spare parts to end-users or to repairers or other service providers not entrusted by the buyer with the repair or servicing of its goods. |
| --- | --- |

(e)

the restriction, agreed between a supplier of components and a buyer who incorporates those components, of the supplier’s ability to sell the components as spare parts to end-users or to repairers or other service providers not entrusted by the buyer with the repair or servicing of its goods.

Article 5

Excluded restrictions

1.   The exemption provided for in Article 2 shall not apply to the following obligations contained in vertical agreements:

| (a) | any direct or indirect non-compete obligation, the duration of which is indefinite or exceeds five years; |
| --- | --- |

(a)

any direct or indirect non-compete obligation, the duration of which is indefinite or exceeds five years;

| (b) | any direct or indirect obligation causing the buyer, after termination of the agreement, not to manufacture, purchase, sell or resell goods or services; |
| --- | --- |

(b)

any direct or indirect obligation causing the buyer, after termination of the agreement, not to manufacture, purchase, sell or resell goods or services;

| (c) | any direct or indirect obligation causing the members of a selective distribution system not to sell the brands of particular competing suppliers. |
| --- | --- |

(c)

any direct or indirect obligation causing the members of a selective distribution system not to sell the brands of particular competing suppliers.

For the purposes of point (a) of the first subparagraph, a non-compete obligation which is tacitly renewable beyond a period of five years shall be deemed to have been concluded for an indefinite duration.

2.   By way of derogation from paragraph 1(a), the time limitation of five years shall not apply where the contract goods or services are sold by the buyer from premises and land owned by the supplier or leased by the supplier from third parties not connected with the buyer, provided that the duration of the non-compete obligation does not exceed the period of occupancy of the premises and land by the buyer.

3.   By way of derogation from paragraph 1(b), the exemption provided for in Article 2 shall apply to any direct or indirect obligation causing the buyer, after termination of the agreement, not to manufacture, purchase, sell or resell goods or services where the following conditions are fulfilled:

| (a) | the obligation relates to goods or services which compete with the contract goods or services; |
| --- | --- |

(a)

the obligation relates to goods or services which compete with the contract goods or services;

| (b) | the obligation is limited to the premises and land from which the buyer has operated during the contract period; |
| --- | --- |

(b)

the obligation is limited to the premises and land from which the buyer has operated during the contract period;

| (c) | the obligation is indispensable to protect know-how transferred by the supplier to the buyer; |
| --- | --- |

(c)

the obligation is indispensable to protect know-how transferred by the supplier to the buyer;

| (d) | the duration of the obligation is limited to a period of one year after termination of the agreement. |
| --- | --- |

(d)

the duration of the obligation is limited to a period of one year after termination of the agreement.

Paragraph 1(b) is without prejudice to the possibility of imposing a restriction which is unlimited in time on the use and disclosure of know-how which has not entered the public domain.

Article 6

Non-application of this Regulation

Pursuant to Article 1a of Regulation No 19/65/EEC, the Commission may by regulation declare that, where parallel networks of similar vertical restraints cover more than 50 % of a relevant market, this Regulation shall not apply to vertical agreements containing specific restraints relating to that market.

Article 7

Application of the market share threshold

For the purposes of applying the market share thresholds provided for in Article 3 the following rules shall apply:

| (a) | the market share of the supplier shall be calculated on the basis of market sales value data and the market share of the buyer shall be calculated on the basis of market purchase value data. If market sales value or market purchase value data are not available, estimates based on other reliable market information, including market sales and purchase volumes, may be used to establish the market share of the undertaking concerned; |
| --- | --- |

(a)

the market share of the supplier shall be calculated on the basis of market sales value data and the market share of the buyer shall be calculated on the basis of market purchase value data. If market sales value or market purchase value data are not available, estimates based on other reliable market information, including market sales and purchase volumes, may be used to establish the market share of the undertaking concerned;

| (b) | the market shares shall be calculated on the basis of data relating to the preceding calendar year; |
| --- | --- |

(b)

the market shares shall be calculated on the basis of data relating to the preceding calendar year;

| (c) | the market share of the supplier shall include any goods or services supplied to vertically integrated distributors for the purposes of sale; |
| --- | --- |

(c)

the market share of the supplier shall include any goods or services supplied to vertically integrated distributors for the purposes of sale;

| (d) | if a market share is initially not more than 30 % but subsequently rises above that level without exceeding 35 %, the exemption provided for in Article 2 shall continue to apply for a period of two consecutive calendar years following the year in which the 30 % market share threshold was first exceeded; |
| --- | --- |

(d)

if a market share is initially not more than 30 % but subsequently rises above that level without exceeding 35 %, the exemption provided for in Article 2 shall continue to apply for a period of two consecutive calendar years following the year in which the 30 % market share threshold was first exceeded;

| (e) | if a market share is initially not more than 30 % but subsequently rises above 35 %, the exemption provided for in Article 2 shall continue to apply for one calendar year following the year in which the level of 35 % was first exceeded; |
| --- | --- |

(e)

if a market share is initially not more than 30 % but subsequently rises above 35 %, the exemption provided for in Article 2 shall continue to apply for one calendar year following the year in which the level of 35 % was first exceeded;

| (f) | the benefit of points (d) and (e) may not be combined so as to exceed a period of two calendar years; |
| --- | --- |

(f)

the benefit of points (d) and (e) may not be combined so as to exceed a period of two calendar years;

| (g) | the market share held by the undertakings referred to in point (e) of the second subparagraph of Article 1(2) shall be apportioned equally to each undertaking having the rights or the powers listed in point (a) of the second subparagraph of Article 1(2). |
| --- | --- |

(g)

the market share held by the undertakings referred to in point (e) of the second subparagraph of Article 1(2) shall be apportioned equally to each undertaking having the rights or the powers listed in point (a) of the second subparagraph of Article 1(2).

Article 8

Application of the turnover threshold

1.   For the purpose of calculating total annual turnover within the meaning of Article 2(2), the turnover achieved during the previous financial year by the relevant party to the vertical agreement and the turnover achieved by its connected undertakings in respect of all goods and services, excluding all taxes and other duties, shall be added together. For this purpose, no account shall be taken of dealings between the party to the vertical agreement and its connected undertakings or between its connected undertakings.

2.   The exemption provided for in Article 2 shall remain applicable where, for any period of two consecutive financial years, the total annual turnover threshold is exceeded by no more than 10 %.

Article 9

Transitional period

The prohibition laid down in Article 101(1) of the Treaty shall not apply during the period from 1 June 2010 to 31 May 2011 in respect of agreements already in force on 31 May 2010 which do not satisfy the conditions for exemption provided for in this Regulation but which, on 31 May 2010, satisfied the conditions for exemption provided for in Regulation (EC) No 2790/1999.

Article 10

Period of validity

This Regulation shall enter into force on 1 June 2010.

It shall expire on 31 May 2022.

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

Done at Brussels, 20 April 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ 36, 6.3.1965, p. 533.

1

(*1)  With effect from 1 December 2009, Article 81 of the EC Treaty has become Article 101 of the Treaty on the Functioning of the European Union. The two Articles are, in substance, identical. For the purposes of this Regulation, references to Article 101 of the Treaty on the Functioning of the European Union should be understood as references to Article 81 of the EC Treaty where appropriate.

*1

(2)  
  OJ L 336, 29.12.1999, p. 21.

2

(3)  
  OJ L 1, 4.1.2003, p. 1.

3

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/8 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/8

---

COMMISSION REGULATION (EU) No 331/2010

of 22 April 2010

amending Regulation (EC) No 1580/2007 as regards the trigger levels for additional duties on cucumbers and cherries, other than sour cherries

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 143(b), in conjunction with Article 4 thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules of Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (2) provides for surveillance of imports of the products listed in Annex XVII thereto. That surveillance is to be carried out in accordance with the rules laid down in Article 308d of Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (3). |
| --- | --- |

(1)

Commission Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules of Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (2) provides for surveillance of imports of the products listed in Annex XVII thereto. That surveillance is to be carried out in accordance with the rules laid down in Article 308d of Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (3).

| (2) | For the purposes of applying Article 5(4) of the Agreement on Agriculture (4) concluded as part of the Uruguay Round of multilateral trade negotiations and in the light of the latest data available for 2007, 2008 and 2009, the trigger levels for additional duties on cucumbers and cherries, other than sour cherries, should be adjusted. |
| --- | --- |

(2)

For the purposes of applying Article 5(4) of the Agreement on Agriculture (4) concluded as part of the Uruguay Round of multilateral trade negotiations and in the light of the latest data available for 2007, 2008 and 2009, the trigger levels for additional duties on cucumbers and cherries, other than sour cherries, should be adjusted.

| (3) | Regulation (EC) No 1580/2007 should therefore be amended accordingly. |
| --- | --- |

(3)

Regulation (EC) No 1580/2007 should therefore be amended accordingly.

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

(4)

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

HAS ADOPTED THIS REGULATION:

Article 1

Annex XVII to Regulation (EC) No 1580/2007 is replaced by the text set out in the Annex to this Regulation.

Article 2

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

It shall apply from 1 May 2010.

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

Done at Brussels, 22 April 2010.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  
  OJ L 350, 31.12.2007, p. 1.

2

(3)  
  OJ L 253, 11.10.1993, p. 1.

3

(4)  
  OJ L 336, 23.12.1994, p. 22.

4

---

ANNEX

‘ANNEX XVII

ADDITIONAL IMPORT DUTIES: TITLE IV, CHAPTER II, SECTION 2

Without prejudice to the rules governing the interpretation of the Combined Nomenclature, the description of the products is deemed to be indicative only. The scope of the additional duties for the purposes of this Annex is determined by the scope of the CN codes as they exist at the time of the adoption of this Regulation.

| Order number | CN code | Description | Period of application | Trigger level (tonnes) |
| --- | --- | --- | --- | --- |
| 78.0015 | 0702 00 00 | Tomatoes | From 1 October to 31 May | 415 907 |
| 78.0020 | From 1 June to 30 September | 40 107 |
| 78.0065 | 0707 00 05 | Cucumbers | From 1 May to 31 October | 11 879 |
| 78.0075 | From 1 November to 30 April | 18 611 |
| 78.0085 | 0709 90 80 | Artichokes | From 1 November to 30 June | 8 866 |
| 78.0100 | 0709 90 70 | Courgettes | From 1 January to 31 December | 55 369 |
| 78.0110 | 0805 10 20 | Oranges | From 1 December to 31 May | 355 386 |
| 78.0120 | 0805 20 10 | Clementines | From 1 November to end of February | 529 006 |
| 78.0130 | 0805 20 30
  0805 20 50
  0805 20 70
  0805 20 90 | Mandarins (including tangerines and satsumas); wilkings and similar citrus hybrids | From 1 November to end of February | 96 377 |
| 78.0155 | 0805 50 10 | Lemons | From 1 June to 31 December | 334 680 |
| 78.0160 | From 1 January to 31 May | 62 311 |
| 78.0170 | 0806 10 10 | Table grapes | From 21 July to 20 November | 89 140 |
| 78.0175 | 0808 10 80 | Apples | From 1 January to 31 August | 829 840 |
| 78.0180 | From 1 September to 31 December | 884 648 |
| 78.0220 | 0808 20 50 | Pears | From 1 January to 30 April | 224 927 |
| 78.0235 | From 1 July to 31 December | 38 957 |
| 78.0250 | 0809 10 00 | Apricots | From 1 June to 31 July | 5 785 |
| 78.0265 | 0809 20 95 | Cherries, other than sour cherries | From 21 May to 10 August | 90 511 |
| 78.0270 | 0809 30 | Peaches, including nectarines | From 11 June to 30 September | 131 459 |
| 78.0280 | 0809 40 05 | Plums | From 11 June to 30 September | 129 925 ’ |

Order number

CN code

Description

Period of application

Trigger level (tonnes)

78.0015

0702 00 00

Tomatoes

From 1 October to 31 May

415 907

78.0020

From 1 June to 30 September

40 107

78.0065

0707 00 05

Cucumbers

From 1 May to 31 October

11 879

78.0075

From 1 November to 30 April

18 611

78.0085

0709 90 80

Artichokes

From 1 November to 30 June

8 866

78.0100

0709 90 70

Courgettes

From 1 January to 31 December

55 369

78.0110

0805 10 20

Oranges

From 1 December to 31 May

355 386

78.0120

0805 20 10

Clementines

From 1 November to end of February

529 006

78.0130

0805 20 30

0805 20 50

0805 20 70

0805 20 90

Mandarins (including tangerines and satsumas); wilkings and similar citrus hybrids

From 1 November to end of February

96 377

78.0155

0805 50 10

Lemons

From 1 June to 31 December

334 680

78.0160

From 1 January to 31 May

62 311

78.0170

0806 10 10

Table grapes

From 21 July to 20 November

89 140

78.0175

0808 10 80

Apples

From 1 January to 31 August

829 840

78.0180

From 1 September to 31 December

884 648

78.0220

0808 20 50

Pears

From 1 January to 30 April

224 927

78.0235

From 1 July to 31 December

38 957

78.0250

0809 10 00

Apricots

From 1 June to 31 July

5 785

78.0265

0809 20 95

Cherries, other than sour cherries

From 21 May to 10 August

90 511

78.0270

0809 30

Peaches, including nectarines

From 11 June to 30 September

131 459

78.0280

0809 40 05

Plums

From 11 June to 30 September

129 925 ’

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/10 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/10

---

COMMISSION REGULATION (EU) No 332/2010

of 22 April 2010

amending Annex I to Regulation (EC) No 798/2008 as regards the entry for Israel in the list of third countries, territories, zones or compartments

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1) and in particular the introductory phrase of Article 8, the first paragraph of point 1 of Article 8 and point 4 of Article 8 thereof,

Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (2), and in particular Article 24(2) thereof,

Whereas:

| (1) | Directive 2002/99/EC lays down the general animal health rules governing all stages of the production, processing and distribution within the Union and the introduction from third countries of products of animal origin and products obtained therefrom intended for human consumption. That Directive provides that special import conditions are to be established for each third country or group of third countries, having regard to their animal health situation. |
| --- | --- |

(1)

Directive 2002/99/EC lays down the general animal health rules governing all stages of the production, processing and distribution within the Union and the introduction from third countries of products of animal origin and products obtained therefrom intended for human consumption. That Directive provides that special import conditions are to be established for each third country or group of third countries, having regard to their animal health situation.

| (2) | Directive 2009/158/EC lays down the animal health conditions governing trade within the Union and imports from third countries of poultry and hatching eggs. That Directive provides that poultry is to come from third countries free of avian influenza or which, although they are not free from that disease, apply measures to control it which are at least equivalent to those laid down by the relevant Union legislation. |
| --- | --- |

(2)

Directive 2009/158/EC lays down the animal health conditions governing trade within the Union and imports from third countries of poultry and hatching eggs. That Directive provides that poultry is to come from third countries free of avian influenza or which, although they are not free from that disease, apply measures to control it which are at least equivalent to those laid down by the relevant Union legislation.

| (3) | Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (3) provides that the commodities covered by it are only to be imported into and transited through the Union from the third countries, territories, zones or compartments listed in the table in Part 1 of Annex I thereto. |
| --- | --- |

(3)

Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (3) provides that the commodities covered by it are only to be imported into and transited through the Union from the third countries, territories, zones or compartments listed in the table in Part 1 of Annex I thereto.

| (4) | Pursuant to that Regulation, where an outbreak of highly pathogenic avian influenza (HPAI) occurs in a third country, territory, zone or compartment previously free of that disease, that third country, territory, zone or compartment is to again be considered as free of HPAI, provided that certain conditions are met; said conditions concern the implementation of a stamping out policy to control the disease, including adequate cleansing and disinfection carried out on all previously infected establishments. In addition, avian influenza surveillance must have been carried out in accordance with Part II of Annex IV to that Regulation during a three-month period following completion of the stamping out policy and cleansing and disinfection. |
| --- | --- |

(4)

Pursuant to that Regulation, where an outbreak of highly pathogenic avian influenza (HPAI) occurs in a third country, territory, zone or compartment previously free of that disease, that third country, territory, zone or compartment is to again be considered as free of HPAI, provided that certain conditions are met; said conditions concern the implementation of a stamping out policy to control the disease, including adequate cleansing and disinfection carried out on all previously infected establishments. In addition, avian influenza surveillance must have been carried out in accordance with Part II of Annex IV to that Regulation during a three-month period following completion of the stamping out policy and cleansing and disinfection.

| (5) | Israel is currently listed in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country free from highly pathogenic avian influenza. Imports of poultry commodities to which that Regulation applies are therefore authorised from the whole territory of that third country. |
| --- | --- |

(5)

Israel is currently listed in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country free from highly pathogenic avian influenza. Imports of poultry commodities to which that Regulation applies are therefore authorised from the whole territory of that third country.

| (6) | Israel has notified to the Commission an outbreak of highly pathogenic avian influenza of the H5N1 subtype on its territory. |
| --- | --- |

(6)

Israel has notified to the Commission an outbreak of highly pathogenic avian influenza of the H5N1 subtype on its territory.

| (7) | Due to the confirmed outbreak of HPAI, the territory of Israel may no longer be considered as free from that disease and the veterinary authorities of Israel have suspended issuing veterinary certificates for consignments of certain poultry commodities accordingly. Israel has also implemented a stamping out policy in order to control the disease and limit its spread. |
| --- | --- |

(7)

Due to the confirmed outbreak of HPAI, the territory of Israel may no longer be considered as free from that disease and the veterinary authorities of Israel have suspended issuing veterinary certificates for consignments of certain poultry commodities accordingly. Israel has also implemented a stamping out policy in order to control the disease and limit its spread.

| (8) | The information on the control measures taken has been submitted to the Commission. That information and the epidemiological situation in Israel have been evaluated by the Commission. |
| --- | --- |

(8)

The information on the control measures taken has been submitted to the Commission. That information and the epidemiological situation in Israel have been evaluated by the Commission.

| (9) | The prompt and decisive action taken by Israel to confine the disease and the positive outcome of the evaluation of the epidemiological situation allows limiting the restrictions on imports into the Union for certain poultry commodities to the zones affected by the disease, which the veterinary authorities of Israel have placed under restrictions due to the outbreak of highly pathogenic avian influenza. |
| --- | --- |

(9)

The prompt and decisive action taken by Israel to confine the disease and the positive outcome of the evaluation of the epidemiological situation allows limiting the restrictions on imports into the Union for certain poultry commodities to the zones affected by the disease, which the veterinary authorities of Israel have placed under restrictions due to the outbreak of highly pathogenic avian influenza.

| (10) | In addition, Israel is carrying out surveillance activities for avian influenza which appear to meet the requirements laid down in Part II of Annex IV to Regulation (EC) No 798/2008. |
| --- | --- |

(10)

In addition, Israel is carrying out surveillance activities for avian influenza which appear to meet the requirements laid down in Part II of Annex IV to Regulation (EC) No 798/2008.

| (11) | Taking into account the favourable development of the epidemiological situation and related surveillance activities for avian influenza in resolving the outbreak, it is appropriate to limit the time period during which the authorisation for imports into the Union is suspended until 1 May 2010. |
| --- | --- |

(11)

Taking into account the favourable development of the epidemiological situation and related surveillance activities for avian influenza in resolving the outbreak, it is appropriate to limit the time period during which the authorisation for imports into the Union is suspended until 1 May 2010.

| (12) | Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly. |
| --- | --- |

(12)

Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

| (13) | In order to implement the zoning requirements and thereby allowing trade to resume as soon as possible this Regulation should enter into force the day after publication. |
| --- | --- |

(13)

In order to implement the zoning requirements and thereby allowing trade to resume as soon as possible this Regulation should enter into force the day after publication.

| (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

Part 1 of Annex I to Regulation (EC) No 798/2008 is replaced by the text in the Annex to this Regulation.

Article 2

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

It shall apply from 26 January 2010.

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

Done at Brussels, 22 April 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 18, 23.1.2003, p. 11.

1

(2)  
  OJ L 343, 22.12.2009, p. 74.

2

(3)  
  OJ L 226, 23.8.2008, p. 1.

3

---

ANNEX

Part 1 of Annex I to Regulation (EC) No 798/2008 is replaced by the following:

‘PART 1

List of third countries, territories, zones or compartments

| ISO code and name of third country or territory | Code of third country, territory, zone or compartment | Description of third country, territory, zone or compartment | Veterinary certificate | Specific conditions | Specific conditions | Avian influenza surveillance status | Avian influenza vaccination status | Salmonella control status |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Model(s) | Additional guarantees | Closing date (1) | Opening date (2) |
| 1 | 2 | 3 | 4 | 5 | 6 | 6A | 6B | 7 | 8 | 9 |
| AL — Albania | AL-0 | Whole country | EP, E | | | | | | | S4 |
| AR — Argentina | AR-0 | Whole country | SPF | | | | | | | |
| POU, RAT, EP, E | | | | | A | | S4 |
| WGM | VIII | | | | | | |
| AU — Australia | AU-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| BPP, DOC, HEP, SRP | | | | | | | S0, ST0 |
| BPR | I | | | | | | |
| DOR | II | | | | | | |
| HER | III | | | | | | |
| POU | VI | | | | | | |
| RAT | VII | | | | | | |
| BR — Brazil | BR-0 | Whole country | SPF | | | | | | | |
| BR-1 | States of:
  Rio Grande do Sul, Santa Catarina, Paraná, São Paulo and Mato Grosso do Sul | RAT, BPR, DOR, HER, SRA | | N | | | A | | |
| BR-2 | States of:
  Mato Grosso, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo | BPP, DOC, HEP, SRP | | N | | | | S5, ST0 |
| BR-3 | Distrito Federal and States of:
  Goiás, Minas Gerais, Mato Grosso, Mato Grosso do Sul, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo | WGM | VIII | | | | | | |
| EP, E, POU | | N | | | | | S4 |
| BW — Botswana | BW-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| BPR | I | | | | | | |
| DOR | II | | | | | | |
| HER | III | | | | | | |
| RAT | VII | | | | | | |
| BY — Belarus | BY-0 | Whole country | EP and E (both “only for transit through the EU”) | IX | | | | | | |
| CA — Canada | CA-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| BPR, BPP, DOR, HER, SRA, SRP | | N | | | A | | S1, ST1 |
| DOC, HEP | | L, N | | | |
| WGM | VIII | | | | | | |
| POU, RAT | | N | | | | | |
| CH — Switzerland | CH-0 | Whole country | (3) | | | | | A | | (3) |
| CL — Chile | CL-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP | | N | | | A | | S0, ST0 |
| WGM | VIII | | | | | | |
| POU, RAT | | N | | | | | |
| CN — China | CN-0 | Whole country | EP | | | | | | | |
| CN-1 | Province of Shandong | POU, E | VI | P2 | 6.2.2004 | — | | | S4 |
| GL — Greenland | GL-0 | Whole country | SPF | | | | | | | |
| EP, WGM | | | | | | | |
| HK — Hong Kong | HK-0 | The whole territory of the Hong Kong Special Administrative Region | EP | | | | | | | |
| HR — Croatia | HR-0 | Whole country | SPF | | | | | | | |
| BPR, BPP, DOR, DOC, HEP, HER, SRA, SRP | | N | | | A | | S2, ST0 |
| EP, E, POU, RAT, WGM | | N | | | | | |
| IL — Israel | IL-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| IL-1 | Area of Israel excluding IL-2 | BPR, BPP, DOC, DOR, HEP, HER, SRP | | N | | | A | | S5, ST1 |
| WGM | VIII | | | | | | |
| POU, RAT | | N | | | | | S4 |
| | IL-2 | Area of Israel inside the following boundaries:






  — | to the west:
  road number 4. |

ISO code and name of third country or territory

Code of third country, territory, zone or compartment

Description of third country, territory, zone or compartment

Veterinary certificate

Specific conditions

Specific conditions

Avian influenza surveillance status

Avian influenza vaccination status

Salmonella control status

Model(s)

Additional guarantees

Closing date (1)

Opening date (2)

1

2

3

4

5

6

6A

6B

7

8

9

AL — Albania

AL-0

Whole country

EP, E

S4

AR — Argentina

AR-0

Whole country

SPF

POU, RAT, EP, E

A

S4

WGM

VIII

AU — Australia

AU-0

Whole country

SPF

EP, E

S4

BPP, DOC, HEP, SRP

S0, ST0

BPR

I

DOR

II

HER

III

POU

VI

RAT

VII

BR — Brazil

BR-0

Whole country

SPF

BR-1

States of:

Rio Grande do Sul, Santa Catarina, Paraná, São Paulo and Mato Grosso do Sul

RAT, BPR, DOR, HER, SRA

N

A

BR-2

States of:

Mato Grosso, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo

BPP, DOC, HEP, SRP

N

S5, ST0

BR-3

Distrito Federal and States of:

Goiás, Minas Gerais, Mato Grosso, Mato Grosso do Sul, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo

WGM

VIII

EP, E, POU

N

S4

BW — Botswana

BW-0

Whole country

SPF

EP, E

S4

BPR

I

DOR

II

HER

III

RAT

VII

BY — Belarus

BY-0

Whole country

EP and E (both “only for transit through the EU”)

IX

CA — Canada

CA-0

Whole country

SPF

EP, E

S4

BPR, BPP, DOR, HER, SRA, SRP

N

A

S1, ST1

DOC, HEP

L, N

WGM

VIII

POU, RAT

N

CH — Switzerland

CH-0

Whole country

(3)

A

(3)

CL — Chile

CL-0

Whole country

SPF

EP, E

S4

BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP

N

A

S0, ST0

WGM

VIII

POU, RAT

N

CN — China

CN-0

Whole country

EP

CN-1

Province of Shandong

POU, E

VI

P2

6.2.2004

—

S4

GL — Greenland

GL-0

Whole country

SPF

EP, WGM

HK — Hong Kong

HK-0

The whole territory of the Hong Kong Special Administrative Region

EP

HR — Croatia

HR-0

Whole country

SPF

BPR, BPP, DOR, DOC, HEP, HER, SRA, SRP

N

A

S2, ST0

EP, E, POU, RAT, WGM

N

IL — Israel

IL-0

Whole country

SPF

EP, E

S4

IL-1

Area of Israel excluding IL-2

BPR, BPP, DOC, DOR, HEP, HER, SRP

N

A

S5, ST1

WGM

VIII

POU, RAT

N

S4

IL-2

Area of Israel inside the following boundaries:

—

to the west:

road number 4.

| — | to the south:
  road number 5812 connecting to road number 5815. |
| --- | --- |

—

to the south:

road number 5812 connecting to road number 5815.

| — | to the east:
  the security fence until road number 6513. |
| --- | --- |

—

to the east:

the security fence until road number 6513.

| — | to the north:
  road number 6513 until the junction with road 65.
  From this point in a straight line to the entrance of Givat Nili and from there in a straight line to the junction of roads 652 and 4. |
| --- | --- |

—

to the north:

road number 6513 until the junction with road 65.

From this point in a straight line to the entrance of Givat Nili and from there in a straight line to the junction of roads 652 and 4.

BPR, BPP, DOC, DOR, HEP, HER, SRP

N, P2

26.1.2010

1.5.2010

A

S5, ST1

WGM

VIII

P2

26.1.2010

1.5.2010

POU, RAT

N, P2

26.1.2010

1.5.2010

S4

IN — India

IN-0

Whole country

EP

IS — Iceland

IS-0

Whole country

SPF

EP, E

S4

KR — Republic of Korea

KR-0

Whole country

EP, E

S4

ME — Montenegro

ME-O

Whole country

EP

MG — Madagascar

MG-0

Whole country

SPF

EP, E, WGM

S4

MY — Malaysia

MY-0

—

—

MY-1

Western Peninsular

EP

E

P2

6.2.2004

S4

| MK — | former Yugoslav Republic of Macedonia (4) |
| --- | --- |

MK —

former Yugoslav Republic of Macedonia (4)

MK-0 (4)

Whole country

EP

MX — Mexico

MX-0

Whole country

SPF

EP

NA — Namibia

NA-0

Whole country

SPF

BPR

I

DOR

II

HER

III

RAT, EP, E

VII

S4

NC — New Caledonia

NC-0

Whole country

EP

NZ — New Zealand

NZ-0

Whole country

SPF

BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP

S0, ST0

WGM

VIII

EP, E, POU, RAT

S4

PM — Saint Pierre and Miquelon

PM-0

Whole territory

SPF

RS — Serbia (5)

RS-0 (5)

Whole country

EP

RU — Russia

RU-0

Whole country

EP

SG — Singapore

SG-0

Whole country

EP

TH — Thailand

TH-0

Whole country

SPF, EP

WGM

VIII

P2

23.1.2004

E, POU, RAT

P2

23.1.2004

S4

TN — Tunisia

TN-0

Whole country

SPF

DOR, BPR, BPP, HER

S1, ST0

WGM

VIII

EP, E, POU, RAT

S4

TR — Turkey

TR-0

Whole country

SPF

EP, E

S4

US — United States

US-0

Whole country

SPF

BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP

N

A

S3, ST1

WGM

VIII

EP, E, POU, RAT

N

S4

UY — Uruguay

UY-0

Whole country

SPF

EP, E, RAT

S4

ZA — South Africa

ZA-0

Whole country

SPF

EP, E

S4

BPR

I

A

DOR

II

HER

III

RAT

VII

ZW — Zimbabwe

ZW-0

Whole country

RAT

VII

EP, E

S4

---

(1)  Commodities, including those transported on the high seas, produced before this date may be imported into the Union during a period of 90 days from this date.

1

(2)  Only commodities produced after this date may be imported into the Union.

2

(3)  In accordance with the agreement between the European Union and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132).

3

(4)  The former Yugoslav Republic of Macedonia; provisional code that does not prejudge in any way the definitive nomenclature for this country, which will be agreed following the conclusion of negotiations currently taking place on this subject in the United Nations.

4

(5)  Not including Kosovo, as defined by United Nations Security Council Resolution 1244 of 10 June 1999.’

5

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/19 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/19

---

COMMISSION REGULATION (EU) No 333/2010

of 22 April 2010

concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Calpis Co. Ltd. Japan, represented in the European Union by Calpis Co. Ltd. Europe Representative Office)

(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 the preparation set out in the Annex to this Regulation. 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 the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets, to be classified in the additive category ‘zootechnical additives’. |
| --- | --- |

(3)

The application concerns the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of that micro-organism preparation has been authorised for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2). |
| --- | --- |

(4)

The use of that micro-organism preparation has been authorised for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2).

| (5) | New data were submitted in support of the application for authorisation for weaned piglets. The European Food Safety Authority (the Authority) concluded in its opinion of 9 December 2009 (3) that Bacillus subtilis C-3102 (DSM 15544) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can improve the performance of the animals. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(5)

New data were submitted in support of the application for authorisation for weaned piglets. The European Food Safety Authority (the Authority) concluded in its opinion of 9 December 2009 (3) that Bacillus subtilis C-3102 (DSM 15544) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can improve the performance of the animals. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (6) | The assessment of Bacillus subtilis C-3102 (DSM 15544) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation. |
| --- | --- |

(6)

The assessment of Bacillus subtilis C-3102 (DSM 15544) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(7)

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 preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, 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 20th day following its publication in the Official Journal of the European Union.

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

Done at Brussels, 22 April 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  OJ L 271, 30.9.2006, p. 19.

2

(3)  
  The EFSA Journal 2010; 8(1):1426.

3

The EFSA Journal

---

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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1820 | Calpis Co. Ltd. Japan, represented in the European Union by Calpis Co. Ltd. Europe Representative Office, France | Bacillus subtilis C-3102 (DSM 15544) | | Additive composition:

  Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g |

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

CFU/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1820

Calpis Co. Ltd. Japan, represented in the European Union by Calpis Co. Ltd. Europe Representative Office, France

Bacillus subtilis C-3102 (DSM 15544)

Additive composition:

Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g

| | Characterisation of the active substance:
  Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544) |
| --- | --- |

Characterisation of the active substance:

Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)

| | Analytical method (1): | Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15874:2009) |
| --- | --- | --- |

Analytical method (1):

Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15874:2009)

| | Identification: pulsed-field gel electrophoresis (PFGE). |
| --- | --- |

Identification: pulsed-field gel electrophoresis (PFGE).

Piglets (weaned)

—

3 × 108

—

| 1. | In the directions for use of the additive, premixture and compound feedingstuff indicate the storage temperature, storage life and stability to pelleting |
| --- | --- |

1.

In the directions for use of the additive, premixture and compound feedingstuff indicate the storage temperature, storage life and stability to pelleting

| 2. | For use in weaned piglets up to approximately 35 kg. |
| --- | --- |

2.

For use in weaned piglets up to approximately 35 kg.

| 3. | For safety: breathing protection, glasses and gloves shall be used during handling. |
| --- | --- |

3.

For safety: breathing protection, glasses and gloves shall be used during handling.

13 May 2020

---

(1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.ec.europa.eu/crl-feed-additives

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/21 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/21

---

COMMISSION REGULATION (EU) No 334/2010

of 22 April 2010

amending Regulation (EC) No 721/2008 as regards the composition of feed additives

(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) | Commission Regulation (EC) No 721/2008 (2) authorises a preparation of red carotenoid-rich bacterium Paracoccus carotinifaciens as a feed additive for salmon and trout until 15 August 2018. That feed additive is classified in the category ‘sensory additives’, functional group ‘a (ii). Colourants; substances which when fed to animals add colours to food of animal origin’. |
| --- | --- |

(1)

Commission Regulation (EC) No 721/2008 (2) authorises a preparation of red carotenoid-rich bacterium Paracoccus carotinifaciens as a feed additive for salmon and trout until 15 August 2018. That feed additive is classified in the category ‘sensory additives’, functional group ‘a (ii). Colourants; substances which when fed to animals add colours to food of animal origin’.

| (2) | The Commission received an application requesting a modification of the conditions of the authorisation as regards the composition of the feed additive. That application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (the Authority). |
| --- | --- |

(2)

The Commission received an application requesting a modification of the conditions of the authorisation as regards the composition of the feed additive. That application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (the Authority).

| (3) | The Authority concluded in its opinion of January 2010 that the requested modification would not affect the safety and efficacy of the product (3). |
| --- | --- |

(3)

The Authority concluded in its opinion of January 2010 that the requested modification would not affect the safety and efficacy of the product (3).

| (4) | The assessment of the modified preparation shows that it satisfies the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The assessment of the modified preparation shows that it satisfies the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003.

| (5) | Regulation (EC) No 721/2008 should therefore be amended accordingly. |
| --- | --- |

(5)

Regulation (EC) No 721/2008 should therefore be amended accordingly.

| (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

In the Annex to Regulation (EC) No 721/2008, in the third column, ‘Composition, chemical formula, description, analytical method’,

| | the words






  ‘— | 10-15 g/kg adonirubin |
| --- | --- | --- |

the words

‘—

10-15 g/kg adonirubin

| — | 3-5 g/kg canthaxanthin’ |
| --- | --- |

—

3-5 g/kg canthaxanthin’

| | are replaced by the words






  ‘— | 7-15 g/kg adonirubin |
| --- | --- | --- |

are replaced by the words

‘—

7-15 g/kg adonirubin

| — | 1-5 g/kg canthaxanthin’. |
| --- | --- |

—

1-5 g/kg canthaxanthin’.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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

Done at Brussels, 22 April 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  OJ L 198, 26.7.2008, p. 23.

2

(3)  
  The EFSA Journal (2010); 8(1):1428.

3

The EFSA Journal

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/22 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/22

---

COMMISSION REGULATION (EU) No 335/2010

of 22 April 2010

concerning the authorisation of zinc chelate of hydroxy analogue of methionine 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 the preparation set out in the Annex to this Regulation. 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 the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’. |
| --- | --- |

(3)

The application concerns the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’.

| (4) | From the opinion of the European Food Safety Authority (‘the Authority’) adopted on 11 November 2009 (2), read in combination with those of 16 April 2008 (3) and 2 April 2009 (4) it results that zinc chelate of hydroxy analogue of methionine does not have an adverse effect on animal health, human health or the environment. According to the opinion of 16 April 2008, the use of that preparation may be considered as a source of available zinc and fulfils the criteria of a nutritional additive for all animal species. The Authority recommends appropriate measures for user safety. It 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

From the opinion of the European Food Safety Authority (‘the Authority’) adopted on 11 November 2009 (2), read in combination with those of 16 April 2008 (3) and 2 April 2009 (4) it results that zinc chelate of hydroxy analogue of methionine does not have an adverse effect on animal health, human health or the environment. According to the opinion of 16 April 2008, the use of that preparation may be considered as a source of available zinc and fulfils the criteria of a nutritional additive for all animal species. The Authority recommends appropriate measures for user safety. It 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of that preparation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation. |
| --- | --- |

(5)

The assessment of that preparation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.

| (6) | By Commission Regulation (EC) No 888/2009 of 25 September 2009 concerning the authorisation of Zinc chelate of hydroxy analogue of methionine as a feed additive for chickens for fattening (5) that preparation was already authorised as a feed additive for chickens for fattening. That Regulation should be repealed. |
| --- | --- |

(6)

By Commission Regulation (EC) No 888/2009 of 25 September 2009 concerning the authorisation of Zinc chelate of hydroxy analogue of methionine as a feed additive for chickens for fattening (5) that preparation was already authorised as a feed additive for chickens for fattening. That Regulation should be repealed.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(7)

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 preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Regulation (EC) No 888/2009 is repealed.

Article 3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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

Done at Brussels, 22 April 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  The EFSA Journal (2009) 7(11): 1381.

2

The EFSA Journal (2009) 7(11): 1381

(3)  
  The EFSA Journal (2008) 694, 1.

3

The EFSA Journal (2008) 694, 1

(4)  
  The EFSA Journal (2009) 1042:1.

4

The EFSA Journal (2009) 1042:1

(5)  
  OJ L 254, 26.9.2009, p. 71.

5

---

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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Content of element (Zn) in mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of nutritional additives. Functional group: compounds of trace elements |
| 3b6.10 | — | Zinc chelate of hydroxy analogue of methionine | | Characterisation of the additive: | Zinc chelate of hydroxy analogue of methionine containing 17,5 %-18 % zinc and 81 % (2-hydroxy-4-methylthio) butanoic acid |

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

Content of element (Zn) in mg/kg of complete feedingstuff with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements

3b6.10

—

Zinc chelate of hydroxy analogue of methionine

Characterisation of the additive:

Zinc chelate of hydroxy analogue of methionine containing 17,5 %-18 % zinc and 81 % (2-hydroxy-4-methylthio) butanoic acid

| | Mineral oil: ≤ 1 % |
| --- | --- |

Mineral oil: ≤ 1 %

| | Analytical method (1):
  Inductively coupled plasma atomic emission spectrometry (ICP-AES) according to EN 15510:2007 |
| --- | --- |

Analytical method (1):

Inductively coupled plasma atomic emission spectrometry (ICP-AES) according to EN 15510:2007

All species

—

Pets: 250 (total)

Fish: 200 (total)

Other species: 150 (total)

Complete and complementary milk replacers: 200 (total)

| 1. | The additive shall be incorporated into feed in the form of a premixture. |
| --- | --- |

1.

The additive shall be incorporated into feed in the form of a premixture.

| 2. | For user safety: breathing protection, safety glasses and gloves shall be worn during handling. |
| --- | --- |

2.

For user safety: breathing protection, safety glasses and gloves shall be worn during handling.

13 May 2020

---

(1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/crl-feed-additives

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/25 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/25

---

COMMISSION REGULATION (EU) No 336/2010

of 21 April 2010

concerning the classification of certain goods in the Combined Nomenclature

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | In order to ensure uniform application of the Combined Nomenclature annexed to Regulation (EEC) No 2658/87, it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation. |
| --- | --- |

(1)

In order to ensure uniform application of the Combined Nomenclature annexed to Regulation (EEC) No 2658/87, it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

| (2) | Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods. |
| --- | --- |

(2)

Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

| (3) | Pursuant to those general rules, the goods described in column 1 of the table set out in the Annex should be classified under the CN codes indicated in column 2, by virtue of the reasons set out in column 3 of that table. |
| --- | --- |

(3)

Pursuant to those general rules, the goods described in column 1 of the table set out in the Annex should be classified under the CN codes indicated in column 2, by virtue of the reasons set out in column 3 of that table.

| (4) | It is appropriate to provide that binding tariff information which has been issued by the customs authorities of Member States in respect of the classification of goods in the Combined Nomenclature but which is not in accordance with this Regulation can, for a period of three months, continue to be invoked by the holder, under Article 12(6) of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (2). |
| --- | --- |

(4)

It is appropriate to provide that binding tariff information which has been issued by the customs authorities of Member States in respect of the classification of goods in the Combined Nomenclature but which is not in accordance with this Regulation can, for a period of three months, continue to be invoked by the holder, under Article 12(6) of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (2).

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee, |
| --- | --- |

(5)

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

HAS ADOPTED THIS REGULATION:

Article 1

The goods described in column 1 of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN codes indicated in column 2 of that table.

Article 2

Binding tariff information issued by the customs authorities of Member States, which is not in accordance with this Regulation, can continue to be invoked for a period of three months under Article 12(6) of Regulation (EEC) No 2913/92.

Article 3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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

Done at Brussels, 21 April 2010.

For the Commission, On behalf of the President,

Algirdas ŠEMETA

Member of the Commission

---

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

1

(2)  
  OJ L 302, 19.10.1992, p. 1.

2

---

ANNEX

| Description of the goods | Classification
  (CN code) | Reasons |
| --- | --- | --- |
| (1) | (2) | (3) |
| 1. | A disc of a diameter of approximately 580 mm and a thickness of approximately 3 mm, consisting of 2 layers made of polyurethane, one of which has machined grooves, whereas the other has an adhesive coating protected by a detachable plastic sheet (so-called ‘polymeric pad’).
  The article is used with machines for the manufacture of silicon and semiconductor wafers. It is fitted on the carrier head of an interchangeable tool of such machines and is used to planarise/flatten and polish the wafers. |

Description of the goods

Classification

(CN code)

Reasons

(1)

(2)

(3)

1.

A disc of a diameter of approximately 580 mm and a thickness of approximately 3 mm, consisting of 2 layers made of polyurethane, one of which has machined grooves, whereas the other has an adhesive coating protected by a detachable plastic sheet (so-called ‘polymeric pad’).

The article is used with machines for the manufacture of silicon and semiconductor wafers. It is fitted on the carrier head of an interchangeable tool of such machines and is used to planarise/flatten and polish the wafers.

3919 90 00

Classification is determined by General Rules 1 and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 3919 and 3919 90 00 .

Classification under heading 8486 as a part or an accessory of a machine of a kind used solely or principally for the manufacture of semiconductor wafers is excluded, as the article does not have the characteristics to be considered as a part or an accessory of such a machine.

As the article constitutes consumable goods, it is to be classified according to its constituent material under CN code 3919 90 00 as a self-adhesive plate or sheet of plastics.

| 2. | A disc of a diameter of approximately 580 mm and a thickness of approximately 2 mm, consisting of 2 layers of synthetic felt, one of them being impregnated with a polymeric binder (polyurethane) (so-called ‘poromeric pad’). The other layer has an adhesive coating protected by a detachable plastic sheet.
  The article is used with machines for the manufacture of silicon and semiconductor wafers. It is fitted on the carrier head of an interchangeable tool of such machines and is used to planarise/flatten and polish the wafers. |
| --- | --- |

2.

A disc of a diameter of approximately 580 mm and a thickness of approximately 2 mm, consisting of 2 layers of synthetic felt, one of them being impregnated with a polymeric binder (polyurethane) (so-called ‘poromeric pad’). The other layer has an adhesive coating protected by a detachable plastic sheet.

The article is used with machines for the manufacture of silicon and semiconductor wafers. It is fitted on the carrier head of an interchangeable tool of such machines and is used to planarise/flatten and polish the wafers.

5911 90 90

Classification is determined by General Rules 1 and 6 for the interpretation of the Combined Nomenclature, Note 7(a) to Section XI, Note 1(e) to Section XVI, Note 7(b) to Chapter 59 and by the wording of CN codes 5911 , 5911 90 and 5911 90 90 .

Classification under heading 8486 as a part or an accessory of a machine of a kind used solely or principally for the manufacture of semiconductor wafers is excluded as the article does not have the characteristics to be considered as a part or an accessory of such a machine.

The product constitutes an article for technical use within the meaning of Note 1(e) to Section XVI, as it is used with machines for the manufacture of silicon and semiconductor wafers to planarise/flatten and polish the wafers.

It is therefore to be classified under CN code 5911 90 90 as a textile article (constituent material) used for technical purposes (see Note 7(b) to Chapter 59).

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/27 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/27

---

COMMISSION REGULATION (EU) No 337/2010

of 22 April 2010

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 Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules for Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (2), and in particular Article 138(1) thereof,

Whereas:

Regulation (EC) No 1580/2007 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 XV, Part A thereto,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 138 of Regulation (EC) No 1580/2007 are fixed in the Annex hereto.

Article 2

This Regulation shall enter into force on 23 April 2010.

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

Done at Brussels, 22 April 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 350, 31.12.2007, 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 | JO | 94,2 |
| MA | 90,1 |
| TN | 106,8 |
| TR | 99,1 |
| ZZ | 97,6 |
| 0707 00 05 | MA | 45,9 |
| TR | 111,1 |
| ZZ | 78,5 |
| 0709 90 70 | MA | 86,8 |
| TR | 91,8 |
| ZZ | 89,3 |
| 0805 10 20 | EG | 45,1 |
| IL | 54,0 |
| MA | 52,3 |
| TN | 48,9 |
| TR | 57,7 |
| ZZ | 51,6 |
| 0805 50 10 | EG | 65,6 |
| IL | 58,2 |
| TR | 63,3 |
| ZA | 63,4 |
| ZZ | 62,6 |
| 0808 10 80 | AR | 94,2 |
| BR | 79,8 |
| CA | 113,4 |
| CL | 86,0 |
| CN | 78,5 |
| MK | 24,7 |
| NZ | 120,7 |
| US | 134,1 |
| UY | 78,3 |
| ZA | 82,2 |
| ZZ | 89,2 |
| 0808 20 50 | AR | 95,6 |
| CL | 102,2 |
| CN | 76,1 |
| NZ | 167,4 |
| ZA | 93,8 |
| ZZ | 107,0 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

JO

94,2

MA

90,1

TN

106,8

TR

99,1

ZZ

97,6

0707 00 05

MA

45,9

TR

111,1

ZZ

78,5

0709 90 70

MA

86,8

TR

91,8

ZZ

89,3

0805 10 20

EG

45,1

IL

54,0

MA

52,3

TN

48,9

TR

57,7

ZZ

51,6

0805 50 10

EG

65,6

IL

58,2

TR

63,3

ZA

63,4

ZZ

62,6

0808 10 80

AR

94,2

BR

79,8

CA

113,4

CL

86,0

CN

78,5

MK

24,7

NZ

120,7

US

134,1

UY

78,3

ZA

82,2

ZZ

89,2

0808 20 50

AR

95,6

CL

102,2

CN

76,1

NZ

167,4

ZA

93,8

ZZ

107,0

---

(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’.

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/29 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/29

---

COMMISSION REGULATION (EU) No 338/2010

of 22 April 2010

fixing the export refunds on beef and veal

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 (1), and in particular Article 164(2), final subparagraph, and Article 170 thereof,

Whereas:

| (1) | Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products listed in Part XV of Annex I to that Regulation and prices for those products on the Community market may be covered by an export refund. |
| --- | --- |

(1)

Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products listed in Part XV of Annex I to that Regulation and prices for those products on the Community market may be covered by an export refund.

| (2) | Given the present situation on the market in beef and veal, export refunds should therefore be set in accordance with the rules and criteria provided for in Articles 162 to 164 and 167 to 170 of Regulation (EC) No 1234/2007. |
| --- | --- |

(2)

Given the present situation on the market in beef and veal, export refunds should therefore be set in accordance with the rules and criteria provided for in Articles 162 to 164 and 167 to 170 of Regulation (EC) No 1234/2007.

| (3) | Article 164(1) of Regulation (EC) No 1234/2007 provides that the refund may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary. |
| --- | --- |

(3)

Article 164(1) of Regulation (EC) No 1234/2007 provides that the refund may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary.

| (4) | Refunds should be granted only on products that are allowed to move freely in the Community and that bear the health mark as provided for in Article 5(1)(a) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2). Those products must also satisfy the requirements laid down in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (3) and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (4). |
| --- | --- |

(4)

Refunds should be granted only on products that are allowed to move freely in the Community and that bear the health mark as provided for in Article 5(1)(a) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2). Those products must also satisfy the requirements laid down in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (3) and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (4).

| (5) | The conditions laid down in the third subparagraph of Article 7(2) of Commission Regulation (EC) No 1359/2007 of 21 November 2007 laying down the conditions for granting special export refunds on certain cuts of boned meat of bovine animals (5) provide for a reduction of the special refund if the quantity of cuts of boned meat to be exported amounts to less than 95 %, but not less than 85 %, of the total weight of cuts produced by boning. |
| --- | --- |

(5)

The conditions laid down in the third subparagraph of Article 7(2) of Commission Regulation (EC) No 1359/2007 of 21 November 2007 laying down the conditions for granting special export refunds on certain cuts of boned meat of bovine animals (5) provide for a reduction of the special refund if the quantity of cuts of boned meat to be exported amounts to less than 95 %, but not less than 85 %, of the total weight of cuts produced by boning.

| (6) | Commission Regulation (EC) No 62/2010 (6) should therefore be repealed and replaced by a new regulation. |
| --- | --- |

(6)

Commission Regulation (EC) No 62/2010 (6) should therefore be repealed and replaced by a new regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(7)

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

HAS ADOPTED THIS REGULATION:

Article 1

1.   Export refunds as provided for in Article 164 of Regulation (EC) No 1234/2007 shall be granted on the products and for the amounts set out in the Annex to this Regulation subject to the conditions provided for in paragraph 2 of this Article.

2.   The products eligible for a refund under paragraph 1 must meet the relevant requirements of Regulations (EC) Nos 852/2004 and 853/2004, notably preparation in an approved establishment and compliance with the health marking requirements laid down in Annex I, Section I, Chapter III to Regulation (EC) No 854/2004.

Article 2

In the case referred to in the third subparagraph of Article 7(2) of Regulation (EC) No 1359/2007, the rate of the refund on products falling within product code 0201 30 00 9100 shall be reduced by EUR 7/100 kg.

Article 3

Regulation (EC) No 62/2010 is hereby repealed.

Article 4

This Regulation shall enter into force on 23 April 2010.

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

Done at Brussels, 22 April 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 139, 30.4.2004, p. 55

2

(3)  
  OJ L 139, 30.4.2004, p. 1.

3

(4)  
  OJ L 139, 30.4.2004, p. 206.

4

(5)  
  OJ L 304, 22.11.2007, p. 21.

5

(6)  
  OJ L 17, 22.1.2010, p. 33.

6

---

ANNEX

Export refunds on beef and veal applicable from 23 April 2010

| Product code | Destination | Unit of measurement | Refunds |
| --- | --- | --- | --- |
| 0102 10 10 9140 | B00 | EUR/100 kg live weight | 25,9 |
| 0102 10 30 9140 | B00 | EUR/100 kg live weight | 25,9 |
| 0201 10 00 9110  (1) | B02 | EUR/100 kg net weight | 36,6 |
| B03 | EUR/100 kg net weight | 21,5 |
| 0201 10 00 9130  (1) | B02 | EUR/100 kg net weight | 48,8 |
| B03 | EUR/100 kg net weight | 28,7 |
| 0201 20 20 9110  (1) | B02 | EUR/100 kg net weight | 48,8 |
| B03 | EUR/100 kg net weight | 28,7 |
| 0201 20 30 9110  (1) | B02 | EUR/100 kg net weight | 36,6 |
| B03 | EUR/100 kg net weight | 21,5 |
| 0201 20 50 9110  (1) | B02 | EUR/100 kg net weight | 61,0 |
| B03 | EUR/100 kg net weight | 35,9 |
| 0201 20 50 9130  (1) | B02 | EUR/100 kg net weight | 36,6 |
| B03 | EUR/100 kg net weight | 21,5 |
| 0201 30 00 9050 | US  (3) | EUR/100 kg net weight | 6,5 |
| CA  (4) | EUR/100 kg net weight | 6,5 |
| 0201 30 00 9060  (6) | B02 | EUR/100 kg net weight | 22,6 |
| B03 | EUR/100 kg net weight | 7,5 |
| 0201 30 00 9100  (2)
   (6) | B04 | EUR/100 kg net weight | 84,7 |
| B03 | EUR/100 kg net weight | 49,8 |
| EG | EUR/100 kg net weight | 103,4 |
| 0201 30 00 9120  (2)
   (6) | B04 | EUR/100 kg net weight | 50,8 |
| B03 | EUR/100 kg net weight | 29,9 |
| EG | EUR/100 kg net weight | 62,0 |
| 0202 10 00 9100 | B02 | EUR/100 kg net weight | 16,3 |
| B03 | EUR/100 kg net weight | 5,4 |
| 0202 20 30 9000 | B02 | EUR/100 kg net weight | 16,3 |
| B03 | EUR/100 kg net weight | 5,4 |
| 0202 20 50 9900 | B02 | EUR/100 kg net weight | 16,3 |
| B03 | EUR/100 kg net weight | 5,4 |
| 0202 20 90 9100 | B02 | EUR/100 kg net weight | 16,3 |
| B03 | EUR/100 kg net weight | 5,4 |
| 0202 30 90 9100 | US  (3) | EUR/100 kg net weight | 6,5 |
| CA  (4) | EUR/100 kg net weight | 6,5 |
| 0202 30 90 9200  (6) | B02 | EUR/100 kg net weight | 22,6 |
| B03 | EUR/100 kg net weight | 7,5 |
| 1602 50 31 9125  (5) | B00 | EUR/100 kg net weight | 23,3 |
| 1602 50 31 9325  (5) | B00 | EUR/100 kg net weight | 20,7 |
| 1602 50 95 9125  (5) | B00 | EUR/100 kg net weight | 23,3 |
| 1602 50 95 9325  (5) | B00 | EUR/100 kg net weight | 20,7 |
| N.B.: The product codes and the ‘A ’ series destination codes are set out in the Commission Regulation (EEC) No 3846/87 (OJ L 366, 24.12.1987, p. 1).
  The destination codes are set out in Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19).
  The other destinations are defined as follows:







  B00 | : | all destinations (third countries, other territories, victualling and destinations treated as exports from the Community). |
| B02 | : | B04 and destination EG . |
| B03 | : | Albania, Croatia, Bosnia-Herzegovina, Serbia, Kosovo (), Montenegro, former Yugoslav Republic of Macedonia, stores and provisions (destinations referred to in Articles 33 and 42, and if appropriate in Article 41, of Commission Regulation (EC) No 612/2009 (OJ L 186, 17.7.2009, p. 1). |
| B04 | : | Turkey, Ukraine, Belarus, Moldova, Russia, Georgia, Armenia, Azerbaijan, Kazakhstan, Turkmenistan, Uzbekistan, Tajikistan, Kyrgyzstan, Morocco, Algeria, Tunisia, Libya, Lebanon, Syria, Iraq, Iran, Israel, West Bank/Gaza Strip, Jordan, Saudi Arabia, Kuwait, Bahrain, Qatar, United Arab Emirates, Oman, Yemen, Pakistan, Sri Lanka, Myanmar (Burma), Thailand, Vietnam, Indonesia, Philippines, China, North Korea, Hong Kong, Sudan, Mauritania, Mali, Burkina Faso, Niger, Chad, Cape Verde, Senegal, Gambia, Guinea-Bissau, Guinea, Sierra Leone, Liberia, Côte-d'Ivoire, Ghana, Togo, Benin, Nigeria, Cameroun, Central African Republic, Equatorial Guinea, Sao Tome Principe, Gabon, Congo, Congo (Democratic Republic), Rwanda, Burundi, Saint Helena and dependencies, Angola, Ethiopia, Eritrea, Djibouti, Somalia, Uganda, Tanzania, Seychelles and dependencies, British Indian Ocean Territory, Mozambique, Mauritius, Comoros, Mayotte, Zambia, Malawi, South Africa, Lesotho. |

Product code

Destination

Unit of measurement

Refunds

0102 10 10 9140

B00

EUR/100 kg live weight

25,9

0102 10 30 9140

B00

EUR/100 kg live weight

25,9

0201 10 00 9110  (1)

B02

EUR/100 kg net weight

36,6

B03

EUR/100 kg net weight

21,5

0201 10 00 9130  (1)

B02

EUR/100 kg net weight

48,8

B03

EUR/100 kg net weight

28,7

0201 20 20 9110  (1)

B02

EUR/100 kg net weight

48,8

B03

EUR/100 kg net weight

28,7

0201 20 30 9110  (1)

B02

EUR/100 kg net weight

36,6

B03

EUR/100 kg net weight

21,5

0201 20 50 9110  (1)

B02

EUR/100 kg net weight

61,0

B03

EUR/100 kg net weight

35,9

0201 20 50 9130  (1)

B02

EUR/100 kg net weight

36,6

B03

EUR/100 kg net weight

21,5

0201 30 00 9050

US  (3)

EUR/100 kg net weight

6,5

CA  (4)

EUR/100 kg net weight

6,5

0201 30 00 9060  (6)

B02

EUR/100 kg net weight

22,6

B03

EUR/100 kg net weight

7,5

0201 30 00 9100  (2)
   (6)

B04

EUR/100 kg net weight

84,7

B03

EUR/100 kg net weight

49,8

EG

EUR/100 kg net weight

103,4

0201 30 00 9120  (2)
   (6)

B04

EUR/100 kg net weight

50,8

B03

EUR/100 kg net weight

29,9

EG

EUR/100 kg net weight

62,0

0202 10 00 9100

B02

EUR/100 kg net weight

16,3

B03

EUR/100 kg net weight

5,4

0202 20 30 9000

B02

EUR/100 kg net weight

16,3

B03

EUR/100 kg net weight

5,4

0202 20 50 9900

B02

EUR/100 kg net weight

16,3

B03

EUR/100 kg net weight

5,4

0202 20 90 9100

B02

EUR/100 kg net weight

16,3

B03

EUR/100 kg net weight

5,4

0202 30 90 9100

US  (3)

EUR/100 kg net weight

6,5

CA  (4)

EUR/100 kg net weight

6,5

0202 30 90 9200  (6)

B02

EUR/100 kg net weight

22,6

B03

EUR/100 kg net weight

7,5

1602 50 31 9125  (5)

B00

EUR/100 kg net weight

23,3

1602 50 31 9325  (5)

B00

EUR/100 kg net weight

20,7

1602 50 95 9125  (5)

B00

EUR/100 kg net weight

23,3

1602 50 95 9325  (5)

B00

EUR/100 kg net weight

20,7

N.B.: The product codes and the ‘A ’ series destination codes are set out in the Commission Regulation (EEC) No 3846/87 (OJ L 366, 24.12.1987, p. 1).

The destination codes are set out in Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19).

The other destinations are defined as follows:

B00

:

all destinations (third countries, other territories, victualling and destinations treated as exports from the Community).

B02

:

B04 and destination EG .

B03

:

Albania, Croatia, Bosnia-Herzegovina, Serbia, Kosovo (), Montenegro, former Yugoslav Republic of Macedonia, stores and provisions (destinations referred to in Articles 33 and 42, and if appropriate in Article 41, of Commission Regulation (EC) No 612/2009 (OJ L 186, 17.7.2009, p. 1).

B04

:

Turkey, Ukraine, Belarus, Moldova, Russia, Georgia, Armenia, Azerbaijan, Kazakhstan, Turkmenistan, Uzbekistan, Tajikistan, Kyrgyzstan, Morocco, Algeria, Tunisia, Libya, Lebanon, Syria, Iraq, Iran, Israel, West Bank/Gaza Strip, Jordan, Saudi Arabia, Kuwait, Bahrain, Qatar, United Arab Emirates, Oman, Yemen, Pakistan, Sri Lanka, Myanmar (Burma), Thailand, Vietnam, Indonesia, Philippines, China, North Korea, Hong Kong, Sudan, Mauritania, Mali, Burkina Faso, Niger, Chad, Cape Verde, Senegal, Gambia, Guinea-Bissau, Guinea, Sierra Leone, Liberia, Côte-d'Ivoire, Ghana, Togo, Benin, Nigeria, Cameroun, Central African Republic, Equatorial Guinea, Sao Tome Principe, Gabon, Congo, Congo (Democratic Republic), Rwanda, Burundi, Saint Helena and dependencies, Angola, Ethiopia, Eritrea, Djibouti, Somalia, Uganda, Tanzania, Seychelles and dependencies, British Indian Ocean Territory, Mozambique, Mauritius, Comoros, Mayotte, Zambia, Malawi, South Africa, Lesotho.

---

(*1)  As defined by United Nations Security Council Resolution 1244 of 10 June 1999.

(1)  Entry under this subheading is subject to the submission of the certificate appearing in the Annex to Commission Regulation (EC) No 433/2007 (OJ L 104, 21.4.2007, p. 3).

(2)  The refund is granted subject to compliance with the conditions laid down in amended Commission Regulation (EC) No 1359/2007 (OJ L 304, 22.11.2007, p. 21), and, if applicable, in Commission Regulation (EC) No 1741/2006 (OJ L 329, 25.11.2006, p. 7).

(3)  Carried out in accordance with Commission Regulation (EC) No 1643/2006 (OJ L 308, 8.11.2006, p. 7).

(4)  Carried out in accordance with Commission Regulation (EC) No 1041/2008 (OJ L 281, 24.10.2008, p. 3).

(5)  The refund is granted subject to compliance with the conditions laid down in Commission Regulation (EC) No 1731/2006 (OJ L 325, 24.11.2006, p. 12).

(6)  The lean bovine meat content excluding fat is determined in accordance with the procedure described in the Annex to Commission Regulation (EEC) No 2429/86 (OJ L 210, 1.8.1986, p. 39).

The term ‘average content’ refers to the sample quantity as defined in Article 2(1) of Commission Regulation (EC) No 765/2002 (OJ L 117, 4.5.2002, p. 6). The sample is to be taken from that part of the consignment presenting the highest risk.

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/33 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/33

---

COMMISSION REGULATION (EU) No 339/2010

of 22 April 2010

granting no export refund for butter in the framework of the standing invitation to tender provided for in Regulation (EC) No 619/2008

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 164(2), in conjunction with Article 4, thereof,

Whereas:

| (1) | Commission Regulation (EC) No 619/2008 of 27 June 2008 opening a standing invitation to tender for export refunds concerning certain milk products (2) provides for a permanent tender. |
| --- | --- |

(1)

Commission Regulation (EC) No 619/2008 of 27 June 2008 opening a standing invitation to tender for export refunds concerning certain milk products (2) provides for a permanent tender.

| (2) | Pursuant to Article 6 of Commission Regulation (EC) No 1454/2007 of 10 December 2007 laying down common rules for establishing a tender procedure for fixing export refunds for certain agricultural products (3) and following an examination of the tenders submitted in response to the invitation to tender, it is appropriate not to grant any refund for the tendering period ending on 20 April 2010. |
| --- | --- |

(2)

Pursuant to Article 6 of Commission Regulation (EC) No 1454/2007 of 10 December 2007 laying down common rules for establishing a tender procedure for fixing export refunds for certain agricultural products (3) and following an examination of the tenders submitted in response to the invitation to tender, it is appropriate not to grant any refund for the tendering period ending on 20 April 2010.

| (3) | The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair, |
| --- | --- |

(3)

The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair,

HAS ADOPTED THIS REGULATION:

Article 1

For the standing invitation to tender opened by Regulation (EC) No 619/2008, for the tendering period ending on 20 April 2010, no export refund shall be granted for the products and destinations referred to in points (a) and (b) of Article 1 and in Article 2 of that Regulation.

Article 2

This Regulation shall enter into force on 23 April 2010.

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

Done at Brussels, 22 April 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 168, 28.6.2008, p. 20.

2

(3)  
  OJ L 325, 11.12.2007, p. 69.

3

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/34 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/34

---

COMMISSION REGULATION (EU) No 340/2010

of 22 April 2010

granting no export refund for skimmed milk powder in the framework of the standing invitation to tender provided for in Regulation (EC) No 619/2008

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 164(2), in conjunction with Article 4, thereof,

Whereas:

| (1) | Commission Regulation (EC) No 619/2008 of 27 June 2008 opening a standing invitation to tender for export refunds concerning certain milk products (2) provides for a standing invitation to tender procedure. |
| --- | --- |

(1)

Commission Regulation (EC) No 619/2008 of 27 June 2008 opening a standing invitation to tender for export refunds concerning certain milk products (2) provides for a standing invitation to tender procedure.

| (2) | Pursuant to Article 6 of Commission Regulation (EC) No 1454/2007 of 10 December 2007 laying down common rules for establishing a tender procedure for fixing export refunds for certain agricultural products (3) and following an examination of the tenders submitted in response to the invitation to tender, it is appropriate not to grant any refund for the tendering period ending on 20 April 2010. |
| --- | --- |

(2)

Pursuant to Article 6 of Commission Regulation (EC) No 1454/2007 of 10 December 2007 laying down common rules for establishing a tender procedure for fixing export refunds for certain agricultural products (3) and following an examination of the tenders submitted in response to the invitation to tender, it is appropriate not to grant any refund for the tendering period ending on 20 April 2010.

| (3) | The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair, |
| --- | --- |

(3)

The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair,

HAS ADOPTED THIS REGULATION:

Article 1

For the standing invitation to tender opened by Regulation (EC) No 619/2008, for the tendering period ending on 20 April 2010, no export refund shall be granted for the product and destinations referred to in point (c) of Article 1 and in Article 2 respectively of that Regulation.

Article 2

This Regulation shall enter into force on 23 April 2010.

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

Done at Brussels, 22 April 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 168, 28.6.2008, p. 20.

2

(3)  
  OJ L 325, 11.12.2007, p. 69.

3

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/35 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/35

---

COMMISSION REGULATION (EU) No 341/2010

of 22 April 2010

fixing the export refunds on eggs

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 (1), and in particular Article 164(2), last subparagraph, and Article 170 thereof,

Whereas:

| (1) | Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products referred to in Part XIX of Annex I to that Regulation and prices in the Community for those products may be covered by an export refund. |
| --- | --- |

(1)

Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products referred to in Part XIX of Annex I to that Regulation and prices in the Community for those products may be covered by an export refund.

| (2) | In view of the current situation on the market in eggs, export refunds should be fixed in accordance with the rules and certain criteria provided for in Articles 162 to 164, 167, 169 and 170 of Regulation (EC) No 1234/2007. |
| --- | --- |

(2)

In view of the current situation on the market in eggs, export refunds should be fixed in accordance with the rules and certain criteria provided for in Articles 162 to 164, 167, 169 and 170 of Regulation (EC) No 1234/2007.

| (3) | Article 164(1) of Regulation (EC) No 1234/2007 provides that refunds may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary. |
| --- | --- |

(3)

Article 164(1) of Regulation (EC) No 1234/2007 provides that refunds may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary.

| (4) | Refunds should be granted only on products which are authorised to move freely within the Community and comply with requirements under Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (2) and of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (3), as well as marking requirements under point A of Annex XIV to Regulation (EC) No 1234/2007. |
| --- | --- |

(4)

Refunds should be granted only on products which are authorised to move freely within the Community and comply with requirements under Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (2) and of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (3), as well as marking requirements under point A of Annex XIV to Regulation (EC) No 1234/2007.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(5)

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

HAS ADOPTED THIS REGULATION:

Article 1

1.   The products on which the export refunds provided for in Article 164 of Regulation (EC) No 1234/2007 may be paid, subject to the conditions laid down in paragraph 2 of this Article, and the amounts of those refunds are specified in the Annex to this Regulation.

2.   The products on which a refund may be paid under paragraph 1 shall meet the requirements under Regulations (EC) Nos 852/2004 and 853/2004 and, in particular, shall be prepared in an approved establishment and comply with the marking conditions laid down in Section I of Annex II to Regulation (EC) No 853/2004 and those defined in point A of Annex XIV to Regulation (EC) No 1234/2007.

Article 2

This Regulation shall enter into force on 23 April 2010.

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

Done at Brussels, 22 April 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 139, 30.4.2004, p. 1.

2

(3)  
  OJ L 139, 30.4.2004, p. 55.

3

---

ANNEX

Export refunds on eggs applicable from 23 April 2010

| Product code | Destination | Unit of measurement | Amount of refund |
| --- | --- | --- | --- |
| 0407 00 11 9000 | A02 | EUR/100 pcs | 0,39 |
| 0407 00 19 9000 | A02 | EUR/100 pcs | 0,20 |
| 0407 00 30 9000 | E09 | EUR/100 kg | 0,00 |
| E10 | EUR/100 kg | 22,00 |
| E19 | EUR/100 kg | 0,00 |
| 0408 11 80 9100 | A03 | EUR/100 kg | 84,72 |
| 0408 19 81 9100 | A03 | EUR/100 kg | 42,53 |
| 0408 19 89 9100 | A03 | EUR/100 kg | 42,53 |
| 0408 91 80 9100 | A03 | EUR/100 kg | 53,67 |
| 0408 99 80 9100 | A03 | EUR/100 kg | 9,00 |
| NB: The product codes and the ‘A ’ series destination codes are set out in Commission Regulation (EEC) No 3846/87 (OJ L 366, 24.12.1987, p. 1), as amended.
  The other destinations are defined as follows:







  E09 | : | Kuwait, Bahrain, Oman, Qatar, the United Arab Emirates, Yemen, Hong Kong SAR, Russia and Turkey. |
| E10 | : | South Korea, Japan, Malaysia, Thailand, Taiwan and the Philippines. |
| E19 | : | all destinations except Switzerland and those of E09 and E10 . |

Product code

Destination

Unit of measurement

Amount of refund

0407 00 11 9000

A02

EUR/100 pcs

0,39

0407 00 19 9000

A02

EUR/100 pcs

0,20

0407 00 30 9000

E09

EUR/100 kg

0,00

E10

EUR/100 kg

22,00

E19

EUR/100 kg

0,00

0408 11 80 9100

A03

EUR/100 kg

84,72

0408 19 81 9100

A03

EUR/100 kg

42,53

0408 19 89 9100

A03

EUR/100 kg

42,53

0408 91 80 9100

A03

EUR/100 kg

53,67

0408 99 80 9100

A03

EUR/100 kg

9,00

NB: The product codes and the ‘A ’ series destination codes are set out in Commission Regulation (EEC) No 3846/87 (OJ L 366, 24.12.1987, p. 1), as amended.

The other destinations are defined as follows:

E09

:

Kuwait, Bahrain, Oman, Qatar, the United Arab Emirates, Yemen, Hong Kong SAR, Russia and Turkey.

E10

:

South Korea, Japan, Malaysia, Thailand, Taiwan and the Philippines.

E19

:

all destinations except Switzerland and those of E09 and E10 .

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/37 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/37

---

COMMISSION REGULATION (EU) No 342/2010

of 22 April 2010

fixing the export refunds on poultrymeat

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 (1), and in particular Article 164(2), last subparagraph, and Article 170 thereof,

Whereas:

| (1) | Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products referred to in Part XX of Annex I to that Regulation and prices in the Community for those products may be covered by an export refund. |
| --- | --- |

(1)

Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products referred to in Part XX of Annex I to that Regulation and prices in the Community for those products may be covered by an export refund.

| (2) | In view of the current situation on the market in poultrymeat, export refunds should be fixed in accordance with the rules and criteria provided for in Articles 162 to 164, 167, 169 and 170 of Regulation (EC) No 1234/2007. |
| --- | --- |

(2)

In view of the current situation on the market in poultrymeat, export refunds should be fixed in accordance with the rules and criteria provided for in Articles 162 to 164, 167, 169 and 170 of Regulation (EC) No 1234/2007.

| (3) | Article 164(1) of Regulation (EC) No 1234/2007 provides that refunds may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary. |
| --- | --- |

(3)

Article 164(1) of Regulation (EC) No 1234/2007 provides that refunds may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary.

| (4) | Refunds should be granted only on products which are authorised to move freely in the Community and bear the identification mark provided for in Article 5(1)(b) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2). Those products should also comply with the requirements of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (3). |
| --- | --- |

(4)

Refunds should be granted only on products which are authorised to move freely in the Community and bear the identification mark provided for in Article 5(1)(b) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2). Those products should also comply with the requirements of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (3).

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(5)

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

HAS ADOPTED THIS REGULATION:

Article 1

1.   The products on which the export refunds provided for in Article 164 of Regulation (EC) No 1234/2007 may be paid, subject to the conditions laid down in paragraph 2 of this Article, and the amounts of those refunds are specified in the Annex to this Regulation.

2.   The products on which a refund may be paid under paragraph 1 shall meet the requirements under Regulations (EC) Nos 852/2004 and 853/2004 and, in particular, shall be prepared in an approved establishment and comply with the identification marking conditions laid down in Section I of Annex II to Regulation (EC) No 853/2004.

Article 2

This Regulation shall enter into force on 23 April 2010.

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

Done at Brussels, 22 April 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 139, 30.4.2004, p. 55.

2

(3)  
  OJ L 139, 30.4.2004, p. 1.

3

---

ANNEX

Export refunds on poultrymeat applicable from 23 April 2010

| Product code | Destination | Unit of measurement | Amount of refund |
| --- | --- | --- | --- |
| 0105 11 11 9000 | A02 | EUR/100 pcs | 0,24 |
| 0105 11 19 9000 | A02 | EUR/100 pcs | 0,24 |
| 0105 11 91 9000 | A02 | EUR/100 pcs | 0,24 |
| 0105 11 99 9000 | A02 | EUR/100 pcs | 0,24 |
| 0105 12 00 9000 | A02 | EUR/100 pcs | 0,47 |
| 0105 19 20 9000 | A02 | EUR/100 pcs | 0,47 |
| 0207 12 10 9900 | V03 | EUR/100 kg | 40,00 |
| 0207 12 90 9190 | V03 | EUR/100 kg | 40,00 |
| 0207 12 90 9990 | V03 | EUR/100 kg | 40,00 |
| NB: The product codes and the ‘A ’ series destination codes are set out in Commission Regulation (EEC) No 3846/87 (OJ L 366, 24.12.1987, p. 1), as amended.
  The other destinations are defined as follows:






  V03 : | A24 , Angola, Saudi Arabia, Kuwait, Bahrain, Qatar, Oman, United Arab Emirates, Jordan, Yemen, Lebanon, Iraq and Iran. |

Product code

Destination

Unit of measurement

Amount of refund

0105 11 11 9000

A02

EUR/100 pcs

0,24

0105 11 19 9000

A02

EUR/100 pcs

0,24

0105 11 91 9000

A02

EUR/100 pcs

0,24

0105 11 99 9000

A02

EUR/100 pcs

0,24

0105 12 00 9000

A02

EUR/100 pcs

0,47

0105 19 20 9000

A02

EUR/100 pcs

0,47

0207 12 10 9900

V03

EUR/100 kg

40,00

0207 12 90 9190

V03

EUR/100 kg

40,00

0207 12 90 9990

V03

EUR/100 kg

40,00

NB: The product codes and the ‘A ’ series destination codes are set out in Commission Regulation (EEC) No 3846/87 (OJ L 366, 24.12.1987, p. 1), as amended.

The other destinations are defined as follows:

V03 :

A24 , Angola, Saudi Arabia, Kuwait, Bahrain, Qatar, Oman, United Arab Emirates, Jordan, Yemen, Lebanon, Iraq and Iran.

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/39 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/39

---

COMMISSION REGULATION (EU) No 343/2010

of 22 April 2010

fixing the export refunds on pigmeat

THE EUROPEAN COMMISSION

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 164(2), final subparagraph, and Article 170 thereof,

Whereas:

| (1) | Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products listed in Part XVII of Annex I to that Regulation and prices for those products on the Community market may be covered by an export refund. |
| --- | --- |

(1)

Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products listed in Part XVII of Annex I to that Regulation and prices for those products on the Community market may be covered by an export refund.

| (2) | Given the present situation on the market in pigmeat, export refunds should therefore be fixed in accordance with the rules and criteria provided for in Articles 162 to 164, 167, 169 and 170 of Regulation (EC) No 1234/2007. |
| --- | --- |

(2)

Given the present situation on the market in pigmeat, export refunds should therefore be fixed in accordance with the rules and criteria provided for in Articles 162 to 164, 167, 169 and 170 of Regulation (EC) No 1234/2007.

| (3) | Article 164(1) of Regulation (EC) No 1234/2007 provides that the refund may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary. |
| --- | --- |

(3)

Article 164(1) of Regulation (EC) No 1234/2007 provides that the refund may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary.

| (4) | Refunds should be granted only on products that are allowed to move freely in the Community and that bear the health mark as provided for in Article 5(1)(a) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2). Those products must also satisfy the requirements laid down in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (3) and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (4). |
| --- | --- |

(4)

Refunds should be granted only on products that are allowed to move freely in the Community and that bear the health mark as provided for in Article 5(1)(a) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2). Those products must also satisfy the requirements laid down in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (3) and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (4).

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(5)

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

HAS ADOPTED THIS REGULATION:

Article 1

1.   Export refunds as provided for in Article 164 of Regulation (EC) No 1234/2007 shall be granted on the products and for the amounts set out in the Annex to this Regulation subject to the condition provided for in paragraph 2 of this Article.

2.   The products eligible for a refund under paragraph 1 must meet the relevant requirements of Regulations (EC) Nos 852/2004 and 853/2004, notably preparation in an approved establishment and compliance with the health marking requirements laid down in Annex I, Section I, Chapter III to Regulation (EC) No 854/2004.

Article 2

This Regulation shall enter into force on 23 April 2010.

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

Done at Brussels, 22 April 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 139, 30.4.2004, p. 55.

2

(3)  
  OJ L 139, 30.4.2004, p. 1.

3

(4)  
  OJ L 139, 30.4.2004, p. 206.

4

---

ANNEX

Export refunds on pigmeat applicable from 23 April 2010

| Product code | Destination | Unit of measurement | Amount of refund |
| --- | --- | --- | --- |
| 0210 11 31 9110 | A00 | EUR/100 kg | 54,20 |
| 0210 11 31 9910 | A00 | EUR/100 kg | 54,20 |
| 0210 19 81 9100 | A00 | EUR/100 kg | 54,20 |
| 0210 19 81 9300 | A00 | EUR/100 kg | 54,20 |
| 1601 00 91 9120 | A00 | EUR/100 kg | 19,50 |
| 1601 00 99 9110 | A00 | EUR/100 kg | 15,20 |
| 1602 41 10 9110 | A00 | EUR/100 kg | 29,00 |
| 1602 41 10 9130 | A00 | EUR/100 kg | 17,10 |
| 1602 42 10 9110 | A00 | EUR/100 kg | 22,80 |
| 1602 42 10 9130 | A00 | EUR/100 kg | 17,10 |
| 1602 49 19 9130 | A00 | EUR/100 kg | 17,10 |
| NB: The product codes and the ‘A ’ series destination codes are set out in Commission Regulation (EEC) No 3846/87 (OJ L 366, 24.12.1987, p. 1) as amended. |

Product code

Destination

Unit of measurement

Amount of refund

0210 11 31 9110

A00

EUR/100 kg

54,20

0210 11 31 9910

A00

EUR/100 kg

54,20

0210 19 81 9100

A00

EUR/100 kg

54,20

0210 19 81 9300

A00

EUR/100 kg

54,20

1601 00 91 9120

A00

EUR/100 kg

19,50

1601 00 99 9110

A00

EUR/100 kg

15,20

1602 41 10 9110

A00

EUR/100 kg

29,00

1602 41 10 9130

A00

EUR/100 kg

17,10

1602 42 10 9110

A00

EUR/100 kg

22,80

1602 42 10 9130

A00

EUR/100 kg

17,10

1602 49 19 9130

A00

EUR/100 kg

17,10

NB: The product codes and the ‘A ’ series destination codes are set out in Commission Regulation (EEC) No 3846/87 (OJ L 366, 24.12.1987, p. 1) as amended.

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/41 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/41

---

COMMISSION REGULATION (EU) No 344/2010

of 22 April 2010

fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 143 thereof,

Having regard to Council Regulation (EC) No 614/2009 of 7 July 2009 on the common system of trade for ovalbumin and lactalbumin (2), and in particular Article 3(4) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices for poultrymeat and egg products and for egg albumin. |
| --- | --- |

(1)

Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices for poultrymeat and egg products and for egg albumin.

| (2) | Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin. The representative prices should therefore be published. |
| --- | --- |

(2)

Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin. The representative prices should therefore be published.

| (3) | In view of the situation on the market, this amendment should be applied as soon as possible. |
| --- | --- |

(3)

In view of the situation on the market, this amendment should be applied as soon as possible.

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

(4)

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

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 1484/95 is replaced by 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, 22 April 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 181, 14.7.2009, p. 8.

2

(3)  
  OJ L 145, 29.6.1995, p. 47.

3

---

ANNEX

to the Commission Regulation of 22 April 2010 fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95

‘ANNEX I

| CN code | Description of goods | Representative price
  (EUR/100 kg) | Security under Article 3(3)
  (EUR/100 kg) | Origin (1) |
| --- | --- | --- | --- | --- |
| 0207 12 10 | Fowls of the species Gallus domesticus, not cut in pieces, presented as “70 % chickens”, frozen | 114,5 | 0 | AR |
| 0207 12 90 | Fowls of the species Gallus domesticus, not cut in pieces, presented as “65 % chickens”, frozen | 124,2 | 0 | BR |
| 108,7 | 3 | AR |
| 0207 14 10 | Fowls of the species Gallus domesticus, boneless cuts, frozen | 217,9 | 25 | BR |
| 223,1 | 23 | AR |
| 291,5 | 3 | CL |
| 0207 14 50 | Fowls of the species Gallus domesticus, breasts, frozen | 190,1 | 7 | BR |
| 0207 14 60 | Fowl of the species Gallus domesticus, legs, frozen | 110,3 | 10 | BR |
| 0207 25 10 | Turkeys, not cut in pieces, presented as “80 % turkeys”, frozen | 146,0 | 4 | BR |
| 0207 27 10 | Turkeys, boneless cuts, frozen | 262,6 | 10 | BR |
| 286,8 | 3 | CL |
| 0408 11 80 | Egg yolks | 318,2 | 0 | AR |
| 0408 91 80 | Eggs, not in shell, dried | 325,9 | 0 | AR |
| 1602 32 11 | Preparations of fowls of the species Gallus domesticus, uncooked | 300,8 | 0 | BR |
| 311,4 | 0 | TH |
| 3502 11 90 | Egg albumin, dried | 531,4 | 0 | AR |

CN code

Description of goods

Representative price

(EUR/100 kg)

Security under Article 3(3)

(EUR/100 kg)

Origin (1)

0207 12 10

Fowls of the species Gallus domesticus, not cut in pieces, presented as “70 % chickens”, frozen

114,5

0

AR

0207 12 90

Fowls of the species Gallus domesticus, not cut in pieces, presented as “65 % chickens”, frozen

124,2

0

BR

108,7

3

AR

0207 14 10

Fowls of the species Gallus domesticus, boneless cuts, frozen

217,9

25

BR

223,1

23

AR

291,5

3

CL

0207 14 50

Fowls of the species Gallus domesticus, breasts, frozen

190,1

7

BR

0207 14 60

Fowl of the species Gallus domesticus, legs, frozen

110,3

10

BR

0207 25 10

Turkeys, not cut in pieces, presented as “80 % turkeys”, frozen

146,0

4

BR

0207 27 10

Turkeys, boneless cuts, frozen

262,6

10

BR

286,8

3

CL

0408 11 80

Egg yolks

318,2

0

AR

0408 91 80

Eggs, not in shell, dried

325,9

0

AR

1602 32 11

Preparations of fowls of the species Gallus domesticus, uncooked

300,8

0

BR

311,4

0

TH

3502 11 90

Egg albumin, dried

531,4

0

AR

---

(1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). The code “
  ZZ
  ” represents “other origins”.’

1

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/43 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/43

---

COMMISSION REGULATION (EU) No 345/2010

of 22 April 2010

fixing the rates of the refunds applicable to eggs and egg yolks exported in the form of goods not covered by Annex I to the Treaty

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 market and on specific provisions for certain agricultural products (single CMO Regulation) (1), and in particular Article 164(2) thereof,

Whereas:

| (1) | Article 162(1)b of Regulation (EC) No 1234/2007 provides that the difference between prices in international trade for the products referred to in Article 1(1)(s) and listed in Part XIX of Annex 1 to of that Regulation and prices within the Community may be covered by an export refund where these goods are exported in the form of goods listed Part V of the Annex XX to that Regulation. |
| --- | --- |

(1)

Article 162(1)b of Regulation (EC) No 1234/2007 provides that the difference between prices in international trade for the products referred to in Article 1(1)(s) and listed in Part XIX of Annex 1 to of that Regulation and prices within the Community may be covered by an export refund where these goods are exported in the form of goods listed Part V of the Annex XX to that Regulation.

| (2) | Commission Regulation (EC) No 1043/2005 of 30 June 2005 implementing Council Regulation (EC) No 3448/93 as regards the system of granting export refunds on certain agricultural products exported in the form of goods not covered by Annex I to the Treaty, and the criteria for fixing the amount of such refunds (2), specifies the products for which a rate of refund is to be fixed, to be applied where these products are exported in the form of goods listed in Part V of Annex XX to Regulation (EC) No 1234/2007. |
| --- | --- |

(2)

Commission Regulation (EC) No 1043/2005 of 30 June 2005 implementing Council Regulation (EC) No 3448/93 as regards the system of granting export refunds on certain agricultural products exported in the form of goods not covered by Annex I to the Treaty, and the criteria for fixing the amount of such refunds (2), specifies the products for which a rate of refund is to be fixed, to be applied where these products are exported in the form of goods listed in Part V of Annex XX to Regulation (EC) No 1234/2007.

| (3) | In accordance with paragraph 2(b) of Article 14 of Regulation (EC) No 1043/2005, the rate of the refund per 100 kilograms for each of the basic products in question is to be fixed for a period of the same duration as that for which refunds are fixed for the same products exported unprocessed. |
| --- | --- |

(3)

In accordance with paragraph 2(b) of Article 14 of Regulation (EC) No 1043/2005, the rate of the refund per 100 kilograms for each of the basic products in question is to be fixed for a period of the same duration as that for which refunds are fixed for the same products exported unprocessed.

| (4) | Article 11 of the Agreement on Agriculture concluded under the Uruguay Round lays down that the export refund for a product contained in a good may not exceed the refund applicable to that product when exported without further processing. |
| --- | --- |

(4)

Article 11 of the Agreement on Agriculture concluded under the Uruguay Round lays down that the export refund for a product contained in a good may not exceed the refund applicable to that product when exported without further processing.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(5)

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

HAS ADOPTED THIS REGULATION:

Article 1

The rates of the refunds applicable to the basic products listed in Annex I to Regulation (EC) No 1043/2005 and in Article 1(1)(s) of Regulation (EC) No 1234/2007, and exported in the form of goods listed in Part V of Annex XX to Regulation (EC) No 1234/2007, shall be fixed as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on 23 April 2010.

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

Done at Brussels, 22 April 2010.

For the Commission, On behalf of the President,

Heinz ZOUREK

Director-General Enterprise and Industry

---

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

1

(2)  
  OJ L 172, 5.7.2005, p. 24.

2

---

ANNEX

Rates of the refunds applicable from 23 April 2010 to eggs and egg yolks exported in the form of goods not covered by Annex I to the Treaty

| (EUR/100 kg) |
| --- |
| CN code | Description | Destination (1) | Rate of refund |
| 0407 00 | Birds' eggs, in shell, fresh, preserved or cooked: | | |
| – Of poultry: | | |
| 0407 00 30 | – – Other: | | |
| (a) | On exportation of ovalbumin of CN codes 3502 11 90 and 3502 19 90 |

(EUR/100 kg)

CN code

Description

Destination (1)

Rate of refund

0407 00

Birds' eggs, in shell, fresh, preserved or cooked:

– Of poultry:

0407 00 30

– – Other:

(a)

On exportation of ovalbumin of CN codes 3502 11 90 and 3502 19 90

02

0,00

03

22,00

04

0,00

| (b) | On exportation of other goods |
| --- | --- |

(b)

On exportation of other goods

01

0,00

0408

Birds' eggs, not in shell and egg yolks, fresh, dried, cooked by steaming or by boiling in water, moulded, frozen or otherwise preserved, whether or not containing added sugar or other sweetening matter:

– Egg yolks:

0408 11

– – Dried:

ex 0408 11 80

– – – Suitable for human consumption:

not sweetened

01

84,72

0408 19

– – Other:

– – – Suitable for human consumption:

ex 0408 19 81

– – – – Liquid:

not sweetened

01

42,53

ex 0408 19 89

– – – – Frozen:

not sweetened

01

42,53

– Other:

0408 91

– – Dried:

ex 0408 91 80

– – – Suitable for human consumption:

not sweetened

01

53,67

0408 99

– – Other:

ex 0408 99 80

– – – Suitable for human consumption:

not sweetened

01

9,00

---

(1)  The destinations are as follows:

| 01 | Third countries. For Switzerland and Liechtenstein these rates are not applicable to the goods listed in Tables I and II to Protocol No 2 to the Agreement between the European Community and the Swiss Confederation of 22 July 1972, |
| --- | --- |
| 02 | Kuwait, Bahrain, Oman, Qatar, United Arab Emirates, Yemen, Turkey, Hong Kong SAR and Russia, |
| 03 | South Korea, Japan, Malaysia, Thailand, Taiwan and the Philippines, |
| 04 | all destinations except Switzerland and those of 02 and 03. |

01

Third countries. For Switzerland and Liechtenstein these rates are not applicable to the goods listed in Tables I and II to Protocol No 2 to the Agreement between the European Community and the Swiss Confederation of 22 July 1972,

02

Kuwait, Bahrain, Oman, Qatar, United Arab Emirates, Yemen, Turkey, Hong Kong SAR and Russia,

03

South Korea, Japan, Malaysia, Thailand, Taiwan and the Philippines,

04

all destinations except Switzerland and those of 02 and 03.

---

DECISIONS

| 23.4.2010 | EN | Official Journal of the European Union | L 102/45 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/45

---

COMMISSION DECISION

of 19 April 2010

on the European Databank on Medical Devices (Eudamed)

(notified under document C(2010) 2363)

(Text with EEA relevance)

(2010/227/EU)

THE EUROPEAN COMMISSION,

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

Having regard to 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 (1), and in particular Article 10b(3) thereof,

Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2), and in particular Article 14a(3) thereof,

Having regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (3), and in particular Article 12(3) thereof,

Whereas:

| (1) | Directives 90/385/EEC, 93/42/EEC and 98/79/EC contain provisions on a European databank for medical devices which require the establishment of that databank. |
| --- | --- |

(1)

Directives 90/385/EEC, 93/42/EEC and 98/79/EC contain provisions on a European databank for medical devices which require the establishment of that databank.

| (2) | The aim of the European databank for medical devices is to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers and authorised representatives, devices and certificates and to vigilance data, to share information on clinical investigation data, as well as to contribute to a uniform application of those Directives, in particular in relation to registration requirements. |
| --- | --- |

(2)

The aim of the European databank for medical devices is to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers and authorised representatives, devices and certificates and to vigilance data, to share information on clinical investigation data, as well as to contribute to a uniform application of those Directives, in particular in relation to registration requirements.

| (3) | The databank should therefore contain the data required by Directives 90/385/EEC, 93/42/EEC and 98/79/EC, in particular on registration of manufacturers and devices, data relating to certificates issued or renewed, modified, supplemented, suspended, withdrawn or refused, data obtained in accordance with the vigilance procedure and data on clinical investigations. |
| --- | --- |

(3)

The databank should therefore contain the data required by Directives 90/385/EEC, 93/42/EEC and 98/79/EC, in particular on registration of manufacturers and devices, data relating to certificates issued or renewed, modified, supplemented, suspended, withdrawn or refused, data obtained in accordance with the vigilance procedure and data on clinical investigations.

| (4) | Such a databank has been developed by the European Commission in cooperation with the Member States under the name ‘European Databank for Medical Devices (Eudamed)’ and is being used by numerous Member States on a voluntary basis. |
| --- | --- |

(4)

Such a databank has been developed by the European Commission in cooperation with the Member States under the name ‘European Databank for Medical Devices (Eudamed)’ and is being used by numerous Member States on a voluntary basis.

| (5) | The data should be entered into the databank using prescribed data transfer methods. |
| --- | --- |

(5)

The data should be entered into the databank using prescribed data transfer methods.

| (6) | It is appropriate to use an internationally recognised nomenclature for medical devices when entering data into Eudamed in order to allow a uniform description of the devices concerned and efficient use of that databank. Given that data can be entered in all official languages of the Community, a numeric code should be used so that devices can be easily searched. |
| --- | --- |

(6)

It is appropriate to use an internationally recognised nomenclature for medical devices when entering data into Eudamed in order to allow a uniform description of the devices concerned and efficient use of that databank. Given that data can be entered in all official languages of the Community, a numeric code should be used so that devices can be easily searched.

| (7) | The Global Medical Device Nomenclature that has been developed based on EN ISO 15225:2000 Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange is such an internationally recognised nomenclature. The need to establish and maintain Eudamed and to start implementing the Global Medical Device Nomenclature as a basis for that databank was recalled in the Council Conclusions of 2 December 2003 on Medical Devices (4). |
| --- | --- |

(7)

The Global Medical Device Nomenclature that has been developed based on EN ISO 15225:2000 Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange is such an internationally recognised nomenclature. The need to establish and maintain Eudamed and to start implementing the Global Medical Device Nomenclature as a basis for that databank was recalled in the Council Conclusions of 2 December 2003 on Medical Devices (4).

| (8) | An appropriate transitional period is necessary to allow Member States to prepare for the mandatory use of Eudamed and to take account of the changes introduced by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (5). |
| --- | --- |

(8)

An appropriate transitional period is necessary to allow Member States to prepare for the mandatory use of Eudamed and to take account of the changes introduced by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (5).

| (9) | Member States should only be required to enter data existing before 1 May 2011 to the extent required for the future functioning of Eudamed. It is necessary for the completeness of Eudamed to enter data existing before 1 May 2011 on the manufacturer, the authorised representative and on device registration, which are required by Directives 93/42/EEC and 98/79/EC, in the form in which such data are available at national level. |
| --- | --- |

(9)

Member States should only be required to enter data existing before 1 May 2011 to the extent required for the future functioning of Eudamed. It is necessary for the completeness of Eudamed to enter data existing before 1 May 2011 on the manufacturer, the authorised representative and on device registration, which are required by Directives 93/42/EEC and 98/79/EC, in the form in which such data are available at national level.

| (10) | The measures provided for in this Decision are in accordance with the opinion of the Committee on Medical Devices, |
| --- | --- |

(10)

The measures provided for in this Decision are in accordance with the opinion of the Committee on Medical Devices,

HAS ADOPTED THIS DECISION:

Article 1

This Decision establishes the European Databank on Medical Devices (Eudamed) as databank for the purposes of Article 10b(3) of Directive 90/385/EEC, Article 14a(3) of Directive 93/42/EEC and Article 12(3) of Directive 98/79/EC.

Article 2

Member States shall ensure that the data referred to in points (a) and (b) of Article 10b(1) of Directive 90/385/EEC, points (a), (b) and (c) of Article 14a(1) of Directive 93/42/EEC and points (a), (b) and (c) of Article 12(1) of Directive 98/79/EC, are entered into Eudamed in accordance with the Annex to this Decision.

For clinical investigations Member States shall ensure that an extract of the notifications referred to in Article 10(1) of Directive 90/385/EEC and in Article 15(1) of Directive 93/42/EEC, as well as the information referred to in Article 10(3) and (4) of Directive 90/385/EEC and in Article 15(6) and (7) of Directive 93/42/EEC are entered into Eudamed in accordance with the Annex to this Decision.

Article 3

Eudamed shall use the Hypertext Transfer Protocol Secure (HTTPS) and the Extensible Mark-up Language (XML).

Article 4

When entering data in Eudamed, Member States may choose between on-line data entry and up-loading of XML files.

Member States shall ensure that when entering data into Eudamed medical devices are described using a code from an internationally recognised nomenclature for medical devices.

Article 5

As concerns data existing before the date referred to in Article 6, Member States shall ensure that the data on registration of manufacturers, authorised representatives and devices are entered into Eudamed in accordance with Article 14a(1)(a) of Directive 93/42/EEC and Article 12(1)(a) of Directive 98/79/EC.

That data shall be entered by 30 April 2012 at the latest.

Article 6

Member States shall apply this Decision from 1 May 2011.

Article 7

This Decision is addressed to the Member States.

Done at Brussels, 19 April 2010.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 189, 20.7.1990, p. 17.

1

(2)  
  OJ L 169, 12.7.1993, p. 1.

2

(3)  
  OJ L 331, 7.12.1998, p. 1.

3

(4)  
  OJ C 20, 24.1.2004, p. 1.

4

(5)  
  OJ L 247, 21.9.2007, p. 21.

5

---

ANNEX

Table detailing the mandatory data fields in the respective module in the Eudamed databank according to the obligations arising from Directives 93/42/EEC, 90/385/EEC and 98/79/EC

| Directive 93/42/EEC | Minimum data required for Eudamed data entry |
| --- | --- |
| Article 14a(1)(a) and Article 14(1) and (2) | 1. | Actor (manufacturer/authorised representative):






  (a) | Name; |

Directive 93/42/EEC

Minimum data required for Eudamed data entry

Article 14a(1)(a) and Article 14(1) and (2)

1.

Actor (manufacturer/authorised representative):

(a)

Name;

| (b) | Street; |
| --- | --- |

(b)

Street;

| (c) | Locality; |
| --- | --- |

(c)

Locality;

| (d) | Postcode; |
| --- | --- |

(d)

Postcode;

| (e) | Country; |
| --- | --- |

(e)

Country;

| (f) | Phone or E-mail; |
| --- | --- |

(f)

Phone or E-mail;

| (g) | Role. |
| --- | --- |

(g)

Role.

| 2. | Device:






  (a) | Internationally recognised nomenclature code (for data generated after 1 May 2011); |
| --- | --- | --- |

2.

Device:

(a)

Internationally recognised nomenclature code (for data generated after 1 May 2011);

| (b) | Device Name/Make or, where not available, generic name. |
| --- | --- |

(b)

Device Name/Make or, where not available, generic name.

Article 14a(1)(b)

| 3. | Certificate:






  (a) | Certificate number; |
| --- | --- | --- |

3.

Certificate:

(a)

Certificate number;

| (b) | Certificate type; |
| --- | --- |

(b)

Certificate type;

| (c) | Date of Issue; |
| --- | --- |

(c)

Date of Issue;

| (d) | Expiration Date; |
| --- | --- |

(d)

Expiration Date;

| (e) | Manufacturer and, if applicable, authorised representative (see fields under 1. Actor); |
| --- | --- |

(e)

Manufacturer and, if applicable, authorised representative (see fields under 1. Actor);

| (f) | Notified Body (selected from system); |
| --- | --- |

(f)

Notified Body (selected from system);

| (g) | General Scope description and, where applicable, details on device (see fields under 2. Device); |
| --- | --- |

(g)

General Scope description and, where applicable, details on device (see fields under 2. Device);

| (h) | Status and, where applicable, reasons for decision of Notified Body. |
| --- | --- |

(h)

Status and, where applicable, reasons for decision of Notified Body.

Article 14a(1)(c) and Article 10(3)

| 4. | Incident (National Competent Authority Report):






  (a) | Competent Authority reference; |
| --- | --- | --- |

4.

Incident (National Competent Authority Report):

(a)

Competent Authority reference;

| (b) | Manufacturer, where applicable authorised representative (see fields under 1. Actor); |
| --- | --- |

(b)

Manufacturer, where applicable authorised representative (see fields under 1. Actor);

| (c) | Manufacturer contact; |
| --- | --- |

(c)

Manufacturer contact;

| (d) | Manufacturer reference/Field Safety Corrective Action (FSCA) nr.; |
| --- | --- |

(d)

Manufacturer reference/Field Safety Corrective Action (FSCA) nr.;

| (e) | Device (see fields under 2. Device), plus where applicable lot number, serial number, software version; |
| --- | --- |

(e)

Device (see fields under 2. Device), plus where applicable lot number, serial number, software version;

| (f) | Notified Body (selected from system); |
| --- | --- |

(f)

Notified Body (selected from system);

| (g) | Device known to be in the market in; |
| --- | --- |

(g)

Device known to be in the market in;

| (h) | Confidential; |
| --- | --- |

(h)

Confidential;

| (i) | Complete investigation; |
| --- | --- |

(i)

Complete investigation;

| (j) | Background Information (Description); |
| --- | --- |

(j)

Background Information (Description);

| (k) | Conclusion; |
| --- | --- |

(k)

Conclusion;

| (l) | Recommendation; |
| --- | --- |

(l)

Recommendation;

| (m) | Action and action description. |
| --- | --- |

(m)

Action and action description.

Article 14a(1)(d) and Article 15(1), (6) and (7)

| 5. | Clinical Investigation:






  (a) | Manufacturer, where applicable authorised representative (see fields under 1. Actor); |
| --- | --- | --- |

5.

Clinical Investigation:

(a)

Manufacturer, where applicable authorised representative (see fields under 1. Actor);

| (b) | Device (see fields under 2. Device); |
| --- | --- |

(b)

Device (see fields under 2. Device);

| (c) | Title of investigation; |
| --- | --- |

(c)

Title of investigation;

| (d) | Protocol number; |
| --- | --- |

(d)

Protocol number;

| (e) | Primary objective; |
| --- | --- |

(e)

Primary objective;

| (f) | Competent Authority Contact for this Clinical Investigation; |
| --- | --- |

(f)

Competent Authority Contact for this Clinical Investigation;

| (g) | Decisions taken by Competent Authority pursuant to Article 15(6), date of decision and grounds; |
| --- | --- |

(g)

Decisions taken by Competent Authority pursuant to Article 15(6), date of decision and grounds;

| (h) | Early termination on safety grounds pursuant to Article 15(7), date of decision and grounds. |
| --- | --- |

(h)

Early termination on safety grounds pursuant to Article 15(7), date of decision and grounds.

Directive 90/385/EEC

Minimum data required for Eudamed data entry

Article 10b(1)(a)

| 6. | Certificate (see fields under 3. Certificate) |
| --- | --- |

6.

Certificate (see fields under 3. Certificate)

Article 10b(1)(b) and Article 8(3)

| 7. | Incident (see fields under 4. Incident) |
| --- | --- |

7.

Incident (see fields under 4. Incident)

Article 10b(1)(c) and Article 10(1), (3) and (4)

| 8. | Clinical Investigation (see fields under 5. Clinical Investigation, (a) to (f)):






  (a) | Decisions taken by Competent Authority pursuant to Article 10(3), date of decision and grounds; |
| --- | --- | --- |

8.

Clinical Investigation (see fields under 5. Clinical Investigation, (a) to (f)):

(a)

Decisions taken by Competent Authority pursuant to Article 10(3), date of decision and grounds;

| (b) | Early termination on safety grounds pursuant to Article 10(4), date of decision and grounds. |
| --- | --- |

(b)

Early termination on safety grounds pursuant to Article 10(4), date of decision and grounds.

Directive 98/79/EC

Minimum data required for Eudamed data entry

Article 12(1)(a) and Article 10(1), (3) and (4) and Annex VIII (4)

| 9. | Actor (for all in vitro diagnostic medical devices (IVD’s):
  Address of manufacturer, respectively authorised representative (see fields under 1. Actor). |
| --- | --- |

9.

Actor (for all in vitro diagnostic medical devices (IVD’s):

Address of manufacturer, respectively authorised representative (see fields under 1. Actor).

| 10. | Device:
  For all IVD’s






  (a) | Device (see fields under Device 2.); |
| --- | --- | --- |

10.

Device:

For all IVD’s

(a)

Device (see fields under Device 2.);

| (b) | Information on whether device is ‘new’; |
| --- | --- |

(b)

Information on whether device is ‘new’;

| (c) | Discontinuation of placing on the market. |
| --- | --- |

(c)

Discontinuation of placing on the market.

In addition for Annex II and self-testing

| (d) | Outcome of performance evaluation, where applicable; |
| --- | --- |

(d)

Outcome of performance evaluation, where applicable;

| (e) | Certificates (see fields under 3. Certificate); |
| --- | --- |

(e)

Certificates (see fields under 3. Certificate);

| (f) | Conformity with Common Technical Specifications, where applicable; |
| --- | --- |

(f)

Conformity with Common Technical Specifications, where applicable;

| (g) | Identification of device. |
| --- | --- |

(g)

Identification of device.

Article 12(1)(b)

| 11. | Certificate (see fields under 3. Certificate) |
| --- | --- |

11.

Certificate (see fields under 3. Certificate)

Article 12(1)(c) and Article 11(3)

| 12. | Incident (see fields under 4. Incident) |
| --- | --- |

12.

Incident (see fields under 4. Incident)

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/49 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/49

---

COMMISSION DECISION

of 21 April 2010

authorising the placing on the market of puree and concentrate of the fruits of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2010) 2397)

(Only the English text is authentic)

(2010/228/EU)

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | On 20 April 2006 Tahitian Noni International Inc. made a request to the competent authorities of Belgium to place puree and concentrate of the fruits of Morinda citrifolia on the market as a novel food ingredient. |
| --- | --- |

(1)

On 20 April 2006 Tahitian Noni International Inc. made a request to the competent authorities of Belgium to place puree and concentrate of the fruits of Morinda citrifolia on the market as a novel food ingredient.

| (2) | On 28 February 2007 the competent food assessment body of Belgium issued its initial assessment report. In that report it came to the conclusion that the use of the puree and concentrate of the fruits of Morinda citrifolia as a food ingredient was acceptable. |
| --- | --- |

(2)

On 28 February 2007 the competent food assessment body of Belgium issued its initial assessment report. In that report it came to the conclusion that the use of the puree and concentrate of the fruits of Morinda citrifolia as a food ingredient was acceptable.

| (3) | The Commission forwarded the initial assessment report to all Member States on 28 March 2007. |
| --- | --- |

(3)

The Commission forwarded the initial assessment report to all Member States on 28 March 2007.

| (4) | Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision. |
| --- | --- |

(4)

Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision.

| (5) | Therefore the European Food Safety Authority (EFSA) was consulted on 7 November 2007. |
| --- | --- |

(5)

Therefore the European Food Safety Authority (EFSA) was consulted on 7 November 2007.

| (6) | On 13 March 2009, EFSA in the ‘Scientific opinion of the Panel on Dietetic Products Nutrition and Allergies’ on a request from the European Commission on the safety of ‘Morinda citrifolia (Noni) fruit puree and concentrate’ as a novel food ingredient came to the conclusion that the Noni fruit puree and concentrate was safe for the general population. |
| --- | --- |

(6)

On 13 March 2009, EFSA in the ‘Scientific opinion of the Panel on Dietetic Products Nutrition and Allergies’ on a request from the European Commission on the safety of ‘Morinda citrifolia (Noni) fruit puree and concentrate’ as a novel food ingredient came to the conclusion that the Noni fruit puree and concentrate was safe for the general population.

| (7) | On the basis of the scientific assessment, it is established that the fruit puree and concentrate from Morinda citrifolia (Noni) complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
| --- | --- |

(7)

On the basis of the scientific assessment, it is established that the fruit puree and concentrate from Morinda citrifolia (Noni) complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

| (8) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(8)

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

Morinda citrifolia (Noni) fruit puree and concentrate as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses listed in Annex II.

Article 2

The designation of the Morinda citrifolia fruit puree authorised by this Decision on the labelling of the foodstuff containing it shall be ‘Morinda citrifolia fruit puree’ or ‘Noni fruit puree’.

The designation of the Morinda citrifolia fruit concentrate authorised by this Decision on the labelling of the foodstuff containing it shall be ‘Morinda citrifolia fruit concentrate’ or ‘Noni fruit concentrate’.

Article 3

This Decision is addressed to Tahitian Noni International Inc., 333 West River Park Drive, Provo, Utah 84604, USA.

Done at Brussels, 21 April 2010.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 43, 14.2.1997, p. 1.

1

---

ANNEX I

Specifications of Morinda citrifolia fruit puree and concentrate

Description:

The fruits of Morinda citrifolia are harvested by hand. Seeds and skin are separated mechanically from the pureed fruits. After pasteurisation, the puree is packaged in aseptic containers and stored under cold conditions.

Morinda citrifolia concentrate is prepared from M. citrifolia puree by treatment with pectinolytic enzymes (50-60 °C for 1-2 h). Then the puree is heated to inactivate the pectinases and then immediately cooled. The juice is separated in a decanter centrifuge. Afterwards the juice is collected and pasteurised, prior to being concentrated in a vacuum evaporator from a brix of 6 to 8 to a brix of 49 to 51 in the final concentrate.

| Composition of Morinda citrifolia fruit puree and concentrate |
| --- |
| Moisture | 89 – 93 % | 48 – 53 % |
| Protein | < 0,6 g/100 g | 3 – 3,5 g/100 g |
| Fat | < 0,2 g/100 g | < 0,04 g/100 g |
| Ash | < 1 g/100 g | 4,5 – 5 g/100 g |
| Total carbohydrates | 5 – 10 g/100 g | 37 – 45 g/100 g |
| Fructose | 0,5 – 2 g/100 g | 9 – 11 g/100 g |
| Glucose | 0,5 – 2 g/100 g | 9 – 11 g/100 g |
| Dietary fibre | 1,5 – 3 g/100 g | 1,5 – 5 g/100 g |
| 5,15-dimethylmorindol (*1) | 0,19 – 0,20 μg/mL | 0,11 – 0,77 μg/mL |
| Lucidin (*1) | Not detectable | Not detectable |
| Alizarin (*1) | Not detectable | Not detectable |
| Rubiadin (*1) | Not detectable | Not detectable |

Composition of Morinda citrifolia fruit puree and concentrate

Moisture

89 – 93 %

48 – 53 %

Protein

< 0,6 g/100 g

3 – 3,5 g/100 g

Fat

< 0,2 g/100 g

< 0,04 g/100 g

Ash

< 1 g/100 g

4,5 – 5 g/100 g

Total carbohydrates

5 – 10 g/100 g

37 – 45 g/100 g

Fructose

0,5 – 2 g/100 g

9 – 11 g/100 g

Glucose

0,5 – 2 g/100 g

9 – 11 g/100 g

Dietary fibre

1,5 – 3 g/100 g

1,5 – 5 g/100 g

5,15-dimethylmorindol (*1)

0,19 – 0,20 μg/mL

0,11 – 0,77 μg/mL

Lucidin (*1)

Not detectable

Not detectable

Alizarin (*1)

Not detectable

Not detectable

Rubiadin (*1)

Not detectable

Not detectable

---

(*1)  By an HPLC-UV method developed and validated by the applicant for the analysis of anthraquinones in Morinda citrifolia puree and concentrate.

Limits of detection: 2,5 ng/mL (5,15 dimethylmorindol); 50,0 ng/mL (lucidin); 6,3 ng/mL (alizarin) and 62,5 ng/mL (rubiadin).

---

ANNEX II

Uses of Morinda citrifolia fruit puree and concentrate

| Use group | Maximum use level of Morinda citrifolia fruit |
| --- | --- |
| puree | concentrate |
| Candy/Confectionery | 45 g/100 g | 10 g/100 g |
| Cereal bars | 53 g/100 g | 12 g/100 g |
| Powdered nutritional drink mixes (dry weight) | 53 g/100 g | 12 g/100 g |
| Carbonated beverages | 11 g/100 g | 3 g/100 g |
| Ice cream & sorbet | 31 g/100 g | 7 g/100 g |
| Yogurt | 12 g/100 g | 3 g/100 g |
| Biscuits | 53 g/100 g | 12 g/100 g |
| Buns, cakes & pastries | 53 g/100 g | 12 g/100 g |
| Breakfast cereal (whole grain) | 88 g/100 g | 20 g/100 g |
| Jams and jellies (fruit preserves) | (*1) 133 g/100 g | 30 g/100 g |
| Sweet spreads, fillings and icings | 31 g/100 g | 7 g/100 g |
| Savoury sauces, pickles, gravies, and condiments | 88 g/100 g | 20 g/100 g |
| Food supplements (in accordance with Directive 2002/46/EC of the European Parliament and of the Council (1)) | 26 g per daily dose as recommended by the manufacturer | 6 g per daily dose as recommended by the manufacturer |

Use group

Maximum use level of Morinda citrifolia fruit

puree

concentrate

Candy/Confectionery

45 g/100 g

10 g/100 g

Cereal bars

53 g/100 g

12 g/100 g

Powdered nutritional drink mixes (dry weight)

53 g/100 g

12 g/100 g

Carbonated beverages

11 g/100 g

3 g/100 g

Ice cream & sorbet

31 g/100 g

7 g/100 g

Yogurt

12 g/100 g

3 g/100 g

Biscuits

53 g/100 g

12 g/100 g

Buns, cakes & pastries

53 g/100 g

12 g/100 g

Breakfast cereal (whole grain)

88 g/100 g

20 g/100 g

Jams and jellies (fruit preserves)

(*1) 133 g/100 g

30 g/100 g

Sweet spreads, fillings and icings

31 g/100 g

7 g/100 g

Savoury sauces, pickles, gravies, and condiments

88 g/100 g

20 g/100 g

Food supplements (in accordance with Directive 2002/46/EC of the European Parliament and of the Council (1))

26 g per daily dose as recommended by the manufacturer

6 g per daily dose as recommended by the manufacturer

---

(*1)  Based on pre-processing quantity to produce final 100 g product.

(1)  
  OJ L 183, 12.7.2002, p. 51.

---

| 23.4.2010 | EN | Official Journal of the European Union | L 102/52 |
| --- | --- | --- | --- |

23.4.2010

EN

Official Journal of the European Union

L 102/52

---

COMMISSION DECISION

of 22 April 2010

concerning the draft Decree from Italy setting out standards governing the labelling of shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk, as well as milk products

(notified under document C(2010) 2436)

(Only the Italian text is authentic)

(Text with EEA relevance)

(2010/229/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1), and in particular Article 19 thereof,

Whereas:

| (1) | In accordance with the procedure provided for in the second paragraph of Article 19 of Directive 2000/13/EC, the Italian authorities notified the Commission on 25 August 2009 of the draft Decree setting out standards governing the labelling of shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk, as well as milk products. |
| --- | --- |

(1)

In accordance with the procedure provided for in the second paragraph of Article 19 of Directive 2000/13/EC, the Italian authorities notified the Commission on 25 August 2009 of the draft Decree setting out standards governing the labelling of shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk, as well as milk products.

| (2) | According to Article 1 of the notified Decree, this applies to shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk as well as milk products. |
| --- | --- |

(2)

According to Article 1 of the notified Decree, this applies to shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk as well as milk products.

| (3) | Article 2 of the notified Decree requires that the labels of sterilised shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk must indicate the place of origin of the milk which has undergone the treatments in question. |
| --- | --- |

(3)

Article 2 of the notified Decree requires that the labels of sterilised shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk must indicate the place of origin of the milk which has undergone the treatments in question.

| (4) | Article 3(1) of the notified Decree provides that the labels of milk products must indicate the place of origin of the milk used in the preparation of such products. |
| --- | --- |

(4)

Article 3(1) of the notified Decree provides that the labels of milk products must indicate the place of origin of the milk used in the preparation of such products.

| (5) | Article 3(3) of the notified Decree provides that the labels of cheeses, including cottage cheeses, containing substances obtained from processing milk or milk products must include those substances in the list of ingredients with a reference to the place of origin of the milk used for processing those substances. |
| --- | --- |

(5)

Article 3(3) of the notified Decree provides that the labels of cheeses, including cottage cheeses, containing substances obtained from processing milk or milk products must include those substances in the list of ingredients with a reference to the place of origin of the milk used for processing those substances.

| (6) | Article 4 of the notified Decree provides that the labels of cheeses obtained from curd must indicate the place of origin of the milk used in the curd. |
| --- | --- |

(6)

Article 4 of the notified Decree provides that the labels of cheeses obtained from curd must indicate the place of origin of the milk used in the curd.

| (7) | Directive 2000/13/EC harmonises the rules governing the labelling of foodstuffs by making provision for, on the one hand, harmonisation of certain national provisions and, secondly, arrangements for non-harmonised national provisions. The scope of harmonisation is defined in Article 3(1) of that Directive, which lists all the particulars that are compulsory on the labelling of foodstuffs in accordance with Articles 4 to 17 and subject to the exceptions contained therein. |
| --- | --- |

(7)

Directive 2000/13/EC harmonises the rules governing the labelling of foodstuffs by making provision for, on the one hand, harmonisation of certain national provisions and, secondly, arrangements for non-harmonised national provisions. The scope of harmonisation is defined in Article 3(1) of that Directive, which lists all the particulars that are compulsory on the labelling of foodstuffs in accordance with Articles 4 to 17 and subject to the exceptions contained therein.

| (8) | In particular, in accordance with Article 3(1)(8) of Directive 2000/13/EC the indication of the place of origin or provenance is mandatory where failure to give such a particular might mislead the consumer to a material degree as to the true origin or provenance of the foodstuff. This provision puts in place an appropriate mechanism to counter the risk of consumers being misled in cases where some elements could imply that a given food comes from an origin or provenance different from the true one. |
| --- | --- |

(8)

In particular, in accordance with Article 3(1)(8) of Directive 2000/13/EC the indication of the place of origin or provenance is mandatory where failure to give such a particular might mislead the consumer to a material degree as to the true origin or provenance of the foodstuff. This provision puts in place an appropriate mechanism to counter the risk of consumers being misled in cases where some elements could imply that a given food comes from an origin or provenance different from the true one.

| (9) | Furthermore, Article 4(2) of Directive 2000/13/EC provides that other particulars in addition to those listed in Article 3(1) of that Directive may be required, in the case of specified foodstuffs, by Union provisions or, in their absence, by national provisions. |
| --- | --- |

(9)

Furthermore, Article 4(2) of Directive 2000/13/EC provides that other particulars in addition to those listed in Article 3(1) of that Directive may be required, in the case of specified foodstuffs, by Union provisions or, in their absence, by national provisions.

| (10) | Article 18(2) of Directive 2000/13/EC allows the adoption of non-harmonised national provisions if they are justified on one of the grounds listed therein, including, inter alia, the prevention of fraud and the protection of public health, and provided they are not of such a nature as to impede application of the definitions and rules laid down by Directive 2000/13/EC. Therefore, where draft national labelling provisions have been proposed in a Member State, it is necessary to examine their compatibility with the above-mentioned requirements and the provisions of the Treaty. |
| --- | --- |

(10)

Article 18(2) of Directive 2000/13/EC allows the adoption of non-harmonised national provisions if they are justified on one of the grounds listed therein, including, inter alia, the prevention of fraud and the protection of public health, and provided they are not of such a nature as to impede application of the definitions and rules laid down by Directive 2000/13/EC. Therefore, where draft national labelling provisions have been proposed in a Member State, it is necessary to examine their compatibility with the above-mentioned requirements and the provisions of the Treaty.

| (11) | The Italian authorities maintain that the notified Decree is necessary to define and regulate the traceability system for sterilised shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk and milk products. They also state that the notified Decree is necessary to regulate the labelling of the foods listed in Article 1 thereof in order to ensure that the interests of the consumer are protected to the greatest extent. |
| --- | --- |

(11)

The Italian authorities maintain that the notified Decree is necessary to define and regulate the traceability system for sterilised shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk and milk products. They also state that the notified Decree is necessary to regulate the labelling of the foods listed in Article 1 thereof in order to ensure that the interests of the consumer are protected to the greatest extent.

| (12) | With regard to the traceability of the products listed in Article 1 of the notified Decree, Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (2) requests that, at all stages of production, processing and distribution, a comprehensive system of traceability should be established by food businesses so that targeted and accurate withdrawals can be undertaken or information given to consumers or control officials. In particular, pursuant to Article 18 thereof, food business operators shall be able to identify any person from whom they have been supplied with a food, and the other businesses to which their products have been supplied. Moreover, Article 19 of that Regulation foresees specific obligations for food business operators. The mandatory indication of origin on the label of the finished products in question is not necessary information for the purpose of meeting those traceability requirements. |
| --- | --- |

(12)

With regard to the traceability of the products listed in Article 1 of the notified Decree, Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (2) requests that, at all stages of production, processing and distribution, a comprehensive system of traceability should be established by food businesses so that targeted and accurate withdrawals can be undertaken or information given to consumers or control officials. In particular, pursuant to Article 18 thereof, food business operators shall be able to identify any person from whom they have been supplied with a food, and the other businesses to which their products have been supplied. Moreover, Article 19 of that Regulation foresees specific obligations for food business operators. The mandatory indication of origin on the label of the finished products in question is not necessary information for the purpose of meeting those traceability requirements.

| (13) | In addition, apart from a generic reference to the need of protecting the interests of the consumer, the Italian authorities did not provide any justification allowing to conclude that, as regards the products listed in Article 1 of the notified Decree, the mandatory indication of the origin, beyond the obligation laid down in Article 3(1)(8) of Directive 2000/13/EC, is necessary. |
| --- | --- |

(13)

In addition, apart from a generic reference to the need of protecting the interests of the consumer, the Italian authorities did not provide any justification allowing to conclude that, as regards the products listed in Article 1 of the notified Decree, the mandatory indication of the origin, beyond the obligation laid down in Article 3(1)(8) of Directive 2000/13/EC, is necessary.

| (14) | Therefore, the Italian authorities failed to demonstrate that the indication of origin as provided by the notified Decree is necessary to attain one of the objectives listed in Article 18(2) of Directive 2000/13/EC. |
| --- | --- |

(14)

Therefore, the Italian authorities failed to demonstrate that the indication of origin as provided by the notified Decree is necessary to attain one of the objectives listed in Article 18(2) of Directive 2000/13/EC.

| (15) | In light of these observations, the Commission has delivered a negative opinion on the above-mentioned provisions of the notified Decree, pursuant to the third paragraph of Article 19 of Directive 2000/13/EC. |
| --- | --- |

(15)

In light of these observations, the Commission has delivered a negative opinion on the above-mentioned provisions of the notified Decree, pursuant to the third paragraph of Article 19 of Directive 2000/13/EC.

| (16) | The Italian authorities should accordingly be requested not to adopt the provisions of notified Decree in question. |
| --- | --- |

(16)

The Italian authorities should accordingly be requested not to adopt the provisions of notified Decree in question.

| (17) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(17)

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

Italy shall not adopt Article 2, 3(1) and (3) and Article 4 (as far as the obligation to indicate the place of origin of the milk used in the curd is concerned) of the notified Decree setting out standards governing the labelling of shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk, as well as milk products.

Article 2

This Decision is addressed to the Italian Republic.

Done at Brussels, 22 April 2010.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 109, 6.5.2000, p. 29.

1

(2)  
  OJ L 31, 1.2.2002, p. 1.

2

---