# L_2017013EN.01024201.xml

| 17.1.2017 | EN | Official Journal of the European Union | L 13/242 |
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17.1.2017

EN

Official Journal of the European Union

L 13/242

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/64

of 14 December 2016

concerning the authorisation of glycyrrhizic acid ammoniated as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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

Whereas:

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

Glycyrrhizic acid ammoniated 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 an existing product, 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 glycyrrhizic acid ammoniated as a feed additive for all animal species. 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. |
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(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 glycyrrhizic acid ammoniated as a feed additive for all animal species. 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 11 December 2014 (3) that, under the proposed conditions of use in feed glycyrrhizic acid ammoniated does not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of glycyrrhizic acid ammoniated in feed is similar to that on food. The Authority has already concluded that for food glycyrrhizic acid ammoniated is efficacious, as it increases the food smell or palatability. The Authority could not conclude on the safety of for glycyrrhizic acid ammoniated used in water for drinking. However, that substance can be used within a compound feed subsequently administered via water. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 December 2014 (3) that, under the proposed conditions of use in feed glycyrrhizic acid ammoniated does not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of glycyrrhizic acid ammoniated in feed is similar to that on food. The Authority has already concluded that for food glycyrrhizic acid ammoniated is efficacious, as it increases the food smell or palatability. The Authority could not conclude on the safety of for glycyrrhizic acid ammoniated used in water for drinking. However, that substance can be used within a compound feed subsequently administered via water.

| (5) | Restrictions and conditions should be provided for to allow better control. For practical reasons and taking into account the re-evaluation performed by the Authority, maximum recommended contents should be set up. Where the recommended content of the additive in complete feedingstuff is exceeded, the identification number of the feed additive, its name and added amount should be indicated on the label of premixtures, compound feeds and feed materials. |
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(5)

Restrictions and conditions should be provided for to allow better control. For practical reasons and taking into account the re-evaluation performed by the Authority, maximum recommended contents should be set up. Where the recommended content of the additive in complete feedingstuff is exceeded, the identification number of the feed additive, its name and added amount 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 glycyrrhizic acid ammoniated should be considered as irritant to skin, eyes and respiratory tract and as a skin 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. |
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(6)

The Authority concluded that in the absence of data on user safety glycyrrhizic acid ammoniated should be considered as irritant to skin, eyes and respiratory tract and as a skin 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 glycyrrhizic acid ammoniated 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 glycyrrhizic acid ammoniated 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 glycyrrhizic acid ammoniated, 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 glycyrrhizic acid ammoniated, 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, |
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(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 a feed additive 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 6 August 2017 in accordance with the rules applicable before 6 February 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 6 February 2018 in accordance with the rules applicable before 6 February 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 6 February 2019 in accordance with the rules applicable before 6 February 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, 14 December 2016.

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 2015;13(1):3971.

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 |
| 2b16060 | — | Glycyrrhizic acid ammoniated | Additive composition

  Glycyrrhizic acid ammoniated

  Characterisation of the active substance

  Glycyrrhizic acid ammoniated
  Produced by extraction of species of the genus Glycyrrhiza
  Purity: min. 98-100 % (on dry matter basis)
  Chemical formula: C42H65O16

  CAS No 53956-04-0
  FLAVIS No: 16.060

  Method of analysis
   (1)

  For the identification of the glycyrrhizic acid ammoniated in the feed additive and flavouring premixtures:
  European Pharmacopeian 6.0, method 01/2008:1772. | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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

2b16060

—

Glycyrrhizic acid ammoniated

Additive composition

Glycyrrhizic acid ammoniated

Characterisation of the active substance

Glycyrrhizic acid ammoniated

Produced by extraction of species of the genus Glycyrrhiza

Purity: min. 98-100 % (on dry matter basis)

Chemical formula: C42H65O16

CAS No 53956-04-0

FLAVIS No: 16.060

Method of analysis
   (1)

For the identification of the glycyrrhizic acid ammoniated in the feed additive and flavouring premixtures:

European Pharmacopeian 6.0, method 01/2008:1772.

All animal species

—

—

—

1.

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

| 2. | In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. |
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2.

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

| 3. | 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 %:






  — | 0,3 mg/kg for chickens for fattening and laying hens, |
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3.

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 %:

—

0,3 mg/kg for chickens for fattening and laying hens,

| — | 1 mg/kg for other species and categories.’ |
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—

1 mg/kg for other species and categories.’

| 4. | 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:






  — | 0,3 mg/kg for chickens for fattening and laying hens, |
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4.

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:

—

0,3 mg/kg for chickens for fattening and laying hens,

| — | 1 mg/kg for other species and categories. |
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—

1 mg/kg for other species and categories.

| 5. | 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 eyes 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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5.

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 eyes 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.

6 February 2027

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(1)  Details of the analytical methods 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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