# Official Journal L 44/2017

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 44 |
| | |
| English edition | Legislation | Volume 6022 February 2017 |

ISSN 1977-0677

Official Journal

of the European Union

L 44

English edition

Legislation

Volume 6022 February 2017

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2017/307 of 21 February 2017 concerning the authorisation of dry grape extract of Vitis vinifera spp. vinifera as a feed additive for all animal species except for dogs (
  1
  ) | 1 |
| | | Commission Implementing Regulation (EU) 2017/308 of 21 February 2017 establishing the standard import values for determining the entry price of certain fruit and vegetables | 6 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2017/307 of 21 February 2017 concerning the authorisation of dry grape extract of Vitis vinifera spp. vinifera as a feed additive for all animal species except for dogs (
  1
  )

Vitis vinifera

vinifera

1

1

Commission Implementing Regulation (EU) 2017/308 of 21 February 2017 establishing the standard import values for determining the entry price of certain fruit and vegetables

6

| | |
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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. |
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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

| 22.2.2017 | EN | Official Journal of the European Union | L 44/1 |
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22.2.2017

EN

Official Journal of the European Union

L 44/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/307

of 21 February 2017

concerning the authorisation of dry grape extract of Vitis vinifera spp. vinifera as a feed additive for all animal species except for dogs

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | Dry grape extract of Vitis vinifera spp. vinifera, was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

Dry grape extract of Vitis vinifera spp. vinifera, was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of dry grape extract of Vitis vinifera spp. vinifera as feed additives for all animal species except for dogs. The applicant requested that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of dry grape extract of Vitis vinifera spp. vinifera as feed additives for all animal species except for dogs. The applicant requested that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 April 2016 (3) that, under the proposed conditions of use in feed, the substance concerned does not have adverse effect on animal health, human health or the environment. The Authority further concluded that the function of dry grape extract of Vitis vinifera spp. vinifera in feed is similar to that on food. The Authority has already concluded that for food dry grape extract of Vitis vinifera spp. vinifera is efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 April 2016 (3) that, under the proposed conditions of use in feed, the substance concerned does not have adverse effect on animal health, human health or the environment. The Authority further concluded that the function of dry grape extract of Vitis vinifera spp. vinifera in feed is similar to that on food. The Authority has already concluded that for food dry grape extract of Vitis vinifera spp. vinifera is efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed.

| (5) | Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content, and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials. |
| --- | --- |

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content, and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

| (6) | The Authority concluded that in the absence of data on user safety, dry grape extract of Vitis vinifera spp. vinifera should be considered as potentially hazardous to the respiratory tract, skin and eyes and as a skin and respiratory sensitiser. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(6)

The Authority concluded that in the absence of data on user safety, dry grape extract of Vitis vinifera spp. vinifera should be considered as potentially hazardous to the respiratory tract, skin and eyes and as a skin and respiratory sensitiser. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (7) | The assessment of the substance concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. |
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(7)

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

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substance concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
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(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substance concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

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

(9)

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

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 14 October 2017 in accordance with the rules applicable before 14 March 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 14 March 2018 in accordance with the rules applicable before 14 March 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 14 March 2019 in accordance with the rules applicable before 14 March 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 3

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 21 February 2017.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2016;14(6):4476.

3

EFSA Journal

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff with a moisture content of 12 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b485 | — | Dry grape extract | Additive composition

  Dry grape extract of Vitis vinifera spp. vinifera


  Characterisation of the active substance

  Mixture of seed and skin extract as defined by the Council of Europe (1)







  — | ≥ 80 % polyphenols expressed as catechin equivalent, |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b485

—

Dry grape extract

Additive composition

Dry grape extract of Vitis vinifera spp. vinifera

Characterisation of the active substance

Mixture of seed and skin extract as defined by the Council of Europe (1)

—

≥ 80 % polyphenols expressed as catechin equivalent,

| — | ≥ 60 % proanthocyanidins, |
| --- | --- |

—

≥ 60 % proanthocyanidins,

| — | ≥ 0,75 %: anthocyanins and anthocyanidins, |
| --- | --- |

—

≥ 0,75 %: anthocyanins and anthocyanidins,

| — | ≤ 10 % water content. |
| --- | --- |

—

≤ 10 % water content.

CoE No 485

CAS number 85594-37-2

FEMA 4045

Method of analysis
   (2)

For the determination of dry grape extract in the feed additive:

| — | high performance liquid chromatography coupled to UV detection (HPLC-UV) for the identification of gallic acid as the phytomarker, and |
| --- | --- |

—

high performance liquid chromatography coupled to UV detection (HPLC-UV) for the identification of gallic acid as the phytomarker, and

| — | spectrophotometry at 280 nm for the quantification of total polyphenols content, expressed as catechin equivalent. |
| --- | --- |

—

spectrophotometry at 280 nm for the quantification of total polyphenols content, expressed as catechin equivalent.

All animal species except dogs

—

—

—

| 1. | Dry grape extract of Vitis vinifera spp. vinifera may be placed on the market and used as an additive consisting of a preparation. |
| --- | --- |

1.

Dry grape extract of Vitis vinifera spp. vinifera may be placed on the market and used as an additive consisting of a preparation.

| 2. | The additive shall be incorporated into the feed in the form of a premixture. |
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2.

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

| 3. | In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. |
| --- | --- |

3.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 4. | The recommended maximum content of the active substance shall be 100 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

4.

The recommended maximum content of the active substance shall be 100 mg/kg of complete feedingstuff with a moisture content of 12 %.

| 5. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 100 mg/kg’. |
| --- | --- |

5.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 100 mg/kg’.

| 6. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 100 mg/kg. |
| --- | --- |

6.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 100 mg/kg.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
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7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

14 March 2027

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(1)  Natural sources of flavourings — Report No 2 (2007)

(2)  Details of the methods of analysis are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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| 22.2.2017 | EN | Official Journal of the European Union | L 44/6 |
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22.2.2017

EN

Official Journal of the European Union

L 44/6

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/308

of 21 February 2017

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, 21 February 2017.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General

Directorate-General for Agriculture and Rural Development

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

1

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

2

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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 | 75,4 |
| MA | 114,7 |
| TN | 194,0 |
| TR | 102,8 |
| ZZ | 121,7 |
| 0707 00 05 | MA | 79,2 |
| TR | 181,8 |
| ZZ | 130,5 |
| 0709 91 00 | EG | 113,1 |
| ZZ | 113,1 |
| 0709 93 10 | MA | 53,7 |
| TR | 176,0 |
| ZZ | 114,9 |
| 0805 10 22 , 0805 10 24 , 0805 10 28 | EG | 45,1 |
| IL | 75,0 |
| MA | 44,6 |
| TN | 50,4 |
| TR | 68,8 |
| ZA | 196,8 |
| ZZ | 80,1 |
| 0805 21 10 , 0805 21 90 , 0805 29 00 | EG | 88,5 |
| IL | 124,0 |
| JM | 101,3 |
| MA | 92,8 |
| TR | 82,8 |
| ZZ | 97,9 |
| 0805 22 00 | IL | 112,1 |
| MA | 101,0 |
| ZZ | 106,6 |
| 0805 50 10 | EG | 82,4 |
| TR | 76,5 |
| ZZ | 79,5 |
| 0808 10 80 | CN | 128,2 |
| US | 115,7 |
| ZZ | 122,0 |
| 0808 30 90 | CL | 156,1 |
| CN | 95,4 |
| ZA | 126,8 |
| ZZ | 126,1 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

IL

75,4

MA

114,7

TN

194,0

TR

102,8

ZZ

121,7

0707 00 05

MA

79,2

TR

181,8

ZZ

130,5

0709 91 00

EG

113,1

ZZ

113,1

0709 93 10

MA

53,7

TR

176,0

ZZ

114,9

0805 10 22 , 0805 10 24 , 0805 10 28

EG

45,1

IL

75,0

MA

44,6

TN

50,4

TR

68,8

ZA

196,8

ZZ

80,1

0805 21 10 , 0805 21 90 , 0805 29 00

EG

88,5

IL

124,0

JM

101,3

MA

92,8

TR

82,8

ZZ

97,9

0805 22 00

IL

112,1

MA

101,0

ZZ

106,6

0805 50 10

EG

82,4

TR

76,5

ZZ

79,5

0808 10 80

CN

128,2

US

115,7

ZZ

122,0

0808 30 90

CL

156,1

CN

95,4

ZA

126,8

ZZ

126,1

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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’.

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