# Official Journal L 148/2016

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 148 |
| | |
| English edition | Legislation | Volume 594 June 2016 |

ISSN 1977-0677

Official Journal

of the European Union

L 148

English edition

Legislation

Volume 594 June 2016

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2016/885 of 3 June 2016 amending Regulation (EU) No 37/2010 as regards the substance eprinomectin (
  1
  ) | 1 |
| | | Commission Implementing Regulation (EU) 2016/886 of 3 June 2016 establishing the standard import values for determining the entry price of certain fruit and vegetables | 4 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2016/887 of 2 June 2016 amending Annex II to Decision 2007/777/EC as regards the list of third countries or parts thereof from which the introduction into the Union of meat products and treated stomachs, bladders and intestines is authorised
  (notified under document C(2016) 3215)

   (
  1
  ) | 6 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2016/885 of 3 June 2016 amending Regulation (EU) No 37/2010 as regards the substance eprinomectin (
  1
  )

1

1

Commission Implementing Regulation (EU) 2016/886 of 3 June 2016 establishing the standard import values for determining the entry price of certain fruit and vegetables

4

DECISIONS

*

Commission Implementing Decision (EU) 2016/887 of 2 June 2016 amending Annex II to Decision 2007/777/EC as regards the list of third countries or parts thereof from which the introduction into the Union of meat products and treated stomachs, bladders and intestines is authorised
  (notified under document C(2016) 3215)

   (
  1
  )

(notified under document C(2016) 3215)

1

6

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

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(1)   Text with EEA relevance

1

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

EN

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

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

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II Non-legislative acts

REGULATIONS

| 4.6.2016 | EN | Official Journal of the European Union | L 148/1 |
| --- | --- | --- | --- |

4.6.2016

EN

Official Journal of the European Union

L 148/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/885

of 3 June 2016

amending Regulation (EU) No 37/2010 as regards the substance ‘eprinomectin’

(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 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,

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

Whereas:

| (1) | Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (hereinafter ‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation. |
| --- | --- |

(1)

Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (hereinafter ‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation.

| (2) | Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin. |
| --- | --- |

(2)

Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.

| (3) | Eprinomectin is already included in that table as an allowed substance, for bovine, ovine and caprine species, applicable to muscle, fat, liver, kidney and milk. The provisional MRLs for that substance set out for ovine and caprine species, applicable to muscle, fat, liver, kidney and milk expire on 30 June 2016. |
| --- | --- |

(3)

Eprinomectin is already included in that table as an allowed substance, for bovine, ovine and caprine species, applicable to muscle, fat, liver, kidney and milk. The provisional MRLs for that substance set out for ovine and caprine species, applicable to muscle, fat, liver, kidney and milk expire on 30 June 2016.

| (4) | Additional data was provided and assessed by the Committee for Medicinal Products for Veterinary Use, who recommended that the provisional MRLs for eprinomectin in ovine and caprine species should be set as definitive. |
| --- | --- |

(4)

Additional data was provided and assessed by the Committee for Medicinal Products for Veterinary Use, who recommended that the provisional MRLs for eprinomectin in ovine and caprine species should be set as definitive.

| (5) | According to Article 5 of Regulation (EC) No 470/2009, the European Medicines Agency (hereinafter ‘EMA’) is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species. |
| --- | --- |

(5)

According to Article 5 of Regulation (EC) No 470/2009, the European Medicines Agency (hereinafter ‘EMA’) is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.

| (6) | The EMA has considered that the extrapolation of the existing entry for eprinomectin to all ruminants is appropriate. |
| --- | --- |

(6)

The EMA has considered that the extrapolation of the existing entry for eprinomectin to all ruminants is appropriate.

| (7) | Regulation (EU) No 37/2010 should therefore be amended accordingly. |
| --- | --- |

(7)

Regulation (EU) No 37/2010 should therefore be amended accordingly.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, |
| --- | --- |

(8)

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

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 3 June 2016.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 152, 16.6.2009, p. 11.

1

(2)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

2

---

ANNEX

In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘eprinomectin’ is replaced by the following:

| Pharmacologically active Substance | Marker residue | Animal Species | MRL | Target Tissues | Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009) | Therapeutic Classification |
| --- | --- | --- | --- | --- | --- | --- |
| ‘Eprinomectin | Eprinomectin B1a | All ruminants | 50 μg/kg
  250 μg/kg
  1 500 μg/kg
  300 μg/kg
  20 μg/kg | Muscle
  Fat
  Liver
  Kidney
  Milk | NO ENTRY | Antiparasitic agents/Agents against endo- and ectoparasites’ |

Pharmacologically active Substance

Marker residue

Animal Species

MRL

Target Tissues

Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)

Therapeutic Classification

‘Eprinomectin

Eprinomectin B1a

All ruminants

50 μg/kg

250 μg/kg

1 500 μg/kg

300 μg/kg

20 μg/kg

Muscle

Fat

Liver

Kidney

Milk

NO ENTRY

Antiparasitic agents/Agents against endo- and ectoparasites’

---

| 4.6.2016 | EN | Official Journal of the European Union | L 148/4 |
| --- | --- | --- | --- |

4.6.2016

EN

Official Journal of the European Union

L 148/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/886

of 3 June 2016

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 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),

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

Whereas:

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

(1)

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

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

Done at Brussels, 3 June 2016.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 347, 20.12.2013, p. 671.

1

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

2

---

ANNEX

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

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | IL | 259,4 |
| MA | 132,1 |
| TR | 66,0 |
| ZZ | 152,5 |
| 0707 00 05 | TR | 99,6 |
| ZZ | 99,6 |
| 0709 93 10 | TR | 132,0 |
| ZZ | 132,0 |
| 0805 50 10 | AR | 180,9 |
| MA | 160,2 |
| TR | 75,0 |
| ZA | 183,6 |
| ZZ | 149,9 |
| 0808 10 80 | AR | 119,5 |
| BR | 112,6 |
| CL | 127,6 |
| CN | 160,9 |
| NZ | 147,6 |
| PE | 111,0 |
| US | 170,4 |
| ZA | 108,5 |
| ZZ | 132,3 |
| 0809 10 00 | TR | 239,8 |
| ZZ | 239,8 |
| 0809 29 00 | TR | 565,0 |
| US | 721,3 |
| ZZ | 643,2 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

IL

259,4

MA

132,1

TR

66,0

ZZ

152,5

0707 00 05

TR

99,6

ZZ

99,6

0709 93 10

TR

132,0

ZZ

132,0

0805 50 10

AR

180,9

MA

160,2

TR

75,0

ZA

183,6

ZZ

149,9

0808 10 80

AR

119,5

BR

112,6

CL

127,6

CN

160,9

NZ

147,6

PE

111,0

US

170,4

ZA

108,5

ZZ

132,3

0809 10 00

TR

239,8

ZZ

239,8

0809 29 00

TR

565,0

US

721,3

ZZ

643,2

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(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.

---

DECISIONS

| 4.6.2016 | EN | Official Journal of the European Union | L 148/6 |
| --- | --- | --- | --- |

4.6.2016

EN

Official Journal of the European Union

L 148/6

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COMMISSION IMPLEMENTING DECISION (EU) 2016/887

of 2 June 2016

amending Annex II to Decision 2007/777/EC as regards the list of third countries or parts thereof from which the introduction into the Union of meat products and treated stomachs, bladders and intestines is authorised

(notified under document C(2016) 3215)

(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 point 1 of Article 8, point (4) of Article 8 and Article 9(4)(c) thereof,

Whereas:

| (1) | Commission Decision 2007/777/EC (2) lays down, inter alia, the conditions for the introduction into the Union of consignments of certain meat products and of treated stomachs, bladders and intestines which have undergone one of the treatments laid down in Part 4 of Annex II thereto (‘the commodities’), including a list of third countries or parts thereof from which the introduction into the Union of the commodities is authorised. |
| --- | --- |

(1)

Commission Decision 2007/777/EC (2) lays down, inter alia, the conditions for the introduction into the Union of consignments of certain meat products and of treated stomachs, bladders and intestines which have undergone one of the treatments laid down in Part 4 of Annex II thereto (‘the commodities’), including a list of third countries or parts thereof from which the introduction into the Union of the commodities is authorised.

| (2) | Where third countries are regionalised for the purpose of being listed in Decision 2007/777/EC the regionalised parts of their territory are listed in Part 1 of Annex II thereto. |
| --- | --- |

(2)

Where third countries are regionalised for the purpose of being listed in Decision 2007/777/EC the regionalised parts of their territory are listed in Part 1 of Annex II thereto.

| (3) | Part 2 of Annex II to Decision 2007/777/EC sets out the list of third countries or parts thereof which are authorised for the introduction into the Union of the commodities, provided that they have undergone a relevant treatment referred to in that Part of Annex II. Those treatments are aimed at eliminating certain animal health risks linked to the specific commodities. Part 4 of that Annex sets out a non-specific treatment ‘A’ and specific treatments ‘B’ to ‘F’ listed in descending order of severity of the animal health risk linked to the specific commodity. |
| --- | --- |

(3)

Part 2 of Annex II to Decision 2007/777/EC sets out the list of third countries or parts thereof which are authorised for the introduction into the Union of the commodities, provided that they have undergone a relevant treatment referred to in that Part of Annex II. Those treatments are aimed at eliminating certain animal health risks linked to the specific commodities. Part 4 of that Annex sets out a non-specific treatment ‘A’ and specific treatments ‘B’ to ‘F’ listed in descending order of severity of the animal health risk linked to the specific commodity.

| (4) | Argentina and Brazil have requested to be listed in Part 2 of Annex II to Decision 2007/777/EC as authorised for the introduction of commodities of domestic bovine animals from all parts of their territory that are already authorised for introduction into the Union of fresh meat of the same species of animals as described in Part 1 of Annex II to Commission Regulation (EU) No 206/2010 (3). |
| --- | --- |

(4)

Argentina and Brazil have requested to be listed in Part 2 of Annex II to Decision 2007/777/EC as authorised for the introduction of commodities of domestic bovine animals from all parts of their territory that are already authorised for introduction into the Union of fresh meat of the same species of animals as described in Part 1 of Annex II to Commission Regulation (EU) No 206/2010 (3).

| (5) | As the commodities to be introduced into the Union must undergo a treatment set out in Part 4 of Annex II to Decision 2007/777/EC, the description of the regionalised territories of Argentina and Brazil for the commodities referred to as AR-1, AR-2 and BR-2 in Part 1 of Annex II to Decision 2007/777/EC, should be amended in order to be aligned with the regionalisation applied to Argentina and Brazil for the introduction into the Union of fresh meat of domestic bovine animals as described in Part 1 of Annex II to Regulation (EU) No 206/2010. |
| --- | --- |

(5)

As the commodities to be introduced into the Union must undergo a treatment set out in Part 4 of Annex II to Decision 2007/777/EC, the description of the regionalised territories of Argentina and Brazil for the commodities referred to as AR-1, AR-2 and BR-2 in Part 1 of Annex II to Decision 2007/777/EC, should be amended in order to be aligned with the regionalisation applied to Argentina and Brazil for the introduction into the Union of fresh meat of domestic bovine animals as described in Part 1 of Annex II to Regulation (EU) No 206/2010.

| (6) | In addition, Brazil has requested a new area of Brazil to be authorised for the introduction into the Union of commodities which have been obtained from domestic bovine animals and subjected to the specific treatment ‘B’ set out in Part 4 of Annex II to Decision 2007/777/EC. Considering that that area is part of the territory of Brazil which is recognised as free of foot-and-mouth disease (FMD) (4) without vaccination by the World Organisation for Animal Health (the OIE) and the application of the specific treatment ‘B’ to the commodities concerned, that area should be authorised for the introduction of the commodities into the Union. |
| --- | --- |

(6)

In addition, Brazil has requested a new area of Brazil to be authorised for the introduction into the Union of commodities which have been obtained from domestic bovine animals and subjected to the specific treatment ‘B’ set out in Part 4 of Annex II to Decision 2007/777/EC. Considering that that area is part of the territory of Brazil which is recognised as free of foot-and-mouth disease (FMD) (4) without vaccination by the World Organisation for Animal Health (the OIE) and the application of the specific treatment ‘B’ to the commodities concerned, that area should be authorised for the introduction of the commodities into the Union.

| (7) | Therefore that part of the territory of Brazil should be listed in Part 1 of Annex II to Decision 2007/777/EC as BR-4. Consignments of commodities obtained from domestic bovine animals from the part of Brazil described as BR-4, should be authorised for introduction into the Union, subject to the specific treatment ‘B’ as set out in Part 4 of that Annex and therefore BR-4 should be listed in Part 2 of that Annex. |
| --- | --- |

(7)

Therefore that part of the territory of Brazil should be listed in Part 1 of Annex II to Decision 2007/777/EC as BR-4. Consignments of commodities obtained from domestic bovine animals from the part of Brazil described as BR-4, should be authorised for introduction into the Union, subject to the specific treatment ‘B’ as set out in Part 4 of that Annex and therefore BR-4 should be listed in Part 2 of that Annex.

| (8) | Parts 1 and 2 of Annex II to Decision 2007/777/EC should therefore be amended accordingly. |
| --- | --- |

(8)

Parts 1 and 2 of Annex II to Decision 2007/777/EC should therefore be amended accordingly.

| (9) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(9)

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

HAS ADOPTED THIS DECISION:

Article 1

Annex II to Decision 2007/777/EC is amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 2 June 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

---

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

1

(2)  Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries and repealing Decision 2005/432/EC (OJ L 312, 30.11.2007, p. 49).

2

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

3

(4)  http://www.oie.int/en/animal-health-in-the-world/official-disease-status/fmd/list-of-fmd-free-members/

4

---

ANNEX

Annex II to Decision 2007/777/EC is amended as follows:

| (1) | In Part 1, the entries for Argentina and Brazil are replaced by the following:








  ‘Argentina | AR | 01/2004 | Whole country. |
| --- | --- | --- | --- | --- |
| AR-1 | 02/2016 | The territories defined in AR-1 and AR-3 in Part 1 of Annex II to Regulation (EU) No 206/2010. |
| AR-2 | 02/2016 | The territories defined in AR-2 in Part 1 of Annex II to Regulation (EU) No 206/2010. |
| Brazil | BR | 01/2004 | Whole country. |
| BR-1 | 01/2005 | States of Rio Grande do Sul, Santa Catarina, Paraná, São Paulo and Mato Grosso do Sul. |
| BR-2 | 02/2016 | The territories defined in BR-1, BR-2, BR-3 and BR-4 in Part 1 of Annex II to Regulation (EU) No 206/2010. |
| BR-3 | 01/2005 | States of Goiás, Minas Gerais, Mato Grosso, Mato Grosso do Sul, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo. |
| BR-4 | 01/2016 | Distrito Federal, States of Acre, Rondônia, Pará, Tocantins, Maranhão, Piauí, Bahia, Ceará, Rio Grande do Norte, Paraíba, Pernambuco, Alagoas and Sergipe.’ |

(1)

In Part 1, the entries for Argentina and Brazil are replaced by the following:

‘Argentina

AR

01/2004

Whole country.

AR-1

02/2016

The territories defined in AR-1 and AR-3 in Part 1 of Annex II to Regulation (EU) No 206/2010.

AR-2

02/2016

The territories defined in AR-2 in Part 1 of Annex II to Regulation (EU) No 206/2010.

Brazil

BR

01/2004

Whole country.

BR-1

01/2005

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

BR-2

02/2016

The territories defined in BR-1, BR-2, BR-3 and BR-4 in Part 1 of Annex II to Regulation (EU) No 206/2010.

BR-3

01/2005

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

BR-4

01/2016

Distrito Federal, States of Acre, Rondônia, Pará, Tocantins, Maranhão, Piauí, Bahia, Ceará, Rio Grande do Norte, Paraíba, Pernambuco, Alagoas and Sergipe.’

| (2) | In Part 2, the following row is added to the entry for Brazil:


















  ‘Brazil BR-4 | B | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(2)

In Part 2, the following row is added to the entry for Brazil:

‘Brazil BR-4

B

XXX

XXX

XXX

XXX

XXX

XXX

XXX

XXX

XXX

XXX

XXX

XXX’

---