# Official Journal L 44/2011

| | ISSN 1725-2555
  doi:10.3000/17252555.L_2011.044.eng |
| --- | --- |
| Official Journal
  of the European Union | L 44 |
| | |
| English edition | Legislation | Volume 5418 February 2011 |

ISSN 1725-2555

doi:10.3000/17252555.L_2011.044.eng

Official Journal

of the European Union

L 44

English edition

Legislation

Volume 5418 February 2011

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Information relating to the entry into force of the Agreement between the European Union and Georgia on the facilitation of the issuance of visas | 1 |
| | * | Information relating to the entry into force of the Agreement between the European Union and Georgia on the readmission of persons residing without authorisation | 1 |
| | | REGULATIONS |
| | * | Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (
  1
  ) | 2 |
| | * | Commission Regulation (EU) No 144/2011 of 17 February 2011 amending Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (
  1
  ) | 7 |
| | | Commission Regulation (EU) No 145/2011 of 17 February 2011 establishing the standard import values for determining the entry price of certain fruit and vegetables | 21 |
| | | Commission Regulation (EU) No 146/2011 of 17 February 2011 fixing the minimum selling price for skimmed milk powder for the 16th individual invitation to tender within the tendering procedure opened by Regulation (EU) No 447/2010 | 23 |
| | | Commission Regulation (EU) No 147/2011 of 17 February 2011 fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95 | 24 |
| | | Commission Regulation (EU) No 148/2011 of 17 February 2011 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EU) No 867/2010 for the 2010/11 marketing year | 26 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Information relating to the entry into force of the Agreement between the European Union and Georgia on the facilitation of the issuance of visas

1

*

Information relating to the entry into force of the Agreement between the European Union and Georgia on the readmission of persons residing without authorisation

1

REGULATIONS

*

Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (
  1
  )

1

2

*

Commission Regulation (EU) No 144/2011 of 17 February 2011 amending Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (
  1
  )

1

7

Commission Regulation (EU) No 145/2011 of 17 February 2011 establishing the standard import values for determining the entry price of certain fruit and vegetables

21

Commission Regulation (EU) No 146/2011 of 17 February 2011 fixing the minimum selling price for skimmed milk powder for the 16th individual invitation to tender within the tendering procedure opened by Regulation (EU) No 447/2010

23

Commission Regulation (EU) No 147/2011 of 17 February 2011 fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95

24

Commission Regulation (EU) No 148/2011 of 17 February 2011 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EU) No 867/2010 for the 2010/11 marketing year

26

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

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(1)   Text with EEA relevance

1

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

EN

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

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

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II Non-legislative acts

INTERNATIONAL AGREEMENTS

| 18.2.2011 | EN | Official Journal of the European Union | L 44/1 |
| --- | --- | --- | --- |

18.2.2011

EN

Official Journal of the European Union

L 44/1

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Information relating to the entry into force of the Agreement between the European Union and Georgia on the facilitation of the issuance of visas

The Agreement between the European Union and Georgia on the facilitation of the issuance of visas will enter into force on 1 March 2011, the procedure provided for in Article 14 of the Agreement having been completed on 18 January 2011.

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| 18.2.2011 | EN | Official Journal of the European Union | L 44/1 |
| --- | --- | --- | --- |

18.2.2011

EN

Official Journal of the European Union

L 44/1

---

Information relating to the entry into force of the Agreement between the European Union and Georgia on the readmission of persons residing without authorisation

The Agreement between the European Union and Georgia on the readmission of persons residing without authorisation will enter into force on 1 March 2011, the procedure provided for in Article 23 of the Agreement having been completed on 18 January 2011.

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REGULATIONS

| 18.2.2011 | EN | Official Journal of the European Union | L 44/2 |
| --- | --- | --- | --- |

18.2.2011

EN

Official Journal of the European Union

L 44/2

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COMMISSION REGULATION (EU) No 143/2011

of 17 February 2011

amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’)

(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 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Articles 58 and 131 thereof,

Whereas:

| (1) | Regulation (EC) No 1907/2006 provides that substances meeting the criteria for classification as carcinogenic (category 1 or 2), mutagenic (category 1 or 2) and toxic for reproduction (category 1 or 2) in accordance with Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (2), substances that are persistent, bioaccumulative and toxic, substances that are very persistent and very bioaccumulative, and/or substances for which there is scientific evidence of probable serious effects to human health and environment giving rise to an equivalent level of concern may be subject to authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1907/2006 provides that substances meeting the criteria for classification as carcinogenic (category 1 or 2), mutagenic (category 1 or 2) and toxic for reproduction (category 1 or 2) in accordance with Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (2), substances that are persistent, bioaccumulative and toxic, substances that are very persistent and very bioaccumulative, and/or substances for which there is scientific evidence of probable serious effects to human health and environment giving rise to an equivalent level of concern may be subject to authorisation.

| (2) | Pursuant to Article 58(4) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (3), as from 1 December 2010 Article 57(a), (b) and (c) of Regulation (EC) No 1907/2006 shall refer to the classification criteria laid down respectively in Sections 3.6, 3.5 and 3.7 of Annex I to Regulation (EC) No 1272/2008. Therefore, references in this Regulation to the classification criteria referred to in Article 57 of Regulation (EC) No 1907/2006 should be made in accordance with that provision. |
| --- | --- |

(2)

Pursuant to Article 58(4) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (3), as from 1 December 2010 Article 57(a), (b) and (c) of Regulation (EC) No 1907/2006 shall refer to the classification criteria laid down respectively in Sections 3.6, 3.5 and 3.7 of Annex I to Regulation (EC) No 1272/2008. Therefore, references in this Regulation to the classification criteria referred to in Article 57 of Regulation (EC) No 1907/2006 should be made in accordance with that provision.

| (3) | 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) is very persistent and very bioaccumulative in accordance with the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(e) and set out in Annex XIII to that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation. |
| --- | --- |

(3)

5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) is very persistent and very bioaccumulative in accordance with the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(e) and set out in Annex XIII to that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation.

| (4) | 4,4’-Diaminodiphenylmethane (MDA) meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(a) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation. |
| --- | --- |

(4)

4,4’-Diaminodiphenylmethane (MDA) meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(a) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation.

| (5) | Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins – SCCPs) are persistent, bioaccumulative and toxic, and very persistent and very bioaccumulative in accordance with the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(d) and (e) respectively and set out in Annex XIII to that Regulation. They have been identified and included in the candidate list in accordance with Article 59 of that Regulation. |
| --- | --- |

(5)

Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins – SCCPs) are persistent, bioaccumulative and toxic, and very persistent and very bioaccumulative in accordance with the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(d) and (e) respectively and set out in Annex XIII to that Regulation. They have been identified and included in the candidate list in accordance with Article 59 of that Regulation.

| (6) | Hexabromocyclododecane (HBCDD) and the diastereoisomers alpha-, beta- and gamma-hexabromocyclododecane are persistent, bioaccumulative and toxic in accordance with the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(d) and set out in Annex XIII to that Regulation. They have been identified and included in the candidate list in accordance with Article 59 of that Regulation. |
| --- | --- |

(6)

Hexabromocyclododecane (HBCDD) and the diastereoisomers alpha-, beta- and gamma-hexabromocyclododecane are persistent, bioaccumulative and toxic in accordance with the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(d) and set out in Annex XIII to that Regulation. They have been identified and included in the candidate list in accordance with Article 59 of that Regulation.

| (7) | Bis(2-ethylhexyl) phthalate (DEHP) meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation. |
| --- | --- |

(7)

Bis(2-ethylhexyl) phthalate (DEHP) meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation.

| (8) | Benzyl butyl phthalate (BBP) meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation. |
| --- | --- |

(8)

Benzyl butyl phthalate (BBP) meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation.

| (9) | Dibutyl phthalate (DBP) meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation. |
| --- | --- |

(9)

Dibutyl phthalate (DBP) meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 pursuant to Article 57(c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of that Regulation.

| (10) | The abovementioned substances have been prioritised for inclusion in Annex XIV to Regulation (EC) No 1907/2006 by the European Chemicals Agency in its recommendation of 1 June 2009 (4) in accordance with Article 58 of that Regulation. |
| --- | --- |

(10)

The abovementioned substances have been prioritised for inclusion in Annex XIV to Regulation (EC) No 1907/2006 by the European Chemicals Agency in its recommendation of 1 June 2009 (4) in accordance with Article 58 of that Regulation.

| (11) | In December 2009, SCCPs were included as a persistent organic pollutant under the 1998 Protocol on Persistent Organic Pollutants to the 1979 Convention on Long-Range Transboundary Air Pollution. The inclusion of SCCPs in this Protocol has triggered additional obligations for the European Union under Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (5) that could have an impact on the inclusion at this stage of SCCPs in Annex XIV to Regulation (EC) No 1907/2006. |
| --- | --- |

(11)

In December 2009, SCCPs were included as a persistent organic pollutant under the 1998 Protocol on Persistent Organic Pollutants to the 1979 Convention on Long-Range Transboundary Air Pollution. The inclusion of SCCPs in this Protocol has triggered additional obligations for the European Union under Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (5) that could have an impact on the inclusion at this stage of SCCPs in Annex XIV to Regulation (EC) No 1907/2006.

| (12) | For each substance listed in Annex XIV to Regulation (EC) No 1907/2006, where the applicant wishes to continue to use the substance or place the substance on the market, it is appropriate to set a date by which applications must be received by the European Chemicals Agency, in accordance with Article 58(1)(c)(ii) of that Regulation. |
| --- | --- |

(12)

For each substance listed in Annex XIV to Regulation (EC) No 1907/2006, where the applicant wishes to continue to use the substance or place the substance on the market, it is appropriate to set a date by which applications must be received by the European Chemicals Agency, in accordance with Article 58(1)(c)(ii) of that Regulation.

| (13) | For each substance listed in Annex XIV to Regulation (EC) No 1907/2006 it is appropriate to set a date from which the use and placing on the market is prohibited, in accordance with Article 58(1)(c)(i) of that Regulation. |
| --- | --- |

(13)

For each substance listed in Annex XIV to Regulation (EC) No 1907/2006 it is appropriate to set a date from which the use and placing on the market is prohibited, in accordance with Article 58(1)(c)(i) of that Regulation.

| (14) | The European Chemicals Agency recommendation of 1 June 2009 has identified different latest application dates for the substances listed in the Annex to this Regulation. These dates should be set on the basis of the estimated time that would be required to prepare an application for the authorisation, taking into account the information available on the different substances and specifically the information received during the public consultation carried out in accordance with Article 58(4) of Regulation (EC) No 1907/2006. Factors such as the number of actors in the supply chain, their homogeneity or heterogeneity, the existence of ongoing substitution efforts and information on potential alternatives and the expected complexity of the preparation of the analysis of alternatives should be taken into account. |
| --- | --- |

(14)

The European Chemicals Agency recommendation of 1 June 2009 has identified different latest application dates for the substances listed in the Annex to this Regulation. These dates should be set on the basis of the estimated time that would be required to prepare an application for the authorisation, taking into account the information available on the different substances and specifically the information received during the public consultation carried out in accordance with Article 58(4) of Regulation (EC) No 1907/2006. Factors such as the number of actors in the supply chain, their homogeneity or heterogeneity, the existence of ongoing substitution efforts and information on potential alternatives and the expected complexity of the preparation of the analysis of alternatives should be taken into account.

| (15) | In accordance with Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006, the latest application date is to be set at least 18 months before the sunset date. |
| --- | --- |

(15)

In accordance with Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006, the latest application date is to be set at least 18 months before the sunset date.

| (16) | Article 58(1)(e) in conjunction with Article 58(2) of Regulation (EC) No 1907/2006 provides for the possibility of exemptions of uses or categories of uses in cases where there is specific Community legislation imposing minimum requirements relating to the protection of human health or the environment that ensures proper control of the risks. |
| --- | --- |

(16)

Article 58(1)(e) in conjunction with Article 58(2) of Regulation (EC) No 1907/2006 provides for the possibility of exemptions of uses or categories of uses in cases where there is specific Community legislation imposing minimum requirements relating to the protection of human health or the environment that ensures proper control of the risks.

| (17) | DEHP, BBP, and DBP are used in the immediate packaging of medicinal products. Aspects of safety of the immediate packaging of medicines are covered by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (6) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (7). That legislation of the Union provides for a framework to properly control risks of such immediate packaging materials by imposing requirements on the quality, stability, and safety of the immediate packaging materials. It is therefore appropriate to exempt the use of DEHP, BBP, and DBP in the immediate packaging of medicinal products from authorisation under Regulation (EC) No 1907/2006. |
| --- | --- |

(17)

DEHP, BBP, and DBP are used in the immediate packaging of medicinal products. Aspects of safety of the immediate packaging of medicines are covered by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (6) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (7). That legislation of the Union provides for a framework to properly control risks of such immediate packaging materials by imposing requirements on the quality, stability, and safety of the immediate packaging materials. It is therefore appropriate to exempt the use of DEHP, BBP, and DBP in the immediate packaging of medicinal products from authorisation under Regulation (EC) No 1907/2006.

| (18) | In accordance with Article 60(2) of Regulation (EC) No 1907/2006, the Commission should not consider, when granting authorisations, the human health risks associated with the use of substances in medical devices regulated by 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 (8), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (9), or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (10). In addition, Article 62(6) of Regulation (EC) No 1907/2006 provides that applications for authorisation should not include the risks to human health arising from the use of a substance in a medical device regulated under those Directives. It follows that an application for an authorisation should not be required for a substance used in medical devices regulated under Directives 90/385/EEC, 93/42/EEC, or 98/79/EC if such a substance has been identified in Annex XIV to Regulation (EC) No 1907/2006 for human health concerns only. Therefore, an assessment as to whether the conditions for an exemption pursuant to Article 58(2) of Regulation (EC) No 1907/2006 apply is not necessary. |
| --- | --- |

(18)

In accordance with Article 60(2) of Regulation (EC) No 1907/2006, the Commission should not consider, when granting authorisations, the human health risks associated with the use of substances in medical devices regulated by 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 (8), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (9), or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (10). In addition, Article 62(6) of Regulation (EC) No 1907/2006 provides that applications for authorisation should not include the risks to human health arising from the use of a substance in a medical device regulated under those Directives. It follows that an application for an authorisation should not be required for a substance used in medical devices regulated under Directives 90/385/EEC, 93/42/EEC, or 98/79/EC if such a substance has been identified in Annex XIV to Regulation (EC) No 1907/2006 for human health concerns only. Therefore, an assessment as to whether the conditions for an exemption pursuant to Article 58(2) of Regulation (EC) No 1907/2006 apply is not necessary.

| (19) | On the basis of the information currently available it is not appropriate to set exemptions for product and process orientated research and development. |
| --- | --- |

(19)

On the basis of the information currently available it is not appropriate to set exemptions for product and process orientated research and development.

| (20) | On the basis of the information currently available it is not appropriate to set review periods for certain uses. |
| --- | --- |

(20)

On the basis of the information currently available it is not appropriate to set review periods for certain uses.

| (21) | The measures provided for in this Regulation are in accordance with the opinion of the Committee established pursuant to Article 133 of Regulation (EC) No 1907/2006, |
| --- | --- |

(21)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established pursuant to Article 133 of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

Article 1

Annex XIV to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 17 February 2011.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 396, 30.12.2006, p. 1.

1

(2)  
  OJ 196, 16.8.1967, p. 1.

2

(3)  
  OJ L 353, 31.12.2008, p. 1.

3

(4)  http://echa.europa.eu/chem_data/authorisation_process/annex_xiv_rec_en.asp

4

(5)  
  OJ L 158, 30.4.2004, p. 7.

5

(6)  
  OJ L 311, 28.11.2001, p. 1.

6

(7)  
  OJ L 311, 28.11.2001, p. 67.

7

(8)  
  OJ L 189, 20.7.1990, p. 17.

8

(9)  
  OJ L 169, 12.7.1993, p. 1.

9

(10)  
  OJ L 331, 7.12.1998, p. 1.

10

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ANNEX

In Annex XIV to Regulation (EC) No 1907/2006 the following table is inserted:

| ‘Entry Nr | Substance | Intrinsic property(ies) referred to in Article 57 | Transitional arrangements | Exempted (categories of) uses | Review periods |
| --- | --- | --- | --- | --- | --- |
| Latest application date (1) | Sunset date (2) |
| 1. | 5-tert-butyl-2,4,6-trinitro-m-xylene
  (Musk xylene)
  EC No: 201-329-4
  CAS No: 81-15-2 | vPvB | 21 January 2013 | 21 July 2014 | — | — |
| 2. | 4,4’-Diaminodiphenylmethane

  (MDA)

  EC No: 202-974-4
  CAS No: 101-77-9 | Carcinogenic
  (category 1B) | 21 January 2013 | 21 July 2014 | — | — |
| 3. | Hexabromocyclododecane
  (HBCDD)
  EC No: 221-695-9,
  247-148-4,
  CAS No: 3194-55-6
  25637-99-4
  alpha-hexabromocyclododecane







  CAS No | : | 134237-50-6, |

‘Entry Nr

Substance

Intrinsic property(ies) referred to in Article 57

Transitional arrangements

Exempted (categories of) uses

Review periods

Latest application date (1)

Sunset date (2)

1.

5-tert-butyl-2,4,6-trinitro-m-xylene

(Musk xylene)

EC No: 201-329-4

CAS No: 81-15-2

vPvB

21 January 2013

21 July 2014

—

—

2.

4,4’-Diaminodiphenylmethane

(MDA)

EC No: 202-974-4

CAS No: 101-77-9

Carcinogenic

(category 1B)

21 January 2013

21 July 2014

—

—

3.

Hexabromocyclododecane

(HBCDD)

EC No: 221-695-9,

247-148-4,

CAS No: 3194-55-6

25637-99-4

alpha-hexabromocyclododecane

CAS No

:

134237-50-6,

beta-hexabromocyclododecane

| CAS No | : | 134237-51-7 |
| --- | --- | --- |

CAS No

:

134237-51-7

gamma-hexabromocyclododecane

| CAS No | : | 134237-52-8 |
| --- | --- | --- |

CAS No

:

134237-52-8

PBT

21 January 2014

21 July 2015

—

—

4.

Bis(2-ethylhexyl) phthalate

(DEHP)

EC No: 204-211-0

CAS No: 117-81-7

Toxic for reproduction

(category 1B)

21 July 2013

21 January 2015

Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.

5.

Benzyl butyl phthalate

(BBP)

EC No: 201-622-7

CAS No: 85-68-7

Toxic for reproduction

(category 1B)

21 July 2013

21 January 2015

Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.

6.

Dibutyl phthalate

(DBP)

EC No: 201-557-4

CAS No: 84-74-2

Toxic for reproduction

(category 1B)

21 July 2013

21 January 2015

Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.

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(1)  Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006.

1

(2)  Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006.’

2

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| 18.2.2011 | EN | Official Journal of the European Union | L 44/7 |
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18.2.2011

EN

Official Journal of the European Union

L 44/7

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COMMISSION REGULATION (EU) No 144/2011

of 17 February 2011

amending Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements

(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 subparagraph of Article 8(1) and Article 9(2)(b) thereof,

Having regard to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC (2), and in particular the first subparagraph of Article 6(1) and Article 7(e) thereof,

Whereas:

| (1) | Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (3) applies to intra-Union trade in bovine animals. It provides that bovine animals for breeding and production must come from an officially enzootic-bovine-leukosis-free herd and if more than 12 months old, have reacted negatively to an individual test carried out during the 30 days prior to leaving the herd of origin and complying with the provisions of Annex D thereto. |
| --- | --- |

(1)

Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (3) applies to intra-Union trade in bovine animals. It provides that bovine animals for breeding and production must come from an officially enzootic-bovine-leukosis-free herd and if more than 12 months old, have reacted negatively to an individual test carried out during the 30 days prior to leaving the herd of origin and complying with the provisions of Annex D thereto.

| (2) | Directive 64/432/EEC also sets out diagnostic tests to be used for brucellosis and the certification requirements for intra-Union trade in bovine animals for breeding and production. In addition, that Directive, as amended by Commission Decision 2008/984/EC (4), now includes fluorescence polarization assay as a standard diagnostic test. |
| --- | --- |

(2)

Directive 64/432/EEC also sets out diagnostic tests to be used for brucellosis and the certification requirements for intra-Union trade in bovine animals for breeding and production. In addition, that Directive, as amended by Commission Decision 2008/984/EC (4), now includes fluorescence polarization assay as a standard diagnostic test.

| (3) | Directive 2004/68/EC lays down the animal health requirements for the importation into, and transit through, the Union of live ungulates. Those requirements include specific animal health requirements for live ungulates which are to be based on the rules laid down in Union legislation for the diseases to which those animals are susceptible. |
| --- | --- |

(3)

Directive 2004/68/EC lays down the animal health requirements for the importation into, and transit through, the Union of live ungulates. Those requirements include specific animal health requirements for live ungulates which are to be based on the rules laid down in Union legislation for the diseases to which those animals are susceptible.

| (4) | Directive 2004/68/EC also provides that specific conditions may be laid down for third countries for which equivalence has been formally recognised by the Union based on the official health guarantees provided by the third country concerned. |
| --- | --- |

(4)

Directive 2004/68/EC also provides that specific conditions may be laid down for third countries for which equivalence has been formally recognised by the Union based on the official health guarantees provided by the third country concerned.

| (5) | Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (5) lays down the veterinary certification requirements for the introduction into the Union of certain consignments of live animals or fresh meat. Annexes I and II thereto lay down lists of third countries, territories or parts thereof from which consignments of those animals and meat may be introduced into the Union. |
| --- | --- |

(5)

Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (5) lays down the veterinary certification requirements for the introduction into the Union of certain consignments of live animals or fresh meat. Annexes I and II thereto lay down lists of third countries, territories or parts thereof from which consignments of those animals and meat may be introduced into the Union.

| (6) | In addition, Annex I to Regulation (EU) No 206/2010 sets out specific conditions for the introduction into the Union of domestic bovine animals intended for breeding and production, together with a model veterinary certificate for those animals, including Bubalus and Bison species, and their cross-breeds (BOV-X). |
| --- | --- |

(6)

In addition, Annex I to Regulation (EU) No 206/2010 sets out specific conditions for the introduction into the Union of domestic bovine animals intended for breeding and production, together with a model veterinary certificate for those animals, including Bubalus and Bison species, and their cross-breeds (BOV-X).

| (7) | Special condition ‘IVb’ of Annex I to Regulation (EU) No 206/2010 refers to ‘territory with approved holdings recognised as having an official enzootic-bovine-leukosis (EBL) free status for the purposes of exports to the Union of live animals certified according to the model of certificate (BOV–X)’. That special condition should be amended to take account of the provisions concerning officially enzootic-bovine-leukosis-free herds laid down in Directive 64/432/EEC. |
| --- | --- |

(7)

Special condition ‘IVb’ of Annex I to Regulation (EU) No 206/2010 refers to ‘territory with approved holdings recognised as having an official enzootic-bovine-leukosis (EBL) free status for the purposes of exports to the Union of live animals certified according to the model of certificate (BOV–X)’. That special condition should be amended to take account of the provisions concerning officially enzootic-bovine-leukosis-free herds laid down in Directive 64/432/EEC.

| (8) | Accordingly, specific condition IVb set out in Part 1 of Annex I to Regulation (EU) No 206/2010 and model of veterinary certificate (BOV-X) set out in Part 2 of that Annex should therefore be amended accordingly. |
| --- | --- |

(8)

Accordingly, specific condition IVb set out in Part 1 of Annex I to Regulation (EU) No 206/2010 and model of veterinary certificate (BOV-X) set out in Part 2 of that Annex should therefore be amended accordingly.

| (9) | In addition, Part 6 of Annex I to Regulation (EU) No 206/2010 should be amended to take account of the flurorescence polarization essay diagnostic test set out in Directive 64/432/EEC. |
| --- | --- |

(9)

In addition, Part 6 of Annex I to Regulation (EU) No 206/2010 should be amended to take account of the flurorescence polarization essay diagnostic test set out in Directive 64/432/EEC.

| (10) | Regulation (EU) No 206/2010 also provides that fresh meat introduced into the Union must satisfy the requirements set out in the appropriate veterinary certificate for that meat in accordance with the models set out in Part 2 of Annex II, taking into account any specific conditions or supplementary guarantees required for such meat. |
| --- | --- |

(10)

Regulation (EU) No 206/2010 also provides that fresh meat introduced into the Union must satisfy the requirements set out in the appropriate veterinary certificate for that meat in accordance with the models set out in Part 2 of Annex II, taking into account any specific conditions or supplementary guarantees required for such meat.

| (11) | Botswana has requested the authorisation to export to the Union de-boned and matured bovine meat of animals from the veterinary control zone 4a within the territory identified as BW-4 in column 2 of the table in Part 1 of Annex II to Regulation (EU) No 206/2010. |
| --- | --- |

(11)

Botswana has requested the authorisation to export to the Union de-boned and matured bovine meat of animals from the veterinary control zone 4a within the territory identified as BW-4 in column 2 of the table in Part 1 of Annex II to Regulation (EU) No 206/2010.

| (12) | Requirements for imports of meat from third countries into the Union depend on the animal health status of the exporting third country, territory or part thereof. The World Organisation for Animal Health (OIE) determines the foot-and-mouth disease (FMD) status of its member countries and in May 2010 recognised the area in question as a FMD free zone where vaccination is not practised. Botswana has established an intensive surveillance zone of 10 km to segregate the disease free zone from other parts of that country. |
| --- | --- |

(12)

Requirements for imports of meat from third countries into the Union depend on the animal health status of the exporting third country, territory or part thereof. The World Organisation for Animal Health (OIE) determines the foot-and-mouth disease (FMD) status of its member countries and in May 2010 recognised the area in question as a FMD free zone where vaccination is not practised. Botswana has established an intensive surveillance zone of 10 km to segregate the disease free zone from other parts of that country.

| (13) | Botswana should thus be authorised for the introduction into the Union of de-boned and matured bovine meat of animals from the disease free zone. Column 4 of the table in Part 1 of Annex II to Regulation (EU) No 206/2010 should therefore refer to model veterinary certificate BOV. Part 1 of Annex II to that Regulation should therefore be amended accordingly. |
| --- | --- |

(13)

Botswana should thus be authorised for the introduction into the Union of de-boned and matured bovine meat of animals from the disease free zone. Column 4 of the table in Part 1 of Annex II to Regulation (EU) No 206/2010 should therefore refer to model veterinary certificate BOV. Part 1 of Annex II to that Regulation should therefore be amended accordingly.

| (14) | Annexes I and II to Regulation (EU) No 206/2010 should therefore be amended accordingly. |
| --- | --- |

(14)

Annexes I and II to Regulation (EU) No 206/2010 should therefore be amended accordingly.

| (15) | It is necessary to provide for a transitional period in order to give Member States and the industry sufficient time to take the necessary measures to comply with the requirements laid down in Regulation (EU) No 206/2010, as amended by this Regulation, without any disruption to trade. |
| --- | --- |

(15)

It is necessary to provide for a transitional period in order to give Member States and the industry sufficient time to take the necessary measures to comply with the requirements laid down in Regulation (EU) No 206/2010, as amended by this Regulation, without any disruption to trade.

| (16) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(16)

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

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and II to Regulation (EU) No 206/2010 are amended in accordance with the Annex to this Regulation.

Article 2

For a transitional period until 31 May 2011, consignments of domestic bovine animals intended for breeding and/or production after import accompanied by a veterinary certificate in accordance with the Model BOV-X, as set out in Part 2 of Annex I to Regulation (EU) No 206/2010 before the amendments introduced by Article 1 of this Regulation, may continue to be introduced into the Union.

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, 17 February 2011.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  
  OJ L 139, 30.4.2004, p. 321.

2

(3)  
  OJ 121, 29.7.1964, p. 1977.

3

(4)  
  OJ L 352, 31.12.2008, p. 38.

4

(5)  
  OJ L 73, 20.3.2010, p. 1.

5

---

ANNEX

The Annexes to Regulation (EU) No 206/2010 are amended as follows:

| (1) | Annex I is amended as follows:






  (a) | In Part 1, specific condition ‘IVb’ is replaced by the following:






  ‘ “IVb”: | recognised as having officially enzootic-bovine-leukosis (EBL)-free herds equivalent to the requirements set out in Annex D to Directive 64/432/EEC for the purposes of exports to the Union of live animals certified according to the model of certificate BOV–X.’ |
| --- | --- | --- | --- |

(1)

Annex I is amended as follows:

(a)

In Part 1, specific condition ‘IVb’ is replaced by the following:

‘ “IVb”:

| (b) | In Part 2, Model BOV-X is replaced by the following:

  ‘
  Model BOV-X




  Text of image

  Part I: Details of dispached consignment
  COUNTRY
  Veterinary certificate to EU
  I.1. Consignor
  Name
  Address
  Tel.
  I.2. Certificate reference No
  I.2.a.
  I.3. Central competent authority
  I.4. Local competent authority
  I.5. Consignee
  Name
  Address
  Postal code
  Tel.
  I.6.
  I.7. Country of origin
  ISO code
  I.8. Region of origin
  Code
  I.9. Country of destination
  ISO code
  I.10. Region of destination
  Code
  I.11. Place of origin
  Name
  Approval number
  Address
  I.12.
  I.13. Place of loading
  Address
  Approval number
  I.14. Date of departure
  I.15. Means of transport
  Aeroplane
  Ship
  Railway wagon
  Road vehicle
  Other
  Identification
  Documentary references
  I.16. Entry BIP in EU
  I.17.
  I.18. Description of commodity
  I.19. Commodity code (HS code)
  01.02
  I.20. Quantity
  I.21.
  I.22. Number of packages
  I.23. Seal/Container No
  I.24.
  I.25. Commodities certified for:
  Breeding
  Fattening
  I.26.
  I.27. For import or admission into the EU
  I.28. Identification of the commodities
  Species
  (scientific name)
  Breed
  Identification system
  Identification number
  Age
  Sex




  Text of image

  Part II: Certification
  COUNTRY
  Model BOV-X
  II. Health information
  II.a. Certificate reference number
  II.b.
  II.1. Public Health Attestation
  I, the undersigned official veterinarian, hereby certify, that the animals described in this certificate:
  II.1.1. come from holdings which have been free from any official prohibition on health grounds, for the past 42 days in the case of brucellosis, for the past 30 days in the case of anthrax and for the past 6 months in the case of rabies, and, have not been in contact with animals from holdings which did not satisfy these conditions;
  II.1.2. have not received:
  any stilbene or thyrostatic substances,
  oestrogenic, androgenic, gestagenic or β-agonist substances for purposes other than therapeutic or zootechnic treatment (as defined in Directive 96/22/EC),
  II.1.3. with regard to bovine spongiform encephalopathy (BSE):
  (1) (2) either [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;
  (b) if there have been BSE indigenous cases in the country concerned, the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]
  (1) (3) or [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;
  (b) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]
  (1) (4) or [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;
  (b) the animals were born at least 2 years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]
  II.2. Animal Health attestation:
  I, the undersigned official veterinarian, hereby certify, that the animals described above meet the following requirements:
  II.2.1. they come from the territory with code: ... (5) which, at the date of issuing this certificate:
  (1) either [(a) has been free for 24 months from foot-and-mouth disease, for 12 months from rinderpest, bluetongue, Rift valley fever, contagious bovine pleuropneumonia, lumpy skin disease and epizootic haemorrhagic disease, and for 6 months from vesicular stomatitis,]
  (1) or [(a) (i) has been free for 12 months from rinderpest, bluetongue, Rift valley fever, contagious bovine pleuropneumonia, lumpy skin disease and epizootic haemorrhagic disease, and for 6 months from vesicular stomatitis,
  (ii) has been considered free from foot-and-mouth disease since ... (dd/mm/yyyy), without having had cases/outbreaks after that date, and authorised to export these animals by Commission Decision / /EU, of ... (dd/mm/yyyy),]
  and (b) where during the last 12 months, no vaccination against these diseases has been carried out and imports of domestic cloven-hoofed animals vaccinated against these diseases are not permitted;
  II.2.2. they have remained in the territory described under point II.2.1. since birth, or for at least the last 6 months before dispatch to the Union and without contact with imported cloven-hoofed animals for the last 30 days;




  Text of image

  COUNTRY
  Model BOV-X
  II. Health information
  II.a. Certificate reference No
  II.b.
  II.2.3. they have remained since birth or at least 40 days before dispatch in the holding(s) of origin described under box reference I.11.:
  (a) in and around which, in an area with a 150 km radius, there has been no case/outbreak of bluetongue and epizootic haemorrhagic disease during the previous 60 days,
  (b) in and around which, in an area with a 10 km radius, there has been no case/outbreak of the other diseases referred to in point II.2.1. during the previous 40 days;
  II.2.4. they are not animals to be killed under a national programme for the eradication of diseases, nor have they been vaccinated against the diseases referred to under point II.2.1.;
  II.2.5. they come from herds that are not restricted under the national legislation pertaining to the eradication of tuberculosis, brucellosis and enzootic bovine leukosis;
  II.2.6. they come from herds recognised as officially tuberculosis-free (6);
  and (1) (7) either [come from a region which is recognised as officially tuberculosis-free (6);]
  (1) or [have been subjected to an intradermal tuberculin test (8) carried out with negative results within the past 30 days before dispatch to the Union;]
  (1) or [are less than 6 weeks old;]
  [II.2.7. they have not been vaccinated against brucellosis and come from herds recognised as officially brucellosis-free (6);
  and (1) (7) either [come from a region which is recognised as officially brucellosis-free (6),]
  (1) or [have been subjected to at least one test for bovine brucellosis (8) carried out on samples taken within the past 30 days before dispatch to the Union,]
  (1) or [are less than 12 months old,]
  (1) or [are castrated males of any age,]
  (1) either [II.2.8A. they come from herds included in an official system for the control of enzootic bovine leukosis, and in which there has been no evidence either clinical or as a result of a laboratory test of this disease during the past 2 years,]
  (1) or [II.2.8A. they come from herds recognised as officially enzootic-bovine-leukosis-free (6) (6a),]
  and (1) (7) either [come from a region which is recognised as officially enzootic-bovine-leukosis-free (6);]
  (1) or [have been subjected to an individual test for enzootic bovine leukosis (8) carried out with negative result on samples taken within the past 30 days before dispatch to the Union;]
  (1) or [are less than 12 months old;]
  (1) (9) [II.2.8B. they have reacted negatively to a serological test for the detection of antibody for bluetongue and epizootic haemorrhagic disease, carried out on two occasions on samples of blood taken at the beginning of the isolation/quarantine period and at least 28 days later, on ... (dd/mm/yyyy) and on ... (dd/mm/yyyy), the second of which must have been taken within 10 days before export;]
  II.2.9 they are/were (1) dispatched from their holding(s) of origin, without passing through any market:
  (1) either [directly to the Union,]
  (1) or [to the officially authorised assembly centre described under box reference I.13. situated within the territory described under point II.2.1.,]
  and, until dispatched to the Union:
  (a) they did not come in contact with other cloven-hoofed animals not complying with the health requirements as described in this certificate,




  Text of image

  COUNTRY
  Model BOV-X
  II. Health information
  II.a. Certificate reference No
  II.b.
  (b) they were not at any place where, or around which, within a 10 km radius, during the previous 30 days there has been a case/outbreak of any of the diseases referred to in point II.2.1.;
  II.2.10. any transport vehicles or containers in which they were loaded were cleaned and disinfected before loading with an officially authorised disinfectant;
  II.2.11. they were examined by an official veterinarian within 24 hours of loading and showed no clinical sign of disease;
  II.2.12. they have been loaded for dispatch to the Union on (dd/mm/yyyy) (10) in the means of transport described under box reference I.15. above that were cleaned and disinfected before loading with an officially authorised disinfectant and so constructed that faeces, urine, litter or fodder could not flow or fall out of the vehicle or container during transportation.
  II.3. Animal transport attestation
  I, the undersigned official veterinarian, hereby certify, that the animals described above have been treated before and at the time of loading in accordance with the relevant provisions of Regulation (EC) No 1/2005, in particular as regards watering and feeding, and they are fit for the intended transport.
  (1) (11) [II.4. Specific requirements
  II.4.1. According to official information, no clinical or pathological evidence of infectious bovine rhinotracheitis (IBR) has been recorded in the holding(s) of origin referred to in box reference I.11., for the last 12 months;
  II.4.2. the animals referred to in box reference I.28.:
  (a) have been isolated in accommodation approved by the competent authority for the last 30 days immediately prior to dispatch for export,
  (b) have been subjected to a serological test for IBR on sera taken at least 21 days after entry into isolation, with negative results, and all animals in isolation have also given negative results to this test, and
  (c) have not been vaccinated against IBR.]
  Notes
  This certificate is meant for domestic bovine animals (including Bubalus and Bison species and their cross-breeds) intended for breeding and/or production.
  After importation the animals must be conveyed without delay to the holding of destination where they shall remain for a minimum period of 30 days before further movement outside the holding, except in the case of a dispatch to a slaughterhouse.
  Part I:
  Box reference I.8.: Provide the code of territory as appearing in Part 1 of Annex I to Regulation (EU) No 206/2010.
  Box reference I.13.: The assembly centre, if any, must fulfil the conditions for its approval, as laid down in Part 5 of Annex I to Regulation (EU) No 206/2010.
  Box reference I.15.: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In case of unloading and reloading, the consignor must inform the BIP of entry into the Union.
  Box reference I.23.: For containers or boxes, the container number and the seal number (if applicable) should be included.
  Box reference I.28.: Identification system: The animals must bear:
  An individual number which permits tracing of their premises of origin. Specify the identification system (such as tag, tattoos, brand, chip, transponder),
  An ear tag that includes the ISO code of the exporting country. The individual number must permit tracing of their premises of origin,




  Text of image

  COUNTRY
  Model BOV-X
  II. Health information
  II.a. Certificate reference number
  II.b.
  Box reference I.28.: Species: Select amongst “Bos”, “Bison” and “Bubalus” as appropriate.
  Box reference I.28.: Age: Date of birth (dd/mm/yy).
  Box reference I.28.: Sex (M = male, F = female, C = castrated).
  Box reference I.28.: Breed: select purebred, crossbreed.
  Part II:
  (1) Keep as appropriate
  (2) Only if the animals were born and continuously reared in a country or region categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk and listed as such in Decision 2007/453/EC.
  (3) Only if the country or region of origin is categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk and is listed as such in Decision 2007/453/EC.
  (4) Only if the country or region of origin has not been categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 or has been categorised as a country or region with undetermined BSE risk and listed as such in Decision 2007/453/EC.
  (5) Code of the territory as it appears in Part 1 of Annex I to Regulation (EU) No 206/2010
  (6) Officially tuberculosis/brucellosis-free regions and herds as laid down in Annex A to Directive 64/432/EEC; and enzootic-bovine-leukosis-free regions and herds as laid down in Chapter I of Annex D to Directive 64/432/EEC.
  (6a) Only for officially enzootic-bovine-leukosis-free herds recognised as equivalent to the requirements as laid down in Chapter I of Annex D to Directive 64/432/EEC for the purpose of exports to the EU of live animals according to the model certificate BOV-X from the territory that, in column 6 of Part 1 of Annex I to Regulation (EU) No 206/2010, appears with the entry “IVb” as regards enzootic bovine leukosis.
  (7) Only for a territory that, in column 6 of Part 1 of Annex I to Regulation (EU) No 206/2010, appears with the entry “II”, as regards tuberculosis, “III”, as regards brucellosis, and/or “IVa” as regards enzootic bovine leukosis.
  (8) Tests carried out in accordance with the protocols that, for the disease concerned, are described in Part 6 of Annex I to Regulation (EU) No 206/2010.
  (9) Supplementary guarantees to be provided when required in column 5 “SG” of Part 1 of Annex I to Regulation (EU) No 206/2010, with the entry “A”.
  Tests for bluetongue and for epizootic haemorrhagic disease in accordance with Part 6 of Annex I to Regulation (EU) No 206/2010.
  (10) Date of loading. Imports of these animals shall not be allowed when the animals were loaded either prior to the date of authorisation for exportation to the Union of the third country, territory or part thereof referred to in Boxes I.7 and I.8, or during a period where restrictive measures have been adopted by the Union against imports of these animals from this third country, territory or part thereof.
  (11) When required by the EU Member State of destination or Switzerland, in accordance with Decision 2004/558/EC and in accordance with the Agreement between the Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132).
  Official veterinarian
  Name (in capital letters):
  Qualification and title:
  Date:
  Signature:’

  Stamp: |
| --- | --- |

(b)

In Part 2, Model BOV-X is replaced by the following:

‘
  Model BOV-X

Part I: Details of dispached consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

I.12.

I.13. Place of loading

Address

Approval number

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification

Documentary references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

01.02

I.20. Quantity

I.21.

I.22. Number of packages

I.23. Seal/Container No

I.24.

I.25. Commodities certified for:

Breeding

Fattening

I.26.

I.27. For import or admission into the EU

I.28. Identification of the commodities

Species

(scientific name)

Breed

Identification system

Identification number

Age

Sex

Part II: Certification

COUNTRY

Model BOV-X

II. Health information

II.a. Certificate reference number

II.b.

II.1. Public Health Attestation

I, the undersigned official veterinarian, hereby certify, that the animals described in this certificate:

II.1.1. come from holdings which have been free from any official prohibition on health grounds, for the past 42 days in the case of brucellosis, for the past 30 days in the case of anthrax and for the past 6 months in the case of rabies, and, have not been in contact with animals from holdings which did not satisfy these conditions;

II.1.2. have not received:

any stilbene or thyrostatic substances,

oestrogenic, androgenic, gestagenic or β-agonist substances for purposes other than therapeutic or zootechnic treatment (as defined in Directive 96/22/EC),

II.1.3. with regard to bovine spongiform encephalopathy (BSE):

(1) (2) either [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;

(b) if there have been BSE indigenous cases in the country concerned, the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]

(1) (3) or [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;

(b) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]

(1) (4) or [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;

(b) the animals were born at least 2 years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]

II.2. Animal Health attestation:

I, the undersigned official veterinarian, hereby certify, that the animals described above meet the following requirements:

II.2.1. they come from the territory with code: ... (5) which, at the date of issuing this certificate:

(1) either [(a) has been free for 24 months from foot-and-mouth disease, for 12 months from rinderpest, bluetongue, Rift valley fever, contagious bovine pleuropneumonia, lumpy skin disease and epizootic haemorrhagic disease, and for 6 months from vesicular stomatitis,]

(1) or [(a) (i) has been free for 12 months from rinderpest, bluetongue, Rift valley fever, contagious bovine pleuropneumonia, lumpy skin disease and epizootic haemorrhagic disease, and for 6 months from vesicular stomatitis,

(ii) has been considered free from foot-and-mouth disease since ... (dd/mm/yyyy), without having had cases/outbreaks after that date, and authorised to export these animals by Commission Decision / /EU, of ... (dd/mm/yyyy),]

and (b) where during the last 12 months, no vaccination against these diseases has been carried out and imports of domestic cloven-hoofed animals vaccinated against these diseases are not permitted;

II.2.2. they have remained in the territory described under point II.2.1. since birth, or for at least the last 6 months before dispatch to the Union and without contact with imported cloven-hoofed animals for the last 30 days;

COUNTRY

Model BOV-X

II. Health information

II.a. Certificate reference No

II.b.

II.2.3. they have remained since birth or at least 40 days before dispatch in the holding(s) of origin described under box reference I.11.:

(a) in and around which, in an area with a 150 km radius, there has been no case/outbreak of bluetongue and epizootic haemorrhagic disease during the previous 60 days,

(b) in and around which, in an area with a 10 km radius, there has been no case/outbreak of the other diseases referred to in point II.2.1. during the previous 40 days;

II.2.4. they are not animals to be killed under a national programme for the eradication of diseases, nor have they been vaccinated against the diseases referred to under point II.2.1.;

II.2.5. they come from herds that are not restricted under the national legislation pertaining to the eradication of tuberculosis, brucellosis and enzootic bovine leukosis;

II.2.6. they come from herds recognised as officially tuberculosis-free (6);

and (1) (7) either [come from a region which is recognised as officially tuberculosis-free (6);]

(1) or [have been subjected to an intradermal tuberculin test (8) carried out with negative results within the past 30 days before dispatch to the Union;]

(1) or [are less than 6 weeks old;]

[II.2.7. they have not been vaccinated against brucellosis and come from herds recognised as officially brucellosis-free (6);

and (1) (7) either [come from a region which is recognised as officially brucellosis-free (6),]

(1) or [have been subjected to at least one test for bovine brucellosis (8) carried out on samples taken within the past 30 days before dispatch to the Union,]

(1) or [are less than 12 months old,]

(1) or [are castrated males of any age,]

(1) either [II.2.8A. they come from herds included in an official system for the control of enzootic bovine leukosis, and in which there has been no evidence either clinical or as a result of a laboratory test of this disease during the past 2 years,]

(1) or [II.2.8A. they come from herds recognised as officially enzootic-bovine-leukosis-free (6) (6a),]

and (1) (7) either [come from a region which is recognised as officially enzootic-bovine-leukosis-free (6);]

(1) or [have been subjected to an individual test for enzootic bovine leukosis (8) carried out with negative result on samples taken within the past 30 days before dispatch to the Union;]

(1) or [are less than 12 months old;]

(1) (9) [II.2.8B. they have reacted negatively to a serological test for the detection of antibody for bluetongue and epizootic haemorrhagic disease, carried out on two occasions on samples of blood taken at the beginning of the isolation/quarantine period and at least 28 days later, on ... (dd/mm/yyyy) and on ... (dd/mm/yyyy), the second of which must have been taken within 10 days before export;]

II.2.9 they are/were (1) dispatched from their holding(s) of origin, without passing through any market:

(1) either [directly to the Union,]

(1) or [to the officially authorised assembly centre described under box reference I.13. situated within the territory described under point II.2.1.,]

and, until dispatched to the Union:

(a) they did not come in contact with other cloven-hoofed animals not complying with the health requirements as described in this certificate,

COUNTRY

Model BOV-X

II. Health information

II.a. Certificate reference No

II.b.

(b) they were not at any place where, or around which, within a 10 km radius, during the previous 30 days there has been a case/outbreak of any of the diseases referred to in point II.2.1.;

II.2.10. any transport vehicles or containers in which they were loaded were cleaned and disinfected before loading with an officially authorised disinfectant;

II.2.11. they were examined by an official veterinarian within 24 hours of loading and showed no clinical sign of disease;

II.2.12. they have been loaded for dispatch to the Union on (dd/mm/yyyy) (10) in the means of transport described under box reference I.15. above that were cleaned and disinfected before loading with an officially authorised disinfectant and so constructed that faeces, urine, litter or fodder could not flow or fall out of the vehicle or container during transportation.

II.3. Animal transport attestation

I, the undersigned official veterinarian, hereby certify, that the animals described above have been treated before and at the time of loading in accordance with the relevant provisions of Regulation (EC) No 1/2005, in particular as regards watering and feeding, and they are fit for the intended transport.

(1) (11) [II.4. Specific requirements

II.4.1. According to official information, no clinical or pathological evidence of infectious bovine rhinotracheitis (IBR) has been recorded in the holding(s) of origin referred to in box reference I.11., for the last 12 months;

II.4.2. the animals referred to in box reference I.28.:

(a) have been isolated in accommodation approved by the competent authority for the last 30 days immediately prior to dispatch for export,

(b) have been subjected to a serological test for IBR on sera taken at least 21 days after entry into isolation, with negative results, and all animals in isolation have also given negative results to this test, and

(c) have not been vaccinated against IBR.]

Notes

This certificate is meant for domestic bovine animals (including Bubalus and Bison species and their cross-breeds) intended for breeding and/or production.

After importation the animals must be conveyed without delay to the holding of destination where they shall remain for a minimum period of 30 days before further movement outside the holding, except in the case of a dispatch to a slaughterhouse.

Part I:

Box reference I.8.: Provide the code of territory as appearing in Part 1 of Annex I to Regulation (EU) No 206/2010.

Box reference I.13.: The assembly centre, if any, must fulfil the conditions for its approval, as laid down in Part 5 of Annex I to Regulation (EU) No 206/2010.

Box reference I.15.: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In case of unloading and reloading, the consignor must inform the BIP of entry into the Union.

Box reference I.23.: For containers or boxes, the container number and the seal number (if applicable) should be included.

Box reference I.28.: Identification system: The animals must bear:

An individual number which permits tracing of their premises of origin. Specify the identification system (such as tag, tattoos, brand, chip, transponder),

An ear tag that includes the ISO code of the exporting country. The individual number must permit tracing of their premises of origin,

COUNTRY

Model BOV-X

II. Health information

II.a. Certificate reference number

II.b.

Box reference I.28.: Species: Select amongst “Bos”, “Bison” and “Bubalus” as appropriate.

Box reference I.28.: Age: Date of birth (dd/mm/yy).

Box reference I.28.: Sex (M = male, F = female, C = castrated).

Box reference I.28.: Breed: select purebred, crossbreed.

Part II:

(1) Keep as appropriate

(2) Only if the animals were born and continuously reared in a country or region categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk and listed as such in Decision 2007/453/EC.

(3) Only if the country or region of origin is categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk and is listed as such in Decision 2007/453/EC.

(4) Only if the country or region of origin has not been categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 or has been categorised as a country or region with undetermined BSE risk and listed as such in Decision 2007/453/EC.

(5) Code of the territory as it appears in Part 1 of Annex I to Regulation (EU) No 206/2010

(6) Officially tuberculosis/brucellosis-free regions and herds as laid down in Annex A to Directive 64/432/EEC; and enzootic-bovine-leukosis-free regions and herds as laid down in Chapter I of Annex D to Directive 64/432/EEC.

(6a) Only for officially enzootic-bovine-leukosis-free herds recognised as equivalent to the requirements as laid down in Chapter I of Annex D to Directive 64/432/EEC for the purpose of exports to the EU of live animals according to the model certificate BOV-X from the territory that, in column 6 of Part 1 of Annex I to Regulation (EU) No 206/2010, appears with the entry “IVb” as regards enzootic bovine leukosis.

(7) Only for a territory that, in column 6 of Part 1 of Annex I to Regulation (EU) No 206/2010, appears with the entry “II”, as regards tuberculosis, “III”, as regards brucellosis, and/or “IVa” as regards enzootic bovine leukosis.

(8) Tests carried out in accordance with the protocols that, for the disease concerned, are described in Part 6 of Annex I to Regulation (EU) No 206/2010.

(9) Supplementary guarantees to be provided when required in column 5 “SG” of Part 1 of Annex I to Regulation (EU) No 206/2010, with the entry “A”.

Tests for bluetongue and for epizootic haemorrhagic disease in accordance with Part 6 of Annex I to Regulation (EU) No 206/2010.

(10) Date of loading. Imports of these animals shall not be allowed when the animals were loaded either prior to the date of authorisation for exportation to the Union of the third country, territory or part thereof referred to in Boxes I.7 and I.8, or during a period where restrictive measures have been adopted by the Union against imports of these animals from this third country, territory or part thereof.

(11) When required by the EU Member State of destination or Switzerland, in accordance with Decision 2004/558/EC and in accordance with the Agreement between the Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132).

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:’

Stamp:

| (c) | In Part 6, the protocol for Brucellosis (Brucella abortus) (BRL) is replaced by the following:

  ‘
  Brucellosis (Brucella abortus) (BRL)

  The serum agglutination test, complement fixation test, buffered brucella antigen test, enzyme-linked immunosorbent assays (ELISA) and fluorescence polarisation assay (FPA) shall be carried out according to Annex C to Directive 64/432/EEC.’ |
| --- | --- |

(c)

In Part 6, the protocol for Brucellosis (Brucella abortus) (BRL) is replaced by the following:

Brucella abortus

‘
  Brucellosis (Brucella abortus) (BRL)

Brucellosis (Brucella abortus

The serum agglutination test, complement fixation test, buffered brucella antigen test, enzyme-linked immunosorbent assays (ELISA) and fluorescence polarisation assay (FPA) shall be carried out according to Annex C to Directive 64/432/EEC.’

| (2) | In Annex II, Part 1, is replaced by the following:

  ‘PART 1

  List of third countries, territories and parts thereof
   (1)













  ISO code and name of third country | Code of Territory | Description of third country, territory or part thereof | Veterinary certificate | Specific conditions | Closing date (2) | Opening date (3) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Model(s) | SG |
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
| AL – Albania | AL-0 | Whole country | — | | | | |
| AR – Argentina | AR-0 | Whole country | EQU | | | | |
| AR-1 | The Provinces of: | Buenos Aires, |

(2)

In Annex II, Part 1, is replaced by the following:

‘PART 1

List of third countries, territories and parts thereof
   (1)

List of third countries, territories and parts thereof

1

ISO code and name of third country

Code of Territory

Description of third country, territory or part thereof

Veterinary certificate

Specific conditions

Closing date (2)

2

Opening date (3)

3

Model(s)

SG

1

2

3

4

5

6

7

8

AL – Albania

AL-0

Whole country

—

AR – Argentina

AR-0

Whole country

EQU

AR-1

The Provinces of:

Buenos Aires,

| | Catamarca, |
| --- | --- |

Catamarca,

| | Corrientes (except the departments of Berón de Astrada, Capital, Empedrado, General Paz, Itati, Mbucuruyá, San Cosme and San Luís del Palmar) |
| --- | --- |

Corrientes (except the departments of Berón de Astrada, Capital, Empedrado, General Paz, Itati, Mbucuruyá, San Cosme and San Luís del Palmar)

| | Entre Ríos, |
| --- | --- |

Entre Ríos,

| | La Rioja, |
| --- | --- |

La Rioja,

| | Mendoza, |
| --- | --- |

Mendoza,

| | Misiones, |
| --- | --- |

Misiones,

| | Part of Neuquén (excluding territory included in AR-4), |
| --- | --- |

Part of Neuquén (excluding territory included in AR-4),

| | Part of Río Negro (excluding territory included in AR-4), |
| --- | --- |

Part of Río Negro (excluding territory included in AR-4),

| | San Juan, |
| --- | --- |

San Juan,

| | San Luis, |
| --- | --- |

San Luis,

| | Santa Fe, |
| --- | --- |

Santa Fe,

| | Tucuman, |
| --- | --- |

Tucuman,

| | Cordoba, |
| --- | --- |

Cordoba,

| | La Pampa, |
| --- | --- |

La Pampa,

| | Santiago del Estero, |
| --- | --- |

Santiago del Estero,

| | Chaco, Formosa, Jujuy and Salta, excluding the buffer area of 25 Km from the border with Bolivia and Paraguay that extends from the Santa Catalina District in the Province of Jujuy, to the Laishi District in the Province of Formosa |
| --- | --- |

Chaco, Formosa, Jujuy and Salta, excluding the buffer area of 25 Km from the border with Bolivia and Paraguay that extends from the Santa Catalina District in the Province of Jujuy, to the Laishi District in the Province of Formosa

BOV

A

1

18 March 2005

RUF

A

1

1 December 2007

RUW

A

1

1 August 2010

AR-2

Chubut, Santa Cruz and Tierra del Fuego

BOV, OVI, RUW, RUF

1 March 2002

AR-3

Corrientes: the departments of Berón de Astrada, Capital, Empedrado, General Paz, Itati, Mbucuruyá, San Cosme and San Luís del Palmar

BOV

RUF

A

1

1 December 2007

AR-4

Part of Río Negro (except: in Avellaneda the zone located north of the Provincial road 7 and east of the Provincial road 250, in Conesa the zone located east of the Provincial road 2, in El Cuy the zone located north of the Provincial road 7 from its intersection with the Provincial road 66 to the border with the Department of Avellaneda, and in San Antonio the zone located east of the Provincial roads 250 and 2)

Part of Neuquén (except in Confluencia the zone located east of the Provincial road 17, and in Picun Leufú the zone located east of the Provincial road 17)

BOV, OVI, RUW, RUF

1 August 2008

AU – Australia

AU-0

Whole country

BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW

BA – Bosnia and Herzegovina

BA-0

Whole country

—

BH – Bahrain

BH-0

Whole country

—

BR – Brazil

BR-0

Whole country

EQU

BR-1

State of Minas Gerais

State of Espírito Santo;

State of Goiás;

State of Mato Grosso

State of Rio Grande Do Sul, State of Mato Grosso Do Sul (except for the designated high surveillance zone of 15 Km from the external borders in the municipalities of Porto Murtinho, Caracol, Bela Vista, Antônio João, Ponta Porã, Aral Moreira, Coronel Sapucaia, Paranhos, Sete Quedas, Japorã, and Mundo Novo and the designated high surveillance zone in the municipalities of Corumbá and Ladário).

BOV

A and H

1

1 December 2008

BR-2

State of Santa Catarina

BOV

A and H

1

31 January 2008

BR-3

States of Paraná and São Paulo

BOV

A and H

1

1 August 2008

BW – Botswana

BW-0

Whole country

EQU, EQW

BW-1

The veterinary disease control zones 3c, 4b, 5, 6, 8, 9 and 18

BOV, OVI, RUF, RUW

F

1

1 December 2007

BW-2

The veterinary disease control zones 10, 11, 13 and 14

BOV, OVI, RUF, RUW

F

1

7 March 2002

BW-3

The veterinary disease control zone 12

BOV, OVI, RUF, RUW

F

1

20 October 2008

20 January 2009

BW-4

The veterinary disease control zone 4a, except the intensive surveillance buffer zone of 10 km along the boundary with the foot and mouth disease vaccination zone and wildlife management areas

BOV

F

1

[insert the date of application of present Regulation]

BY – Belarus

BY-0

Whole country

—

BZ – Belize

BZ-0

Whole country

BOV, EQU

CA – Canada

CA-0

Whole country

BOV, OVI, POR, EQU, SUF, SUW, RUF, RUW

G

CH – Switzerland

CH-0

Whole country

*

CL – Chile

CL-0

Whole country

BOV, OVI, POR, EQU, RUF, RUW, SUF

CN – China

CN-0

Whole country

—

CO – Colombia

CO-0

Whole country

EQU

CR – Costa Rica

CR-0

Whole country

BOV, EQU

CU – Cuba

CU-0

Whole country

BOV, EQU

DZ – Algeria

DZ-0

Whole country

—

ET – Ethiopia

ET-0

Whole country

—

FK – Falkland Islands

FK-0

Whole country

BOV, OVI, EQU

GL – Greenland

GL-0

Whole country

BOV, OVI, EQU, RUF, RUW

GT – Guatemala

GT-0

Whole country

BOV, EQU

HK – Hong Kong

HK-0

Whole country

—

HN – Honduras

HN-0

Whole country

BOV, EQU

HR – Croatia

HR-0

Whole country

BOV, OVI, EQU, RUF, RUW

IL – Israel

IL-0

Whole country

—

IN – India

IN-0

Whole country

—

IS – Iceland

IS-0

Whole country

BOV, OVI, EQU, RUF, RUW

KE – Kenya

KE-0

Whole country

—

MA – Morocco

MA-0

Whole country

EQU

ME – Montenegro

ME-0

Whole country

BOV, OVI, EQU

MG – Madagascar

MG-0

Whole country

—

MK – Former Yugoslav Republic of Macedonia (4)

4

MK-0

Whole country

OVI, EQU

MU – Mauritius

MU-0

Whole country

—

MX – Mexico

MX-0

Whole country

BOV, EQU

NA – Namibia

NA-0

Whole country

EQU, EQW

NA-1

South of the cordon fences which extend from Palgrave Point in the west to Gam in the east

BOV, OVI,RUF, RUW

F and J

1

NC – New Caledonia

NC-0

Whole country

BOV, RUF, RUW

NI – Nicaragua

NI-0

Whole country

—

NZ – New Zealand

NZ-0

Whole country

BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW

PA – Panama

PA-0

Whole country

BOV, EQU

PY – Paraguay

PY-0

Whole country

EQU

PY-1

Whole country except for the designated high surveillance zone of 15 Km from the external borders

BOV

A

1

1 August 2008

RS – Serbia (5)

5

RS-0

Whole country

BOV, OVI, EQU

RU – Russia

RU-0

Whole country

—

RU-1

Region of Murmansk, Yamolo-Nenets autonomous area

RUF

SV – El Salvador

SV-0

Whole country

—

SZ – Swaziland

SZ-0

Whole country

EQU, EQW

SZ-1

Area west of the “red line” fences which extends northwards from the river Usutu to the frontier with South Africa west of Nkalashane,

BOV, RUF, RUW

F

1

SZ-2

The veterinary foot and mouth disease surveillance and vaccination control areas as gazetted as a Statutory Instrument under legal notice number 51 of 2001

BOV, RUF, RUW

F

1

4 August 2003

TH – Thailand

TH-0

Whole country

—

TN – Tunisia

TN-0

Whole country

—

TR – Turkey

TR-0

Whole country

—

TR-1

The provinces of Amasya, Ankara, Aydin, Balikesir, Bursa, Cankiri, Corum, Denizli, Izmir, Kastamonu, Kutahya, Manisa, Usak, Yozgat and Kirikkale

EQU

UA – Ukraine

UA-0

Whole country

—

US – United States

US-0

Whole country

BOV, OVI, POR, EQU,SUF, SUW, RUF, RUW

G

UY – Uruguay

UY-0

Whole country

EQU

BOV,

A

1

1 November 2001

OVI

A

1

ZA – South Africa

ZA-0

Whole country

EQU, EQW

ZA-1

The whole country except:

| — | the part of the foot-and-mouth disease control area situated in the veterinary regions of Mpumalanga and Northern provinces, in the district of Ingwavuma of the veterinary region of Natal and in the border area with Botswana east of longitude 28°, and, |
| --- | --- |

—

the part of the foot-and-mouth disease control area situated in the veterinary regions of Mpumalanga and Northern provinces, in the district of Ingwavuma of the veterinary region of Natal and in the border area with Botswana east of longitude 28°, and,

| — | the district of Camperdown, in the province of KwaZulu-Natal, |
| --- | --- |

—

the district of Camperdown, in the province of KwaZulu-Natal,

BOV, OVI, RUF, RUW

F

1

ZW – Zimbabwe

ZW-0

Whole country

—

| * | = | Requirements as in accordance with the Agreement between the European Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132). |
| --- | --- | --- |
| — | = | No certificates are laid down and fresh meat imports are prohibited (except for those species where indicated in the line comprising the entry for the whole country). |

*

=

Requirements as in accordance with the Agreement between the European Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132).

—

=

No certificates are laid down and fresh meat imports are prohibited (except for those species where indicated in the line comprising the entry for the whole country).

“1”   Category restrictions:

“1”

Category restrictions:

No offal is authorised for introduction into the Union (except, in the case of bovine species, diaphragm and masseter muscles).‘

---

(1)  Without prejudice to specific certification requirements provided for in Union agreements with third countries.

1

(2)  Meat from animals slaughtered on or before the date set out in column 7 may be imported into the Union for 90 days from that date. Consignments carried on vessels on the high seas may be imported into the Union if certified before the date set out in column 7 for 40 days from that date.(N.B.: no date in column 7 means that there are no time restrictions).

2

(3)  Only meat from animals slaughtered on or after the date set out in column 8 may be imported into the Union (no date in column 8 means that there are no time restrictions).

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 which is at present under international administration pursuant to United Nations Security Council Resolution 1244 of 10 June 1999

5

---

| 18.2.2011 | EN | Official Journal of the European Union | L 44/21 |
| --- | --- | --- | --- |

18.2.2011

EN

Official Journal of the European Union

L 44/21

---

COMMISSION REGULATION (EU) No 145/2011

of 17 February 2011

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 18 February 2011.

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

Done at Brussels, 17 February 2011.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 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 | IL | 120,5 |
| JO | 87,5 |
| MA | 71,9 |
| TN | 102,0 |
| TR | 102,5 |
| ZZ | 96,9 |
| 0707 00 05 | JO | 204,2 |
| MK | 171,4 |
| TR | 186,3 |
| ZZ | 187,3 |
| 0709 90 70 | MA | 46,9 |
| TR | 92,0 |
| ZZ | 69,5 |
| 0805 10 20 | EG | 59,2 |
| IL | 66,4 |
| MA | 57,4 |
| TN | 45,1 |
| TR | 69,7 |
| ZZ | 59,6 |
| 0805 20 10 | IL | 145,2 |
| MA | 95,9 |
| TR | 79,6 |
| ZZ | 106,9 |
| 0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90 | CN | 66,4 |
| IL | 111,7 |
| JM | 80,9 |
| MA | 112,9 |
| TR | 63,9 |
| ZZ | 87,2 |
| 0805 50 10 | EG | 62,1 |
| MA | 49,3 |
| TR | 58,5 |
| ZZ | 56,6 |
| 0808 10 80 | CA | 91,1 |
| CM | 53,6 |
| CN | 83,6 |
| MK | 51,2 |
| US | 110,9 |
| ZZ | 78,1 |
| 0808 20 50 | AR | 120,7 |
| CL | 61,3 |
| CN | 54,1 |
| US | 117,3 |
| ZA | 105,4 |
| ZZ | 91,8 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

IL

120,5

JO

87,5

MA

71,9

TN

102,0

TR

102,5

ZZ

96,9

0707 00 05

JO

204,2

MK

171,4

TR

186,3

ZZ

187,3

0709 90 70

MA

46,9

TR

92,0

ZZ

69,5

0805 10 20

EG

59,2

IL

66,4

MA

57,4

TN

45,1

TR

69,7

ZZ

59,6

0805 20 10

IL

145,2

MA

95,9

TR

79,6

ZZ

106,9

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

CN

66,4

IL

111,7

JM

80,9

MA

112,9

TR

63,9

ZZ

87,2

0805 50 10

EG

62,1

MA

49,3

TR

58,5

ZZ

56,6

0808 10 80

CA

91,1

CM

53,6

CN

83,6

MK

51,2

US

110,9

ZZ

78,1

0808 20 50

AR

120,7

CL

61,3

CN

54,1

US

117,3

ZA

105,4

ZZ

91,8

---

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

---

| 18.2.2011 | EN | Official Journal of the European Union | L 44/23 |
| --- | --- | --- | --- |

18.2.2011

EN

Official Journal of the European Union

L 44/23

---

COMMISSION REGULATION (EU) No 146/2011

of 17 February 2011

fixing the minimum selling price for skimmed milk powder for the 16th individual invitation to tender within the tendering procedure opened by Regulation (EU) No 447/2010

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 43(j), in conjunction with Article 4 thereof,

Whereas:

| (1) | Commission Regulation (EU) No 447/2010 (2) has opened the sales of skimmed milk powder by a tendering procedure, in accordance with the conditions provided for in Commission Regulation (EU) No 1272/2009 of 11 December 2009 laying down common detailed rules for the implementation of Council Regulation (EC) No 1234/2007 as regards buying-in and selling of agricultural products under public intervention (3). |
| --- | --- |

(1)

Commission Regulation (EU) No 447/2010 (2) has opened the sales of skimmed milk powder by a tendering procedure, in accordance with the conditions provided for in Commission Regulation (EU) No 1272/2009 of 11 December 2009 laying down common detailed rules for the implementation of Council Regulation (EC) No 1234/2007 as regards buying-in and selling of agricultural products under public intervention (3).

| (2) | In the light of the tenders received in response to individual invitations to tender, the Commission should fix a minimum selling price or should decide not to fix a minimum selling price, in accordance with Article 46(1) of Regulation (EU) No 1272/2009. |
| --- | --- |

(2)

In the light of the tenders received in response to individual invitations to tender, the Commission should fix a minimum selling price or should decide not to fix a minimum selling price, in accordance with Article 46(1) of Regulation (EU) No 1272/2009.

| (3) | In the light of the tenders received for the 16th individual invitation to tender, a minimum selling price should be fixed. |
| --- | --- |

(3)

In the light of the tenders received for the 16th individual invitation to tender, a minimum selling price should be fixed.

| (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

For the 16th individual invitation to tender for selling of skimmed milk powder within the tendering procedure opened by Regulation (EU) No 447/2010, in respect of which the time limit for the submission of tenders expired on 15 February 2011, the minimum selling price for skimmed milk powder shall be EUR 250,10/100 kg.

Article 2

This Regulation shall enter into force on 18 February 2011.

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

Done at Brussels, 17 February 2011.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 126, 22.5.2010, p. 19.

2

(3)  
  OJ L 349, 29.12.2009, p. 1.

3

---

| 18.2.2011 | EN | Official Journal of the European Union | L 44/24 |
| --- | --- | --- | --- |

18.2.2011

EN

Official Journal of the European Union

L 44/24

---

COMMISSION REGULATION (EU) No 147/2011

of 17 February 2011

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, 17 February 2011.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

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

1

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

2

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

3

---

ANNEX

to the Commission Regulation of 17 February 2011 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 | 129,8 | 0 | AR |
| 0207 12 90 | Fowls of the species Gallus domesticus, not cut in pieces, presented as “65 % chickens”, frozen | 134,5 | 0 | BR |
| 143,6 | 0 | AR |
| 0207 14 10 | Fowls of the species Gallus domesticus, boneless cuts, frozen | 212,1 | 26 | BR |
| 263,1 | 11 | AR |
| 320,8 | 0 | CL |
| 0207 14 50 | Fowls of the species Gallus domesticus, breasts, frozen | 179,2 | 10 | BR |
| 0207 25 10 | Turkeys, not cut in pieces, presented as “80 % turkeys”, frozen | 208,9 | 0 | BR |
| 0207 27 10 | Turkeys, boneless cuts, frozen | 273,5 | 7 | BR |
| 390,3 | 0 | CL |
| 0408 91 80 | Eggs, not in shell, dried | 421,8 | 0 | AR |
| 1602 32 11 | Preparations of fowls of the species Gallus domesticus, uncooked | 267,0 | 6 | BR |
| 3502 11 90 | Egg albumin, dried | 541,4 | 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

129,8

0

AR

0207 12 90

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

134,5

0

BR

143,6

0

AR

0207 14 10

Fowls of the species Gallus domesticus, boneless cuts, frozen

212,1

26

BR

263,1

11

AR

320,8

0

CL

0207 14 50

Fowls of the species Gallus domesticus, breasts, frozen

179,2

10

BR

0207 25 10

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

208,9

0

BR

0207 27 10

Turkeys, boneless cuts, frozen

273,5

7

BR

390,3

0

CL

0408 91 80

Eggs, not in shell, dried

421,8

0

AR

1602 32 11

Preparations of fowls of the species Gallus domesticus, uncooked

267,0

6

BR

3502 11 90

Egg albumin, dried

541,4

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

---

| 18.2.2011 | EN | Official Journal of the European Union | L 44/26 |
| --- | --- | --- | --- |

18.2.2011

EN

Official Journal of the European Union

L 44/26

---

COMMISSION REGULATION (EU) No 148/2011

of 17 February 2011

amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EU) No 867/2010 for the 2010/11 marketing year

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 951/2006 of 30 June 2006 laying down detailed rules for the implementation of Council Regulation (EC) No 318/2006 as regards trade with third countries in the sugar sector (2), and in particular Article 36(2), second subparagraph, second sentence thereof,

Whereas:

| (1) | The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2010/11 marketing year are fixed by Commission Regulation (EU) No 867/2010 (3). These prices and duties have been last amended by Commission Regulation (EU) No 141/2011 (4). |
| --- | --- |

(1)

The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2010/11 marketing year are fixed by Commission Regulation (EU) No 867/2010 (3). These prices and duties have been last amended by Commission Regulation (EU) No 141/2011 (4).

| (2) | The data currently available to the Commission indicate that those amounts should be amended in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006, |
| --- | --- |

(2)

The data currently available to the Commission indicate that those amounts should be amended in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006,

HAS ADOPTED THIS REGULATION:

Article 1

The representative prices and additional duties applicable to imports of the products referred to in Article 36 of Regulation (EC) No 951/2006, as fixed by Regulation (EU) No 867/2010 for the 2010/11, marketing year, are hereby amended as set out in the Annex hereto.

Article 2

This Regulation shall enter into force on 18 February 2011.

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

Done at Brussels, 17 February 2011.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

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

1

(2)  
  OJ L 178, 1.7.2006, p. 24.

2

(3)  
  OJ L 259, 1.10.2010, p. 3.

3

(4)  
  OJ L 43, 17.2.2011, p. 29.

4

---

ANNEX

Amended representative prices and additional import duties applicable to white sugar, raw sugar and products covered by CN code 1702 90 95 from 18 February 2011

| (EUR) |
| --- |
| CN code | Representative price per 100 kg net of the product concerned | Additional duty per 100 kg net of the product concerned |
| 1701 11 10  (1) | 57,94 | 0,00 |
| 1701 11 90  (1) | 57,94 | 0,00 |
| 1701 12 10  (1) | 57,94 | 0,00 |
| 1701 12 90  (1) | 57,94 | 0,00 |
| 1701 91 00  (2) | 55,44 | 0,84 |
| 1701 99 10  (2) | 55,44 | 0,00 |
| 1701 99 90  (2) | 55,44 | 0,00 |
| 1702 90 95  (3) | 0,55 | 0,19 |

(EUR)

CN code

Representative price per 100 kg net of the product concerned

Additional duty per 100 kg net of the product concerned

1701 11 10  (1)

57,94

0,00

1701 11 90  (1)

57,94

0,00

1701 12 10  (1)

57,94

0,00

1701 12 90  (1)

57,94

0,00

1701 91 00  (2)

55,44

0,84

1701 99 10  (2)

55,44

0,00

1701 99 90  (2)

55,44

0,00

1702 90 95  (3)

0,55

0,19

---

(1)  For the standard quality defined in point III of Annex IV to Regulation (EC) No 1234/2007.

(2)  For the standard quality defined in point II of Annex IV to Regulation (EC) No 1234/2007.

(3)  Per 1 % sucrose content.

---